FDA Issues Good Manufacturing Practices for Supplements

FDA will issue a final rule next week in the Federal Register that describes official good manufacturing practices (GMPs) for dietary supplements.

The rule is intended to ensure the quality of dietary supplements and prevent them from containing contaminated, impure, or adulterated materials. The GMPs set requirements for creating quality control procedures, designing and manufacturing plants, and identity testing of both individual ingredients and finished products. The rule also imposes procedures for recordkeeping and handling consumer complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” Robert Brackett, PhD, director of FDA’s Center for Food Safety and Applied Nutrition, said on June 22.

Large companies with at least 500 employees have until June 2008 to comply with the new GMPs, while smaller companies with fewer than 500 employees will need to meet the requirements by June 2009. The GMPs will go into effect for companies with fewer than 20 employees in June 2010.

Under the final GMPs, manufacturers may use a certificate of analysis for specifications other than the identity of dietary ingredients, but they must monitor in-process controls and store batch production records. Manufacturers must maintain records for at least one year beyond a product’s shelf life or expiration date when such dates are used, or for at least two years beyond the date of distribution of the last batch of supplements associated with those records.

FDA will also issue a second interim rule that describes a process that manufacturers can use to request an exemption from some ingredient testing. Under the interim rule, only manufacturers that provide documentation that reduced frequency of testing would still ensure the identity of dietary ingredients would receive the exemption. FDA opened a 90-day comment period on the interim rule and will accept comments until September 24.

Several dietary supplement trade associations expressed optimism about the rules but said it will take days or weeks to read through the 815-page document.

“It is too soon to know how well FDA incorporated the comments submitted by industry to the 2003 proposed rule, or to completely understand the economic implications of the final rule,” said Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD). “I encourage all AHPA members to review the rule promptly and to communicate your thoughts to me at your earliest opportunity.”

“We applaud FDA for bringing closure to this long, arduous process,” said Steve Mister, CEO of the Council for Responsible Nutrition (Washington, DC.). “We are now eager to dive into the details of this important regulation to determine both its appropriateness for our industry and to determine how companies can best implement it.”

FDA was authorized to establish the GMPs under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

To read the GMPs, click here.