Since DSHEA passed in 1994, several developments have occurred:
Serious adverse event reporting. On Dec. 22, 2006, President Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This law amends the Federal Food, Drug, and Cosmetic Act and makes mandatory the reporting to the FDA of serious adverse events for dietary supplements.
Current Good Manufacturing Practices. On June 25, 2007, the FDA issued a final rule regarding CGMPs for dietary supplements, establishing the minimum CGMPs necessary for manufacturing, packaging, labeling or holding dietary supplements to ensure their identity, purity, quality, strength and composition. This rule became effective Aug. 24, 2007. The compliance date was June 25, 2008 for businesses with 500 or more employees. For businesses employing fewer than 500, but 20 or more full-time-equivalent employees, the compliance date was June 25, 2009. For businesses that employ fewer than 20 full-time-equivalent employees, the compliance date is June 25, 2010.
Stronger FDA oversight. In August 2009, FDA Commissioner Margaret Hamburg outlined initial steps to strengthen FDA oversight that were put into action quickly and will continue in 2010:
The FDA established timelines for the food, supplement and drug industry to respond to inspection findings, generally giving no more than 15 days to respond before a warning letter was issued.
The warning letter process was streamlined by limiting centralized review of the letters. Warning letters can go to any industry player, from manufacturers to retailers.
The FDA claimed it would work quickly to follow up on corrective action taken by the industry after a warning letter was issued or a major recall occurred.
The agency also said it would be prepared to take immediate action in response to public health risks, perhaps proceeding before issuing a formal warning letter.