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 cover 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).
Below is a guide to food and non-food products for start-ups and other companies that manufacture or process a product that is subject to regulation by the FDA. In general, the FDA regulates the following:
Food Products
There are many regulatory requirements that apply to food businesses. Some of these requirements apply to all food businesses, and some are specific to a particular food product. In addition to the FDA’s requirements, food businesses are subject to other federal, state, and local requirements.
All foods are regulated, including dietary supplements, bottled water, food additives, and infant formulas (meat, poultry, and egg products are regulated by the USDA). Products that are consumed by humans, including chewing gum, beverages, and dietary supplements, are considered foods. Facilities that manufacture or process food products must register with the FDA.
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, soft gels, gel caps, 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 supplement requirements are found under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In June 2007, the 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 identity, purity, quality, and strength.
Over-The-Counter Products
The FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter (OTC) and prescription drugs, including generic drugs. OTC drugs are drugs that have been found to be safe and appropriate for use without the supervision of a healthcare professional such as a physician, and they can be purchased by consumers without a prescription. For example, fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens are all considered OTC drugs.
This classification includes prescription and non-prescription (OTC) drugs. Products that are intended to cure, treat, mitigate, diagnose, or prevent disease in humans or intended to affect the structure or function of the human body (other than food) are considered human drugs or biologics if they achieve their primary intended purpose through chemical action and they are metabolized by the human body.
OTC Requirements
Any firm involved in any aspect of the manufacturing, packaging, and/or labeling of an OTC product must register with the FDA. In addition to registration, all OTC firms must formally list all of their drug products in commercial distribution in the United States with the FDA. It is important to note that registration of a drug establishment with the FDA and submission of a listing with the FDA does not in any way indicate approval of the firm or its product by the FDA. Any reference that infers such approval may constitute misbranding as false and misleading information.
The FDA requires that all OTC establishments adhere to Good Manufacturing Practices and follow labeling requirements as specified in 21 CFR Part 201. In addition to the information that must appear on the label or immediate container, the Drug Facts Rule published by the FDA in 1999 standardized the format and content requirements for the labeling of all OTC products. Drug Facts labeling requires, among other things, a description of the active ingredients and their purpose, the products’ uses, warnings, directions, other information, and inactive ingredients.
Other FDA Regulations
In addition to foods, dietary supplements, and OTC products, the FDA strictly regulates the following items:
- Biologics – including vaccines, blood and blood products, cellular and gene therapy products, tissue and tissue products, and allergenics.
- Medical Devices – including both simple items (tongue depressors) and complex technologies (pacemakers), dental devices, and surgical implants and prosthetics. Products that are intended to cure, treat, mitigate, diagnose, or prevent disease in humans or intended to affect the structure or function of the human body (other than food) are considered medical devices if they do not achieve their primary intended purpose through chemical action and are not metabolized by the human body are considered medical devices.
- Electronics – products that emit radiation, including microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps.
- Cosmetics – including color additives found in makeup and other personal care products, skin moisturizers and cleaners, nail polish, and perfume. Products or product ideas that are cosmetics applied to the body to cleanse or alter the appearance of the body (excluding products with an SPF or products intended for protection against sun, cold, wind, skin damage, dandruff, or perspiration) are considered cosmetics.
Summary
The FDA regulates both food and non-food items 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. Those manufacturers 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
Some have considered the FDA tough in specific industries, such as small businesses, and too lax in others, such as medical devices. In any case, the FDA is closely monitored by both government and non-governmental organizations and creates necessary standards for safety in many industries.