26 February, 2008

The FDA Smackdown

The FDA recently gave some purveyors of snake oil the smackdown:

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as "Chemicals found in Cherries may help fight diabetes." The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products' label and labeling comply with the law.


I went to the Brownwood Acres website but didn't find any claims such as those to which the FDA objects. Nor could I find any links to supposedly independent sites touting their products. Back to the FDA:

The companies have a history of promoting unapproved claims on their product labels, brochures, and Web sites, stating that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies' Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres' president and contained similar unproven statements claiming benefits for their products.

False claims and deceptive advertising from a natural foods company? I am shocked, SHOCKED, I tell you. The company's fruity products are touted with the line, "Powerful Antioxidants - To Attack Your Body's Harmful Free Radicals". (Oddly enough, preservatives such as BHA and BHT that are so scorned by natural food lovers are…guess what?...antioxidants.) So, do antioxidants actually attack the free radicals in your body?



According to Dr. Steven Novella, the jury is still out.

He points to a few studies which have shown the effect of antioxidants to be ambiguous, at best, and having no effect, at worst. One is the recent study which found that vitamins C and E, both having "significant antioxidant activity", did not lower incidence of dementia or Alzheimer's disease. Novella:

The evidence for antioxidants in ALS is largely negative. In Parkinson’s disease (PD) the picture is a bit more complex. There is some evidence that eating Vitamin E rich foods may help prevent PD but not Vitamin E supplements. So perhaps it is something other than the Vitamin E in these foods that is of benefit, or perhaps eating healthy foods is simply a marker for some other variable that protect against PD. In other words, the evidence is ambiguous.

He concludes:

Antioxidants may one day play an important role in the treatment of certain diseases or in routine health maintenance, but so far there is insufficient evidence to make any confident predictions or to make specific recommendations.

Yet the public laps antioxidant claims up like water. I take back what I wrote above. The worst case scenario isn't that antioxidants have no effect, but rather that using some antioxidant supplements can increase your chances of dying sooner.

3 comments:

  1. Anonymous12:49 PM

    The “Chemicals found in cherries may help fight diabetes” quote comes from the abstract of the study, done by the University of Michigan, and not from the FruitFast company. The FDA considered this labeling, even tough it was posted on a third party site and only referenced by the FruitFast company. You can learn about the benefits of cherries by visiting www.choosecherries.com. I don't think the average consumer understands what the FDA considers to be a part of the label. I do know that I would rather eat what people coming out of the healh food store eat then people coming from the drug store.

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  2. Anonymous12:54 PM

    I just visited the www.brownwoodacres.com website referenced in our blog. The site does not smack me as being overblown or overstating it's products. I have read many studies on the benefits of fruit, particularly Wild Blueberries. Certainly prevention with natural products is cheaper than treatment with drugs, I agree with the author above.

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  3. Anon #1 - thanks for the extra info. I went to choosecherries.com and see that they're low in fat and cholesterol but the other major claim I see is antioxidant content, which as Dr. Novella noted, may or may not be the health panacea that folks claim. I have nothing against cherries and this reminds me that I preserved a bunch last summer and that I should bust open a pint. Saying that you'd rather see people coming out of a health food store rather than a drug store seems to me to be a false dichotomy. I don't think it's a case of either people consuming supplements that have no proof of their safety or efficacy or of them simply taking more drugs. I'm with the Cherry Marketing Institute, the people behind choosecherries.com - I think people should eat cherries. But to make claims about products containing cherries that are either misleading or unproven is not the way to go.

    I looked up the Univ. of Michigan study and found that it was done on rats. Quoting from the Univ. itself:

    http://www.med.umich.edu/opm/newspage/2007/cherries.htm

    "It’s not yet known if cherry-rich diets might have a similar impact in humans"

    Also from the same page:

    "Seymour and the laboratory’s director, U-M cardiac surgeon Steven Bolling, M.D., caution that their results cannot be directly translated into humans."

    It appears that the FruitFast folks were saying that, if it works for rats, you should buy our product because it may be good for people too. Well, lots of things could be good for people. Ergo I think the claim was bogus.

    Anon #2 - As I said in my post, I didn't see any claims at the website that the FDA seemed to be objecting to when I went to their site either. But the judge handed down the ruling earlier this month and I haven't looked for a cached copy of the webpage. I'm certainly not against people eating cherries or wild blueberries, both of which I love, but I am against the notion of making unsubstantiated claims for "natural" products.

    I'd much rather have people buy cherries and blueberries for less money than an expensive bottle of pills from rather unsavory businesses.

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