The FDA regulates foods, prescription and non-prescription drugs (including vaccines, blood products and other biologics), medical devices, certain x-ray and radiation emitting electronic products, cosmetics, veterinary products and tobacco products. FDA regulations of foods covers safety and truthful labeling of all food products including dietary supplements, venison and other game meat, bottled water, food additives and infant formulas. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).
Food
There are many regulatory requirements that apply to food businesses. Some of these requirements apply to all food businesses, and some are specific to the particular food product. In addition to the FDA’s requirements, food businesses are subject to other federal, state and local requirements.
The FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the USDA. Under FDA regulations, facilities that manufacture, process, pack or hold food that is intended for human or animal consumption in the US must register with the FDA. Food businesses are also required to maintain certain records, depending on the food commodity and type of food processing in the business.
Food manufacturers and distributors are also required to adhere to current Good Manufacturing Practices (cGMP). These regulations require that food offered for sale or introduced into interstate commerce be produced under safe and sanitary conditions. FDA regulations include labeling requirements for food products, including nutritional information. Food manufacturers are responsible for developing labels that comply with all legal requirements and ensuring that labels are truthful and not misleading. In addition to labeling requirements found in the CFR, the labeling of food is also covered under the Federal Food, Drug, and Cosmetic Act (FFD&C), the Fair Packaging and Labeling Act and the Nutrition Labeling and Education Act.
Dietary Supplements
A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains one or more “dietary ingredients.” The dietary ingredients in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and other substances found in the human diet (such as enzymes). Dietary supplements 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.
Although supplement manufacturers and distributors are not required to obtain approval from the FDA before marketing dietary supplements, the firm is responsible for ensuring that the products are safe, any claims made about the products are not false or misleading and the products comply with FDA regulations in all other aspects.
The FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products. Dietary supplements requirements are found under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.
Summary
The FDA regulates both food and dietary supplements under Title 21 of the Code of Federal Regulations (CFR). Facilities that manufacture, process, pack or hold food products and dietary supplements that are intended for human or animal consumption in the US must register with the FDA, and must abide by FDA regulations and follow Current Good Manufacturing Practices (cGMP). Additional information can be found on the FDA’s website at www.fda.gov