Product rules
Beauty, wellness and kids’ products have extra rules.
If you make skin care, hair care, supplements or anything for children, here’s what the FDA, FTC and CPSC say.
Cosmetics you make yourself
-
Claims can turn a cosmetic into a drug
FDA decides whether a product is a cosmetic or a drug by its intended use, and claims on labels, ads, and websites help establish that use. Claims like restoring hair growth or reducing cellulite can make a product a drug, even if it's sold as a cosmetic.
Source: FDA, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
-
Making cosmetics at home
It's legal to make cosmetics at home, but the maker is responsible for producing them in conditions that won't make them adulterated, for example through microbial contamination.
Source: FDA, Small Businesses & Homemade Cosmetics: Fact Sheet
-
Safety and labeling responsibility
FDA doesn't approve cosmetics or their ingredients before sale, except color additives. Anyone who makes or markets cosmetics is legally responsible for their safety and labeling.
Source: FDA, Small Businesses & Homemade Cosmetics: Fact Sheet
-
Business address on cosmetic labels
Cosmetic labels must name the manufacturer, packer, or distributor and its place of business, including street address, city, state, and ZIP code. A P.O. box or website doesn't meet this requirement.
Source: FDA, Small Businesses & Homemade Cosmetics: Fact Sheet
-
Ingredient list and net quantity
Cosmetic ingredients must be listed in descending order of predominance. The front panel must show the product's name, what it is or does, and an accurate net quantity of contents.
-
"Natural" and "organic" labels
FDA hasn't defined "natural" for cosmetic labels and has no cosmetics rules for "organic," which USDA regulates for agricultural products. All cosmetic labeling still has to be truthful and not misleading.
Source: FDA, Small Businesses & Homemade Cosmetics: Fact Sheet
MoCRA, the 2022 cosmetics law
-
MoCRA became law
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became law on December 29, 2022. Initial facility registration was due by December 29, 2023, and FDA said it wouldn't enforce registration until July 1, 2024.
-
MoCRA small business definition
Under MoCRA, a small business averages less than $1,000,000 a year in US cosmetic product sales over the previous 3 years, adjusted for inflation, and doesn't make or process certain product types listed in the law.
-
What the small business exemption covers
MoCRA exempts qualifying small businesses from good manufacturing practice, facility registration, and product listing requirements. The exemption doesn't apply to makers of products that regularly touch the eye's mucus membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours.
Source: FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
-
Adverse event reports and safety records
The responsible person named on a cosmetic label must report serious adverse events to FDA within 15 business days and keep records supporting the product's safety. FDA describes the small business exemption as covering GMP, registration, and listing, not these duties.
Source: FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
-
Contact info for adverse event reports
Each cosmetic label must include a US address, US phone number, or electronic contact information, which can be a website, where the responsible person can receive adverse event reports.
Supplements and wellness claims
-
Supplement and wellness claims
The FTC's Health Products Compliance Guidance (December 2022) says claims about the health benefits or safety of dietary supplements and other health-related products need competent and reliable scientific evidence.
-
Health and safety claims need science
Health or safety claims usually need competent and reliable scientific evidence. Statements from happy customers usually aren't enough to support them.
Products for children
-
Children's products need testing
In general, makers and importers of children's products must have them tested by a CPSC-accepted third-party lab and certify compliance in a Children's Product Certificate (CPC).
Source: CPSC, Small Batch Manufacturers and Third Party Testing
-
Who's a small batch manufacturer
A small batch manufacturer makes no more than 7,500 units of a covered product in the previous calendar year and stays under a total revenue limit. CPSC's page shows that limit as $1,436,864 in its example for calendar year 2022, so check the current figure with CPSC before you rely on it.
Source: CPSC, Small Batch Manufacturers and Third Party Testing
-
Small batch makers must register yearly
Qualifying doesn't bring relief automatically. Small batch makers must register with CPSC on SaferProducts.gov, and registration is good for the current calendar year only.
Source: CPSC, Small Batch Manufacturers and Third Party Testing
-
Some tests are never waived
Registered small batch makers can use lower-cost ways to show compliance only for Group B rules. Group A rules, such as lead in paint, small parts, pacifiers, and lead in children's metal jewelry, always need third-party testing, and a Children's Product Certificate is still required.
Source: CPSC, Small Batch FAQ