Do deodorants need FDA approval?
Asked by: Rocky Jast | Last update: October 2, 2025Score: 4.6/5 (22 votes)
What products do not need FDA approval?
The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.
Who regulates deodorants?
In fact, deodorants are considered cosmetic, while antiperspirants are classified as an over-the-counter drug and are regulated by the Food and Drug Administration (FDA).
Do skin products have to be FDA approved?
The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded.
Are fragrances regulated by the FDA?
Fragrance ingredients in cosmetics must meet the same requirement for safety as other cosmetic ingredients. The law does not require FDA approval before they go on the market, but they must be safe for consumers when they are used according to labeled directions, or as people customarily use them.
Is Aluminum Bad For You? (In Deodorants)
Does deodorant need FDA approval?
Some examples are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, shampoos, permanent waves, hair colors, toothpastes, and deodorants. These products and their ingredients are not subject to FDA premarket approval, except color additives (other than coal tar hair dyes).
Can you sell products without FDA approval?
You could have an amazing product that checks off all the boxes for making a profit—low competition, affordable manufacturing costs, high demand—but if it's not approved by the U.S. Food and Drug Administration (FDA), it can't be sold. That's why understanding the implications of FDA compliance upfront is so important.
Does toothpaste require FDA approval?
Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market.
Do I need FDA approval to sell bath bombs?
Most of the bath bombs we list below are considered cosmetics and are treated like soaps or lotions by governing bodies. If you plan on marketing your bath bombs for their medicinal benefits, your products must be FDA approved for effectiveness as well as safety.
What products need FDA?
The FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic ...
Who can prescribe deodorant?
If nonprescription products don't help control your sweating, your doctor may prescribe a stronger product. These are strong solutions that can cause rashy, swollen and itchy skin in some people.
Is Lume deodorant FDA approved?
A: Even though Lume is in the cosmetic category and does not require FDA approval, Lume and its manufacturers are in compliance with FDA regulations for manufacturing.
Is there a restriction on deodorant?
The TSA prohibits containers with more than 3.4 ounces of liquid in carry-on luggage, so if you have a liquid or semi-liquid antiperspirant, be sure to check the quantity on the container. For example, many stick deodorants and antiperspirants come in sizes under 3.4 ounces, so it's fine to bring in your carry-on bag.
Does everything have to be FDA-approved?
While not all products require pre-approval by the FDA, the FDA still has regulatory authority in the event of public safety concerns. The FDA has regulatory authority in the event of a public safety issue related to your product.
Is Cerave FDA-approved?
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE unauthorized cosmetic product, CERAVE MOISTURISING LOTION FOR DRY TO VERY DRY SKIN.
How to know if a product is not FDA-approved?
Look up the drug or biological product in Drugs @ FDA.
Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.
Does shampoo need FDA approval?
Under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is color additives (other than coloring materials used in coal-tar hair dyes), which must be approved for their intended use.
Can you sell soap without FDA approval?
Neither the product nor its ingredients need approval by FDA before they go on the market, except for any color additives it contains. It is your responsibility to make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled.
Does perfume need FDA approval?
Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.
Is deodorant FDA approved?
Anti-perspirants/Deodorants
The anti-perspirant component still requires an approved aluminum compound as the active ingredient. Because of this, all anti-perspirant/deodorant products are considered OTC drugs and are regulated by the FDA.
Can I sell homemade lotion?
The items must appear safe and sanitary. As long as the soaps and lotion/balms are not being sold by making health claims as cures or treatments they can be sold at farmer's markets. The FDA has provided guidance for small businesses and homemade cosmetics makers in a fact sheet.
Do toothbrushes need FDA approval?
A manual toothbrush is 510(k) exempt, meaning it does not require premarket notification or approval.
Do I need a license to sell body butter?
The Food and Drug Administration does not license cosmetic firms for product sales.
Is nail polish FDA approved?
Under the law, cosmetic products and ingredients, including nail products, do not need FDA approval before they go on the market, with the exception of most color additives.
Is it OK to take something not FDA approved?
Unapproved medication
There are still some medications that have never been approved by the FDA for any use. No one should take these drugs. If a medication has never been through the FDA approval process, we don't know enough about it to know if it is safe.