FDA Releases GMP Regulations For Supplements

July 1, 2007

Press Release

July 1, 2007

By Lee Bechtel, NHF National Lobbyist June 26, 2007

On June 22nd, the Food and Drug Administration (FDA) released its Final Rule for Good Manufacturing Practices (GMP) for dietary-supplement manufacturers, and an Interim Final Rule (IFR) for small companies to receive exemption from coverage under the GMP regulation.

It is important to point out that the final CGMP and the IFR are effective August 24, 2007, but that the FDA is also asking for comments. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. However, there may well be other issues, such as using science-based safety evidence, for manufacturing safety, that may be included and should be reviewed for an informed analysis, and a creditable response for health-freedom advocates to file with the FDA as a comment to the regulations.

The NHF and its lobbyist are reviewing the 800-plus pages of the regulations to provide an informed and accurate analysis on the potential impact of the FDA's regulations on supplement manufacturers, distributors, medical practitioners, and consumers of dietary supplements.

This analysis will be provided and the NHF will assess what actions can and should be taken to correct any problems posed by these regulations. An analysis will be made available in a few days on the NHF website. The regulations as published may be viewed from the following link www.thenhf.com/DS_GMP_Rules.pdf

NHF’s president Scott Tips notes, “The NHF has long opposed the FDA’s version of these CGMP regulations as far-too drug-like in their scope, wildly overbroad, largely unnecessary, and so discriminatory against small businesses as to be almost certainly intended deliberately to drive small businesses out of the marketplace. It is interesting, therefore, that the FDA has decided to institute a ‘phase-in’ of its harsh and unnecessarily expensive-to-implement regulations as to small businesses so as to limit the outcry.”

It has been a busy Congressional legislative year with the NHF leading the lobbying efforts on Senate and House FDA reform bills. This proactive representation with Congressional decision-makers will continue in concert with FDA regulatory actions to protect health freedoms of choice.

As the oldest and best-respected health-freedom group on Capitol Hill, the NHF continues to be the credible source of objective assessment of, and proactive actions on, Congressional legislation and FDA matters that have material impact upon our freedom-of-health choices and access to dietary supplements and nutritional foods.

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About the National Health FederationEstablished in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without government restrictions. With consumer members all over the world, and a Board of Governors and Advisory Board containing representatives from 6 different countries, the Federation is unique is being the only consumer health freedom organization in the world to enjoy official observer status with the Codex Alimentarius Commission.

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