Vitamin B12 - From illegal substance to "hero"

I received this email from Dr. Jonathan V. Wright's Nutrition and Healing Health e-Tips on Thursday morning:

One frightening morning in 1991, Dr. Wright's Tahoma Clinic was violently raided. Two dozen heavily armed thugs blew past the patient peacefully waiting in her wheelchair and kicked down the door.

In a nightmare scenario straight out of an action movie, clinic staff members were held at gunpoint for two hours before being ejected from the building. The gang then went on to destroy medical equipment and ransack the clinic.

These thugs weren't criminals getting their kicks. The situation was far worse. They were sent by the FDA to harass Dr. Wright, all because he was giving his patients access to...not illegal drugs, not phony prescriptions. Oh no--his clinic was attacked because he was prescribing preservative-free B vitamins!

Now, twenty years later, the mainstream press is breathlessly celebrating the very substance that was the target of the 1991 raid!

Unbelievable? Well...probably not. I mean, we are talking about the FDA here.

Late last month, The New York Times broke the story that vitamin B12--one of those very vitamins that was at the root of Dr. Wright's receptionist having a gun put to her face--is good for your brain. Imagine that!

In the article, they detail the story of a woman who, at the age of 85, started becoming more and more confused. She was diagnosed with early Alzheimer's disease, and was prescribed Aricept. Her daughter says the drug made things worse, and no wonder--Aricept's (donepezil) potential side effects include depression, nervousness, changes in behavior, and...confusion (yeah, that's a head-scratcher for me, too).

Thankfully, someone thought to test her B12 levels. They found they were quite low, and her doctor started her on weekly injections. Her daughter was thrilled at how quickly her mother's condition started improving. But she had to wonder--why aren't B12 levels checked more regularly?

Excellent question! I'm sure the answer has nothing to do with Aricept being a cash cow and B12 being a lowly vitamin that isn't covered in dollar signs. No, nothing at all.

As we age, our bodies just can't absorb B12 from food as effectively as they once could. And the symptoms of B12 deficiency can easily be misdiagnosed or written off as a normal part of aging (muscle weakness, incontinence, low blood pressure, cognitive problems, and so on).

This is far from the first time I've told you about the cognitive protection offered by B-vitamins. But we certainly haven't seen such coverage in the mainstream--and of course they're acting like it's a breakthrough discovery--despite the fact that, 20 years ago, it was all pitchforks and torches for a doctor who dared prescribe B to his patients. Sheesh.

Of course, it's nice to see people spreading the word about potent natural healers, but the fact that it took so long for such a powerful vitamin to get some recognition makes me want to bang my head against the wall.

I mean, just imagine how many more people could have put the brakes on their cognitive decline without the dangerous side effects of "miracle" drugs if the mainstream would have been just a little more open to what Nature has to offer.

Instead, we've been handed dangerous drugs--or the excuse that memory loss is just a sad fact of aging--for years. Meanwhile, doctors who know the truth about Nature's healers--doctors like our own Dr. Wright--are forced into nightmarish scenarios that put their livelihood, and perhaps even their very lives, at risk.

It's not too late to harness the power of B12 and the other B-vitamins. Injections are often the best way to correct a B12 deficiency. Dr. Wright has also recommended taking a good quality "B- complex 50" or "B-complex 100" supplement (which also includes B12 in addition to the other important members of the "B" family) each day. Of course, before starting any vitamin or supplement regimen, you should consult a doctor skilled in natural medicine.

Yours in good health,

Christine O'Brien

P.S. Vitamin B12 is just one of the many natural secrets to living younger. Become one of the few "in the know," and you'll be on the fast track to looking, thinking, and feeling better than you have in YEARS. Click here to learn more.

Should we trust our restaurants to provide us safe food?

Our bodies are probably a whole lot more resilient (and resistant to disease) than most of us are willing to give them credit for.

Just yesterday I read an article that referenced some of the results of poor hygiene practices engaged in (or, rather, hygiene practices not engaged in) by many employees at different fast food joints.

It didn't discuss any of the rather startling chemical ingredients added to so many of the even supposedly "healthy" foods available at Americans' favorite restaurants.

It didn't reference the lousy--I mean, truly horrific--feed practices followed by the CAFOs (Concentrated Animal Feed[ing] Operations; often likened to the inhumane and horrifying Nazi concentration/death camps of the 1930s and early '40s) that supply most of the meat used in the restaurants we frequent. I mean, were you aware that a Pfizer Pharmaceuticals subsidiary has been including arsenic--a known carcinogen--in its chicken feed for years? (How did they justify this adulteration? On the grounds that the arsenic never found its way into the human food chain because the chickens pooped it out before it became incorporated within their meat. Of course, now they tell us that, "Oh! Sorry about that! Hmmmm. I guess it is in the chicken meat, after all!" . . . Oh. . . . Except . . . now wait a second! Where did all that chicken poop go? . . . No! You've got to be kidding me! . . . Nope. The majority of the chicken litter went into cow feed. . . . So did the FDA really think we were being protected from Pfizer's arsenic-laced chicken feed after all?)

But this morning, I came across another article about how the FDA refuses to promote health with respect to the ubiquitous use of antibiotics in animal feed. Such enforcement would be "too expensive and resource intensive," you see. It took them 12 1/2 years finally, to respond to a citizen petition seeking rescension of the FDA's approval of subtherapeutic uses of antibiotics in livestock feed.

The response to petitioners says,

Although we share your concern about the use of medically important antimicrobial drugs in food-producing animals for growth promotion and feed efficiency indications (i.e., production uses), . . . FDA is denying your petition.

Why? Two reasons (and, of course, remember that it has taken the FDA 12 1/2 years to come to this conclusion!):

1. "[B]ecause there is a formal evidentiary process that must be followed before new animal drug approvals may be withdrawn. In order to withdraw a new animal drug’s approval, FDA must follow a number of statutory requirements, such as providing the sponsor of the new animal drug with notice that the Agency proposes to withdraw approval of the drug and an opportunity for a formal evidentiary hearing on the matter. FDA cannot withdraw approval of a new animal drug until the legally-mandated process is complete. . . .
   
   "FDA must provide the drug’s sponsor with notice and an opportunity for a formal administrative hearing ("NOOH").
   
   "Because no hearings have been held with respect to the animal drugs at issue in the Citizen Petition, and because the Commissioner has not made any final determination about whether grounds for withdrawal under section 5 12(e) of the FD&C Act have been satisfied, the relief requested in the Citizen Petition cannot be granted at this time."
    
2. "Recognizing that the process of reviewing safety information for antimicrobial drugs approved before 2003, and pursuing withdrawal proceedings in some cases, would take many years and would impose significant resource demands on the Agency, in June 2010, FDA proposed a different strategy to promote the judicious use of medically important antimicrobials in food-producing animals in a draft guidance entitled, 'The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals' draft Guidance for Industry #209 ('draft GFT 9209'). . . .
   
   "Draft GFI #209 proposes two principles aimed at ensuring the judicious use of medically important antimicrobials in food-producing animals. The first principle set out in the draft guidance is that the use of medically important antimicrobial drugs in foodproducing animals should be limited to those uses that are considered necessary for assuring animal health. As set out in the draft guidance, FDA does not consider production uses of such drugs to be necessary for assuring animal health. . . . [I.e., "We agree that the use of these antibiotics is not necessary for assuring animal health. So these drugs really ought not to be used for promoting growth. But . . ." --JAH] The second principle set out in the draft guidance is that the use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation. This principle speaks to the need for the scientific and clinical training of licensed veterinarians in assuring that medically important antimicrobials are used in a judicious manner. . . . [So, again, "We agree with you. However . . ." --JAH]
   
   "Based on feedback this Agency has received following the issuance of draft GFI #209, FDA believes that the animal pharmaceutical industry is generally responsive to the prospect of working cooperatively with the Agency to implement the principles recommended in draft GFI #209. FDA intends to work with sponsors who approach FDA and are interested in working cooperatively with the Agency to phase out production uses of medically important antimicrobials and to transition medically important antimicrobials currently approved for over-the-counter use in food-producing animals to a marketing status that involves veterinary oversight."

Really? The pharmaceutical industry is "generally responsive" to the prospect of phasing out the use of this huge source of revenue because it is concerned for the health of human beings? When the FDA itself, in 1977, found that adding antibiotics to animal feed undeniably causes antibiotic resistance? Is Big Pharma any more interested in human health than Big Tobacco?

Somehow, I doubt it!

(By the way, if you want a virtually identical response--only six and a half years in the making--to a virtually identical petition, you can find it here.)

But getting back to the original point of this post: Sadly, there are precious few restaurants to which you can go where they will feed you all-natural, truly open-range, grass-fed, grass-finished meats.

And I will confess that I haven't yet weaned myself from my favorite hamburgers at certain hamburger joints. But the more I learn about our food, the more I am moving toward that kind of lifestyle. Who wants to be filling their bodies with the kind of junk the FDA, Big Pharma, and Industrial Agriculture want to push upon us?

