The legal class of a Dietary Supplement was created with the Dietary Supplement Health and Education Act of 1994 (DSHEA).
- A dietary supplement is a product taken by mouth that contains a "dietary ingredient” intended to supplement the diet. The "dietary ingredients" in these products 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, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.
Dietary supplements are classified as a food by the Food and Drug Administration (FDA) and therefore, regulated by the Center for Food Safety and Applied Nutrition (CSFAN). However, the FDA regulates dietary supplements under a very different set of regulations than those covering "conventional" foods. There are in fact, numerous FDA regulatory requirements that apply to dietary supplements including:
- Current Good Manufacturing Practices (cGMPs) dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
- Labeling requirements provided in 21 CFR 101, Food Labeling.
- Electronic system requirements in 21 CFR 11, Electronic Records, Electronic Signatures.
- Requirements for reporting Serious Adverse Events per the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.
- The Foreign Supplier Verification Program (FSVP) rule of the Food Safety Modernization Act of 2011 (FSMA) applies to dietary supplement firms if materials or products are imported into the United States. The extent of an FSVP program needed will depend on a variety of factors, but is likely to require only a modified program.
- The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires owners, operators, or agents in charge of domestic and foreign facilities that manufacture, process, pack, or hold food for human consumption (including dietary supplements) in the United States to register their facilities with FDA.
- A stability program based on International Conference on Harmonization (ICH) guidance is necessary in order to provide data to support any expiration or ‘‘best if used by’’ date placed on a dietary supplement product label as dictated in the Preamble to 21 CFR 111. This stability program is also needed to determine appropriate overages to ensure that all dietary ingredients meet at least 100% of product label claims upon release and throughout the product shelf life as required in 21 CFR 101.
- Some dietary supplements may also be acid foods that have a natural pH ≤ 4.6. When this is the case 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers and/or 21 CFR 114, Acidified Foods, may apply.
TLC Regulatory and Laboratory Consulting can provide assistance to clients with all of these dietary supplement regulatory requirements.