Is Vegalab FDA approved?

FDA does not approve cosmetics, and no cosmetic product in the United States carries FDA approval or an FDA certificate. Under the Modernization of Cosmetics Regulation Act, cosmetic facilities register with FDA and products are listed with their ingredients; Vegalab's facility registration and product listing have been filed.

Manufacturing is in conformity with ISO 22716 cosmetic GMP guidelines, and the full ingredient declaration is published on each product page.

What MoCRA requires

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest change to US cosmetic law since the Federal Food, Drug, and Cosmetic Act of 1938. It requires facilities that manufacture or process cosmetics for the US market to register with FDA, and requires each cosmetic product to be listed with its ingredients. It also added serious adverse event reporting, safety substantiation and record-keeping duties, and gave FDA authority to order a recall.

Registration is a listing requirement, not an FDA approval or endorsement. FDA does not review a cosmetic before it goes on sale and does not issue certificates for cosmetics. A brand that shows an "FDA certificate" for a serum is showing something FDA does not issue.

The status of each Vegalab filing, by market: regulatory status.

What FDA does approve

FDA approves new drugs, and it regulates over-the-counter drugs through monographs. A product can be a cosmetic or a drug, or both, depending on its intended use as shown by its claims. A product that claims to treat or prevent a disease, or to affect the structure or function of the body, is a drug under US law, whatever it looks like.

That is why sunscreens are regulated as over-the-counter drugs in the United States, while a moisturizer that makes only appearance claims is a cosmetic. See UV filters.

Within cosmetics, the one class of ingredient FDA approves is color additives. With the exception of coal-tar hair dyes, a color additive used in a cosmetic must be approved for that use.

How Canada regulates cosmetics

Canada has no approval system for cosmetics either. Under the Cosmetic Regulations, the manufacturer or importer notifies Health Canada of each cosmetic within 10 days after it is first sold in Canada, including its ingredients. A notification is a filing, not an approval. Health Canada can ask for evidence of safety, and certain ingredients are restricted or prohibited through its Cosmetic Ingredient Hotlist.

As in the United States, the line between a cosmetic and a drug in Canada is drawn by what the product is represented to do.

What you can check yourself

A registration number tells you a filing exists. These tell you more about the product in your hand.

The ingredient list. Every Vegalab product page publishes the full declaration in descending order. How to read one: how to read an ingredient list.

The manufacturing standard. Manufactured in conformity with ISO 22716 cosmetic GMP guidelines. What the standard covers: manufacturing and ISO 22716.

The carton. On a sealed vial set such as Hyaluronic Skin Repair NanoSerum, Sealed Vial Set, every carton carries its expiry date and lot number.

A route for problems. MoCRA requires a US contact for adverse event reports on the label. To report a reaction to a Vegalab product: report a reaction.

Words that sound official

FDA approval, FDA certification and FDA clearance do not exist for a cosmetic. Testing terms on cosmetic labels are not regulatory statuses either. What they can and cannot tell you: what testing claims on a label mean.

Questions from clinics and distributors on regulation and documentation: professional FAQ. More guides: Beauty Science knowledge.

Sources

• Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(i) (definition of cosmetic) and 21 U.S.C. 361; 21 CFR Parts 700 to 740.
• Modernization of Cosmetics Regulation Act of 2022, enacted as part of the Consolidated Appropriations Act, 2023 (Public Law 117-328).
• 21 CFR Parts 70 to 82 (color additives).
• Cosmetic Regulations, C.R.C., c. 869; Food and Drugs Act, R.S.C. 1985, c. F-27.