PS: For the original news release on the FDA decision, please see PR Newsline's FDA Denies Citizen Petitions on Animal Antibiotics.

Federal government to extinguish naturopathic remedies?

This story has been brewing for weeks, now. No, actually, for months. But I didn't want to sound the alarm too quickly. And, honestly, I haven't been able to work my way through the proposed FDA "guidance" to form my own opinion about just how problematic the proposed regulations really are. (And it is possible that's indicative, right there, about just how problematic they are. On the other hand, if you are a professional/commercial manufacturer of supplements, it does seem reasonable that you should go through a certain level of "proof" for your product before unleashing it on the market.

Anyway.

The doctors (Rowen, Mercola and others) are saying it's now time to act.

Dr. Robert Rowen writes:

Do you enjoy your HD cable television set or your iPhone? How would you feel if the government stepped in to tell you that you can't use these anymore? Instead, you have to return to the archaic analogue bulky phones of more than 17 years ago, or switch back to just network TV with its rabbit-ear antenna. Would you sit and take it? I hope not!

Well, that's exactly what's going to happen to your supplements at the hands of our rulers if we don't act and act decisively. The FDA has sat and watched (not always peacefully) the supplement industry make incredible progress for 17 years.

After 17 years with a near-perfect safety record (ephedra being one of the only exceptions), the FDA has announced a new set of guidelines for supplements. These new guidelines will roll back the availability of supplements to those that were sold in 1994, and in the forms [in which] they were sold at that time.

In other words, these guidelines will roll back a decade of innovation, discovery, and improvements. We have discovered incredible combinations of supplements, better delivery methods, improved methods of extraction, etc. But your rulers say they know better than science and you. They plan to remove the majority of supplements that you well know, including fish oil, high-potency vitamin C products, new bioflavonoids (such as resveratrol), and combination products.

In order to get these non-patentable formulations to you, the supplement companies will have to comply with costs and regulations that will drive them out of business.

It's no wonder this is happening. Big Pharma's in big trouble. Its products not only don't work, but they also kill and maim people. Profitable drugs are going off patent, which will incur bazillions in lost revenue. Pharma's products simply cover symptoms with chemicals, resulting in yet more symptoms, needing yet more treatment. [See my post that includes a doctor's summary of just one woman's experience of this. --JAH] This is great for the drug companies. But it's horrific for you and your wallet.

Big Pharma knows it's selling snake oil. And it knows the public is getting wise to its ponzi scheme. So if you can't beat the competition with a superior product, as a true free market system should provide, then buy the government and destroy your competition with regulations. Big Pharma has the billions of dollars it takes to buy and control government. The FDA says it's doing all this to protect you. But the reality is the FDA is doing this to protect Big Pharma.

It's not just the government and FDA that Pharma own and runs. It's also the medical journals that are supposed to publish information that can help save your life. In light of the FDA's move to wipe out supplements, I'd like to give a nod to cardiologist Stephen Sinatra, MD. Two recent articles in mainstream medicine admitted that conventional medicine has NOTHING to offer for a serious and growing heart problem - diastolic dysfunction. Dr. Sinatra wrote the Archives of Internal Medicine a letter (in his capacity as a cardiologist) to the editor in response to the two reports pointing out his effective approach using the "awesome foursome" for heart: D-ribose, CoQ10, magnesium, and L-carnitine, the very supplements I recommend here.

You'd think that the journal would snap up a treatment for a major disorder. This disorder affects millions worldwide, has no drug treatment, and can lead to serious heart failure. Add to this that it's a disorder often caused by statins!

But, no, he quickly got a form letter of rejection. Sinatra noted that previous medical research found that the more pharmaceutical advertising a journal publishes, the less reporting on supplements it does. And, what these journals report is generally negative. [See Sinatra's newsletter for the original source of Rowen's story, here. --JAH]

Now please consider that there is NO drug that cures any disease (except perhaps antibiotics for infection). Consider that nutrition insufficiency is 100% proven as a major cause of disease. It's also 100% proven to help or cure certain conditions, like the above heart condition. So, is there any wonder who owns the FDA and who has every interest in controlling the disease maintenance system of America?

Here's what you need to do today:

Complaining to the FDA will likely do little. Leopards don't change their spots. Neither will those who are working actively FOR Pharma. Please contact your U.S. elected officials. You can find their contact information at www.usa.gov/Contact/Elected.shtml.

Please call their offices AND write letters demanding that they rein in the FDA to protect your rights to the supplements you choose (not supplements based on the knowledge of two decades ago). There is already enough protection written into law for the FDA to move on anything found unsafe. We don't need to wipe out an entire industry at this time of economic hardship. We don't need to wipe out your means to maintain and regain your health, at a time when "symptom suppression" costs are skyrocketing. We need to empower people to keep well.

My publisher Garret Wood has a far more detailed story that you can read here. Please read it thoroughly and join me in my continuing efforts to totally wrest our medical freedoms from draconian government interventions. Please act NOW to prevent the 200-year-old warnings of Thomas Jefferson and Benjamin Rush from happening.

"Was the government to prescribe to us our medicine and diet, our bodies would be in such keeping as our souls are now." - Thomas Jefferson
"The Constitution of this Republic should make special provision for medical freedom. To restrict the art of healing to one class will constitute the Bastille of medical science. All such laws are un-American and despotic.

...Unless we put medical freedom into the constitution the time will come when medicine will organize into an undercover dictatorship and force people who wish doctors and treatment of their own choice to submit to only what the dictating outfit offers." - Benjamin Rush (famous colonial physician, Founding Father and signer of the Declaration of Independence, 1787).

Yours for better health and medical freedom,

Robert J. Rowen, MD

Food wars: It's us (consumers) v. them (the processors)

Please excuse the occasional scatological language the author uses in The 6 Most Horrifying Lies The Food Industry is Feeding You. The information is solid. And, I hope, will alarm you enough to take action . . . at least to avoid the most egregious offenders. Someone needs to stand up against the processed foods juggernaut.

Ever since I realized I had to begin eating gluten-free, Sarita and I have attempted to become more diligent about reading our food labels (when we buy processed foods).

There are times--when we go out to eat--that we do the equivalent of the two (out of three) "See No Evil, Hear No Evil, Speak No Evil" monkeys. We cover our eyes and ears and simply eat what is put before us . . . as long as they tell us the food is gluten free.

But for everyday eating, we have become ever-more-diligent about reading our labels. Perhaps this article will encourage you to begin doing that, too.

In preparation for some of your label-reading, you can't do much better than The 6 Most Horrifying Lies The Food Industry is Feeding You.

I've known about the top four lies ("Bulls**t Health Claims," "'Free Range' Chickens That Are Crammed Into a Giant Room." "Fake Berries," and "Ammonia-Infused Hamburger"). But I didn't know about Number 5 ("Zombie Orange Juice"--referring to that premium "Not From Concentrate" juice I have loved ever since I first discovered it) or Number 6 ("The Secret Ingredient: Wood").

Rather maddening--no, infuriating--to find out what the FDA permits in our food and to be said or implied about our food--so long as it has been processed.

Even more maddening what they won't permit to be said about natural, unprocessed foods . . . like walnuts and cherries.

Senate passes bill that may jail food makers for speaking honestly about their foods

And now for the so-called "Food Safety Accountability Act." (The last one was called the "Food Safety Modernization Act.")

I got this notice from the Life Extension Foundation yesterday afternoon:

Despite protests from health freedom activists, the Senate passed a bill that enables the FDA to put food makers in jail for ten years!
If enacted by the House of Representatives, this bill would empower the FDA to imprison food makers if they quote findings from peer-reviewed published scientific studies on their websites.

This draconian proposal is concealed in a bill titled the Food Safety Accountability Act (S.216). This bill passed the Senate because it inflicts harsh jail sentences against anyone who knowingly contaminates food for sale. But there already are strong laws to punish anyone who commits this crime, so this bill instead serves the purpose of enriching pharmaceutical interests by censoring what healthy food makers can say about their products.

Drug companies now want to convince your representative that this overreaching law needs to be enacted to further empower the FDA.

The problem is the FDA can proclaim a food as “misbranded” even if the best science in the world is used to describe its biological effects in the body. The fear is the FDA will use the term “misbranded” in the same way it defines “adulterated” in order to jail food makers under the guise that they are selling contaminated food.

The big issue is that if this bill is passed in the House, it gives the FDA legal authority to threaten and coerce small companies into signing crippling consent decrees that will deny consumers access to truthful non-misleading information about natural approaches to protect against age-related disease.

Please tell your representative to OPPOSE the Food Safety Accountability Act (S.216) in its present form. You can do this in a few minutes on our convenient Legislative Action Center on our website.

Before you click through, let me try to affirm, with evidence, the truth of what they are saying about "misbranding." This is the part of the story I have been following for some time and, actually, about which I reported back in October of last year.

