Proposed Rule for Dietary Supplement CGMPs by Weaver & Amin

Proposed Rule for Dietary Supplement CGMPs

The Food and Drug Administration (FDA) recently released a proposed Rule that would require adherence to its Current Good Manufacturing Practices (CGMPs) regarding manufacturing, packaging and holding of dietary supplement products. The FDA indicated that the proposed rule will enable consumers to confidently discover accurate listing of supplement ingredients, such as identity, purity, quality, strength, and composition that is claimed on the label by regulating the design of physical plants, establishing quality control procedures, and requiring testing of dietary ingredients and dietary supplements. The FDA is obviously twisting the truth and reality to an unprecedented level because the FDA has had for many years ample regulations covering the identity, purity, quality, strength and composition claimed on dietary supplements. The FDA has simply done a poor job of enforcing the current regulations in place prohibiting misbranding. Although the FDA may have forgotten its powers to prevent misbranding under the Food, Drug & Cosmetic Act and its powers under DSHEA, and although these GMPs may really not have been needed in the form as proposed by the FDA, the supplement industry should definitely be educated on the regulations. The supplement industry should also put a positive spin on the situation despite the FDA’s intent to distort the truth for self-serving and biased reasons which unfortunately the press feeds upon and conveys to the public.

The proposed Rule follows the FDA's consumer initiative announced last December allegedly intended 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 FDA, in an effort to address such alleged concerns, proposes that manufacturers adhere to new industry-wide standards, as suggested in the proposed Rule, to substantiate that dietary supplements are not contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities and are properly labeled to accurately describe what they contain. Moreover, manufacturers are apparently only now, if the proposed GMPs become final, responsible to accurately reflect on the product label the identity, purity, quality, strength, and composition of dietary supplements, which, in effect, would give consumers greater confidence knowing what the dietary supplement they use will contain.

Specifically, the proposed CGMPs rule for dietary supplements would require the manufacturers to: (1) employ qualified employees and supervisors; (2) design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, and holding; (3) use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use; (4) establish and use a quality control unit and master manufacturing and batch production records; (5) hold and distribute materials used to manufacture, package, and label dietary ingredients, dietary supplements, and finished products under appropriate conditions of temperature, humidity, light, and sanitation so that their quality is not affected; (6) keep a written record of each consumer product quality complaint related to CGMPs; and (7) retain records for 3 years beyond the date of manufacture of the last batch of dietary ingredients or dietary supplements.

In addition, manufacturers would also be responsible for providing adequate evidence to show that any representations or claims made about their products are not false or misleading. The FDA would have the authority to determine standards that firms should apply in production and labeling.

The proposed CGMPs rule would apply to all firms, domestic and foreign, that manufacture, package, or hold dietary ingredients or dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them. However, to limit any disruption for dietary supplements produced by small businesses, FDA is proposing a three-year phase-in of a final rule for small businesses. The proposal includes flexible standards that can evolve with improvements in the state of science, such as in validating tests for identity, purity, quality, strength, and composition of dietary ingredients.

For more information on the proposed regulations, please go to http://www.fda.gov or contact the firm.


Weaver & Amin concentrates its practice in Food and Drug Administration, Federal Trade Commission, and related Federal and State regulatory compliance and litigation matters, Contracts and Business Transactions, and Intellectual Property prosecution, maintenance, licensing, and litigation. Both Karen Weaver and Rakesh Amin are registered pharmacists and licensed attorneys who focus their law practice on science and technologically-sophisticated disciplines. http://www.weaveramin.com

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