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Which Products are Regulated by the FDA?

Below is a guide to FDA-Regulated products for start-ups and other companies who manufacture or process a product which is subject to regulation by the FDA. In general, the FDA regulates the following:

FOOD, including dietary supplements, bottled water, food additives, infant formulas (meat, poultry and egg products are regulated by the USDA). Products which are consumed by humans, including chewing gum, beverages and dietary supplements are considered foods. Facilities which manufacture or process food products must register with the FDA.

DRUGS, including prescription and non-prescription (OTC) drugs. Products which 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.

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 which 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.

ELECTRONIC PRODUCTS THAT EMIT RADIATION, including microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps and sunlamps. Products which emit radiation of any kind may be regulated by the FDA.

COSMETICS, including color additives found in makeup and other personal care products, skin moisturizers and cleaners, nail polish and perfume. Products or product ideas which are a cosmetic applied to the body to cleanse or alter the appearance of the body (excluding products with a SPF, or products intended for protection against sun, cold, wind, skin damage, dandruff or perspiration) are considered cosmetics.

VETERINARY PRODUCTS, including livestock feeds, pet foods and veterinary drugs and devices. Products or product ideas that are a drug, device, or food given to, or used on an animal are considered Veterinary Products.

TOBACCO PRODUCTS, including cigarettes, tobacco and smokeless tobacco. Products which are made from or derived from tobacco are considered tobacco products. Recently, the FDA indicated that it would start regulating e-cigarettes and the e-liquids that are used in e-cigarettes.
Note: Alcohol products are regulated the Alcohol and Tobacco Trade Bureau (TTB). Pesticides are regulated by the EPA.

Some have considered the FDA tough in certain industries such as small business 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.

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