A closer look at FDA regulations governing preparation and marketing of dietary supplements and functional foods, The Inside Counsels forum on manufacturing, marketing, and distribution of dietary supplements, Nutraceuticals, and functional foods, San Francisco, CA (May 15-17, 2007). FDA & Federal Trade Commission Regulations for Nutraceuticals, American Pharmaceutical Association 146th Annual Meeting and Exposition, San Antonio, Texas (March 5-9). Regulation of dietary and herbal supplements in the United States, The Longjiang River Conference on Health Products, New York, NY, (January 21, 2004). On June 5, 1998 (63 FR 30615), FDA amended regulations regarding the nutritional labelling of extracts used in food additives
On January 15, 1997 (62 FR 2218), we published regulations that required label advisory statements for dietary supplements that contain added iron. On September 23, 1997 (62 FR 49826), FDA implemented the DSHEE by issuing several landmark regulations regarding the statement of identity, nutrition labelling, ingredients labelling, and the nutritional and health claims of dietary supplements. The 1994 Dietary Supplement Health and Education Act (DSHEA) amended Federal food regulations, in part, by defining dietary supplements as, adding specific labeling requirements for dietary supplements, and providing for the addition of an optional statement of labeling. In the European Union, dietary supplements are regulated as foods, with the legislation focused on vitamins and minerals used as ingredients of dietary supplements.
Labelling Rules and Regulations
In Australia, most dietary supplements are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and are regulated by food authorities. Non-dietary supplements (herbs and botanicals, metabolites) are not foods, but may instead fall within drug regulations. Some states view dietary supplements as food products, as they typically carry labels that say “Nutrition Facts” instead of “Supplement Facts” or “Drug Facts”. These only apply to supplements containing vitamins and/or minerals, in which those products are regulated as foods, and address supplement ingredients, including safety, purity, and bioavailability. These include premarket notification requirements for some new dietary ingredients, but FDA reviews of these notifications are not comparable to the preapproval process for medications.
Furthermore, in contrast to the framework for medications, compliance with a U.S. Pharmacopeia-National Formulary (USP-NF) standard for public quality is voluntary for all dietary supplements. USPs documented standards for dietary supplements are supported by chemical reference standards, which are highly characterized samples of the food ingredients, impurities, and degrading products, and USP-compendium reagents and performance calibrators, that are specified for use in conducting formal USP-NF tests and analyses.
Dietary supplements that fail to meet specifications required under the CGMP regulations are considered violate; however, the FDA generally may make this determination only after a product is placed on the market, and products in the food supply are not regularly tested by the FDA to determine if product specifications are being met. Under DSHEA, supplement manufacturers are not required to demonstrate safety or effectiveness; Rather, DSHEA deliberately minimizes U.S. FDA oversight and emphasizes the industry’s value to the U.S. economy.
To prevent patient harm and to facilitate evidence-based prescription drug use, FDA requires manufacturers to submit data showing a medication is effective and safe before it can promote a medication for a specific indication. The concern that the disclaimer might be overshadowed by other marketing content is especially pertinent to complex health products, including food additives and prescription drugs promoted for use outside the prescribed labelling. The most prevalent disclaimer in the health care market is one found on packaging and advertising of most vitamins and nutritional supplements. The use of multivitamin supplements in older American food programs is of concern due to their potential use in food programs as an alternative to diets following the American dietary guidelines.
The U.S. dietary supplement industry has grown from approximately 4,000 products in 1994 to an estimated 50,0000 to 80,000 products as of fiscal year 2021,1 and about 80 percent of U.S. adults reported taking dietary supplements, according to a consumer survey conducted in 2021. These increases in the number of products and in consumers usage highlight the importance of physicians understanding of potential concerns regarding product quality for products presented as dietary supplements, given that the U.S. Food and Drug Administration (FDA) does not rigorously regulate supplements as drugs.
Surveys and interviews of 51 female, community-based regular supplement users, including labelling knowledge. We call on the Agency to publish a final new dietary ingredient (NDI) guideline offering protections to innovation and research; to set out and clarify the legal pathway for the marketing of cannabis-derived cannabidiol (CBD) as a food additive; to mandate product listings providing transparency for regulators and consumers alike; and to resolve issues regarding N-acetyl-l-cysteine (NAC) and other ingredients shared between supplements and medications.
We urge the agency to release final New Dietary Ingredient (NDI) guidance that offers protection for innovation and research; to establish and clarify a legal path to market for hemp-derived cannabidiol (CBD) as a dietary supplement; to implement a mandatory product listing that provides transparency for regulators and consumers alike; and to address the issues around N-acetyl-L-cysteine (NAC) and other ingredients that are shared among supplements and drugs. CHPA has enjoyed positive and productive cooperation with the FDAs Office of Nutrition Supplement Programs, as well as proposals for strengthening regulatory oversight, implementing a new process for new product notifications, as well as to create additional resources to support increased inspections and review activities. BIOs Cassandra Soltis brings a broad background of experience at both the in-house and law-firm level at Bayne and Associates, providing guidance on regulatory matters related to foods, dietary supplements, drugs, medical devices, and cosmetics, including product development, marketing claims, and FDA/FTC compliance. Most recently, Cassandra Solti’s served as in-house counsel for Starbucks Coffee Company, where she regularly advised on issues with the FDA, the FTC, the USDA, and the CPSC, including labelling and marketing claims for foods, FDA registration and reporting requirements for food facilities, food/consumer product recalls, food/consumer product recalls, food plant regulatory inspections, food manufacturing, food manufacturing, food manufacturing, food manufacturing, and food manufacturing, product development, and compliance with FSMA.