The problem: As the publisher of one of the newsletters I receive wrote in February:

FDA bureaucrats . . . last year sent an ominous "warning letter" to Diamond Foods, Inc.

[They] have an issue with the way Diamond referenced scientific and medical studies in their marketing. In essence, the FDA told Diamond Foods, Inc. – Walnuts Are Drugs! Here are some excerpts from the ridiculous letter (emphasis mine):

"...your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use..."

Just to be clear, we're talking about the whole food – walnuts. Not a molecule or derivative or modified extract made from walnuts. It's the same walnuts you find in a fruit cake!

"...your firm's website also contains several additional unauthorized health claims..."

The FDA doesn't have an issue with the validity of the scientific or medical research referenced, such as the benefits of Omega-3 fatty acids found in walnuts. Its issue is that it did not authorize Diamond Foods, Inc. to say so.

"...You should take prompt action to correct these violations. Failure to do so may result in regulatory action... seizure or injunction."

It's Just Walnuts,
Not Illicit Narcotics or Poisons that Harm Consumers!
The FDA is taking on Diamond Foods, Inc. because it was promoting the health benefits of walnuts, nothing more.

• Diamond was not using false statements.
  
• Walnuts are not dangerous to your health (as are many FDA-approved prescription medications, whose side effects and improper administration kill hundreds of thousands of Americans every year).
  
• The scientific and medical research referenced by Diamond was true and accurate.

But because Diamond was promoting health benefits, the FDA claimed that it now has the authority to step in, classify walnuts as drugs, and force Diamond to correct violations or face "regulatory action... seizure or injunction."

There are other examples. I encourage you to read my Follow the money, Part 1 post from last year. Or simply read this brief section from that post:

[L]et me link to a few typical warning letters from the FDA, so you can see how they phrase things.

Check out, for example, this letter to Payson Fruit Growers of Payson, Utah, or to Cherry Lands Best of Appleton, Wisconsin. --Or take a look at any of the dozens of similar "Labeling and Promotional Violations" letters on the FDA website. --October 17, 2005 was a good date for cherry marketers.

As the letters explain, under the Federal Food, Drug, and Cosmetic Act, "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs" and any health claims made for any product "cause [such] product to be a drug."

Because [cherries, walnuts, or whatever food are] not generally recognized as safe and effective when used as labeled, [they are] also . . . new drug[s] as defined in Section 201(p) of the Act [21 U.S.C. 321(p)]. Under Section 505 of the Act (21 U.S .C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).

With all of this as background, then, the Life Extension Foundation urges us to use their Legislative Action Center, a very slick tool for contacting legislators, to, yes, contact our representatives.

I took the standard email letter they have already provided and edited it as follows:

Subject: Please STOP the Food Safety Accountability Act (S.216) from proceeding in the House!

Sir:

I am astonished and dismayed at how the corporate interests of Industrial Agriculture and Big Pharma are taking over policy at the federal level. The so-called Food Safety Accountability Act (S.216) is "just" the most recent example.

Most disturbing: in its present form, this bill refers to the Food, Drug and Cosmetic Act for its definitions of the terms "adulterated" and "misbranded." This enables the FDA to charge food makers with "misbranding" if they make completely true statements about the health properties of a food or food product but have not first acquired FDA permission.

Need some specific examples? There are many. But in case you are unaware, please consider what happened just a few months ago to Diamond Foods, Inc. when Diamond referenced scientific and medical studies in their marketing and on their website.

For their temerity in referencing such studies, the FDA told Diamond (see http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm) that they were obviously promoting the use of an "unapproved drug" and this "unapproved drug," their "walnut products" [whole walnuts!] were being "offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also MISBRANDED under Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use." (Emphasis added.)

Is this ridiculous? I think it is!

Obviously, the FDA had no basis for an issue with the validity of the scientific or medical research referenced, such as the benefits of Omega-3 fatty acids found in walnuts. Its issue was that it did not authorize Diamond Foods, Inc. to communicate about these benefits.

Talk about First Amendment issues!

Oh. Meanwhile? While FDA goes after Diamond for scientifically-backed claims about the healthy nature of their walnuts, a truly healthy food, what do they do about Frito-Lay and their health claims about Doritos and other such processed junk food?

Nothing!

(Please see FDA Says Walnuts Are Drugs and Doritos Are Heart Healthy.)

I ask that you take assertive action to block the introduction of S.216 into the House.

Thank you.

Finally, for a slightly (but only slightly!) different perspective on the issue, see the Eye on FDA ("RX for Pharma Industry Communications and Planning") blog, where the author, Mark Senak, an attorney for a major corporate PR firm who specializes in "the approval and marketing of pharmaceutical drugs, particularly as related to their regulation by the FDA," writes (January 19, 2011):

Last week, the General Accounting Office issued a report entitled “FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims” where – well, the title sort of gives away the gist of the thing, doesn’t it. FDA does need to re-think this. . . .

The GAO report is a really good primer for those who want to get familiar with [the topic of health claims], and includes not only concise definitions, but an overview of FDA activities around different health claims in food in general (with a table describing each action) as well as the two during 2010 that were particular to qualified health claims.

[O]ne of the conclusions of the report is that stakeholders find the various types and levels of health-related labeling to be confusing. All you have to do is try to sort through the various areas of FDA’s Web site about health label claims and one can easily see why. There is no easy way to discern the differences or any basic English communication that explains it. The GAO report also stated that the FDA has not given companies enough guidance on the types of scientific support needed in support of a claim.

On a side note, it is also important to point out that along with FDA, the Federal Trade Commission is also involved in regulating claims. There were at least two instances in 2010 where health claims and labels got in trouble with both the FDA and the FTC for the same product. As we head into an era of greater interest in health and food, it is important for the environment to be clarified and simplified for all stakeholders – manufacturers and consumers.

Infuriating power grabs . . .

This just in from the Life Extension Foundation:

Senate Bill Would Jail Food Makers for Ten Years!

As if Congress does not have enough urgent work to do, a bill has just been introduced that would vastly expand the FDA’s power to put food makers in jail for ten years!

Just a few days ago, [we informed you] that a walnut [distributor] capitulated to FDA pressure and removed truthful health claims from its website. [I have copied the article below. --JAH] The bill just introduced in the Senate would grant the FDA far more draconian powers to censor this kind of health information.

This Senate bill will enable the FDA to incarcerate food makers if they cite findings from peer-reviewed published scientific studies on their websites.

The pretext for these draconian proposals is a bill titled the Food Safety Accountability Act (S.216). The ostensible purpose of the bill is to punish anyone who knowingly contaminates food for sale. Since there are already strong laws to punish anyone who commits this crime, this bill serves little purpose other than enriching pharmaceutical interests by censoring what healthy food makers can say about their products.

The sinister scheme behind this bill is to exploit the public’s concern about food safety. Drug companies want to convince your senators that an overreaching law needs to be enacted to grant the FDA powers to define “food contamination” any way it chooses.

The problem is the FDA can proclaim a food as “misbranded” even if the best science in the world is used to describe its biological effects in the body. The fear is the FDA will use the term “misbranded” in the same way it defines “adulterated” in order to jail food makers as if they were selling contaminated food.

While the new bill only refers to food violations and not supplements, the FDA may not interpret it this way. The big issue here is that if this bill is passed, it would give the FDA legal authority to threaten and coerce small companies into signing crippling consent decrees that will deny consumers access to truthful non-misleading information about natural approaches to protect against age-related disease.

Please tell your two senators to OPPOSE the Food Safety Accountability Act (S.216) in its present form. You can do this in a few minutes on our convenient Legislative Action Center on our website.

And the story of the walnut distributor?

Walnut [Distributor] Capitulates to FDA Censorship

Life Extension^® has published 57 articles that describe the health benefits of walnuts.

Some of this same scientific data was featured on the website of Diamond Foods, Inc., a distributor of packaged walnuts.

Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’ website.

According to the FDA, these walnuts were classified as “drugs” and the “unauthorized health claims” cause them to become “misbranded,” thus subjecting them to government “seizure or injunction.”

Despite pleas from health freedom activists to challenge this blatant example of censorship, Diamond Foods capitulated and removed from its website statements about the benefits of walnuts.

FDA thus scored a victory by denying some Americans access to scientific data about a food that can reduce the risk of the most common diseases afflicting aging humans.^1-15

You now have the opportunity to strike back

On April 5, 2011, a bipartisan bill was introduced into the House of Representatives called the Free Speech about Science Act (H.R. 1364). This landmark legislation protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.

The Free Speech about Science bill has the potential to transform medical practice by educating the public about the real science behind natural health.

For this very reason, the bill will have opposition. It will be opposed by the FDA since it restricts their ability to censor the dissemination of published scientific data. It will be opposed by drug companies fearing competition from natural health approaches based on diet, dietary supplements, and lifestyle.

