How to get FDA approval for food?
U.S. FDA do not have the authority to approve food products before marketing. So, food facilities do not have to obtain any type of FDA approval for food products before marketing them in the US. However, food facilities are required to register with FDA, but being registered with FDA does not show FDA approval of its products. But FDA has the authority to approve certain ingredients before they are used in foods. If a manufacturer desires to use a new food additive in his product, he need to prove to FDA that the additive is safe through appropriate testing. So, if any new food additives and color additives used in food, FDA approval is required for that ingredient.
Though food products do not require FDA premarket approval, since FDA is responsible for protecting public health, most are under the regulatory authority of the FDA in the event of safety related concerns. FDA enforces its regulatory requirements through routine facility inspections and randomized batch inspections at the US. So, Food products must be proven safe and effective before companies put them on the market. The agency must also approve new food additives prior to their use in foods.
Do cosmetics need FDA approval?
No. Cosmetic products, ingredients and their labeling, do not require FDA approval before they distribute on the market. But color additives other than coal-tar hair dyes require FDA approval, and each must be used only in compliance with its approved uses, specifications and restrictions.
Though cosmetics do not require FDA premarket approval, it is the responsibility of cosmetic manufacturers to ensure that the products are safe when used as directed in their label. FDA enforces its regulatory requirements through randomized batch inspections at the US. So, cosmetics must be proven safe and effective before companies put them on the market. FDA requires color additives used in cosmetics to be tested for safety and be listed by FDA for their proposed uses.