Do skin care products have to be FDA approved?

Author: Mikayla Larkin  |  Last update: Wednesday, July 9, 2025

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.

Can you sell products without FDA approval?

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.

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.

Do products have to be FDA approved?

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.

What happens if not FDA approved?

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.

New FDA Cosmetic Regulations WILL Affect Small Businesses

Can I sell homemade skin care products?

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.

Who regulates skin care products?

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.

Is retinol FDA-approved?

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.

Does the FDA regulate lotion?

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 homemade sunscreen?

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.

How do I get my product approved by 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.

Can products be sold without FDA approval?

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.

What makeup brand is the cleanest?

  • Merit Beauty. Cruelty free. ...
  • 100% Pure. American made. Cruelty free. ...
  • RMS Beauty. Cruelty free. Eco friendly packaging. ...
  • Kosas. Cruelty free. Eco friendly packaging. ...
  • Alima Pure. 1% for the planet. Cruelty free. ...
  • Saie. 1% for the planet. Climate neutral. ...
  • Cheekbone Beauty. 1% for the planet. BIPOC Owned. ...
  • Axiology. American made. Cruelty free.

Can you sell homemade lip balm?

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.

Who should avoid using retinol?

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.

What if a vitamin is not FDA approved?

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.

Is o two o FDA approved?

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).

What is not regulated by the FDA?

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.

How do I start my own skin care brand?

How to Start a Skincare Line
  1. Identify your place in the skincare market. ...
  2. Define your target market. ...
  3. Write a business plan. ...
  4. Choose your brand name and logo. ...
  5. Incorporate your skincare business. ...
  6. Find a skincare product manufacturer or supplier. ...
  7. Meet FDA regulations. ...
  8. Choose a price point for your items.

Do you need a license to sell skincare on Etsy?

Etsy's seller policies do not require you to have a business license to sell on their platform.

Does handmade soap need FDA approval?

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.

Previous article
What is hair loss an indicator of?
Next article
What ethnicity has golden skin?