The public, on the other hand, wants access to credible information they can use to make wise dietary choices. Please don’t let special interests stop this bill.

I ask that each of you log on to our Legislative Action website that enables you to conveniently e-mail and ask your Representative to cosponsor the Free Speech about Science Act (H.R. 1364).

Passage of the Free Speech about Science Act will stop federal agencies from squandering tax dollars censoring what you are allowed to learn about health-promoting foods.

Our Legislative Action website provides you direct contact with your Representative to let them know that you want H.R. 1364 (Free Speech about Science Act) enacted into law.

---

References
1. Ros E, Núñez I, Pérez-Heras A, et al. A walnut diet improves endothelial function in hypercholesterolemic subjects: a randomized crossover trial. Circulation. 2004 Apr 6;109(13):1609-14.
2. Feldman EB. The scientific evidence for a beneficial health relationship between walnuts and coronary heart disease. J Nutr. 2002 May;132(5):1062S-1101S.
3. Blomhoff R, Carlsen MH, Andersen LF, Jacobs DR Jr. Health benefits of nuts: potential role of antioxidants. Br J Nutr. 2006 Nov;96 Suppl 2:S52-60.
4. Mozaffarian D. Does alpha-linolenic acid intake reduce the risk of coronary heart disease? A review of the evidence. Altern Ther Health Med. 2005 May-Jun;11(3):24-30; quiz 31, 79.
5. Zhao G, Etherton TD, Martin KR, West SG, Gillies PJ, Kris-Etherton PM. Dietary alpha-linolenic acid reduces inflammatory and lipid cardiovascular risk factors in hypercholesterolemic men and women. J Nutr. 2004 Nov;134(11):2991-7.
6. Tapsell LC, Gillen LJ, Patch CS, Batterham M, Owen A, Baré M, Kennedy M. Including walnuts in a low-fat/modified-fat diet improves HDL cholesterol-to-total cholesterol ratios in patients with type 2 diabetes. Diabetes Care. 2004 Dec;27(12):2777-83.
7. West SG. Alpha-Linolenic Acid from Walnuts P85 and Flax Increases Flow-Mediated Dilation of the Brachial Artery in a Dose-Dependent Fashion. Pennsylvania State University. American Heart Association’s 5th Annual Conference on Arteriosclerosis, Thrombosis, and Vascular Biology in San Francisco. May 2004.
8. Iwamoto M, Imaizumi K, Sato M, Hirooka Y, Sakai K, Takeshita A, Kono M. Serum lipid profiles in Japanese women and men during consumption of walnuts. Eur J Clin Nutr. 2002 Jul;56(7):629-37.
9. Morgan JM, Horton K, Reese D, et al.Effects of walnut consumption as part of a low-fat, low-cholesterol diet on serum cardiovascular risk factors. Int’l J for Vit & Nutr Research. 2002 72:341-347.
10. Hu FB, Stampfer MJ, Manson JE, et al. Frequent nut consumption and risk of coronary heart disease in women: prospective cohort study. BMJ. 1998 Nov 14;317(7169):1341-5.
11. Chisholm A, Mann J, Skeaff M, et al. A diet rich in walnuts favourably influences plasma fatty acid profile in moderately hyperlipidaemic subjects. Eur J Clin Nutr. 1998 Jan;52(1):12-6.
12. de Lorgeril M, Renaud S, Mamelle N, et al. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9.
13. Cortés B, Núñez I, Cofán M, et al. Acute effects of high-fat meals enriched with walnuts or olive oil on postprandial endothelial function. J Am Coll Cardiol. 2006 Oct 17;48(8):1666-71.
14. Ros E, Mataix J. Fatty acid composition of nuts—implications for cardiovascular health. Br J Nutr. 2006 Nov;96 Suppl 2:S29-35.
15. Ma Y, Njike VY, Millet J, et al. Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care. 2010 Feb;33(2):227-32.

Food Safety Bill Passes . . .

Not particularly unexpected.

This is from Judith McGeary of the Farm and Ranch Freedom Alliance. (I met Judith at the Acres USA conference two weeks ago. I appreciate her level-headed, thoughtful approach. She is less excitable than me or Mike Adams :-) ):

This afternoon, the House voted 215-144 to approve the FDA Food Safety Modernization Act (now HR 2751), including the Tester-Hagan amendment.

The bill has taken many bizarre procedural twists. Throughout the process, Agribusiness repeatedly tried to prevent the Tester-Hagan amendment from being included. Even today, members of the House critiqued the bill's protections for small-scale direct marketing producers.

It's clear that, without your calls, the bill would have passed without any protection for small-scale producers. Thank you for all of your calls and letters over the last year!

As passed, the bill includes the same version of the Tester-Hagan amendment as S510: It exempts producers grossing under $500,000 (adjusted for inflation) and selling more than half of their products directly to “qualified end users” from the HACCP-type requirements and the produce safety standards. “Qualified end users” means individual consumers (with no geographic limitation), or restaurants and retail food establishments that are EITHER located in the same state OR within 275 miles of the producer. While complex, this amendment effectively carves out small-scale producers who are selling in-state or to local foodsheds from two of the most burdensome provisions of the bill. More details on the Tester-Hagan amendment are available on our website.

There is still cause for concern about how FDA will exercise the new powers granted to it in S510. The agency's track record is one of favoring Agribusiness at the expense of both family farmers and consumers. S510 does not address the underlying problems of consolidation of our food system or the industry capture of the agency, which result in the agency's flawed policies. But the inclusion of the Tester-Hagan amendment provides critical protections for producers who sell at farmers markets, through CSAs, and at local co-ops and groceries, helping us to continue to build our movement and fight for fundamental changes.

We owe a thank you to Senator Tester and Senator Hagan for standing up for local producers and consumers.

WHAT’S NEXT?

The bill will now go to the President, who is expected to sign it.

Passing the law is still only one step in this process. Next year, Congress will face the issue of how to fund all of the new regulations and new FDA bureaucrats. To actually implement the entire bill, Congress will have to approve $1.4 billion of new spending or cut other programs accordingly, based on the CBO estimates. This gives us a chance to affect the level of funding and seek limits how the money can be spent.

And, on the agency side, the FDA will have to go through the rulemaking process. We expect that the agency will focus on writing rules that benefit Agribusiness and disadvantage independent producers, as usual. We will have to take action to ensure that our concerns are on the record and to urge Congressional official to take steps to rein in the agency from overstepping its bounds.

S510 back from the dead

Ay-yi-yi!
Looks like Monsanto, Cargill, and the other major industrial food suppliers may get their way and get “their own“ bought-and-paid-for food czar in charge of all food production in the U.S.

Speak of tyranny!
Please read S 510 Food Safety bill is still alive and may unleash a new army of FDA agents . . . and call your senators.
What‘s got me worked up?

• Even with the Tester Amendment (that permits farms with less than $500,000 annual revenue off the hook), this law encompasses virtually any and every viable “real“ farm in America. --$500,000 revenue will hardly permit enough profit to support a single family, much less an operation that requires a non-family employee or two.
  
• Constitutionally, according to the 5th Amendment, what is the U.S. Congress doing providing for the FDA to regulate local food growers/producers/distributors? If i grow fruits and vegetables (or meat or milk or any farm product) solely for sale to people in my own state, according to the 5th Amendment, the Congress ought not to be seeking to regulate my trade with my neighbors. (But, of course, the federal government has justified its infringements in these matters for decades. So I should probably simply acquiesce, right?)
  
• The issue that Mike Adams emphasizes in the article I have highlighted here: the plan to move full regulation of food production to the administrative whims of individual bureaucrats who can be bought off by special interests--bureaucrats who can always hide behind the justification that they had “reason to believe“ that something might be harmful. No judicial review. No appropriate due process. Simply the decision of a new “food czar.“

And we think we live in “the land of the free“?

Your federal taxes protecting scientifically-based medicine?

I was floored by Dr. Douglass' claim this morning:

Inside the mystery placebos

Why bother creating a good drug -- all you really need to do is come up with a bad placebo.

Statins, for example, would look positively fantastic if you could somehow spike the placebo with strychnine.

Far-fetched? Maybe not -- because the truth is, nobody knows what the heck is in most of the placebos used in drug trials.

Nobody, that is, except for the researchers and their Big Pharma backers.

In a new analysis, researchers looked at 176 studies published in four major medical journals between January 2008 and December 2009 to see what placebos were used.

They didn't get very far: Just 8.2 percent of all pill studies and 26.7 percent of all injection studies disclosed the contents of the placebo, according to the study in the Annals of Internal Medicine.

Think that's outrageous? That's nothing -- the real outrage here is that the feds have NO requirement at all that researchers disclose the contents of their placebos.

None.

And if you think researchers aren't taking full advantage of that little loophole, well, there's probably a job opening for you at the FDA.

But all you need to do is look at some of the placebos that we do have information on to realize there's plenty of room for funny business.

