Are Cosmetics Regulated by the FDA?

We shed light on the regulations you need to be aware of as a cosmetics manufacturer.

It’s important as a maker of cosmetic and beauty products to be aware of regulations that you need to comply with.

What is the FDA?

The Food, Drug Administration (FDA) develops regulations based on the different laws set by the Food, Drug and Cosmetics Act (FD&A Act). This act helps to protect public health by ensuring that drugs and devices are safe for human and animal use.

If your product meets the conditions of FDA’s definition of soap, it is regulated by the Consumer Product Safety Commission (CPSC) and not FDA. While if your product is a cosmetic, it is regulated by the FDA. This is why it’s really important to know which of your products falls under the category of “soap” and which is actually a “cosmetic”.

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Hybrid Regulations

Products can be considered both a cosmetic and drug by the FDA if the product results in improving appearances and causing a change. Products that are known as drugs by the FDA are those that affect the way one’s body works.

Some of these products include anti-dandruff shampoos and SPF moisturisers. As these products have different uses, such as SPF moisturisers helping to protect one from the sun and moisturise skin, they are considered both a cosmetic and drug.

These hybrid products will need to adhere to both drug and cosmetics regulations.

As the FD&A Act does not recognize cosmeceuticals, products can only be a drug, cosmetic, or both.

Organic Cosmetics

To label your product as “organic”, your product will need to comply with the FDA regulations for organic products.

The FDA regulates “organic” products through the US Department of Agriculture (USDA). This term is regulated through 3 different ways — production, handling and labelling.

Although the USDA requirements for “organic” products are different from FDA’s regulations, these organic cosmetic products will need to comply with both USDA and FDA regulations.

Note that an ingredient’s source does not determine its safety. You will still need to comply with FDA’s safety requirements.

Product Labels

Cosmetics that are marketed in the United States, regardless of whether it is manufactured locally or abroad, must be in compliance with the FD&A Act and the Fair Packaging and Labelling Act (FP&L Act).

According to FDA, labelling means “all labels and other written, printed or graphic matter on or accompanying a product”. All products that include false or misleading labels will be considered misbranded and may result in regulatory actions.

Safety of Ingredients

While there are no specific tests to demonstrate the safety of products and ingredients, companies and individuals are legally responsible to ensure the safety of their own products. FDA has stated that products can be demonstrated as ‘safe’ through:

  • Toxicological test data on individual ingredients
  • Performance on any other tests in light of existing information and data

Import and Export

If you are exporting your products overseas, you may also need to comply with that particular country’s regulations. According to FDA, an exported product will not be considered misbranded if it:

  • Meets the requirements of the foreign country
  • Is not in conflict with laws of the foreign country
  • Labelled as a product intending to be exported
  • Is not offered for sale in domestic commerce

If you are exporting products to a particular country, it is your responsibility to ensure that your products comply with the regulations in that particular country.

Do note that if you intend to sell these exported products in the US, it will also need to comply with FDA’s regulations.

Nicole Pascoe Nicole Pascoe - Profile

Written by Nicole Pascoe

Nicole is the co-founder of Craftybase, inventory and manufacturing software designed for small manufacturers. She has been working with, and writing articles for, small manufacturing businesses for the last 12 years. Her passion is to help makers to become more successful with their online endeavors by empowering them with the knowledge they need to take their business to the next level.