Marketing Claims Turn Cosmetics Into Drugs

This warning letter shows us where the line is between allowable cosmetic claims, the "not really okay structure-function claims, and disease claims. In this letter, the disease claims tipped the scale to regulatory action.

Cosmetics have a narrow definition of what types of marketing claims are allowed. First, let's start with FDA's cosmetic definition. "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." This is very narrow and leaves little room for bold marketing statements.

Structure-function claims. Although not permitted for cosmetics FDA tends not to cite cosmetic companies for making lighter "supplement" structure-function claims such as "joint comfort" or "promotes skin elasticity." In this example, the company was making supplement-style claims about an ingredient in the formula. These types of statements, while not ultra-high risk, should still be avoided.

• From warning letter. "Magnesium Chloride helps with the normal functioning of cells, nerves, bones, and the heart."

Disease claims. Here are some examples that cross the compliance line.

From warning letter.

• "5 Benefits of Natural Progesterone Cream: Treats Fibroid Tumors . . . Helps Endometriosis"

• "Lower the risk of urinary tract infections (UTIs)"

•  "May help relieve skin flares caused by Psoriasis & Eczema"

GMP violations. This warning letter also includes GMP violations, such as the very common "you didn't test your glycerin for DEG" citation. I write more about this here. 

Cosmetics and supplements are not FDA-approved. I typically don't take pleasure in other company's misfortunes, but I rather enjoy seeing "FDA-approved" statements called out in warning letters. This serves as a reminder that cosmetics and supplements are not "FDA approved," which differs from "FDA registered." Interestingly, the website's "FDA approved" statement and the ambiguous website "FDA inspected and certified facility" claim were cited. I doubt the label claims would have been called out in this letter without the blatant "FDA-approved" website claims. I will add this to my Apex Compliance keyword lists, which helps companies find and replace risky statements before they lead to lawsuits or letters.

• ·From warning letter.  "the website for Magnesium 50 mg Body Cream includes the image of a blue circle with the claim, "FDA * APPROVED * FACILITY." Further, the product labels and/or websites for the other seven before-listed products include statements that these products are made or manufactured in an "FDA inspected and Certified Facility," a "Certified FDA registered facility,"

I ran Apex Compliance on this company's website and found lots more very high-risk claims that can lead to additional warning letters or lawsuits. For example, "may help with depression" when promoting vitamin D ingredients. For just $500, I can provide a line-by-line report showing where risky phrases occur, a risk rating, notes, and more. Let me know if interested.

There is a lot more to this letter. Read the full warning letter here. 

DATE ORIGINALLY POSTED: 8/28/24

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.