Take the Gardasil vaccine I've been warning you about. [For some of Douglass' warnings, see for example, his report on adverse reactions to the vaccine released by the FDA only after a FOIA demand by Judicial Watch, the non-partisan conservative anti-corruption watchdog organization; or this follow-up from last month--JAH]

In one trial, the researchers spiked the placebo with aluminum, a metal that can cause the same types of nerve damage that have been linked to Gardasil.

That's a placebo "effect" straight out of hell.

In a study mentioned in the new analysis, a med for anorexic cancer patients went up against a "placebo" made of lactose. Of course, cancer patients are often lactose intolerant, and a lactose pill will certainly cause side effects.

And if I know that, you can bet the researchers behind that study sure as heck did as well.

Think about that next time you read about a "placebo-controlled" trial -- because in reality, there's no control at all.

Douglass is often pooh-poohed as a quack. I figure I need to be extra-vigilant if I am going to quote him. So I decided to look up this un-referenced analytical study. Is it a hoax?

Apparently not.

It appeared just a little over a month ago in the Annals of Internal Medicine (October 19, 2010 153:532-535)--abstract available for free here. And though I have not read the full article, every reference elsewhere on the 'net indicates Dr. Douglass is accurately communicating the study's findings. The study authors themselves graciously conclude, "Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials."

Respondents to the study are a bit more outspoken:

It [is a big] ethical problem when the placebo in some cases now have been shown to actually have had adverse effects on these patients['] health, by not being acceptable zero point-standards for the actual medications on trial.

. . . It is also of ethical concern when the patients having the luck of being selected for the "proper" medical treatment, have actually been subjected to medication where its positive effect has been overestimated, non-exist[ant], or even of the negative kind; and all because the treatment effects ha[ve] been compared to a placebo which was not a non-active zero-point-substance, but rather a substance having negative health effects, and thereby, in the comparison, ended up documenting a false positive medical healing effect of the medication.

Conclusion: We now have no way of knowing which medicines are being beneficial to the patients being treated, and which are having no effects at all, or which are actually having negative effects on the patients['] health.

With this report, the whole of pharmaceutical research have lost its credibility. It may or may not be a cynical act by the individual researcher and/or by his/her research group or leader. It is, however, not easy to make excuses for the pharmaceutical companies, since the actual research as a common universal procedure, should have been submitted to meticulous quality control by independ[e]nt researchers h[a]ving no bonds to the company, before a final approval was being given, and the medication was being introduced to the medical community.

This report is weakening the whole foundation wall of all pharmaceutical research. It is from now on not possible to trust any existing information about the effects and side-effects of pharmaceutical medicine. Unfair as it may be, this will affect honest and dishonest researchers alike!

There's more, but I will encourage you to read the comments for yourself.

. . . This kind of report continues to undermine my faith in Big Pharma and the FDA as caretakers of my health. How about you?

Love to buy fresh fruit from the neighbors? Corn from a roadside stand? Pie from a skilled baker friend? Such pleasures may soon go bye-bye!

Sorry. I'm so "into" research, I'm afraid I forgot how to "market" ideas!

The title of this post tells the real story of my post last night.

Is the world going to come to an end if S510 passes . . . and especially without the Tester-Hagan amendment? No. The world won't end.

But plan to see the federal government, by means of its ever-vigilant-against-the-little-guys/ever-vigilant-in-behalf-of-the-big-guys FDA, cracking down hard on the family gardeners and small-town farmers who dare attempt to sell their fruit or vegetables or homemade pies without first paying $500/year in protection money (not to mention filing mounds of newly-required government reports)!

Yes, by everything I can see, that really is the import of this egregious attempted power-grab on the part of the major industrial agriculture vendors.

I know. It seems hard to believe. But, please: READ THE EVIDENCE. Follow the links.

It really is that bad.

S510--Industrial ag businesses show their true colors!

S510 is all about food safety. That's what the bill's sponsors want us to believe. That's its title: The FDA Food Safety Modernization Act.

But when you get down to it, is it really about food safety? Or is it, as so many federal bills and rules and regulations seem to be today, window dressing on the problem ("lipstick on the pig"), a protection scheme for major agribusinesses, and a brilliant (hidden) means for those self-same agribusinesses to put their smaller competitors out of business or, at least, at a serious disadvantage?

The Weston A. Price Foundation sent out the following update on Monday evening:

Last week, the Senate voted 74-25 to move to consideration of S.510, the Food Safety Modernization Act. After thirty hours of debate and behind-the-scenes negotiations, the Senators released a final Managers Amendment that includes a compromise version of the Tester-Hagan amendment.

The compromise Tester-Hagan amendment . . .

• Exempts producers whose revenue is less than $500,000 a year and who sell more than half of their products directly to consumers or "qualified end-users."
  
• Specifies that "retail food establishments" -- which are exempt from the existing requirements to register with FDA and from the other new federal requirements in this law -- includes businesses that sell directly to consumers through farmers' markets, roadside stands and other local outlets.
  
• Requires the FDA to conduct a study that looks at the incidence of foodborne illness in relation to the size and type of the facility, as well as the risks associated with commingling, processing, transporting, and storing food, "including differences in risk based on the scale and duration of such activities." In other words, for the first time, the FDA will have to collect and evaluate data on how different management practices affect the risk of foodborne illness.
  
• Requires the FDA to consider the data mentioned above as it defines "very small businesses," which will also be exempt from the new requirements.

(For the full text of the amendment, go here.)

On constitutional grounds,I don't see how the Senate has any right to make any such rule concerning businesses whose commerce is conducted wholly within one state or another. The federal government, according to the Constitution, has the right and responsibility only to oversee interstate commerce, not intrastate commerce.

But ignoring that not-so-fine point of constitutional law, and granting the federal government powers it has no right to have, still, considering the requirements of the unamended law--requirements that place a relatively minor burden on large ("industrial scale") food processors, but could put smaller, family-run operations out of business--it seems to me that the Tester-Hagan Amendment is the least the Senate should do in behalf of small-scale and local farm sand food distributors.

Anyway.

So the Tester-Hagan amendment is currently included in S510. Good news, yes?

Maybe not!

According to Weston A. Price Foundation:

[E]ven though an agreement was reached on the Tester-Hagan amendment last week, the issue is . . . not over. The final vote on the bill has been delayed until Monday, November 29. . . . And, in the meantime, Agribusiness has shown its true colors.

For over a year, the big Agribusiness trade organizations have supported passage of S.510. From Agribusinesses'' perspective, the bill was a win-win: they could absorb the costs of the regulations because of their size; they'd gain good PR for supposedly improving food safety practices; and the competition created by local food producers, which is rapidly growing, would be crushed by the regulatory burdens.

This was only speculation until now. But when the Senators agreed to include the Tester-Hagan amendment in the bill, . . . twenty Agribusiness trade organizations fired off a letter stating that they would now oppose the bill.

The letter from the Agribusiness groups states:

[B]y incorporating the Tester amendment in the bill, consumers will be left vulnerable to the gaping holes and uneven application of the law created by these exemptions. In addition, it sets an unfortunate precedent for future action on food safety policy by Congress that science and risk-based standards can be ignored.

What science and risk? No one has produced any data or evidence of any widespread problems caused by local producers and marketed directly to consumers. All of the major foodborne illness outbreaks have been caused by products that went through the long supply chains of Agribusiness.

Agribusinesses' real concern about the Tester-Hagan amendment isn't food safety, but the precedent set by having Congress recognize that small, direct-marketing producers are different, and should be regulated differently than large Agribusinesses.

Agribusiness is trying to convince the Senators to pull the Tester-Hagan amendment back out. While the amendment is currently part of the Managers Package, the amended version of the bill agreed to by six bipartisan sponsors, nothing is certain until the actual vote.

ACTION TO TAKE

This Thanksgiving week, please take a moment to call or email your Senators to tell them to hold firm on KEEPING the Tester-Hagan amendment part of the bill.

You can call the Capitol Switchboard at 202-224-3121 or go to www.senate.gov to find their website (if the phone lines are busy, the best way to reach them is through the Contact Page on their website)

Oh, come on! I can hear some of my readers say. What's the big deal? Indeed, if you have read the Snopes article on the subject of the Food Safety Acts, you may be tempted to say the entire concern is overblown and tantamount to a hoax. After all, their attempt at a level-headed evaluation says the grounds for concerns expressed about these bills possibly "eliminat[ing] home gardens and put[ting] organic farmers out of business" are "Mostly False." Most of the claims about "dire results citizens would face should the bill pass . . . [were/are] unwarranted by anything stated within the bill itself."

Whew! Relax! Take a deep breath!

. . . Interesting, then, to see the same Snopes article suggest that "Sources such as the Farm-To-Consumer Legal Defense Fund are better starting points for grasping some of the issues regarding how [the bill] might affect small farmers."

