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

According to the FDA, cosmetics defined by the way they are to use: “articles intended to 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 FDACE PRO, 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 comply 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 complies.

Get clarity on the language you can use on your cosmetics packaging and marketing. Contact FDACE PRO to review and more. 

Voluntary Cosmetic Registration Program (VCRP/CPIS)

Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the firm's responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the US FDA regulations.

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US. There are two parts in the FDA Voluntary Cosmetic Registration Program; you may participate in both parts of the program or only one part.

Cosmetic manufacturing establishment registration with the US FDA

Cosmetic manufacturers or packers whose products are in commercial distribution in the US should register their cosmetic establishments with the US FDA, using a separate Form for each cosmetic manufacturing location. Only cosmetic manufacturers and packers should register, not cosmetic distributors. FDA assigns a registration number to each cosmetic establishment registered and sends you a receipt.

Cosmetic Product Ingredient Statements (CPIS) Filing with the US FDA

A cosmetic manufacturer, packer, or distributor should file a statement for each cosmetic product the firm has entered into commercial distribution in the US. With the distributor's permission, a private labeler or packer also may file these forms.

FDACE PRO can assist you in

Voluntary Cosmetic Registration with the US FDA

Cosmetic Product Ingredient Statement Filing with the US FDA

****Cosmetics - EU Regulations*****

Cosmetic products like cleanser, hair products, deodorant, toothpaste, luxury bath items including perfumes and makeup are regulated in European countries to ensure consumer safety.

Cosmetics legislation at the EU requires that all the products sold in the EU must register in the CPNP (Cosmetic Product Notification Panel) before marketing the product.

A Responsible person must be designated for each product placed on the market to ensure compliance with the product rules in the Regulation. A responsible person should maintain a product information file (PIF) which is open to inspection by the authorities.

PIF should have the product description, safety report, method of manufacturing in accordance with GMP, etc...

Cosmetics must be labeled with precise information which includes an address within the EU (Where PIF is available), declaration of ingredients, and expiry date, and also customer care numbers.

Cosmetic Product Safety Reports which includes formula review, label review, and CPNP Notification is the most important part of PIF