The Regulation of Dietary Supplements

By Joanna K. Sax
[Ed. Note: Cross-posted on HealthLawProfBlog.]

How have the massive amounts of dietary supplements on the market evaded significant regulatory oversight for so long? Dietary supplements are regulated as food, which means that for practical purposes the FDA only has the ability to pull them off the shelves upon a showing that they are harmful.

Many consumers use dietary supplements for the same purposes that someone may use a non-prescription drug. Some consumers actually feel safer using a dietary supplement because it is labeled as “natural,” rather than using an FDA approved over-the-counter drug. This doesn’t and shouldn’t make sense. Many natural things are harmful – would you eat any wild mushroom? Tobacco in in cigarettes is natural. Just because something is natural doesn’t mean that it is safe. Conversely, just because something isn’t “natural” in a drug doesn’t mean it is unsafe.

One of the main problems with regulating dietary supplements is that they are not all the same. We probably don’t need heavy regulation for Vitamin C, except maybe in formulation/content. We know, for example, that it is water soluble, so it is hard to take too much. So, maybe Vitamin C doesn’t pose the same safety concerns as other supplements. However, a recent article in Nature, vol. 510, pages 462-4, described different scientific viewpoints about the efficacy of vitamin supplements in healthy populations. So, unless you have a Vitamin C deficiency, then there is probably little reason to take it.

We put pregnant women on folic acid, a dietary supplement. This is because we have scientific studies demonstrating that it helps neural tube development.   We know less about the effect of other types of supplements on fetal development.

But, we need more regulation for other types of supplements, such as weight loss supplements, that contain ephedra alkaloids, for example. We often know little about some of the ingredients in weight loss supplements. And, we know even less about how some ingredients may interact with other commonly used supplements or other drugs.

And then there is the cost. Consumers like the lower cost of dietary supplements. Dietary supplements can cost less than drugs because they don’t have to go through the same expensive regulatory process.

There are a lot of moving parts. But, if we are concerned about safety, then we should be really concerned about some of the supplements on the market. We need a regulatory regime that allows for classifications of supplements; some that have to undergo some sort of pre-market testing and some that are exempt – and all of this should be based on or determined by scientific studies.

2 thoughts on “The Regulation of Dietary Supplements

  1. Supplements are regulated. See FDA’s Website
    The problem with your post is you start from the presumption that the absence of regulation is a problem, rather than a hard look at whether there are large, systemic safety problems with the consumption of dietary supplements. In fact, although FDA did pass a regulation, an intensive look into the existence of such a problem showed that there was not, in fact, any thing more than a few scatter anecdotal problems. Congress has made it clear, and surveys of consumers validate, that this is one area where the public does not want FDA to regulate (the ingredients). For many people, given our outmoded drug regulation regime, this gives them one place to go when all else has failed.

  2. We should be concerned about safety, but we should also be concerned about efficacy. Dietary supplements have a huge snake-oil problem. I don’t think that there is any good solution other than regulation, which is itself far from perfect. Nobody has the incentive to debunk spurious claims of efficacy and to publicize those debunkings at a level comparable to the incentives of sellers. If we waste a billion dollars on supplements, even if they don’t kill anyone, it is still a big waste. We need to regulatory models (other than ban/allow) to sort the wheat from the chaff.

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