John McCain Introduces Dietary Supplement Safety Act

Senator John McCain (R-AZ) held a press conference last week introducing the Dietary Supplement Safety Act of 2010. The proposed legislation, which has been cosponsored by Senator Byron Dorgan (D-ND), would amend the Federal Food, Drug, and Cosmetic Act (FFDCA), making a host of changes to operations of dietary supplement industry.

Under the proposed bill, dietary supplement facilities would be required to file information identifying all brand names, ingredients, and facility names and addresses with which they conduct business. The definition of new dietary ingredients (NDIs) would also be rewritten, with FDA compiling a new list of 'Accepted Dietary Ingredients.' Ingredients marketed prior to October 15, 1994, effectively protected as 'grandfather ingredients' by the Dietary Supplement Health and Education Act (DSHEA), would have to seek inclusion in the list of Accepted Dietary Ingredients.

Provisions related to recall authority and adverse event reports (AERs) have also been included in McCain...s bill. FDA would also have new mandatory recall authority on any dietary supplements believed to be misbranded, adulterated, or cause serious, adverse health consequences or death. AERs would be affected by the requirement of annual AER reports (even including nonserious AERs).

The Dietary Supplement Safety Act of 2010 has received mixed opinion from the dietary supplement industry. Last week, an official press release from the Council for Responsible Nutrition (Washington, DC) applauded the efforts of the bill, while also noting that '"where the legislation would deter retailers from offering a wide variety of legitimate supplements to consumers or would overburden manufacturers, we will seek alternate solutions.'

The American Herbal Products Association (AHPA; Silver Spring, MD) noted that AER requirements are currently softer on the food industry. 'Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,' said AHPA president Michael McGuffin in a press release last Wednesday.

The legislation is currently supported by the United States Anti-Doping Agency (USADA) and a host of professional sports organizations, including Major League Baseball (MLB), the National Basketball Association (NBA), the National Football League (NFL), and the National College Athletic Association (NCAA).

The bill can be read at AHPA...s website here.