So let's go to the Farm-To-Consumer Legal Defense Fund (FTCLDF) website and find out what they have to say.

The Snopes article, written in early 2009, actually links to an article that has to do with a bill that is now out of date.

So let us take an article that deals with the situation we face today.

Sign the petition to Reject S.510, it begins. "More than ever S510 represents a major threat to the local food movement, states' autonomy to regulate food, and the country's ability to become self-sufficient in food production," it continues.

Whoa! What?!?

Because S510 is really a parallel to a House Bill (HR2749), and the arguments for and against one are generally good for and against the other, I am taking the best material from articles about both bills to help you understand the issues at stake.

In HR 2749’s Real Impacts: a Response to Consumers’ Union, FTCLDF writes,

The FTCLDF agrees that the industrial food safety system has serious flaws and needs to be fixed. The country has seen numerous outbreaks of foodborne illnesses caused by imported foods or domestic foods that were processed in huge facilities and shipped throughout the country. Unfortunately, [the bill] does not focus FDA’s efforts on these very real problems. Instead, it creates a regulatory framework that will heavily burden the small farms and local food processors, the very people who provide a safe, healthy alternative to the industrial food supply.

Food safety is a priority shared by everyone. The FTCLDF calls on [proponents of the bill] to explain exactly how the bill would address the industrial food supply problems without harming the local food movement. The fact that massive, industrial food companies, such as Peanut Corporation of America, have killed or sickened people is a strong argument for regulating such companies, and we applaud CU’s efforts to improve the industrial food supply. But the wrongs committed by these companies are not a valid basis for harming the hundreds of thousands of safe, healthy small farms and artisan producers who will be burdened, or even driven out of business, by [the bill].

FTCLDF then goes into detail about the problems:

• $500 Annual Registration Fee (not to mention paperwork required to report to the FDA) for any "facility" that holds, processes, or manufactures food.
  

  While the statute excludes “farms,” the FDA’s current regulations take a very narrow view of what qualifies. Under the existing regulations, a place that grows food and does any processing of that food for sale [is] not . . . a farm, and thus would be subject to [the bill]. . . . In other words, a farm that washes greens, cut vegetables, or dries fruit before selling it would be forced to register and pay the annual fee under the regulatory definition of “farm.”
  
  Currently, FDA has a guidance document that modifies the regulation and allows “farms” to process food so long as the ingredients are grown on the same farm. [However, e]ven under the guidance document, many small farms and artisanal producers could be required to register. FDA has not strictly enforced this requirement so far, but that is no guarantee about future actions by the agency. And if the agency were to revoke the guidance document and enforce the registration requirement in accordance with the definition of “farm” contained in the regulations, many farms would be required to register and, under the FSEA, pay an annual fee.
  
  Moreover, farms are not the only issue. There are thousands of individuals who are making artisan foods, such as making jams, breads, fermented vegetables, cheese, or other foods, which they sell to directly to customers at local farmers markets and similar venues. All of these individuals would be forced to pay an annual fee of $500 to the FDA and comply with extensive paperwork burdens. Notably, the fee is the same regardless of whether it applies to an individual selling a few hundred dollars worth of product or a multi-million dollar company shipping products all over the country.
  
  It is not equitable for a local grandmother making jam from farmers’ excess fruit to have to pay the same fee as a Heinz processing plant. Nor does the FTCLDF believe local artisan food processor should be subject to the same extensive paperwork requirements as the massive industrial processing plants.

• Regulation of how farms grow and harvest crops.
  
  FTCLDF agrees . . . that [the bill] does not call for the elimination of organic practices. However, the bill’s provision directing the [FDA] to set standards for how food is grown and harvested is very troubling. For example, after the E. coli outbreak linked to spinach that was grown in California and then processed and sent all over the country, the agency developed guidelines that were based entirely on the industrial agriculture model. . . . The guidelines were expensive, burdensome, and wholly unnecessary for small, diversified farms.
  
  After FTCLDF issued its first alert, [the Food Safety bill] was amended to direct FDA “to take into consideration, consistent with ensuring enforceable public health protection, the impact on small scale and diversified farms . . .”While this is an encouraging step, it does not provide sufficient protection.
  
  The FDA has yet to demonstrate that it has any understanding whatsoever of the needs of small scale and diversified farms. And the new language does not prevent FDA from developing standards that drive such farms out of business under the guise of developing “enforceable standards.”
  
  No one has demonstrated any need for FDA to regulate growing practices on small and diversified farms. No major outbreaks have been traced to such farms. There is nothing to be gained, and much to be lost, by granting FDA this authority.
  
• And the list continues . . .

How truly problematic is this legislation? And how necessary is it to begin with? What is it really meant to address?

I thought the following articles were enlightening.

The September 2010 Acres USA magazine includes a brief report that references an article in Food Safety News. How did E. coli O145 infect romaine lettuce that then sickened people around the country? The Acres USA author notes,

One of the largest cattle feedlots in the country is located about 20 miles from the heart of Arizona's leafy green production in the Gila and Dome Valleys. Conditions in the feedlot produce huge volumes of mud, as dirt mix manure and water. When dry, hot, windy weather hits, the mud dries, the cattle breakdown clumps into dust, and the dust blows, often for many miles.

The FDA is pushing ahead with the process of establishing new leafy green food safety regulations. The new requirements fail to target . . . sick or stressed cattle shedding E. coli . . . and other [pathogens] in their manure.

Then there's the article Risk, bacteria, and the tragedy of food-safety reform from Grist.org:

It is impossible, it seems, to come up with a policy that zeroes in on the real systematic risk of the food system: the exponential expansion of hazard that comes from concentrating huge amounts of production in relatively small spaces.

Clearly, highly profitable industries like Big Food wield tremendous power in our political system. Just as no health-care reform could pass that didn't respect the privileges of the insurance and pharmaceutical industries, just as no climate policy could even be attempted without including massive giveaways to the very industries that cause climate change (see Ryan Lizza's tragicomic post-mortem in The New Yorker), food safety reform is evidently hostage to Big Food.

The Grocery Manufacturers of America, a potent trade group whose members range from Monsanto and Cargill to Kraft and McDonald's, supports S. 510. That alone tells me that the bill at best promotes marginal, techno-based solutions to the food-safety problem, ones that don't challenge the interests, or practices, of the food giants. As Food and Water Watch's Elanor Starmer recently pointed out on Grist, the bill's new inspection powers for the FDA are so weak that they would not even have prevented the notorious salmonella-tainted peanut butter scandal of 2009. And yet -- as David Gumpert argued forcefully in our forum -- those same powers may well prove too strong for the small-scale, vulnerable operations that are busily building up alternatives to Big Food. . . .

to tease out my point, let's consider the role of the federal government in regulating two kinds of dairy farms: industrial-scale ones in Wisconsin, and a small artisanal operation in Washington State.

In a fantastic investigative piece last year, The New York Times' Charles Duhigg looked at a spate of illnesses in a dairy-intensive Wisconsin county. He wrote:

There are 41,000 dairy cows in Brown County, which includes Morrison, and they produce more than 260 million gallons of manure each year, much of which is spread on nearby grain fields. Other farmers receive fees to cover their land with slaughterhouse waste and treated sewage.

After an early thaw last year, some of those quarter-billion gallons of cow shit found their way into people's drinking water. Reports Duhigg:

In Morrison, more than 100 wells were polluted by agricultural runoff within a few months, according to local officials. As parasites and bacteria seeped into drinking water, residents suffered from chronic diarrhea, stomach illnesses and severe ear infections.

So here we have a case of vast concentration of production, and a situation wherein known microbial pathogens (including E. coli and fecal coliform) are destined to foul people's water and make them ill. This is systematic, predictable risk. The federal government's response?

[R]unoff from all but the largest farms is essentially unregulated by many of the federal laws intended to prevent pollution and protect drinking water sources. The Clean Water Act of 1972 largely regulates only chemicals or contaminants that move through pipes or ditches, which means it does not typically apply to waste that is sprayed on a field and seeps into groundwater.

Now let's look at case No. 2: Estrella Family Creamery in Washington state, where Kelli Estrella and her family tend 36 cows and 40 goats and turn their milk into highly regarded unpasteurized cheeses. New York Times food-business reporter William Neuman reports that -- unlike those Wisconsin dairies -- the Estrella operation has made no one sick. Yet FDA inspectors have found listeria in some of her cheeses -- and moved to shut down her operation after she refused to submit to a "voluntary" recall. And they've banned Estrella from selling both her hard and soft cheeses, even though only her soft cheese tested positive for listeria.

Now, I don't want to make light of the threat of listeria, a truly nasty bacteria. But let's look as the risks here. Unlike the case of the Wisconsin dairies, the risks are incidental, not systematic. People made cheese for millenia before the advent of pasteurization in the 19th century -- and in much of Europe, nearly all cheese is still made with raw milk. Small children and pregnant mothers aren't regularly falling over from cheese-eating in France. Listeria can infect raw milk cheese, but by no means does it always infect raw milk cheese.

