In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA). According to the legislation, a dietary supplement is a product intended to supplement the diet and is not represented for use as a conventional food or as the sole item of a meal or a diet. Under DSHEA, the U.S. Food and Drug Administration (FDA) was given several post-marketing responsibilities to ensure the safety of dietary supplements. In addition, the U.S. Federal Trade Commission regulates dietary supplement advertising. CHPA fully supports the full implementation and enforcement of DSHEA.
On June 25, 2007, FDA released the final rule for dietary supplement Good Manufacturing Practices (GMPs). This rule, which establishes uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and holding of dietary supplement products, was implemented in 2008 for large companies and followed a three-year phase-in for smaller companies. Beginning in June 2010, all companies manufacturing, packaging, labeling, or holding dietary supplements were required to comply.
CHPA also strongly supports mandatory adverse event reporting for dietary supplements. In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, requiring that dietary supplement manufacturers promptly communicate serious adverse events to FDA. This requirement went into effect December 22, 2007.
More recently (in July 2011), FDA issued draft guidance on New Dietary Ingredient (NDI) notifications. Under DSHEA, a manufacturer wishing to include a new dietary ingredient in a product to be brought to market must first notify the FDA of its intent 75 days before doing so. This pre-market review period allows FDA to examine safety data for new ingredients. While it is the responsibility of each supplement manufacturer to determine that a dietary ingredient is safe, the responsibility for enforcing safety falls to the FDA.
With this new draft guidance on NDI notifications, FDA appeared to attempt to shift the enforcement burden from the agency to the manufacturers, creating significant bureaucratic hurdles to new product innovations and market availability. FDA also attempted to bring the notification requirements to the same status as food additives, a point that was specifically excluded in DSHEA as dietary supplements were given separate status. The trade associations representing the manufacturers of dietary supplements, including CHPA, worked in concert to develop comments to submit to FDA on the NDI draft guidance. In June 2012, following a meeting with Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa), FDA agreed that it needed to substantially revise the guidance to address the concerns voiced by industry.
On July 25, 2012, Senators Sheldon Whitehouse (D-R.I.) and Orrin Hatch introduced the “Designer Anabolic Steroid Control Act” (DASCA; S. 3431). If enacted, this bill would expand the current list of designer anabolic steroids to incorporate some additional chemicals. It would also enhance the penalties associated with violating labeling requirements with regard to anabolic steroids. CHPA has long supported introduction of this legislation as it would further discourage rogue manufacturers of dietary supplements from “spiking” their products with anabolic steroids. CHPA supported the original version of this legislation, which was introduced by former Senator Arlen Specter (D-PA). CHPA sent a letter to the bill sponsors thanking them for their leadership on this issue.