Which Products Need FDA Approval? | Products-Liability-Insurance.com (2024)

It’s not just for food and drugs

Many of my current and potential clients are entrepreneurs marketing cosmetics, foods, dietary supplements and other products they’ve created for human and pet use and consumption. When discussing their insurance needs, I often get questions regarding FDA approval.

Not all such products require FDA approval before going on the market. Most are, however, under the regulatory authority of the FDA in the event of safety-related concerns.

Products requiring FDA premarket approval:

Drugs and biologics are required to be proven safe and effective. According to the FDA, the product’s benefits must outweigh any risks related to its intended use.
Animal drugs and food additives in animal food, which includes pets, poultry, and livestock.
Medical devices. Approval depends on the risk classification of the device. Class I devices, such as dental floss and bandages, are subject to the least regulation. Catheters and wheelchairs are examples of Class II devices that require FDA “clearance” prior to marketing. These products are under regulatory controls that reasonably assure their safety and effectiveness. Implants and life-sustaining devices such as heart valves are examples of Class III devices, which require premarket approval by the FDA and are subject to the highest levels of regulation.
Human tissues and cells for use in humans, such as corneas, skin and bone that can transmit infectious diseases are regulated. They must be preapproved prior to marketing if they pose risks other than the transmission of disease.
Food ingredients and additives, such as preservatives and texturizers must be proven to be safe. Additives are also anything in the packaging, such as paper, adhesive or the plastic, that can intentionally or unintentionally come into contact with the food.
Color additives that are used in any FDA-regulated products, which include drugs, food, dietary supplements, and cosmetics.

What doesn’t need FDA approval?

While the product categories below don’t require premarket approval, they do fall under the FDA’s regulations and/or are subject to FDA inspection.

Compounded drugs, which are ingredients combined, mixed, or altered by a licensed pharmacist in order to tailor a medication for an individual patient.
Healthcare-related companies, such as hospitals, surgery centers and other health facilities, laboratories, or manufacturers.
Tobacco products are regulated based the product’s risks to the population as a whole. New tobacco products must receive a written order from the FDA stating the product complies with FDA requirements. This does not signify the product is safe or approved.
Cosmetics,including makeup, shampoo, hair dyes and hair products, perfumes, moisturizers and soaps.
Infant formulas have to be compliant with federal nutrient standards and be registered with the FDA.
Dietary supplement manufacturers must notify the FDA before marketing products that contain new dietary ingredients.
Food labels, though they must include the Nutrition Facts panel.