FDA proposes rule on GMPs for supplements...finally

The Food and Drug Administration (FDA) has finally released the long-awaited proposals for good manufacturing practices for dietary supplements.

The proposed rule includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to GMPs.

The FDA says the new regulations will ensure that dietary supplements and ingredients are not adulterated with contaminants or impurities, and are labeled to accurately reflect the active ingredients and other ingredients in the product.

"This proposed regulation is another major step in our efforts to help Americans take more control over their own health. This proposed regulation would require that dietary supplements provide accurate information on the type and amount of ingredients they contain and that dietary supplements are produced using safe methods, "​ said Mark B. McClellan, the Food and Drug Administration Commissioner.

The regulation is part of a consumer initiative announced last December to improve FDA's policies on providing information about health consequences of food and dietary supplements and to increase enforcement efforts to prevent misleading health claims made by certain dietary supplement manufacturers. The agency has recently pulled up a number of firms making unsubstantiated claims for their products, often those promoting weight-loss, and there have been a number of recalls over the past months.

However new laws would also permit more informative research on dietary supplements by reducing variation among different products.

"Since credible research studies cannot be performed using many of the current, highly variable products, these practices will also speed our ability to provide the public with more definitive data about the safety and effectiveness of popular dietary supplements,"​ said Dr Stephen Straus, director of the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

Under the CGMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The FDA is however proposing a three-year phase-in of a final rule for small businesses. The proposal includes flexible standards that can evolve with improvements in science and testing of dietary ingredients.

Trade body the National Nutritional Foods Association (NNFA), which has repeatedly campaigned for the GMPs and Congress support for the rules, said: "The release of this proposed regulation represents a major industry milestone."​Like the Council for Responsible Nutrition (CRN), it is planning to thoroughly review the document, but had already noticed "several red flags…that were of concern to the association"​ including the potential difficulties for small to medium who may not be able to meet some of the production controls.

It added that many of the production controls specified "rely on analytical testing, some of which is just being developed and currently unavailable"​.

CRN president Annette Dickinson said: "We commend the Agency for taking these necessary steps that will provide fuller implementation of the Dietary Supplement Health and Education Act (DSHEA). Although our own member companies are already operating under strong good manufacturing practices, it is important that a GMP rule be finalized and enforced in order to raise the bar for the industry as a whole and to build consumer confidence in our industry and the quality products that are produced."​

The FDA​ is asking for comments from the public and industry on the proposed rule. Written comments will be received until 90 days after the date of publication in the Federal Register and may be addressed to: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

A draft of the regulation can be downloaded on the NNFA website​.