Is Current Regulation of Supplements Safe?

Every semester, groups of students in my class debate over this exact topic. I think it’s a relevant point and one that individuals who enjoy having the liberty of choosing several different types of products at reasonable prices should fight for and speak up about when needed. The sensationalist approach often used in the media who write articles that leaves the reader or worse yet a mother of a child trembling with fear that their child or a friend is going to suffer serious health consequences provides one side of the argument. These are the people that feel all of the supplements need to be regulated in a manner similar to how pharmaceutical drugs and foods are regulated. The other side of the argument fights for their right to choose. The current regulatory system, while not regulated in a manner at all similar to drugs, does allow for quicker entry into the market, more choices, etc. thus creating more supply and lower prices.

Much of the fight for tighter regulation focuses upon issues related to the claims that can be made that often sound somewhat over-the-top and coercive. Another argument against the current system would say is the relative lack of control over what is actually in the product that hits the shelves as critics will say it could contain nothing but sugar inside it. Or if you are a current-day professional baseball player who gets caught with a performance enhancing drug in their system, you say it was a tainted nutritional supplement that you for some reason can’t remember the name of, where you bought it or what happened to the bottle it came in. No matter, I hope I’m not then supposed to believe that every plant where pharmaceuticals are made has an FDA watchdog person checking every bottle or case that leaves the plant. If I am supposed to believe that, I don’t. Yes, the pharmaceutical system is much more rigorous, takes much more time and is much more expensive for companies to get a drug to market. Changing to this type of a regulatory model would inflict a fatal blow to the nutritional supplement industry as a whole, and this is something that government doesn’t want to do because it is a multi-billion dollar industry.

Overall, I think the system is working well, but can and will be tweaked by the government in the future. Looking back since the passage of the Dietary Supplement and Health Education Act (DSHEA) in 1994 there has only been one ingredient that consistently generated enough serious adverse events for the FDA to take action and remove it from the market. That ingredient was of course, ephedra. People will say that over 150 people died from taking ephedra-based products, but when you compare this to the number of people taking it and other available products, it’s an extremely low incidence rate. In fact, the incidence rates pale in comparison to the number of serious adverse events from alcohol, drugs, tobacco, ibuprofen, methamphetamine or even asprin usage on a monthly basis. While the system certainly has its challenges and more research needs to be required by the companies before a product or ingredient is released, the system has worked in the past and is continuing to work.