Do I Need FDA Approval for Cosmetics?

 

 

FDA does not require the approval of cosmetic products and their ingredients before they go on the market. but FDA approval is required for color additives used in cosmetics, drugs, food, and some medical devices.

 

But wait, is that all you need to know in terms of FDA approval?

 

Here are some other things to know. 

 

 

What does FDA approval mean?

The FDA doesn’t require approval when it comes to anything classified as a cosmetic before marketing but when it comes to anything classified as a drug (or ‘cosmetic’ and ‘drug’), it does need FDA approval. Which means, it depends on your product classification.

 

 

FDA approval is not required in cosmetics?

Yes or No

 

FDA does not require the approval of cosmetic products and their ingredients

But, FDA approval is required for color additives used in cosmetics for their intended use.

 

For example, a particular color additive may only be used in an eyeshadow if it is approved for cosmetic use, including the area of the eyes. Many colors even have to be “certified” by FDA. That means that samples from each batch must pass special testing for purity in FDA’s own labs before they may be used.

 

 

How can I define my cosmetic product as a cosmetic or a drug?

FDA laws define a cosmetic product as something for cleansing the human body, making a person more attractive, or changing a person’s appearance such as; makeup, moisturizer, perfumes, nail care products etc.

 

But a drug is considered anything that is intended to affect the way a person’s body works or to treat or prevent disease. Since they have more authority over drug regulation, they have to make sure that manufacturers aren’t selling drugs under the guise of cosmetics.

 

To learn more about selling cosmetics in the United States by complying with FDA regulations,

 

 

Check out this post “3 key things to check before selling cosmetics in the US“

 

 

Are your cosmetics FDA approved?

First and the foremost, let’s clarify the terms between “FDA approved” and “FDA compliant”.

 

Again, anything that heals is a considered a ‘drug’ and therefore has to go through a much more rigorous certification and approval process from the FDA.

 

But, cosmetics are created to help with appearance and they don’t change or heal the body, so cosmetic companies have to be FDA compliant in terms of cosmetic products and their ingredients (other than color additives). FDA-regulated does not mean FDA-approved. 

 

 

Do I need to register with FDA?

Cosmetic registration in the United States is voluntary, not mandatory. But they do have to be safe for their intended use. Also, no registration number is required to import cosmetics into the United States.

 

However, FDA encourages cosmetic companies to register their establishments and file Cosmetic Product Ingredient Statements through Voluntary Cosmetic Registration Program (VCRP) as it provides an opportunity for cosmetic manufacturers to engage the FDA early to ensure there are no delays in imports or in sales due to formulation or labeling.

 

If you want to know more about what’s the benefit of FDA VCRP registration,

check out our post “ the benefit of VCRP registration“ 

 

✔ Need assistance with submitting color additives?

✔ Need color batch certification?

✔ Confused with U.S. FDA regulations?

 

For additional questions regarding how to comply with FDA regulations and our FDA regulatory compliance service,

Click here to send an inquiry or phone at +1 646 513 2815 for the U.S. and  +44 20 3318 2439 for Europe.