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.
So, FDA approval is not required in cosmetics?
Yes OR No
FDA does not require the approval of cosmetic products and their ingredients (other than color additives)
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”. That means that samples from each batch must pass special testing for purity in FDA’s own labs before they may be used.
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)
Do I need to register with FDA?
No. 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 VCRP registration, check out this post “the benefit of VCRP registration”
✔ Need assistance on submitting color additives?
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