According to the Administration, Cell Vitals creams and moisturizers are more like drugs than cosmetics and it issued a warning letter on November 24th.
The FDA had issues with claims for three products, one a moisturizer, marketed as having “antibacterial” and “anti-cancer” properties.
A cleanser that claimed to strengthen capillaries and to help “heal” the skin as well as a “Stem Cell Eye Cream,” marketed as having the ability to activate collagen synthesis and repair skin damage caused by ultraviolet rays.
According to the FDA, these attributes are reserved for products regulated as drugs, therefore Cell Vitals was called on to immediately stop using these claims or seek approval for them using a New Drug Application (NDA).
FDA cracking down on cosmetic manufacturers
In recent years, a handful of cosmetic manufacturers have come under the harsh scrutiny of the US Food and Drug Administration (FDA) over marketing claims.
When developing products, companies walk a fine line in terms of formulating for efficacy and marketing claims, meaning it is important to understand the regulatory and legal implications of such decisions.
In both cases, the companies were marketing their products in such a way that they should be promoted as drugs under section 201 of the Federal Food, Drug and Cosmetic Act.
It is not just these two companies that are guilty however, as the FDA has been cracking down on the beauty industry in the past few years, particularly on cosmetic companies who have begun to market their cosmetic products using drug-like claims.
The key factor in all this comes down to the ‘intended use’ of the product in question, and this is determined by advertising claims and consumer perception.
If the products claim to provide specific health benefits then they cease to be classed as cosmetic products but rather as a drug, as they are claiming a ‘cure’.
So what’s the big deal?
The problem arises as the classification of the product affects the regulatory process and approval procedure for the product.
Cosmetics do not require any FDA approval before going to market, whereas drugs are either approved by the FDA prior to hitting the market or must conform to preset rules for a particular drug category.