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FDA Publishes Final Rules for Good Manufacturing Practices for Dietary Supplements

(Austin, Texas, June 22, 2007) The US Food and Drug Administration (FDA) announced today that it has published final regulations for Good Manufacturing Practices (GMPs) for dietary supplements. In a conference call with members of the dietary supplement industry, consumer groups, academic organizations and other stakeholders, officials of the FDA explained the publication of the long-awaited final rules.

"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," said Robert E. Brackett, PhD, director of FDA's Center for Food Safety and Applied Nutrition, in a press release distributed by the FDA just after the conference call.

“This is a long-awaited and welcome development,” said Mark Blumenthal, Founder and Executive Director of the American Botanical Council, an independent, nonprofit, science education organization dealing with herbs and herbal products in Austin, Texas.

“It has been 13 years since Congress authorized the FDA to produce more stringent GMPs to help ensure the proper identity, purity, and content of dietary supplement products,” Blumenthal added. “This is a significant day for consumers and health professionals who use these natural products for their health. It will result in their having more confidence in these products and their potential benefits,” he noted. “It is also an important event for the industry, the responsible members of which have been pushing for these rules for many years.”

In general, GMPs, also referred to as current Good Manufacturing Practices (cGMPs), specify all the methods and processes necessary to ensure proper processing, manufacture, labeling, and storage of food and drug ingredients and finished products. Dietary supplements (like vitamins, minerals, herbs, and other ingredients) are technically classified as foods, not drugs, under federal law.  The Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized the FDA to promulgate new GMPs for the processing, manufacture, labeling and storage of ingredients for dietary supplements as well as the finished dietary supplement products. Such dietary supplement GMPs were to be modeled on GMPs required for foods, not the more stringent GMP requirements of drugs.

Since 1994 many members of the dietary supplement industry have urged the FDA to publish GMPs for dietary supplements. In 1997 a group of industry trade associations collectively and voluntarily submitted to FDA some proposed GMPs for the agency’s consideration in formulating the GMPs. In 2003 FDA published draft GMPs for public comment, but these were not finalized and published until today. During the intervening years, FDA has received considerable pressure from industry, Congress, consumer groups and the media to publish the final GMP rules for dietary supplements. During all this time, dietary supplement manufacturers have had to comply with GMPs designed for processors and manufacturers of conventional foods, which deal primarily with issues related to proper sanitation. The new GMPs for supplements and their ingredients will require more detailed rules and procedures regarding testing of raw materials as well as finished goods to help ensure proper identity, purity, etc.

The FDA stated today that the final GMP regulation and another interim final rule (see below) are effective August 24, 2007. The new rules will take up to three years to go into effect, depending on the size of the company. Large companies (more than 500 employees) will have to comply with the rules within one year (June 2008), while medium-sized companies (less than 500 employees) will have two years (June 2009), and small companies (less than 20 employees) will have up to three years (June 2010) to meet the new requirement.

“The new rules will probably have minimal impact on many responsible and foresighted manufacturers of herbs and other dietary supplements,” noted ABC’s Blumenthal. “These companies, anticipating the eventual publication of these new rules, have invested millions of dollars over the past decade in creating in-house laboratories and hiring the qualified technical personnel needed for testing the ingredients and the final products produced in their facilities. Many have also instituted newly-enhanced procedures and record-keeping necessary for ensuring product quality the kinds of procedures that are presumably being required or suggested in the FDA’s new rules.”

As part of its nonprofit educational mission, ABC recently published a handbook for use in quality control laboratories to help ensure that manufacturers can properly identify botanical raw materials before they are subjected to processing into herbal teas, dietary supplements, cosmetics or other products. The new book, The Identification of Medicinal Plants: A Handbook of the Morphology of Botanicals in Commerce by botanist Wendy Applequist, PhD, was produced in cooperation with the Missouri Botanical Garden in St. Louis, one of the world’s leading botanical research institutions, and is available through the ABC bookstore. Along with the new GMPs, the FDA also published a companion document, an interim final rule outlining a petition process for manufacturers to request an exemption to the GMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements. According to the FDA press release issued today, under this interim final rule “the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007.” (Comments on this interim rule may be addressed to the Division of Dockets Management Branch.)

The FDA posted a press release on its website at about 11:30 am EDT today explaining its new rules. The FDA also published a backgrounder document and a “Fact Sheet” dealing with the new GMPs. The agency also has published a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements".

The final rule, which will be published in the Federal Register on June 25, 2007, may be viewed online in advance. An advance copy of the interim final rule is also available.