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.
