Press Release

This June marks the 10th anniversary of the issuance of the final rule for dietary supplement Good Manufacturing Practices (GMPs), a critical component of the law (21 C.F.R. Part 111) that ensures identity, purity, quality, strength and composition of dietary supplements. Benefitting the consumer and leveling the playing field for the industry, GMPs grant FDA inspection authority and set control standards by which all companies must adhere, including raw materials quality assurance; record-keeping; standards for cleanliness and safety; qualifications of manufacturing personnel; finished product specifications; and production and process controls.

“Good manufacturing practices for dietary supplements marked an important turning point for this industry. This milestone anniversary reminds all companies manufacturing dietary supplements that they have a responsibility to consumers and a legal obligation to follow these regulations,” said Duffy MacKay, N.D., senior vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN). “We commend those companies who are not only following GMPs, but who then go above and beyond to adopt additional self-regulatory standards and best practices. More than 170 million Americans take dietary supplements each year with overall confidence, and this can be attributed in part to the mainstream industry’s adherence to the law and dedication to manufacturing products of the highest quality.”

In recognition of the anniversary, CRN will be hosting a Twitter chat from 3 – 4 pm EDT on June 22 to discuss the importance of GMPs and to call for increased compliance within the industry. To join the Twitter chat, follow CRN on Twitter (@CRN_Supplements) and use the hashtag #GMPsTurn10.

Background

Prior to the issuance of supplement-specific GMPs in 2007, dietary supplements were covered under conventional food GMPs. Dietary supplement GMPs established more appropriate standards for this specific product category of food. The new GMPs for dietary supplements expanded regulations, among other things, to include control measures such as identity testing of incoming raw materials as well as identity testing of finished products. For more information on dietary supplement regulations, visit: www.crnusa.org/industry-regulation.