Regulatory status by market

In brief

Vegalab Beauty Science products are cosmetics, sold globally. Each product is placed on each market under that market's cosmetic rules. In the United States, they are covered by facility registration and product listing with FDA.

United States

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.

Registration is a listing requirement, not an FDA approval or endorsement.

What makes a product a cosmetic. In United States law, a product's intended use decides its category, and its claims are the evidence of intended use. A product that claims to change the structure or function of the body, or to treat a condition, is regulated as a drug. That is why our product pages describe how skin and hair look and feel. The rules we write to are in the science and claims charter.

Serious adverse events. Under MoCRA, the company responsible for a cosmetic reports any serious adverse event to FDA within 15 business days of receiving the report. To report a reaction, use report a reaction.

The question most buyers ask is answered in full in the FDA question, answered.

Canada

The Cosmetic Regulations require the full ingredient list on the label, and Health Canada's Cosmetic Ingredient Hotlist names ingredients that are prohibited or restricted in cosmetics. A product's claims decide whether it is regulated as a cosmetic, a drug or a natural health product, on the same principle as in the United States.

European Union

Regulation (EC) No 1223/2009 governs cosmetics in the European Union and requires them to be manufactured in compliance with good manufacturing practice.

Manufacturing standard

Manufactured in conformity with ISO 22716 cosmetic GMP guidelines. What that standard covers, and how conformity is attested, is on manufacturing and GMP.

Nano ingredients

How the regulation of nanomaterials in cosmetics differs by market is set out on nano definitions and regulation.

Sources

• Federal Food, Drug, and Cosmetic Act, section 201(i), 21 U.S.C. 321(i) (definition of a cosmetic)
• Modernization of Cosmetics Regulation Act of 2022 (FDA overview)
• Section 605 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 364a (serious adverse event reporting)
• Section 607 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 364c (registration and product listing)
• Food and Drugs Act, R.S.C. 1985, c. F-27
• Cosmetic Regulations, C.R.C., c. 869
• Cosmetic Ingredient Hotlist, Health Canada
• Regulation (EC) No 1223/2009 on cosmetic products

Related

The science hub sets out how Beauty Science is governed. The commitments behind each lot are in the quality charter.