FDA Cosmetics Products

Know the subtle ways cosmetics differ from OTC drugs within FDA regulation

According to the FDA, cosmetics are defined by the way they are to be used: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

Problems arise when cosmetics companies make drug or disease claims for their cosmetics products. 

For example, if a cosmetic product claims that it will restore hair growth, reduce cellulite, or remove wrinkles, then these are considered to be drug-related claims. As a result, the product will then need to abide by the specific regulations relating to drugs. If you fail to understand these very subtle differences, you could face enforcement action by the FDA.

At FDA Atty, we help your business navigate the tightrope between cosmetics and OTC drugs according to FDA regulations. Here’s what we do:

Ingredient and label review: We ensure any claims your product makes on the packaging or in your marketing materials is in compliance with FDA rules and regulations for cosmetics.

OTC drug products: If you want to market your cosmetics product with drug claims, then you’ll need to meet the strict regulations of that industry. We guide you through the application process and ensure your business is in compliance.

Get clarity on the language you can use on your cosmetics packaging and marketing. Click the button below to contact FDA Atty to review the language and more. 

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