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Is My Cosmetic, Soap, or Aromatherapy Product Subject to FDA Labeling Regulations?

Steve Leung Jan 1 Updated Jun 12
How to label cosmetics, soaps, and aromatherapies in accordance with the FDA

The Food and Drug Administration (FDA) is an organization dedicated to protecting our health. As manufacturers of cosmetic, soap, and aromatherapy products, it's your responsibility to comply with the rules and regulations outlined by the FDA. The information below will help you understand those guidelines and ensure your product is providing consumers with the necessary information they need to stay safe and healthy.

How are cosmetics, soaps, and aromatherapies regulated?

The FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act was created in 1938, authorizing the FDA to oversee the safety of food, drugs, and cosmetics. However, it does not require that cosmetics receive FDA approval before going to market, paving the way for the FPLA in 1967. The FPLA directs the Federal Trade Commission (FTC) and FDA to issue label regulations for all consumer commodities.

How does the FDA define a label?

Both the FD&C Act and the FPLA define the term 'label,' but their descriptions vary. According to the FD&C Act, a label is "a display of written, printed or graphic matter upon the immediate container," whereas under the FPLA, it is a "written, printed or graphic matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity."

What category does my product fall under?

The following definitions were pulled from the FDA website in order to help you identify your product category. Note: The categories are not mutually exclusive, e.g. a cosmetic can also be a drug.

Cosmetics

"Product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Soaps

Products mainly composed of the alkali salts of fatty acids which can be the only material that results in the product's cleaning action. If your product meets this definition, it falls under the Consumer Product Safety Commission (CPSC). If the product is intended to moisturize the skin, make the consumer smell nice, deodorize the user's body, or if it contains synthetic detergents, it's a cosmetic. If it is intended to treat or prevent disease, such as by killing germs or treating skin conditions, it's a drug. The FDA has created a Soap FAQ which addresses many questions regarding soap labeling requirements.

Aromatherapy & Essential Oils

Aromatherapy products are regulated based on their intended use: If the intended use is only to cleanse the body or to make a person more attractive, it's a cosmetic. If the use is therapeutic, such as treating disease or affecting the function of the body, it's a drug. If the intended use is akin to air fresheners and scented candles, it falls under the purview of the CPSC.

Visit the FDA's page on aromatherapy for additional information.

Drugs

"Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals."

How do I label my cosmetics to comply with the FDA?

The FDA's cosmetic labeling guide includes sections on label placement and label content, as well as prominence and type size. We've summarized some of the most important points:

  1. Necessary content includes the name of the product, net quantity of the contents, directions for safe use, any warnings, an ingredient list, and the business information.
  2. If there is more than one label, the required information must be on the principal display panel (the label most likely to be shown under customary conditions for sale).
  3. The label has to be large enough that the required information is prominently displayed in a type size that is easy to read.

The FDA has created a small business and homemade cosmetics fact sheet for more frequently asked questions.

If my product falls under the drug category, how do I label it to comply with the FDA?

As you might expect, the requirements for labeling drugs are more extensive than they are for the products listed above. Refer to the FDA's Drug Guidances on labeling for the specific label requirements they are subject to.

Are there any other key pieces of information I should know?

The FDA guidelines require you list the ingredients in weight order, from heaviest to lightest, and under their most commonly accepted industry standard names.




OnlineLabels.com maintains a huge selection of blank labels available for you to customize and adhere to your cosmetics, soaps, aromatherapies, and other consumer goods. We offer a variety of labels in different sizes and materials. Not sure where to begin? See what other OnlineLabels.com customers have created in our Customer Ideas gallery.

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