Why “Private Label Cosmeceuticals” Has No Legal Meaning
If you are sourcing private label cosmeceuticals, the first thing worth knowing is that the FDA does not recognize the word. “Cosmeceutical” has no meaning under the Federal Food, Drug, and Cosmetic Act — the agency says so in plain terms. A product you launch under your own label is either a cosmetic, a drug, or both, and which one it is depends on the claims you make, not on the category you put it in.
That matters because the compliance floor under every US brand owner moved. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest expansion of FDA authority over cosmetics since 1938, and its obligations land on the brand whose name is on the label — not on the factory.
“Cosmeceutical” is a marketing word, not a regulatory one
The industry uses “cosmeceutical” for a cosmetic marketed with drug-like benefits: peptides, retinoids, exosomes, actives that sound clinical. The FD&C Act has no such middle category. A cosmetic is something applied to the body “for cleansing, beautifying, promoting attractiveness, or altering the appearance” [sec. 201(i)]. A drug is something intended to diagnose, cure, mitigate, treat or prevent disease, or to affect the structure or any function of the body [sec. 201(g)(1)].
Read that second half again. You do not need to mention a disease to be selling a drug. “Regenerates cells”, “restores hair growth” and “reduces cellulite” are all listed by the FDA as claims that establish a product as a drug, because each asserts an effect on structure or function.
Intended use is established by everything you publish
The trap for a private label launch is that intended use is not decided by the label alone. The FDA establishes it from claims “stated on the product labeling, in advertising, on the Internet, or in other promotional materials”, from consumer perception, and from ingredients with a well-known therapeutic use (fluoride in toothpaste is its example).
In practice your compliant jar can be made non-compliant by a product page, an affiliate’s script, a paid ad or a founder interview. The formula did not change; the intended use did. Categories with a finalized over-the-counter monograph — acne products, dandruff and psoriasis products, sunscreens — are the fastest route into drug status, because a claim in those areas has a drug pathway waiting for it.
What MoCRA put on the brand owner, not the factory
MoCRA introduced the “responsible person”: the manufacturer, packer or distributor whose name appears on the label. If that is your brand, these are yours:
- Product listing. Each marketed cosmetic product must be listed with the FDA, including its ingredients, with updates annually.
- Safety substantiation. You must hold records supporting adequate safety substantiation. The FDA mandates no specific test and does not require animal testing — but it does expect the data to come from scientifically robust methods, and it can ask to see the records.
- Serious adverse event reporting within 15 business days, with a copy of the retail label, plus any follow-up information received within a year.
- Facility registration, which sits with whoever manufactures or processes, renewable every two years from the initial registration date.
Small-business exemptions from GMP, registration and listing exist, but they do not apply to products that contact the mucous membrane of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours without consumer removal. Several fashionable “cosmeceutical” formats sit inside those carve-outs, so check before relying on the exemption.
What to settle with a manufacturer before the first sample
The useful conversation is not “can you make a cosmeceutical”. It is: here is the claim I intend to make, is this a cosmetic or a drug, and can you document it. Ask where the safety substantiation file will come from, who holds the stability data, and whether the facility works to a recognized GMP standard. FDA’s draft cosmetic GMP guidance was revised with reference to ISO 22716:2007, which is why that certificate is a reasonable proxy to ask for while the statutory GMP rules bed in.
One more distinction worth getting right: cosmetics and their ingredients need no premarket approval, with the exception of color additives. The FDA does not approve cosmetic products, and it does not approve the facilities that make them. Registration is a filing obligation and an inspection trigger. A supplier who blurs that line is telling you how they will handle your paperwork later.
Practical takeaways
- Write the claim first. The claim decides the regulatory category; the formula follows it.
- Audit every surface, not just the carton — site, ads, affiliate scripts and interviews all establish intended use.
- Treat structure-or-function wording as the real risk line, not disease wording alone.
- Confirm in writing who the “responsible person” is, and who holds listing, substantiation and adverse-event duties.
- Ask for a current ISO 22716 cosmetics GMP certificate and verify it with the issuing body rather than accepting a logo.
- Check your format against MoCRA’s small-business exemption carve-outs.
Moe’s Group manufactures skin care, hair care and body care under white label and custom formulation at an ISO-certified, FDA-registered facility in Chatsworth, California; the certificates are downloadable on our certifications page. If you have a claim you want to make and need to know whether it is a cosmetic, bring it to the product inquiry form.
— The Moe’s Group Newsroom
