Selling products in certain countries, specifically any products that are used either on the body or are ingested into the body, will require compliance with the United States Food and Drug Administration (FDA). The organization is responsible for determining requirements that must be put on labels in order to sell cosmetics, personal care or ingestible products like supplements, food or health products in the United States. In order to be in compliance with the FDA, here is some information about the FDA labeling requirements for cosmetic products to be able to sell your products to consumers within the United States.
The Food & Drug Cosmetic Act
To be in compliance with the FDA, cosmetics companies must be in compliance with the Food & Drug Cosmetic Act which is detailed here. The law specifies that there is a clear definition of what is and isn’t a cosmetic, and that there is a difference between cosmetics and cosmetics that are also drugs. The latter should only concern skincare sellers, but cosmetics makers should be aware of the key differences before they begin selling their products in order to make sure their ingredients are in compliance.
The Act defines cosmetics to be “articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.” Cosmetics with active ingredients such as retinol may be considered a cosmetic that is also a drug, so it’s important to work with US regulations on how much of the active ingredient can be present in the product in order to be sold over the counter (not as a prescription). Ingredients that the FDA often considers “active” include things like Alpha-Hydroxy Acids, fragrance, parabens and talc. For a complete list, check here. Understand that, in order to use certain ingredients, you may need to consistently register your product with the FDA.
The biggest thing that the FDA urges cosmetics companies and makers to be careful of is the claims that are being made in the product. While it is important to make sure that your ingredients are in compliance, it’s equally important to make sure that your labels do not make claims that could imply your product can be used to treat a diagnosable illness, disease or disorder. An example of this would be mislabeling your product as sun protecting if it does not contain an SPF.
It’s important to understand the difference between claiming that your product can cure an illness as opposed to treating a symptom. For example, an acne-treating skincare product containing 1.5% Salicylic Acid may be used to treat symptoms of acne, but cannot be labeled as a cure for acne. Here is a complete guide on how to navigate around label claims, determine what you can say on your packaging, and where your ingredients must be listed on your packaging to be FDA compliant.