After the FDA came down on an aloe-based beauty brand’s structure/function claims, I asked New Hope Natural Media’s Standards Department to lend its advice. Here’s how (and how not) to market your beauty product to meet FDA regulations and show at one of our Natural Products Expos.
Science and research come up a lot in the natural beauty industry, particularly as more and more natural companies are relying on plant-based ingredients that have proven benefits for appearance. The use of such ingredients is a good thing. It means better quality and higher performance.
But how manufacturers present this information can get them into deep you know what if they don’t approach it properly. Granted, most cosmetics regulations are loose under the Food, Drug, and Cosmetic Act.
For example, personal care companies can formulate with any ingredient, whether it’s proven to be safe or not, and don’t need to test ingredients for safety before entering the market. However, the act does require cosmetics companies to be careful about making therapeutic structure/function claims that put them into “drug” territory.
No-no cosmetics claims
The FDA just came down on an aloe-based beauty brand, Set-N-Me-Free Aloe, for various claims deemed unacceptable for cosmetics. Some didn’t seem so egregious and show where compliance can get murky.
The company stated that its products are “helping to renew skin flexibility by making regeneration of skin cells occur faster.” We’ve heard that before about beauty products. Other claims were, well, check them out:
- Apricot kernel oil is a “natural source of cancer fighting laetryl lipids”
- Aloe “can alleviate pain deep below the surface”
What was wrong with all of them—including the first? Each states that the products can change the structure of the body, not just the body's appearance.
We talk about FDA compliance quite a bit more with supplement and functional food companies, but this goes to show that beauty companies have to be careful about their claims, too.
Regardless of the industry, there is plenty of confusion, which is precisely why New Hope Natural Media has an entire standards division dedicated to helping manufacturers comply with FDA regulations. Any company that wants to show at one of our expos or advertise with a New Hope publication must pass their companies through the division.
I asked our standards department how it would have advised this company, and here's what the team had to say.
Are your beauty products FDA compliant?
The FDA considers that if a statement about a product or ingredient claims to diagnose, mitigate, treat, cure, or prevent disease or if it has an effect on a specific disease, class of diseases or on the characteristic signs or symptoms of a disease, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.
The FDA defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." Note that while cosmetics may alter the appearance of the body, they may not alter the structure or function of the body. For example: “Reduces the appearance of fine lines on the face,” but not “Reduces cellulite and fat cells to slim down your thighs.”
Labeling (including brochures, sales sheets, catalogs, booth signs and websites) for cosmetic products cannot make direct or implied claims or statements that the product or any of its ingredients are intended to treat, prevent, cure or mitigate a disease or abnormal health condition
Examples of acceptable cosmetics claims: Helps maintain healthy, smooth skin; Gives your complexion a youthful glow; Moisturizes your skin; Lends a soothing, relaxing feeling (for bath products, for example)
- Examples of unacceptable drug claims: Relieves muscle pain; May help treat psoriasis/eczema/dermatitis; Helps with depression; Helps with insomnia; Works transdermally to repair joints and tendons. “Topicals” can have surface effects only, not internal benefits or actions.
How do you keep your cosmetics compliant? Share in the comments.