(June 22, 2007) — The U.S. Food and Drug Administration (FDA) has posted its final rule on current good manufacturing practice (cGMP) for dietary supplements at its website and will soon publish the rule in the Federal Register. The agency has simultaneously posted a related interim final rule that allows for submission to, and review by, FDA of an alternative to required 100-percent identity testing of dietary ingredient, as discussed within the cGMP itself, provided certain conditions are met. These documents are posted on the FDA’s website at http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0441.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0790.pdf, respectively. Additional information is at FDA’s home page at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html.
Since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, companies that manufacture, pack, label or hold dietary supplements have been required to conform to conventional food cGMP. The American Herbal Products Association (AHPA) and its members in 1995 joined with numerous other industry groups to request that FDA establish a higher standard for the dietary supplement industry. In the intervening years AHPA has maintained an active role in communicating with FDA to ensure that cGMP for supplements are “appropriate and necessary,” and has expressed concerns that FDA has often lapsed in its responsibility to enforce the existing cGMP.
FDA’s announcement of the completion of its rulemaking process came this morning during a teleconference with industry stakeholders, including AHPA. FDA representatives on the call included Dr. Robert Brackett, Director of the Center for Food Safety and Applied Nutrition; Dr. Vasilios Frankos, Director of the Division of Dietary Supplements Programs; Dr. Mary Poos, a Senior Science Policy Analyst in FDA’s Office of External Relations; Brad Williams, also of the Division of Dietary Supplements Programs; and Jarilyn Dupont, Directory of Regulatory Policy in FDA’s Office of Policy and Planning.
Dr. Brackett noted that the publication of this rule is a “significant accomplishment” in FDA’s food safety efforts, and that “consumers should have greater confidence” in the quality of dietary supplements in the U.S. market. Dr. Frankos added that the final rule is written in a manner that is intended to provide flexibility to manufacturers without lessening their ultimate responsibility to meet all label claims and prevent product adulteration.
Key elements of the final rule include:
The final rule is relevant only to dietary supplements, and not to dietary ingredients. This is a more narrow scope than was addressed in FDA’s proposed rule in 2003.
The rule is relevant to all dietary supplements sold or offered for sale in the United States, so that even foreign firms will be required to meet the new manufacturing standards.
Very small companies (with less than 20 employees) will have three years to come into compliance with the rule while small companies (less than 500 employees) will have two years and larger firms must comply within one year
Every dietary ingredient used in a dietary supplement will be required to meet “100-percent identity testing,” such that manufacturers will be required to “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.” Manufacturers will also be required to “confirm the identity of other components.”
There will be no requirement for providing an expiration date on dietary supplements, but companies that use such dating will need to have supporting data.
FDA will “exercise enforcement discretion” with regard to products made by practitioners, such as acupuncturists and herbalists, who are “adequately trained in their profession,” and who use the products that they make in a “one-on-one consultation.”
The final rule is not applicable to retailers of dietary supplements.
“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,” commented AHPA’s president, Michael McGuffin. Noting that AHPA’s staff will be studying the rule in great detail, McGuffin also stated, “I encourage all AHPA members to review the rule promptly and to communicate your thoughts to me at your earliest opportunity.” McGuffin can be reached at [email protected].
AHPA will provide additional and more detailed communications on this important topic over the next several days, and will promptly prepare a comparative document to identify all of the new requirements for manufacturing, packing, labeling and holding dietary supplements. In addition, AHPA will continue its educational series on cGMP later this summer with a program design to provide in-depth attention to all of the relevant sections of the final rule.