The Food and Drug Administration (FDA) recently announced that it is planning to crack down on marketers of homeopathic medicines with a focus on products that may contain dangerous ingredients, and will offer a new set of regulations for the category. Should nutritional supplements companies be concerned?
Since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), nutritional supplement companies have been given great leeway when it comes to making claims about what their products do. In general, unless a very specific health claim has been already addressed/approved by the FDA in some fashion, supplement marketers may make generalized "statements of nutritional support", but may not cross the line into making "health claims", which are reserved for products in the "drug" category. And even when making these more general assertions about what the product can do for the user, the company must have clinical data to support the claims they are making. Thus, a nutritional supplement product can claim to "support the immune system" but it cannot claim to cure, treat or prevent colds and flus unless it is a drug. Nutritional supplements are not "foods", which cannot make claims, but also are not "drugs" which require rigorous FDA regulation and oversight. They are a product category, established through DSHEA, that stands squarely in the middle. Since the law's passage, there have been far too many issues with product adulteration and unsubstantiated claims.
And so despite the well-publicized problems with nutritional supplements, it is indeed interesting that FDA has chosen to address the "homeopathic remedy" market instead, which includes popular brands such as Zicam and Cold-Eeze. Homeopathics are a special case as they aren't exactly nutritional supplements or foods. Marketers of homeopathic medicines can state that they are intended for specific symptoms and conditions, which is similar to drugs, but there is no approval process. So they are far more similar to supplements than they are to foods. Confusing isn't it? And a bit sketchy to be sure.
Indeed one can hope that this sort of federal scrutiny is only the beginning, as so much research has shown that many nutritional supplements don't contain what they are supposed to contain, and that marketers have been playing footloose and fancy free with product labeling claims. This is the proverbial "elephant in the living room" for an industry that really does want to do good; and executives there have been both publicly and privately anticipating increased regulatory scrutiny for quite some time now. Let's just say that the industry conferences have been interesting over the years.
The FDA under the previous adminsitration chose a more hands-off approach. But President Trump's FDA might take a more skeptical look at what supplement and homeopathic marketers have been doing. Not only could the existence of the "homeopathic "category itself be questioned, but DSHEA as a law could be challenged. The industry fears this above all else.
Me? I fear clowns. But as far as regulation is concerned, so far it's only potentially-harmful ingredients in homeopathic remedies the agency is looking at. Yet, public safety does seem like a logical place to start. False and misleading claims can come next. The nutritional supplement industry as a whole, which I have been observing intimately for over 25 years, likely would not stand up well to a high level of scrutiny, and self-regulatory efforts have had mixed results.
Discussion: Have you ever used a homeopathic remedy? Have you ever questioned any of the claims marketers make about some of these products? Which ones? Do you think the industry needs more regulatory scrutiny?
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