Moreover, listeria from Estrella Creamery cheese threatens only those people who knowingly buy the product, while runoff from Wisconsin's industrial-scale dairies infects everyone who lives nearby. And the threats from Estrella remain theoretical; unlike in that dairy-intensive Wisconsin county, no one has reported falling ill from eating Estrella cheese.

And yet federal officials take an our-hands-are-tied approach to the menace of tainted water in Wisconsin, and bring down an iron fist on the small dairy in Washington. It's hard not to conclude that the disparate responses stem from the fact that industrial-scale dairy farmers -- and the very few large processors that purchase their milk -- have bought influence in Washington, while artisanal cheese producers haven't. This is food safety as protection racket.

For Big Food, the answer to these microbial dilemmas might well end up being: sterilize it all. Most cheese consumed in the United States is made from pasteurized milk; make them pasteurize all of it. And if runoff from fields sprayed with waste from massive dairies is fouling drinking water, then make those big dairies "treat" the waste with antimicrobials before spreading it.

But Bilger's profile of Sandor Katz suggests a different approach. The real systematic risks in our food system don't come from bacteria itself; indeed, bacteria is fundamental to life. The problem comes from concentration of bacteria to the point where sicknesses become inevitable. So de-concentrate the food system, don't sterilize it.

And as for cases like Estrella Creamery, the push should be to identify the source of the listeria and address it, not to shut the dairy down.

Of course, in our political system, creating a food-safety regime that targets the real systematic risk in food production seems impossible. So, while we take small steps forward like S. 510, let's not lose sight of the need to rein in the giant corporations that generate most of the risk, and nurture the small producers who are doing the necessary work of de-concentrating our pathogen-concentrating food system.

Or, back to FTCLDF and the article FDA's Ace in the Hole:

Despite there being not even a single report of illness, there have been numerous instances over the past four years where licensed raw milk dairies in New York and Pennsylvania have had their sales suspended due to positive tests for Listeria monocytogenes (L-mono), a sometimes virulent foodborne pathogen. The farmers typically lost a week to two weeks in sales plus the price of any milk the farms received back after issuing a recall due to the discovery of L-mono in a milk sample. Some farmers were also fined for adulteration because the raw milk was deemed to contain a “harmful substance which may render the milk injurious to health.”

Sounds good, doesn't it? Why should the government play games with L-mono? If the bacterium is "sometimes virulent," doesn't it make sense to assume it is dangerous?

Well . . . If that's the standard, then the government had better shut down virtually all milk and meat producers, all farms, all water processing plants, all everything. Shouldn't it? Virtually all meats and milks and farm products and water we drink: they all contain pathogens. So why these particular milk producers? Could it, by any chance, have anything to do with the political power of the milk producers who prefer pasteurization over holding themselves to a higher standard of cleanliness throughout the production process (and not only after pasteurization)?

For the last thirty-eight years, and possibly further back, there have been no reports of illness caused by the consumption of raw milk that was attributed to L-mono. . . .

Part of the reason there have been no reports of illness may be because "[t]here are many subtypes of Listeria monocytogenes; many of these subtypes have not been implicated in human illness." And, "Even if the subtype of L-mono is virulent, it still needs to be determined whether the amount of bacteria in the food is enough to cause illness in humans. FDA has a “zero” tolerance policy for L-mono, a standard widely rejected by the scientific community throughout the world. The European Union (EU) allows up to 100 organisms per gram in food at the end of its shelf life."

So what is going on here? Politics?

Check this out:

L-mono is widespread in the environment. If environmental testing at a food plant is positive for L-mono, foods produced in the plant at that time could be found to be adulterated due their having “been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” FDA didn’t find any L-mono in the environment at the Morningland plant but it was not for lack of trying; the agency took one hundred environmental swabs in the plant, all of which came up negative. The agency inspector collecting the swabs promised the dairy’s owners, Joe and Denise Dixon, that they would be getting a copy of the report but to this date no report has been received.

. . . FDA’s position is that if a food sample tests positive for L-mono or any other pathogen, any other food produced on the same equipment is adulterated. This position was also taken by the Missouri Milk Board in its handling of the Morningland case [even though, as indicated, they found no evidence that the equipment at Morningland had been contaminated!].

A Milk Board inspector told Joe that the embargoed cheese would still be suspect even if samples of it did test negative. When Joe asked the inspector, “Why do we even test?” There was no response.

Recently, the United States Food and Drug Administration (FDA) has pressured farmstead cheesemakers in Washington state and Missouri into recalling thousands of pounds of cheese due to samples testing positive for L-mono even though in neither case was there a single report of foodborne illness blamed on the farmstead operations.

Compared to the raw milk incidents mentioned above, the stakes are much higher here. Unlike the raw milk producers who can only sell in their own states due to the federal interstate ban, raw milk cheese aged at least sixty days can be sold anywhere in the U.S. and has a longer shelf life, meaning a great deal more money can be lost due to a recall.

The Missouri farmstead operation, Morningland Dairy, not only recalled over sixty thousand pounds of cheese but there is an additional fifty thousand pounds at the facility that is currently under embargo. The value of the embargoed cheese is around $250,000. In the thirty years it has been in business, there has never been a single case of foodborne [illness] attributed to the consumption of any of the dairy’s products.

The Missouri State Milk Board, pressured by FDA, has ordered that the cheese “be condemned as an adulterated, unlawful product” and has sought a court ruling that the product be destroyed. An inspector from the Milk Board has told the dairy that it must destroy all of the remaining cheese in order to get back into business; [at the time of writing, on October 13, 2010] cheese production at Morningland has been shut down since August 26, shortly after the Milk Board was notified by the California Department of Food and Agriculture (CDFA) that samples of Morningland’s cheese products had tested positive for L-mono and Staphylococcus aureus. [Note in orginal article: Staph aureus, is present normally on everybody’s skin and is considered protective. Most subtypes of this organism do not produce the toxin which can occasionally cause vomiting. Gastrointestinal illness from Staph aureus is self limiting—meaning medical treatment is not necessary].

The article concludes:

The cheese cases are an indicator of what could happen if S510, the FDA Food Safety Modernization Act, passes into law giving FDA mandatory recall power. The cases show how the recall power along with the food safety plan requirement [see HARPC] in the bill would be an effective way for the agency to cripple raw dairy producers who have harmed no one with their products. If S510 passes, state agencies and laboratories will be getting more funding from FDA and the influence of the agency on states in pushing its anti-raw milk agenda will increase. In working toward this end, “Listeria monocytogenes,” in Joe Dixon’s words, “can be FDA’s ace in the hole.”

For more on this subject, please see the Farm and Ranch Freedom Alliance . . . or look up tester-hagan amendment or food safety modernization act.

It is time to put an end to colossal businesses calling the shots in Washington for their own benefit!

As if the federal government doesn't already have more than enough to do . . .

I've been listening to lectures from past Acres USA conferences (2007 and 2008) and have heard quite a bit about NAIS (National Animal Identification System--a federal program "intended to identify animals and track them as they come into contact with, or commingle with, animals other than herdmates from their premises of origin" but that actually places unbelievable financial and paperwork burdens on even backyard keepers of a few chickens, ducks, or goats (not to mention larger animals like horses, donkeys, cows or pigs).

According to the NAIS regulations, every property on which any such animals are kept is supposed to be registered with the federal government, and, then, unless the owner of such animals also owns and/or operates the meat or egg processing plant, every individual animal is also supposed to receive a unique, 15-character animal identification number which is to be attached directly to the animal itself. And--just as FedEx and UPS now track and report the movements of every item throughout their distribution systems, so the movements of every animal are supposed to be tracked and reported to the federal government.

NAIS was supposed to be "voluntary" (ha ha!), but with federal muscle behind it, Wisconsin, the first state to implement the regulations, made it absolutely mandatory. --Interestingly, the registration system, mandated by law, is "not maintained by state government, but instead relies upon the Wisconsin Livestock Identification Consortium (WLIC) to maintain the database of Premises ID registrants. This is currently continuing with the RFID tagging database as well.[19] The WLIC is a private interest group made up of Big Agribusiness, including Cargill, Genetics/Biotech Corporations, like ABS Global, and RFID tagging companies such as Digital Angel[20]. . . . There are also in fact only 6 RFID tags that are approved by WLIC/NAIS at this time: 2 manufactured by Allflex, 2 by Digital Angel, one by Y-Tex and 1 by Global Animal Management. All four are WLIC members." (Wikipedia article on the National Animal Identification System.

Now we are told that, as of February 2010, NAIS was being abandoned in order to

re-focus its efforts on a "new framework" for animal traceability. The Secretary stated the new framework would apply only to animals that cross state lines and would encourage the use of low-tech methods of identification.

