Saturday, September 6, 2008

Dietary Supplement Regulation?

I gave a seminar on dietary supplements this weekend in San Antonio - and was asked to comment on “Why the FDA doesn’t regulate supplements?” This is a very common question based on a huge misperception among consumers, health professionals, and journalists. The truth of the matter is that the FDA strongly regulates the dietary supplement industry - but it does so using different metrics compared to the other industries over which it has oversight (drugs, medical devices, and foods).

The FDA has the power and jurisdiction to take supplements off the market, ban them for sale, restrict claims, impose fines, and arrest violators and throw them in prison (as just happened to Berkeley Premium Nutraceuticals founder, Steve Warshak, who was sentenced to 25 years in prison after his conviction on 93 counts of fraud, conspiracy and money laundering). You can’t get much more “regulated” than a 25 year prison sentence!

Where people (including journalists) get confused is in the differences in regulations between drugs and supplements. Drugs are “new to the world” synthetic molecules that have unknown effects in the human body - so the FDA requires a certain level of pre-market testing and evaluation of the efficacy and safety of these new compounds before allowing them onto the open market. In many recent examples, even the extensive pre-market studies of new drugs is not enough to prevent serious adverse side effects (drugs for cholesterol reduction, pain management, depression, and attention deficit have all been linked recently to serious adverse health effects, including death).

On the other hand, dietary supplements such as vitamins, minerals, amino acids, and herbs, are part of the natural world, and as such, are considered by the FDA to be more like foods than like drugs. This means that the FDA regulates dietary supplements more like it does typical foods like peanut butter and cupcakes, than like synthetic chemical compounds like pharmaceuticals.

Does this mean that all dietary supplements, being “natural,” are also safe? Certainly not - and consumers still need to be vigilant about product claims (which are closely regulated by both the FDA and FTC) as well as prudent in their use of any supplements. By using supplements as directed, and especially by looking for specific products that are backed by scientific evidence (i.e. human feeding trials on the finished product formulation), consumers can be reasonable confident that they are getting a product that provides worthwhile benefits.

Thanks for reading,

Shawn Talbott, PhD

I also blog on a daily basis at: (about various health and wellness topics) (about the pros and cons of dietary supplements) (about weight loss, metabolism, and feeling better) (about traditional Asian medicine, or TAM) (about nutrition for endurance athletes) (about metabolism, nutrition, exercise, and energy)

No comments: