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.

Something you need to be aware of concerning cancer . . .

How do you get good information about health care?

I have been growing increasingly disillusioned with a lot of medical practitioners. My experience tells me they are too focused on treatment of symptoms and nowhere near enough focused on causes. And so, while eliminating one symptom (and ignoring its cause), they create additional problems somewhere else in the body.

Well, this story, from an interview by Dr. Joseph Mercola with Dr. Nicholas Gonzalez (both MDs, by the way!), takes the cake: The Cancer Treatment So Successful - Traditional Doctors SHUT it Down.

I urge you to download the transcript of the interview.

It wouldn't surprise me if the FDA were to come swooping in on Mercola for this kind of commentary.

Mercola introduces his article and interview with these comments:

[Dr. Gonzalez] didn't set out to treat cancer at first . . . let alone treat patients. His original plan was to be a basic science researcher at Sloan-Kettering; a teaching hospital for Cornell Medical College. He had a chance meeting with William Kelley, a controversial dentist who was one of the founders of nutritional typing. Dr. Kelley had been practicing alternative- and nutritional approaches for over two decades at the time, led him to begin a student project investigation of Kelley's work, in the summer of 1981.

"I started going through his records and even though I was just a second year medical student, I could see right away there were cases that were extraordinary," he says. "Patients with appropriately diagnosed pancreatic cancer, metastatic breast cancer in the bone, metastatic colorectal cancer… who were alive 5, 10, 15 years later under Kelley's care with a nutritional approach."

This preliminary review led to a formal research study, which Dr. Gonzalez completed while doing his fellowship in cancer, immunology and bone marrow transplantation.

The "Impossible" Recoveries of Dr. Kelley's Cancer Patients

After going through thousands of Kelley's records, Dr. Gonzalez put together a monograph, divided into three sections:

1. Kelley’s theory
2. 50 cases of appropriately-diagnosed lethal cancer patients still alive five to 15 years after diagnosis, whose long-term survival was attributed to Kelley’s program
3. Patients Kelley had treated with pancreatic cancer between the years 1974 and 1982

According to Dr. Good, the president of Sloan-Kettering who had become Gonzalez' mentor, if Kelley could produce even one patient with appropriately diagnosed pancreatic cancer who was alive 5-10 years later, it would be remarkable. They ultimately tracked down 22 of Kelley's cases. Ten of them met him once and didn't do the program after being dissuaded by family members or doctors who thought Kelley was a quack.

The average survival for that group was about 60 days.

A second group of seven patients who did the therapy partially and incompletely (again, dissuaded by well-intentioned but misguided family members or doctors), had an average survival of 300 days.

The third group consisting of five patients, who were appropriately diagnosed with advanced pancreatic cancer and who completed the full program, had an average survival of eight and a half years! In Dr. Gonzalez' words, this was "just unheard of in medicine."

One of those patients included a woman diagnosed by the Mayo Clinic with stage four pancreatic cancer who had been given six months to live. She'd learned about Kelley's program through a local health food store. She completed his treatment and is still alive today, 29 years later.

The Truth about Medical Journals: Why Gonzalez's Book Was Never Published

However, despite—or rather because of—the remarkable success of the treatment, Gonzalez couldn't get his findings published.

"We tried to publish case reports in the medical journals; the whole book, parts of the book, individual case reports—with no success," he says.

This is an important point that many fail to realize.

Those of us who practice natural medicine are frequently criticized for not publishing our findings. My justification for that is that it's not going to be published anyway, and Dr. Gonzalez' anecdotal story confirms this view.

His mentor and supporter, Dr. Good, was one of the most published authors in the scientific literature at that point, with over 2,000 scientific articles to his name. He'd been nominated for the Nobel Prize three times, and yet he was refused because the findings were "too controversial," and flew in the face of conventional medical doctrine.

If the cream of the crop is refused, how does a general primary care physician get an article published?

He doesn't . . .

"Robert Good was at the top of his profession: President of Sloan-Kettering, father of modern immunology, and did the first bone marrow transplant in history. Yet, he couldn't get it published," Gonzalez says. "He couldn't even get a single case report published.

In fact, I have a letter from one of the editors, dated 1987, who wrote a blistering letter to Good saying "You've been boondoggled by a crazy quack guy. Don't you see this is all a fraud?"

