Washington, D.C.—Former Presidential candidate, Senator John McCain (R-AZ), has introduced new legislation, the Dietary Supplement Safety Act of 2010, which will amend the current Federal Food, Drug, and Cosmetic Act (FD&C Act). In this bi-partisan bill, co-sponsored by Senator Byron Dorgan (D-ND), McCain seeks “to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.” This legislation, proposed to combat “the consumption of dangerous drugs such as designer steroids, often found hidden in over-the-counter supplements promoted as safe and legal,” according to the U.S. Anti-Doping Agency (USADA), came just days before Super Bowl weekend and manifested applause from the National Football League, Major League Baseball, the U.S. Olympic Committee, the American College of Sports Medicine and the PGA Tour.

The 12-page draft of the bill, available online, could revamp many sections of the current FD&C Act. Perhaps the most prominent impact that this legislation will have on the supplement industry is the replacement of the definition of “new dietary ingredients,” currently defined under the Dietary Supplement Health and Education Act (DSHEA) as any ingredient that “was not marketed in the United States before October 15, 1994 and does not include any ingredient which was marketed in the United States before 1994.” This definition will be replaced with the addition of a list of “’Accepted Dietary Ingredients,’ to be prepared, published, and maintained by the Secretary.” Ingredients not included on this list will be considered “new dietary ingredients,” and their use will be prohibited. Another section of the current FD&C Act to be amended includes Section 402: “Adulterated Food,” in which such foods would be defined as “a dietary supplement that is manufactured, held, distributed, labeled or licensed by a dietary supplement facility that is not registered with the Secretary.”

The process of registering products and food facilities would also be changed in Section 415, requiring a dietary supplement facility to register information such as “a list of dietary supplements manufactured, packaged, held, distributed, labeled or licensed” as well as “a full list of the ingredients contained in each dietary supplement, and a copy of the labeling used by the facility for each dietary supplement.”

In addition, Section 413§a would prohibit the use of food ingredients in supplements, unless approved by the Secretary to do so. Further regulatory policing and record keeping by the FDA are also presented in the bill.

USADA CEO, Travis T. Tygart contends, “The McCain bill is a fair and balanced approach that provides significant protections for all consumers of dietary supplements, while at the same time avoids placing unreasonable burdens on legitimate companies in the industry.” But, John Gay, CEO of the Natural Products Association (NPA), rebuts the proposition of additional bureaucracy within the industry in his statement, “What we cannot support is wholesale changes to a regulatory structure that is working, and could work better if measures we have supported were adopted. A series of new laws for criminals to ignore is not the answer.” The measures that the NPA supports to which Gay alludes include additional enforcement funds for regulators, and giving regulators additional authority to act.

Another point of view offered up by noted Michael McGuffin, president of the American Herbal Products Association, is that the bill “places new burdens on dietary supplements that are not required for any other class of food…it appears to be more stringent than retailer requirements under current drug laws.” Supplement makers would have to identify all product ingredients (including information about trademarked blends), submit product labels, and update such information annually.

Although this bi-partisan bill is supported by nearly the entire sports and sports medicine industry, the downstream consequences that this legislation could have on the natural supplement and ingredients industry would be paradigm changing. With a floundering economy trying to stabilize, this bill, if passed, could have a profound and detrimental effect on the productivity of the industry as a whole.

Published in WholeFoods Magazine, March 2010