Dr. Oz and Congress

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Why has Congress decided to expose Dr. Oz as a promoter of numerous questionable supplements? Could it be because there really is little that the Food & Drug Administration (FDA) & Federal Trade Commission (FTC) can do to prevent the promotion of questionable products? Why can't these regulatory agencies stop the promotion of these products by Dr. Oz and similar personalities?

In short, they can’t because of one bill. Congress passed a bipartisan bill sponsored by Senators Hatch & Harkin back in 1994. It was called the Dietary Supplement and Health Education Act (DHSEA), and it basically prevents the regulation of questionable products by the FDA. With this bill, anything labeled as a "food supplement" falls into a special category. Under DSHEA law, the FDA can no longer pull bogus food supplements off the market. Under DHSEA, food supplements can also no longer be regulated as either "foods" or “drugs,” which means that they no longer need any FDA approval before being sold to the public.

So, unlike drugs, "food supplements" cannot be kept off the market until they are first shown to be safe and effective. The products don't even have to be shown to be safe to consume — the way, say, that a new food additive does — before they can be added to foods sold to the public. All of this means that a company that wishes to sell, say, a new artificial sweetener has to pay for extensive scientific research that shows this new food additive is safe before it can be added to any food sold in the USA. Under DSHEA, food supplements can be put on the market with no requirement for research showing that they are even safe for consumption, let alone effective.

The FDA can and often does recall foods, preventing their future sale if they have reason to suspect that the food product may be responsible for making people sick. This is not the case with food supplements. So, DSHEA has no effect on the way the FDA regulates food products. If a food company wants to make some sort of health claim for its food product, then it must have the FDA's approval to do so. If it does not, then it risks a recall of its product. (This happened with Activa recently). The FDA & FTC allow only a few tightly-regulated general health claims to be placed on a food product's label or in an advertisement for that food product.

The FDA also tightly regulates drugs and any health claims made by drug manufacturers and sellers to promote the sale of any FDA-approved drug. Indeed, before a new drug is allowed on the market, that drug must first undergo extensive scientific testing to prove to the FDA's expert panels that the proposed new drug is both effective at treating/preventing some illness and that it is reasonably safe as well.

However, DSHEA now prevents the FDA from regulating food supplements as either foods or drugs. Instead, food supplement companies are free to put almost anything they call a "food supplement" on the market with no prior testing for either safety or efficacy. Even worse, if the FDA gets complaints that the product is harmful, the FDA can only remove it from the market after it harms many people and the FDA has enough evidence to prove that this is the case in a court of law.

Furthermore, under DSHEA, food supplement companies are free to make all sorts of unproven and even disproven claims for their supplements. They can do this to promote their sale as long as those claims are not too specific in terms of treating/preventing a particular disease. So, a supplement's manufacturer/promoter may — legally under DSHEA — claim that their product "helps promote a healthy cardiovascular system,” or "strengthens the immune system,” or "helps maintain a healthy body weight,” even though they have no credible research to support such claims. Thanks to DSHEA, a supplement promoter could not claim that their food supplement “reverses atherosclerosis,” “prevents heart attacks,” "prevents cancer", or "promotes weight loss and reverses insulin resistance," etc. as those would be too specific and the FDA could then consider the "food supplement" as an unapproved new drug and pull it from the market. Call some questionable new product a "miracle" pill to help maintain a healthy body weight and that is just fine, according to DSHEA.

Once you understand how this DSHEA law works, you can understand why the food supplement industry in the USA has been growing much faster than the overall economy.

Under DSHEA, there is almost no cost or risk associated with putting any new product on the market and making all sorts of vague health claims (in terms of both structure and function) in order to promote the sale of that supplement. The food supplement companies are not even required to report to the FDA or any other regulatory agency when they receive reports from customers and/or health professionals that their "food supplement" was likely causing harm.

Bottom Line: So while Congress recently did expose Dr. Oz as an unethical (or ignorant) promoter of dubious weight loss products, the DSHEA law that it passed has led to the proliferation of questionable food supplements.

For an entertaining look at this "grilling of Dr. Oz on the Hill" check out: https://www.youtube.com/watch?v=WA0wKeokWUU&feature=youtu.be

By James J. Kenney, PhD, FACN

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