It was just the most extraordinary, irrational letter... [Because] the patients' names were there, the copies of their pertinent medical records were there… Any of them could have called these patients, like Arlene Van Straten who, 29 years later, will talk to anyone… But no one cared. They wouldn't do it; they didn't believe it.

They couldn't believe it.

It was very disturbing to me because I say, "It is what it is." I come out of a very conventional research orientation, and it was astonishing to me—I had assistance; I had the president of Sloane-Kettering who couldn't get this thing published because it disagreed with the philosophy that was being promoted in medicine; that only chemotherapy, radiation, or immunotherapy can successfully treat cancer, even though the success rate was abysmal.

The idea that medical journals are these objective and unbiased repositories of the truths about science is total nonsense. Most of them are owned by the drug companies. They won't publish anything that disagrees with their philosophy."

The story only gets better from here. Names. Dates. Specific numbers. Even phone numbers and book titles. Who's telling the truth? Who's lying? I'll let you read the details for yourself.

Yipes!

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.

Bedbugs

I have been seeing articles about bedbugs for the last year and a half or so. Last September when our family visited the portion of the family that lives in Virginia, at least one group thought that they had become infested with bedbugs while in the motel where we were staying. That definitely got our attention!

Yesterday I picked up a magazine whose cover story was about bedbugs. Title: Bug Bedlam. I thought it included a bunch of worthwhile information, much of which I had not seen before.

First thing that caught my eye: Denver's bedbug infestation may be one of the worst in the U.S. According to Orkin, Denver is No. 4, behind only Chicago and the Ohio cities of Columbus and Cincinnati. Terminix ranked us "only" No. 6 in the country based on the volume of calls to its offices.

Yow!

More practical: Telltale signs of an infestation include

• blood spots on sheets,
  
• tiny black dots of fecal matter clustered on the edges of mattresses,
  
• piles of translucent skins that the bedbugs shed like snakes,
  
• white eggs the size of dust specks, and, of course,
  
• bedbugs themselves, which are brownish-red, flat, and about as big as an apple seed.

Nowadays, exterminators get rid of bed bugs by cooking them. "[B]edbugs can't withstand temperatures above 120 degrees. So instead of using chemicals, none of which are 100 percent effective, companies have begun offering to essentially turn bug-ridden apartments into ovens and bake the bedbugs to death."

"It only takes one minute at 122 degrees for a bedbug to die," says Chris Covington, co-owner of BedBug Blasters, a Denver area company that specializes in eradicating the pests.

He says [he and his wife] decided to start BedBug Blasters after realizing that the heaters they use [in one of their other businesses] to dry out flooded structures were the same ones being used to kill bedbugs through heat treatment.

And to make sure all the bugs are obliterated, the BedBug Blasters crew will walk their new bedbug-sniffing dog, Bugsy [!!!!--JAH], through a treated apartment two days later.

Bedbug-sniffing dogs?!?

Yep.

The National Entomology Scent Detection Canine Academy in Florida trains detection dogs--which are "98 percent accurate at finding live bedbugs, according to a 2008 study by the University of Florida."

A few other factoids to know about bedbugs:

• Bedbugs survive on blood. They eat blood. Period. Blood of humans, blood of animals, it doesn't matter. But they seem to prefer human blood more.
  
• In order to get their meals without you knowing, they inject you with a numbing agent, then go to work.
  
• Bedbugs are "not known to transmit disease," so "their biggest downside may be the ick factor" . . . and the major discomfort their bites can cause after the fact.
  
• A bedbug can survive for an entire year without a blood meal.
  
• "They're . . . quick and efficient reproducers: A female can lay up to 500 eggs in her lifetime. That's why pest-control operators often say that a bedbug infestation is defined as one pregnant female."
  
• "Bedbugs are easily spread. Though they can't fly or jump, they're excellent hitchhikers. 'You could sit on a public bus and get bedbugs.'"
  
• Though it requires no license (at least not in Colorado) to provide the heat treatment to kill bedbugs, it costs a lot more to kill them via heat than with pesticides.

FWIW.

Oh. Just for the fun of it, maybe you want to read about Bob Hancock, a professor who specializes in bedbugs. His story begins in the third paragraph of p. 5 in the online version of the article.

The article concludes:

"They're amazing insects," Hancock coos. "They cause a lot of problems for a lot of people -- and I don't want them in my bed, necessarily -- but I think they're awesome."

Unfortunately for the bedbug, he may be the only one.