In the wake of the U.S. Anti-Doping Agency’s (USADA) “Supplement Safety Now” campaign, Senator John McCain last week introduced the Dietary Supplement Safety Act of 2010, which is aimed at improving the current level of safety and transparency in the U.S. supplement industry. If signed into law, the legislation would alter portions of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Among the major changes would be a requirement for all supplement manufacturers to go through an annual registration process that would include disclosure of all ingredients contained in products. Additionally, the new law would do away with the current grandfather clause for dietary supplement ingredients that were on the market prior to DSHEA’s passage in 1994. This means that all ingredients would be subject to a new list of accepted dietary ingredients determined by the Secretary of Health and Human Services (HHS) office. Further, instead of only reporting serious adverse events, manufacturers would be required to report even minor adverse events related to their products. Retailers would also be affected by the bill, as they would be required to ensure that all supplement manufacturers’ documentation is compliant with the U.S. Food and Drug Administration (FDA).
The bill is being championed by USADA and several professional sporting leagues, including Major League Baseball. “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,” said USADA CEO Travis T. Tygart. “We are grateful to Senator McCain for his strong leadership on this public health issue and urge other members of Congress to support this bill.”
NBJ Bottom Line
Industry reaction to McCain’s bill has been understandably mixed as different segments of the industry try to understand how the legislation would affect their business if it were to be signed into law. Although doubts remain as to whether the new bill will be passed by Congress, there is little debate that the immediate ramifications would negatively affect sales in the industry. The immediate threat to industry sales would be the removal of products from the market based on a lack of approval from the Secretary of HHS. That is especially threatening if the grandfather clause, which allows variations of products containing ingredients that were on the market prior to 1994, were to be removed.
USADA’s support of the bill—and the group’s outspoken criticism of steroids being marketed as supplements— indicates that sports supplements could be the first category to be thrust under the microscope if the law is passed. In 2008, U.S. consumers spent $2.7 billion on sports supplements, according to Nutrition Business Journal estimates. If passage of the bill resulted in the immediate removal of one or more popular ingredients—similar to the 2004 banning of ephedra—the sports supplement category could see a retraction of 30% or more in sales. If the removal of products were to expand into weight loss and other related categories and remove one or more herb or botanical extract ingredients from the market, the impact could be even greater as that segment of the industry is almost twice as large as the sports supplement category. The retail component of the bill could cause some retailers to stop selling certain dietary supplements if they felt overburdened by the obligation to ensure product safety. It’s too early to say what the full extent of the impact would be, but virtually everyone seems to agree that the $25.2 billion U.S. supplement industry could experience significant attrition and lost sales.
Related NBJ Links:
Is USADA’s ‘Supplement Safety Now’ Campaign a Threat to the DSHEA?
Industry Calls for Greater DSHEA Enforcement, Not New Legislation
Second Major Sports Supplement Recall Could Slow Internet Sales
Related Functional Ingredients magazine links:
Proposed Bill Would Modify Supplement Regs, Alter DSHEA