Are peptide skincare products FDA-approved?

No, and they are not supposed to be. In the United States the law does not require a cosmetic product or its ingredients (other than color additives) to have FDA approval before it is sold, so a peptide serum sold as a cosmetic has no FDA approval of its own to point to.

The short answer

In the United States, no. FDA states that the law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market.¹ A peptide serum sold as a cosmetic is therefore not “FDA-approved.” That is how the system is set up, not a sign that something is wrong with the serum. FDA’s own page on the subject is titled “How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated.”¹

Why the word “approved” matters

Most people hear “FDA-approved” as a stamp of quality or proof that a product works. FDA uses the word for drugs, which must have FDA approval for both safety and effectiveness before they go on the market.³ A cosmetic has no equivalent step. If a product does use the word, it is reasonable to ask what exactly is meant, for example whether it refers to a color additive, to a different product, or to nothing FDA itself has done.

Cosmetic, drug, supplement: three different rules

Some products are both. FDA’s examples include an antidandruff shampoo and moisturizers or makeup marketed with sun-protection claims; such products must meet the requirements for both cosmetics and drugs.²

What decides which category a product is in

The word “peptide” on a label does not decide it. FDA says whether a product is a cosmetic or a drug under the law is determined by its intended use, and that intended use can be established by claims on the labeling, in advertising, on the internet or in other promotional material; by consumer perception; and by ingredients with a well-known therapeutic use.² The practical consequence is on the next page in this cluster: which wording moves a serum from cosmetic to drug.

What FDA can still do about a cosmetic

No premarket approval does not mean no rules. The law prohibits marketing adulterated or misbranded cosmetics in interstate commerce, and FDA requires an ingredient list on cosmetics sold to consumers at retail.¹ FDA can pursue action through the Department of Justice, including by seeking a restraining order.¹ FDA says that under MoCRA it can order a mandatory recall if the responsible person refuses to recall voluntarily and there is a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious adverse health consequences or death.⁵ Because FDA does not approve cosmetic claims before sale, FDA notes that some cosmetics carry claims that go beyond what the law permits, and it monitors the market and can act on them.⁴

Outside the United States

Everything above is US law. Other countries use different categories and different words. Where this site has covered them, see the UK, Canada and the EU.

What this page is not

This page explains a legal concept. It is not a check of any product, and it does not say a given serum is safe, effective or properly labeled. To see which products we have checked against our published standard, go to Check a product; the rules we check against are on How we check. The broader question of which peptides are legal in which form is on Are peptides legal?

As of this review, and what would change it

We will revise and date this page if FDA revises any of those pages, if Congress changes FDA’s authority over cosmetics (FDA notes that would take an act of Congress),¹ or if a reader shows us an error. To report one, use the “Report an error” topic on About.