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 the decisions we make.
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.
The regulation body said that the marketing claims made about these products “indicate that [they] are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with these claims evidencing these intended uses violates the 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 situation highlights the legal implications of marketing products, particularly those classed as ‘cosmeceuticals’ which appear to possess health benefits as well as aesthetic ones; as these are not recogniszed or classified by the FDA.
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.
The latest collection of marketing mishaps highlights further that advertising decisions also have a considerable impact on the entire production and regulation placed on a cosmetic product.
Will the industry continue to market products and make these claims, or will it take not of the increased FDA scrutiny and be more vigilant in their product promotions? We will have to wait and see…