General Regulation on Natural Dietary Supplements in Virginia and Maryland
The food additives industry is regulated by the FDA, mostly through DSHEA provisions. Under DSHEA, supplement manufacturers are not required to demonstrate safety or effectiveness; Rather, DSHEA deliberately minimizes the supervision by the U.S. Food and Drug Administration, focusing instead on the industry’s value to the U.S. economy. FDA regulates dietary supplements through a set of regulations distinct from the regulations that cover conventional foods and drugs. The federal Food, Drug, and Cosmetic Act (FD&C) defines a dietary supplement as a product, taken orally, that contains a food ingredient intended to enhance the diet.
Dietary supplements are available in a variety of forms including pills, capsules, powders, energy bars, and liquids and are available over-the-counter at stores and online FDA regulates dietary supplements manufacturing, production, labelling, and packaging under the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 as an amendment to federal food regulations. Dietary supplement companies are responsible for having proof their products are safe, and ensuring label claims are truthful and non-misleading. Dietary supplements may include generic health claims, nutrient-content claims, or structural-function claims. Certain scientific verifications are required to be submitted to FDA for health claims alone, that is, for claims establishing a direct relationship between use of the supplement and reduced risk for illness.
Cosmetic products are generally exempt from premarket FDA approval, except when making structure or function claims, which would turn them into medicines (see cosmeteuticals). Dietary supplements are regulated differently from regular foods and medications by the U.S. Food and Drug Administration (FDA).8 Pharmaceuticals undergo the rigorous FDA approval process before entering the market; medications are considered unsafe until proven safe
In the European Union, dietary supplements are regulated like foods, with legislation focused on vitamins and minerals used as ingredients of dietary supplements. 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. These only apply to supplements that contain vitamins and/or minerals, in those cases in which those products are regulated as foods, and address supplement composition, including its safety, purity, and bioavailability. Some botanicals are considered to be traditional medicinal herbs, and are used in medicinal products and in dietary supplements.
The Center for Veterinary Medicine (CVM) is the division within FDA that regulates the additives in foods and drugs given to animals. FDA is charged with protecting and promoting the publics health by controlling and supervising the safety of foods, tobacco products, food additives, prescription and over-the-counter drug products (medications), vaccines, biologic drugs, blood transfusions, medical devices, electromagnetic radiation-emitting devices (EREDs), cosmetics, animal foods & feeds, and animal products. The FDAs main emphasis is the enforcement of the federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, particularly Section 361 of the Public Health Service Act, and related regulations. The FD Food greatly increased the FDAs authority to regulate drugs, mandating a premarket safety review for all new drugs, as well as prohibiting falsified treatment claims on drug labels, without requiring the FDA to demonstrate fraudulent intent.
The amendments were adopted simultaneously with adoption by the Virginia Department of Agriculture and Consumer Services (VDACS) of FDAs Current Rule for 2017 food code. To be sold legally in China, each food additive must receive the CFDAs health food approval certificate, which indicates Chinas current emphasis on the products safety and scientific evidence of function. Mexico (among others) is moving towards requirements on front-of-labelling of foods, which we speculate will extend to other countries, and perhaps supplement labels.
As the food additive industry continues to grow, and patients continue to use food additives, there is a need to review and update FDAs Federal Food and Drug Administration’s oversight and Federal Trade Commission’s oversight of the dietary additive industry. The FDA regulates dietary supplement quality, safety, and labelling, while the Federal Trade Commission oversees advertising and marketing; however, there are significant challenges in enforcing regulations, and the best government oversight has yet to be achieved. The dietary supplement, functional food, and natural products industries in the United States are facing numerous regulatory uncertainties with the start of 2021, which will mark the beginning of a new US Administration, on-going global pandemic, and other challenges.
We are calling on the Agency to release final new dietary ingredient (NDI) guidelines that provide 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 implement mandatory product listings that ensure transparency to regulatory agencies and consumers; and to address 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. The Dietary Supplement Quality Collaborative (DSQC) would further advance priority setting and advocacy.