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The FDA and Supplements

By: Jeff Falk
Posted: September 5, 2008, from the September 2008 issue of GCI Magazine.

Until 1994, supplements were subject to the same regulatory requirements as were other foods. A new law amended the Federal Food, Drug, and Cosmetic Act and created a regulatory framework for the safety and labeling of dietary supplements. The U.S. Congress defined “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994 as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The ingredients may include vitamins, minerals, herbs or other botanicals, amino acids and substances such as enzymes, organ tissues, glandulars and metabolites. Dietary supplements can also be extracts or concentrates in the form of tablets, capsules, softgels, gelcaps, liquids, powders and bars—all of which are forms viable for nutricosmetics. Requirments for the label state that the product must not be represented as a conventional food or a sole item of a meal or diet, and DSHEA places dietary supplements in a special category under the general umbrella of “foods,” not drugs.

Under DSHEA, a company is responsible for determining that the supplements it manufactures or distributes are safe and that claims made about them are substantiated by adequate evidence to show that they are not false or misleading. Supplements do not need approval from the FDA before they are marketed, except in the case of a new ingredient in which a pre-market review for safety data and other information is required to substantiate safety or effectiveness. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions for the FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. Because supplements are under the umbrella of foods, the FDA’s Center for Food Safety and Applied Nutrition is responsible for the agency’s oversight of these products, and the FDA monitors the marketplace for potential illegal products that may be unsafe or make false or misleading claims.

The FDA’s Good Manufacturing Practices for supplements includes minimum standards for assembly-line contact surfaces, packaging and labeling equipment, inspection of packaging received from suppliers, relations with third-party packagers and personnel hygiene on the packaging line. A company has to establish written procedures for its packaging operations—based on the minimum standards—and keep records on its packaging for one year beyond the shelf-life dating or, if shelf-life dating is not used, for two years beyond the date of distribution of the last batch.

Packaging and labeling operations must be conducted in a consistent manner, regardless of whether a contract packager was used—the marketer is responsible for the products and needs to determine whether the packaged and labeled products it receives from the packager/labeler conforms to applicable specifications.