McCain’s Proposed Bill & the Sports Nutrition Industry
John McCain (R-Ariz.) announced in a press conference that he intends to introduce new legislation which would effectively amend the Food, Drug & Cosmetic Act, particularly with respect to DSHEA. Click here to see the full text of proposed legislation.
We intend to further analyze this legislation; however, our initial impression is that we cannot see this bill passing without substantial modifications. Here are the highlights. The amendments proposed in McCain’s legislation could certainly be interpreted as throwing out the idea of “grandfathered” ingredients in favor of a list of “acceptable dietary ingredients” which would seem to suggest that FDA will be quite busy assessing all of the dietary ingredients marketed in the United States in order to determine whether they are “reasonably expected to be safe.” Either that or they are going to start from scratch and require every company to just begin filing these notification packets for every single dietary ingredient they currently sell…that shouldn’t take too long for FDA to review. Obviously this issue would require substantial clarification as the legislation retains the term “New Dietary Ingredient” but seems to remove the old section about ingredients marketed prior to 1994, which is what establishes the basis for the “old” or “grandfathered” dietary ingredients.
In addition, he is suggesting that every adverse event should be reported to FDA, an issue that was considered ad debated for more than a year before the Serious Adverse Event Reporting regulation of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was finally agreed upon. Why would FDA want to maintain or even receive a notice of every claim of an “upset stomach” or “sore elbow” that is reported to a supplement company?
The other amendments regarding registration and disclosure of ingredients, products, etc. are certain to ruffle feathers of every Dietary Supplement trade organization, so I would expect significant resistance from the entire industry on these points. Finally, and possibly the most frustrating aspect of the press conference, was McCain’s acknowledgement of certain groups that support the yet-to-be introduced legislation. The supporters include USADA, as well as Major League Baseball, the National Basketball Association, the National Football League, the National Hockey League, the United States Olympic Committee, the American College of Sports Medicine, National College Athletic Association and the PGA Tour.
Hmmmm…not a single one of those groups manufactures, sells, distributes, or even encourages the use of dietary supplements by their athletes/members, with the possible exception of ACSM. So why does it matter that they support McCain’s legislative agenda? Should we notify McCain if the Cub Scouts, Mother’s Against Drunk Driving, and PETA are opposed to the legislation? Unfortunately, while the segment of the dietary supplement industry know as “Sports Nutrition” does develop products for athletes, the primary market is strength athletes and physique enthusiasts seeking to build muscle, lose body fat, and improve endurance and recovery. Nevertheless, not only do sports bodies continue to add additional supplement ingredients to their lists of banned substances, but they are called on to support legislation that may adversely affect the Sports Nutrition Industry.
CMG will continue to monitor this proposed legislation as it develops and we will endeavor to offer input on behalf of industry. Check back for future updates.