On March 13th FDA published a proposed rule for dietary supplement current good manufacturing practices (cGMPs) in the Federal Register. The purpose of the proposed rule, according to FDA, is to establish standards necessary to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled accurately to reflect the active ingredients and other ingredients in the product. Specifically this proposal would require the use of new industry-wide standards in the manufacturing, packing and holding of dietary supplements, thus reducing risks associated with dietary supplements that are contaminated with harmful or undesirable substances such as pesticides, heavy metals or other impurities or are not properly labeled to accurately describe what they contain. In addition, it is intended to ensure that the identity, purity, quality, strength and composition of dietary supplements are accurately reflected on the product label, which would be a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.

Under the cGMP proposed rule, manufacturers would be required to:

• Employ qualified employees and supervisors;
• Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging and holding;
• Use equipment and utensils that are of appropriate design, construction and workmanship for the intended use;
• Establish and use a quality control unit and master manufacturing and batch production records;
• 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.
• Keep a written record of each consumer product quality complaint related to cGMPs and
• Retain records for three years beyond the date of manufacture of the last batch of dietary ingredients or dietary supplements.

While the proposed rule addresses the quality of manufacturing processes for dietary supplements and the accurate listing of supplement ingredients, it does not limit consumers’ access to dietary supplements or address the safety of their ingredients or their effects on health when proper manufacturing techniques are used. Rather, FDA has indicated that the proposed rule is intended to create a level playing field for the industry by ensuring that every firm uses high quality manufacturing procedures and uses the same rules for describing their ingredients.

Examples of product quality problems that the proposed rule would help prevent include dietary supplements that contain much more than listed on the label and may be harmful; dietary supplements that contain less ingredients than listed on the label; wrong ingredient; drug contaminant; other contaminant (e.g., bacteria, pesticide, glass, lead); foreign material in a dietary supplement container; improper packaging and mislabeling.

This proposal is intended to cover all types of dietary supplements. However, to limit any disruption for dietary supplements produced by small businesses, FDA has also proposed 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.

FDA is soliciting comments from the public and industry on how this proposed regulation can best achieve the goals of promoting accurate labeling information and preventing adulteration without imposing unnecessary regulatory burdens. Written comments will be accepted 90 days from the date of publication in the Federal Register and may be addressed to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

More specific information on the proposed cGMPs will be provided in the May issue of Nutraceuticals World.