You’re starting your own small business cosmetic line. Congratulations! Before you can begin selling your products, however, you have to make sure they are FDA compliant.
FDA cosmetic regulations can be complicated, but we’ve complied a brief overview of the most important FDA rules to keep in mind.
From ingredients regulations to handmade cosmetic rules, our cosmetics fact sheet will help you jumpstart your own cosmetic company.
Cosmetics Must be Labeled Correctly
The FDA regulates cosmetics, yes even that handmade delicious smelling face lotion you’re making. Under the Federal Food, Drug and Cosmetic Act, any cosmetics you make must not be misbranded or adulterated.
What does this mean for you?
It means your products must be safe for consumers and be properly labeled for them. Your packaging too cannot mislead your customers.
Also, if you plan on selling your cosmetic products to consumers through retail stores, online, or through door-to-door sales you also have an obligation to meet the ingredient labeling requirements according to the Fair Packaging and Labelling Act.
Check out this link for more information about cosmetic labelling laws.
Your Cosmetic Products Don’t Have to Be FDA Approved
That’s right, your cosmetic products aren’t required to be FDA approved. However, this doesn’t mean you’re free to add just any old ingredient to your products. They still must meet those branding and unaltered standards we mentioned above.
Your focus should be on creating products that are safe and labeled properly. The one caveat is if you are marketing or selling products that could also be considered a drug, and not just a cosmetic. Which leads us to our next point…
Know the Difference Between Drugs & Cosmetics, According to the Law
The FDA considers your labeling to determine whether it is a drug or a cosmetic. According to them, a product is a cosmetic if it’s use is for:
- Enhancing a Person’s Appearance
- Or Changing their Appearance
It is considered a drug if it:
- Treats an illness (or claims to)
- Prevents a Disease
- Affects the way the body works
Some products that are regulated under the FDA’s drug laws include:
- Aromatherapy products
- Dietary supplements
For more information in learning the difference between drugs and cosmetic products and regulations, see this link by the FDA about whether it is a drug or a cosmetic.
What You Need to Know About Color Additives
Unlike standard cosmetic ingredients, color additives are regulated by the FDA. If you have a color additive that isn’t directly related to the intended use of the product, then you have to have it approved of by the FDA. This is called “listing regulations” and it’s important to understand which ones require approval. Here is a quick list to get you started.
Cosmetic Product Registration is Voluntary
While the FDA does recommend registering your cosmetic goodies with the Voluntary Cosmetic Registration Program (VCRP) if you’re starting your own makeup line or something more, it is not a requirement.
The one rule, however, is that if you sell both cosmetics and drugs, or drugs, that you must register with this program.
Yes, You Can Make Handmade Cosmetics in Your Home
That’s right, there are no rules or regulations against making cosmetics in your own home or salon. One thing you must keep in mind, however, is that you must keep your products from being tainted by the environment.
Examples of adulterated cosmetics include:
- Microbial contamination (your products don’t have to be sterile but should have a low number of microbes).
- Color additive violations.
- Additional contaminates
See this guideline/checklist for more information about making cosmetics in your home.
Organic and Natural Labeling is Regulated
Thinking about using “natural” or “organic” ingredients in your cosmetics? If so, it’s important to note that the FDA does not have a definition for anything labeled “natural” and therefore doesn’t regulate it. However, avoid using “natural” in your ingredient statement, as that is a violation of FDA regulations.
Organic is the same. Organic labelling is not regulated in cosmetic products. It is regulated within the agricultural industry, however. If you’d like to learn more about how “organic” is labeled and regulated, then head over to this link.
The important think to keep in mind is not misleading or mislabeling your products intentionally.
Testing Not Required!
The FDA does not require you to test your cosmetics before releasing them to the market. Even still, you are solely responsible for making sure your products are safe for consumer use when used according to the directions on the label.
However, it is a good idea to use safety data from similar products to determine the safety of your own handmade cosmetic ingredients. This website is super helpful with finding out if your ingredients are safe.
Exterior Labeling—What You Should Know
Some requirements for your exterior labeling and packaging include:
- List the name and place of your business
- Same for the packer & manufacturer
- Street Address
- City, State, and ZIP code
Additionally, there are some cosmetic labeling requirements regulated by federal agencies. If, for example, you wish to add “Made In USA” to your label, it must meet the Federal Trade Commission’s requirements.
We highly recommend working with a labeling consultant for all your packaging and labeling concerns. They’ll provide you with the best insight into what your products need to be legally acceptable.
FDA cosmetic regulations are complex. They can have you feeling over your head in legalise. We hope our cosmetics fact sheet gives you greater insight into how to properly label and follow regulations when you sell cosmetics. Some additional resources you may be interested in include the following:
-Information about local requirements for cosmetic businesses: The Small Business Administration
-In-depth Guide to FDA requirements: Cosmetic Resources
-Banned or restricted cosmetic ingredients list: Prohibited and Restricted IngredientsFor more information or any questions you have regarding your cosmetic production, simply reach out to us. We’ll be happy to help anyway we can.