[Food Politics] FDA v First Amendment

Classic · Mar 7, 2012

I read this article and felt compelled to share. For anyone who thinks the FDA is really doing its job, seems no better at 'regulating' than the SEC. Obviously, the financial topics are much more discussed here so this seems a change of pace. A link to an article by a wellness Dr discussing a violation of the First Amendement of a company's right to cite accurate and factual health information regarding its product in favor of corporately aligned interests. If companies were allowed to advertise and make health claims about the content of our food, wouldn't our population be better off in the choices it makes? Are walnuts really a drug because they provide health benefits?

DR Mercola said:

THIS POPULAR NUT SLASHED BREAST CANCER RISK IN MICE BY 50%
FDA SAYS WALNUTS ARE A 'NEW DRUG'

As unbelievable as it sounds, current law makes it illegal for food producers to share certain types of scientific information with you.

So when Diamond Food relayed health information about the omega-3 fats in walnuts on product packaging and also on their Web site, the U.S. Food and Drug Administration (FDA) attacked.

Even though the information was entirely true, and backed by peer-reviewed scientific research.

If a Food Can Prevent a Disease, it Must be a Drug
This is the backward thinking that goes on at the FDA, where regulations currently prohibit manufacturers of dietary supplements or producers of food from referring to any scientific study documenting the potential effect of the substance on a health condition, punishable by large fines and even jail.

Disclosure about the benefits of a dietary supplement or food, no matter how credible, places the food in the category of an "unapproved drug."
In other words, if a product makes a medical claim, it's automatically classified as a drug.

This is how the FDA got away with sending Diamond Food a warning letter1, stating:

"… we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.

The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s... Every time you munch a few walnuts, you're doing your body a big favor … "

These claims are backed by science2, but it doesn't matter under FDA rules, which are so counter to rationality and logic that it boggles the mind. The FDA letter goes on to list several health claims made by Diamond Foods regarding omega-3 fats, claims such as:

•"Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."
•"[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats... "
•"n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."
•"The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."
Walnuts are "New Drugs"

Because Diamond Food dared to let consumers know that natural substances in a natural food may offer some health benefits and protections, the FDA views this as a new drug. In their eyes, only FDA-approved drugs are capable of offering such protections …

The FDA stated in the warning letter3:

"Because of these intended uses, your walnut products are drugs… Your walnut products are also new drugs … because they are not generally recognized as safe and effective for the above referenced conditions. Therefore … they may not be legally marketed with the above claims in the United States without an approved new drug application.

Additionally, 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… in that the labeling for these drugs fails to bear adequate directions for use… "

The FDA's current position is that foods such as walnuts, cherries, broccoli, turmeric, green tea and the like should be subjected to the full FDA approval process. But obtaining a new drug application, as the FDA suggested, can cost billions of dollars. And let's face it -- walnut growers cannot come close to affording that!

Is it Not a Constitutional Right to Share Truthful, Scientific Information?
This is so ridiculous, as censoring a food producer's right to inform others about scientific research is in violation of the first amendment. The American Association for Health Freedom (AAHF) states:

"The FDA ignores first amendment protections and censors the communication of valid scientific information. The agency seems to have lost sight of its mandate to protect the public and has instead come to see itself as the guardian of corporate interests."

Can you imagine the drug companies not being permitted to tell you what their products could do for you... do you think they would roll over for that? Not a chance, but they don't have to simply because they are the ones who can afford the FDA's approval process. With few exceptions, it's impossible for food producers to assume such costs for natural and therefore non-patentable products. It's ludicrous for the FDA to require natural products to be "vetted" the same way as drugs. In nearly every case, natural products are safer and more effective than synthetic drugs, as science has shown, time and time again. Not to mention that natural agents are much less expensive than pharmaceuticals, and can even be grown in your backyard!

It's unfortunate that the FDA is so beholden to the drug industry that it would waste it's time to attack a walnut manufacturer for citing scientific research while allowing Frito Lay to claim that its Lay's potato chips are "heart healthy."

And walnut producers are not alone. Cherry growers have also been threatened by the FDA with jail time if their websites even contain links to scientific studies from Harvard and elsewhere, outlining the health benefits of cherries for gout or arthritis pain.4 Green tea growers have received similar threats. As I said, it truly boggles the mind…

more:
http://articles.mercola.com/sites/articles/archive/2012/03/07/fda-says-walnuts-are-drugs.aspx

Click to expand...

da_juice · Mar 7, 2012

The FDA (and USDA) need massive reforms, that I can agree with.

I'm not entirely comfortable with walnut companies spouting off laundry lists of ailments they "may cure".

When they conduct the research, they are the ones who can determine the results.

Kojirou · Mar 7, 2012

The FDA is bad at regulating food.

Normal solution: Try to reform the FDA.

Libertarian Solution: Destroy the FDA and believe that private companies for some reason will not re-enact the Jungle again.

rhadamanthus · Mar 7, 2012

da_juice said: ↑

The FDA (and USDA) need massive reforms, that I can agree with.

I'm not entirely comfortable with walnut companies spouting off laundry lists of ailments they "may cure".

When they conduct the research, they are the ones who can determine the results.
Click to expand...

This. While I agree with the meat of the article (i.e., that the FDA is a flawed corporate-controlled cluster-****), having every vegetable come with the "may help stop heart attacks" slogan seems a bit much.

Classic · Mar 7, 2012

rhadamanthus said: ↑

This. While I agree with the meat of the article (i.e., that the FDA is a flawed corporate-controlled cluster-****), having every vegetable come with the "may help stop heart attacks" slogan seems a bit much.
Click to expand...

So where is the line?

I think it would be much if every company with every product tried to make some claim to fame but what if dramatic research were revealed about broccoli or kale as related to cancer/heart disease prevention? At this point, no research or health benefits can even be cited in conjunction with any food of any kind-thus, we have no companies willing to do the research.

How bad would it be if people figured out they didn't necessarily need the pharma-beast to cure cancer or treat disease in every case?

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[Food Politics] FDA v First Amendment

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