The USDA's announcement sparked widely divergent reactions. Groups representing independent farmers and local consumers applauded the USDA's decision. But the proponents of NAIS, namely the Big Ag and Big Tech groups, expressed disappointment and issued statements about the horrible things that could supposedly happen without a centralized ID system. These pro-NAIS entities quickly re-grouped and announced plans to adopt "model regulations" (i.e. NAIS-type regulations) at the State level.

But the issue is also still far from over even at the federal level. Despite USDA's announcement, Big Ag and Big Tech are pushing for a more expansive federal program. And key bureaucrats who developed NAIS continue to work within the agency, and they do not seem to have changed their views despite the announcements from the top.

--Farm-to-Consumer Legal Defense Fund (FTCLDF)

Oh! But we haven't begun to discover how far the federal government is wanting to extend its grip into issues for which one would think the interstate commerce clause should limit its reach.

Now comes Senate Bill 510, due for a vote any day now. Possibly even today.

And what does SB510 have to say? Well, here's a rather calm review of some of its more egregious features.

• It will "enable FDA potentially to regulate all farms marketing food products direct to consumers even if the farms engage only in intrastate commerce." --In other words, the local farmers who sell in your local farmer's market: They will be subject to federal oversight. Your neighbor who owns a few chickens and sells or gives you eggs: Such behavior will be subject to federal (FDA) oversight.
  
  If you think it’s a good idea to give FDA more power,
  
  • Here are the agency’s views on your freedom to obtain the foods of your choice; these are direct quotations from the agency’s response to a lawsuit the Farm-to-Consumer Legal Defense Fund (FTCLDF) filed earlier this year challenging the interstate ban on raw milk for human consumption:
    
    • "There is no absolute right to consume or feed children any particular food." [A--p. 25]
      
    • "There is no 'deeply rooted' historical tradition of unfettered access to foods of all kinds." [A--p. 26]
      
    • "Plaintiffs' assertion of a 'fundamental right to their own bodily and physical health, which includes what foods they do and do not choose to consume for themselves and their families' is similarly unavailing because plaintiffs do not have a fundamental right to obtain any food they wish." [A--p. 26]
      
    • "There is no fundamental right to freedom of contract." [A--p. 27]
  • For those who think it is a good idea to give the FDA more power, here are some of the products FDA has allowed in the marketplace:
    
    • MSG (monosodium glutamate),
      
    • high fructose corn syrup (HFCS),
      
    • aspartame,
      
    • genetically-modified organisms (GMOs),
      
    • Avandia (prescribed for type 2 diabetes) and
      
    • Vioxx (arthritis pain medication).
    If none of these items alarms you, I guess I have not been doing my job! There is strong evidence of major human health problems related to each and every one of these substances. But the FDA has done nothing to protect us.
    
    Meanwhile, as reported here a few days ago, the FDA is standing in the way of full disclosure of health benefits of good foods like tart cherries and walnuts, claiming that any producer or distributor of such products who associates any health benefits to these items--even if the benefits are well-documented in peer-reviewed scientific papers--the producer/distributor is engaged in the illegal sale of an unapproved drug until it has submitted its specific cherries or walnuts (or whatever) to a costly FDA approval process. . . .
    
    And we are interested in permitting them more power?

Linn Cohen-Cole wrote a powerful post on an earlier (and less-egregious-than-it-is-now) version of the same bill:

Wisdom says stop a bill that is broad as everything yet more vague even than it is broad.

Wisdom says stop a bill that comes with massive penalties but allows no judicial review.

Wisdom says stop a bill with everything unspecified and actually waits til next year for an unspecified “Administrator” to decide what’s what.

Where we come from, that’s called a blank check. Who writes laws like that? ”Here, do what you want about whatever you want and here’s some deadly punishments to make it stick.”

Wisdom says know who wrote that bill and be forewarned.

Wisdom says wake up.

Here’s the bill. Let’s use our imaginations and extrapolate from the little bit it reveals and from the reality we know.

SEC. 206. FOOD PRODUCTION FACILITIES.

(a) Authorities- In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respectto food production facilities, to–

(1) visit and inspect food production facilities in the United Statesand in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;

(2) review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;

(3) set good practice standards to protect the public and animal health and promote food safety;

(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate;

(5) collect and maintain information relevant to public health andfarm practices.

(b) Inspection of Records- A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator–

(1) to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or

(2) to track the food in commerce.

(c) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall–

(1) consider all relevant hazards, including those occurring naturally,and those that may be unintentionally or intentionally introduced;

(2) require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;

(3) include with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment . . . and water;

Ah, such a little paragraph, and so much evil packed in it. Notice they mention harvesting, sorting and storage operations? Notice they never mention seeds? But they are precisely what those words cover.

Come again? What's that? Why this concern about seeds?

Because, Cohen-Cole says, that is exactly what these kinds of regulations are always about: maximizing profits for Big Ag (the Monsantos and Cargills of the world). [Interesting: That is what the FTCLDF also says: "[The] FDA’s true clients are not the American people but rather the pharmaceutical and biotechnology industries."

But, but . . . wait a second! What do seeds have to do with Big Ag? And why this interest in seeds?

• Watch where Monsanto is and has been going for the last 15 to 20 years, say the observers. Monsanto has been aiming for a monopoly on seed production worldwide. And they are getting closer than most of us would care to know!

Cohen-Cole writes:

When you know that Monsanto with the help of the US government plundered ancient and rare seed banks in Iraq that held seeds with a genetic heritage (a biohistory belonging to all of us) going back 1000s of years and then made it a crime for farmers there to collect or use their own normal and non-patented seeds off their own land, you see how extreme the intent to control is. . . .

The Iraqis are now utterly at the mercy of Monsanto and the US for survival itself and will have to pay whatever prices are set for food. They can no longer just grow their own and be free people. So, no matter what form of government they may ever have, as long as this is true, they are now enslaved because the control over them is that extreme. Kissinger was right – control food and you control people. . . .

In Afghanistan, people are buying and planting beans from America which at the end of the season have nothing whatever inside, the pods are empty. In Ecuador, the potatoes there do not develop eyes so can’t be planted next season to grow potatoes.

Biotech’s claim to care about feeding starving multitudes is belied by its blocking human access to normal seeds and its terminator technology (empty beans). Monopoly is monopoly is monopoly. And at this level, and when it comes to seeds which are life itself, monopoly terminates democracy as well as beans.

Please, read The World According to Monsanto by Marie-Monique Robin I told you about a few days ago.

"Watch how they will be able to easily criminalize seed banking and all holding of seeds," Cohen-Cole writes.

First, to follow how this will be done, you must understand that:

1. there is a small list inside the FDA called “sources of seed contamination” and

2. the FDA has now defined “seed” as food,

3. so seeds can now be controlled through “food safety.” . . .

Farmers, gardeners, seed saving exchanges, seed companies, scientific seed projects, and seed banks, all require sorting. All are working overtime to protect biodiversity that is rapidly disappearing specifically because of genetic engineering. As Monsanto began reducing access to seeds, people around the world have worked hard to compensate.

But now the effort is to take over the whole game, going after even these small sources of biodiversity – by simply defining seeds as food and . . . all farmers’ affordable mechanisms for harvesting (collecting), sorting (seed cleaning) and storing (seed banking or saving) as too dirty to be safe for food.

Set the standard for “food safety” and certification high enough that no one can afford it and punish anyone who tries to save seed in ways that have worked fine for thousands of years, with a million dollar a day fine and/or ten years in prison, and presto, you have just criminalized seed banking.

The penalties are tremendous, the better to protect us from nothing dangerous whatsoever, but to make monopoly over seed absolutely absolute. One is left with control over farmers, an end to seed exchanges, an end to organic seed companies, an end to university programs developing nice normal hybrids, and an end to democracy – reducing us to abject dependence on corporations for food and gratitude even for genetically engineered food and at any price. . . .

There are three other items of the list which surely will be controlled as well. In toto, that little list of six items (agricultural water, manure, harvesting, transporting and seed cleaning equipment, and seed storage facilities) contains the pieces to deconstruct farming itself, especially organic farming.

Oh, there is more, much more! Please take a look at the Farm-to-Consumer Legal Defense Fund page about S510. As I said above, it is non-alarmist. But it ought to cause your hair to stand on end.

The article was written in September and concludes,

S510 is not about protecting the public health but rather about increasing federal control over food and transferring market share from the local food system to the industrial food system. The bill grants broad rulemaking power to FDA, a grant not merited by the agency’s track record. Its passage will cripple local food over time.

There have been reports in the media that S510 is dead. Don’t believe them. The bill could still be brought to the Senate floor before Congress’ pre-election break and it could also be brought up for a vote during a lameduck session after the elections.

Guess what? Cloture was passed yesterday. It is being voted on during the lameduck session. It is time to take action.

For more on the subject, see S510 Talking Points by Pete Kennedy, Esq.

And for a relatively easy method of figuring out how to communicate with your senators, go to the FTCLDF's Action Page.