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.
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.
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.
Not all such products require FDA approval before going on the market. Most are, however, under the regulatory authority of the FDA in the event of safety-related concerns. Below is a list of the type of products that are regulated by the federal government.
Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality or whether their label is complete and accurate.
Yes. FDA regulates cosmetics under the Federal Food, Drug and Cosmetic Act (FD&C Act). Under MoCRA, which expanded FDA's authority under the FD&C Act law, cosmetics must not be adulterated or misbranded.
The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) . FDA regulates cosmetics under the authority of these laws.
Retinol is a Cosmetic Ingredient that is Not FDA-Approved
This means that, when retinol is applied to the skin and absorbed, it is converted into tretinoin over multiple steps. Tretinoin is the compound with the anti-aging effects. Retinol is included in many over-the-counter skincare products but is not FDA-approved.
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.
However, if you plan to sell cosmetics that contain APIs (active pharmaceutical ingredients) like sunscreens, salicylic acid, antiperspirants and others, then you do need to register your business and your products with the FDA.
A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.
New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.
Did you know that six out of ten women use lip balm*? That makes it more popular than lipstick! You can start serving this massive market by manufacturing and selling your own lip balm today. It's an easy and inexpensive product to make, which makes it a great choice for new entrepreneurs.
Avoid retinol products if you have a sunburn, broken skin or other skin irritations. Use SPF 30 and wear sun protective clothing and hats to reduce your exposure to the sun. Ask your healthcare provider about the best time to apply moisturizer as part of your skincare routine.
In general, FDA is limited to postmarket enforcement because, unlike drugs that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to approve dietary supplements for safety before they reach the consumer.
The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, O. TWO. O MATTE LIP TINT KISS PROOF MASKPROOF 24H LONG LASTING LIQUID (VLG 1, VLG 2, VLG 3, VLG 4, VLG 5, VLG 6, VLG 7, VLG 8, VLG 9, VLG 10, VLG 11, VLG 12).
The FDA does not regulate alcohol, consumer products, illegal drugs, or health insurance. It's easy to make this mistake given the agency's proximity to those things, but the lines are very intentionally kept clear.
Etsy's seller policies do not require you to have a business license to sell on their platform.
You don't need FDA approval to sell soap if it meets the regulatory definition of soap and is marketed solely for cleansing. If you market your product as moisturizing or you make any therapeutic claims, it may be classified as a cosmetic or drug, which requires following different regulations.