Need FDA Approval for Cosmetic Products?

Do I need FDA cosmetics approval?

Many cosmetic manufacturers and suppliers are asking us that if they need FDA approval for cosmetics, how to get FDA approval for skincare products.

FDA cosmetics approval is not require and neither their ingredients before marketing. (aside from color additives). This means Cosmetic companies are not required to register with FDA. FDA registration (registering cosmetic establishments or filing product formulations) is not mandatory, but voluntary.

FDA Approval for Cosmetics Safety?

Although FDA cosmetics approval is not required before they go on the market, a cosmetic company is responsible for ensuring the safety of its own products and ingredients. FDA regulations do not require specific tests to demonstrate the safety of cosmetic products or ingredients. but FDA advises cosmetic companies to use testing to ensure the safety of cosmetics.

FDA approval for Color additives?

If color additives used in food, drugs, cosmetics, and some medical devices, FDA approval is required. Besides, certain high-risk colors also require FDA color batch certification of every individual batch. Except for coal-tar coal dyes, all color additives must meet U.S.color additive requirements. Failure to comply with it, your cosmetic products will be detained in U.S. port.

FDA Approval for OTC Drug

If a product is intended for use for a cure, treatment, or prevention, it is classified as a drug. Unlike cosmetics, depends on whether the new drug conforms to an over-the-counter (OTC) monograph, FDA approval for OTC drug is needed. Once an OTC monograph is finalized, drug establishments can market OTC drugs that conform to the monograph without FDA approval.

FDA has published monographs for certain OTC drug categories. These monographs state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use. Some of the nonprescription drug categories covered by OTC monographs are acne medications, treatments for dandruff, seborrheic dermatitis, psoriasis, and sunscreens. If you are selling OTC products or drugs, check our article “How the FDA classifies a cosmetic or a drug?“

If you are unsure about the classification of your cosmetic product, need help with FDA registration, Please contact our FDA regulatory consultant or call us +1 646 513 2815 for the U.S. and  +44 20 3318 2439 for Europe. We can also help you review cosmetic ingredients, labeling, and FDA detention assistance!