In another example of the more enlightened approach being taken elsewhere, renowned herbal medicine specialist Dr Gunnaram Khonikar appealed to the Government of Assam “to include and introduce herbal medicines in the school syllabus so that students would be able to identify medicinal plants with their medicinal properties and cultivation as well as preservation.”

Report from the Assam Tribune brought to you by the Hindustan Times

The CGMPs for dietary supplements do not apply to dietary ingredient manufacturers, labelers, packers and those who hold dietary ingredients unless and only if a dietary ingredient is sold in bulk and then repackaged and, without further processing, is sold as a single component dietary supplement. If the latter occurs, the dietary ingredient supplier, whether in the United States or not, is subject to these cGMPs. Therefore, an ingredient supplier has a duty to find out from its purchaser the intended use of the dietary ingredient. The term “dietary ingredient” has been replaced by “component” throughout the final regulation , also called a Final Rule. The preamble (discussion) of the 70 page regulation is about 750 pages.

The cGMP for dietary supplements will be legally binding on those involved as manufacturers, packers, labelers and holders no sooner than 12 months after the federal regulation is published in the Federal Register. The federal regulation is expected to be published in the Federal Register tomorrow, Monday, June 25, 2007. For most dietary supplement companies, the compliance date will be June 25, 2009.

The Final Rule for CGMPS for dietary supplements was published today in the Federal Register at page 34, 712. The preamble (discussion of the Final Rule which is the actual federal regulation) is found at pages 34, 712 through 34,942 which is 230 pages. The actual regulation is only 16 pages in length and will be cited as 21 CFR Part 111. For very small companies, i.e. those with 20 employees or less, the compliance date is June 25, 2010.
The new cGMPs for dietary supplements will constitute Part 111 of 21 CFR. A violation of Part 111 is an act of adulteration by the person who is responsible for the act in question.

The FDA , by Interim Final Regulation published in the Federal Register on Monday, June 25, 2007, established a procedure for an industry company to request an exemption from the newly issued federal cGMP regulation for dietary supplements.,21 CFR 111..75 (a)(1 ) that compels a manufacturer to conduct at least one test to verify the identity of 100% of alls incoming dietary ingredient ( now called a component). Of course, the exemption does not apply until the Compliance Date for all of the cGMPs with respect to your company.

21 CFR 111.1 (b) clearly states that the cGMPs that apply to the “holding” (i.e. storage) of dietary supplements do NOT apply if “you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers.” “Holding ” is not defined by these regulations.

(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 on the FDA’s website HERE and HERE

Additional information is at FDA’s home page.

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 mmcguffin@ahpa.org.

HRF president Rob McCaleb presented a research update on GSE at Supply Side West in October, 2007. The Powerpoint presentation is available online, HERE.