In 2018, the U.S. was considered the most valuable beauty and personal care market in the world, generating approximately 89.5 billion U.S. dollars in revenue that year. A dynamic market that attracts both local entrepreneurs and international companies!
But how to sell cosmetics in the U.S.? How are beauty and personal care products regulated? And by whom? What are the key steps to follow to ensure success?
Our regulatory experts provide you with a quick sum-up of the key points you need to have in mind! To study your compliance project in more detail, please contact us.
Who regulates cosmetics in the U.S.?
The FDA (Food and Drug Administration) regulates cosmetic products in the U.S. at a national level, with the FD&C Act (Food, drug and cosmetics Act). Other legislations also has to be followed, such as:
- The Code of Federal Regulation (CFR)
- The Fair Packaging and Labeling Act (FPLA)
In addition, certain states also have their own regulations to complete the ones at national level. It’s the case of California, with the California Safe Cosmetic Program (CSCP), that is more stringent than the FD&C Act.
Definition of a cosmetic product
What is a cosmetic product? The exact definition can vary from a country to another, and substantially impacts the regulation of your product. In the U.S., you should double check if your product is considered as a cosmetic, an OTC or even a medical device!
> To know the difference between an OTC or a cosmetic, read this article! <
The FD&C Act defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance".
10 things you need to know for selling cosmetics in the U.S.
1/ Product registration isn’t mandatory
In the U.S., it’s not mandatory for cosmetic products to be registered before launch on the market. However, you can participate in FDA's Voluntary Cosmetic Registration Program (VCRP) using the online registration system:
https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program
“If it’s not mandatory, why should I register my products?”, you may wonder. Well, because it’s a good way to be absolutely sure you have all the information required to prove that your product is safe, and it can also help you prevent product recalls or other problems due to ingredient issues!
- 2/ Safety assessment is very important
Even if product registration isn’t mandatory, you still need to be able to prove that your product is safe and you are responsible for it!
Cosmetic firms are required to assess and demonstrate the safety of ingredients and finished products for an intended use. In case of control by the FDA, you, as a cosmetic firm, need to be able to refer to data on individual ingredients to prove their safety.
- 3/ Products testing may be required
As you are responsible to ensure that the ingredients of your products are safe for consumers, you may need to run tests to prove it.
The FDA doesn’t provide a specific set of tests or documents to prove products’ safety. It is up to manufacturers, importers, or distributors to determine what are the tests required to prove the safety of ingredients used.
- 4/ Adulterated cosmetics are forbidden
Adulteration is the term used to describe a violation of safe cosmetic composition as a result of "[the] ingredients [used], contaminants, processing, packaging or shipping and handling." Generally, a cosmetic has been considered adulterated if the composition:
- Contains a poisonous or deleterious substance which would cause harm under prescribed use
- Contains any filthy, putrid or decomposed substance
- Has been prepared, packaged or stored in unsanitary conditions
- Is packaged in any poisonous or deleterious materials
- Contains an unsafe color additive as defined by section 721(a) of the FD&C Act (with the exception of coal-tar hair dyes).
- 5/ FDA controls and enforcements are real
If cosmetic products are found to be adulterated or misbranded, the FDA can seize the products or remove them from the market, either when products are already being distributed or when they’re being imported.
The FDA is also in power of:
- Restraining order against further distribution
- Making recall recommendations and monitoring its progress
- Requesting a company to issue a public notification for public safety
- Issuing a press release concerning the product
The FDA works with the U.S. Customs and Border Protection to prevent non-compliant cosmetics from entering the country. If your cosmetic product is refused entry into the U.S. over a regulatory violation, your company and the product in question will be made public on the FDA's Import Refusal Report.
- 6/ Labeling review is key
The labeling of cosmetic products in the U.S. must be compliant with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act. The "Cosmetic Labeling Guide" issued by the FDA contains all the information you need about mandatory mentions, directions, warnings, sizes, languages and lists of ingredients of your labels.
A label must at least include the following information:
- An identity statement, indicating the nature and use of the product
- An accurate statement of net content
- Name and place of business
- Distributor statement: manufactured by xxx or distributed by xxxx
- Material facts (Failure to reveal material facts is one form of misleading labeling, it makes a product misbranded)
- Warning and caution statements
- Ingredients
Cosmetics’ labeling in the U.S. is something you should take really seriously: if there is an issue with a product, the FDA can claim that labeling is not adequate, and hold you responsible for it.
- 7/ Such as claims review
Be very careful when defining your products’ claims, as it may impact the category of your product. For example, if a cosmetic claims to reduce the appearance of wrinkles, it is regulated as a cosmetic; but if the same product claims to actually get rid of wrinkles, it may be a drug (because it is affecting the structure of the skin).
> To avoid any mistakes, read this article about cosmetic claims regulation. <
Cosmetic products’ claims are regulated by the FDA and the FTC (Federal Trade Commission) and must be truthful and not misleading. If the FDA considers it being marketed with “drug” claims, it can issue warning letters asking the company to either remove the drug claims from their product labeling or to seek FDA approval to market the products as drugs (which can take years and cost millions of dollars).
You must be aware that in the U.S., all communication about a cosmetic product is considered as a claim, including a website, advertisements, social media, etc. You should monitor closely what your partners are saying about your products.
- 8/ Color additives must be approved by FDA
If finished products and cosmetic ingredients don’t need to be reviewed by the FDA before launch, it’s not the case with color additives! All color additives in cosmetic products must be permitted by the FDA before being used.
The FD&C Act regulates ingredients, concentration, specifications, and application areas of the color additives.
- 9/ You should follow the Good Manufacturing Practices (GMP)
The FD&C Act also requires cosmetic manufacturers to observe Good Manufacturing Practice (GMP). The aim of this regulation is to better control manufacturing processes and thus minimize the risk of adulteration or misbranding of cosmetics.
The GMP is a set of principles and guidelines for manufacturing products, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous.
The FDA provides a set of GMP guidelines applicable to the cosmetic, drugs, and food industries, and includes the following:
- Building and facilities
- Equipment
- Personnel
- Raw materials
- Production
- Laboratory controls
- Records
- Labeling
- Complaints
- Others
- 10/ Be advised by regulatory experts
Last but not least, the best way to ensure your products’ compliance in the U.S., is to work with a local regulatory partner. Whether you are a U.S. company or an international one, FDA principles can be tricky to follow and it may be even harder to comply with local regulations of the states you are considering selling in.
Our regulatory experts based in North America know everything about cosmetics regulations in the U.S. and have a 10 year experience in this market. They can help you with:
- Safety Assessment
- Voluntary product registration (VCRP)
- Labeling and claim review
- Color additives registration
- Products portfolio review (OCT, cosmetic, medical device?)
Partnering with local regulatory experts for the launch of your cosmetics, is choosing serenity and success.
Wish to know more about the regulation of cosmetic products in the U.S.?
For more information, do not hesitate to contact Emmanuel Fritsch.
