Cosmetics vs Drugs: Registering with the FDA

by | Oct 27, 2021 | Analytics, Compliance, Consulting Group, Cosmetics, Data, FDA, Guidance, ISO, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


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Registering a cosmetic product with the FDA is simple, so simple it is not even required by the FDA. The Voluntary Cosmetic Registration Program (VCRP) is the program that a company can use to file their product with the FDA if they want to.[1] It is an entirely voluntary process. Registering the cosmetic with the FDA also does not mean that the FDA has given the product its approval, it simply means that it is registered.

The process for registering cosmetics is vastly different than the process for drugs. First, drugs need to be approved by the FDA before they can make it market. There are multiple different approval pathways that depend on the type of drug being developed. Drug manufacturers are also required to register their sites with the FDA along with all the drug products they have on the market.[2]  The reason for this difference is relatively simple, drugs present a much higher degree of risk to people than cosmetics do.

While these two registration methods are different there is a scenario where both may be necessary. A cosmetic product that contains a drug or is classified as a drug would have to follow the FDA requirements for both cosmetics and drugs.1 This would mean that the registration is no longer voluntary, though the manufacturing may still voluntarily register as a cosmetic manufacturing site in addition to being registered as a drug manufacturing site. A product that is both a cosmetic and a drug will often have two intended uses.[3]

The intended use of the product plays a big role in if it gets classified as a cosmetic or a drug or both. The hard part is knowing if the intended use of the product makes it classified as a drug or cosmetic. Even the wrong wording can result in the product being misclassified by the manufacturer. EMMA International can help make that distinction and help register products regardless of what they are classified as. From cosmetics to medical devices EMMA International is capable of bringing your product to the market, ensuring that it meets all necessary standards and regulations. For more information, please visit our website at www.emmainterntational.com. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (August 2020) Voluntary Cosmetic Registration Program, Retrieved 10/25/2021 from https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program

[2] FDA (August 2020) Registration and Listing, Retrieved 10/25/2021 from https://www.fda.gov/industry/fda-basics-industry/registration-and-listing

[3] FDA (August 2020) Is It a Cosmetic, Drug, or Both? (Or is it Soap?) Retrieved 10/25/2021 from https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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