Invented in 1984 by Dr. Albert Kligman as a way to describe innovative skincare products that have a physiological impact, cosmeceuticals are products sold as cosmetics that offer more substantial results. Initially defined by Kligman as “a topical preparation that is sold as a cosmetic, but has performance characteristics that suggest pharmaceutical action,” many products designed to promote anti-aging fall into this realm, as they offer benefits more substantial than cosmetics, but not as powerful as drugs.

Cosmeceuticals and the FDA

The Federal Food, Drug, and Cosmetic Act does not recognize cosmeceuticals as a separate category. Products are simply grouped as either drugs or cosmetics, depending on their intended use. Basically, the cosmeceutical designation is nothing more than a marketing term used to let customers know they’re buying a product that may offer more substantial benefits than a standard cosmetic item.

Pharmaceuticals often contain ingredients like vitamins, alpha-hydroxy acids, botanicals, and peptides that offer healing benefits, but don’t require approval by the U.S. Food and Drug Administration. Instead of touting the results of clinical trials — that may or may not have been conducted — to promote products, companies often sidestep FDA scrutiny by using the testimonials of real people.

Cosmeceuticals and Customers

While cosmeceuticals have been around for more than 30 years, the somewhat mysterious nature of this category is often confusing to consumers. Many see the seemingly official sounding word and assume products have been approved by the FDA, when in reality, they’re subject to very little, if any scrutiny.

As discussed earlier in our consumer safety series, cosmetic items — with the exception of color additives — are not governed by the FDA. However, drugs do require FDA premarket approval, but many consumers are not aware of this distinction. It’s important to be honest and upfront with buyers, because once you lose their trust, it can be impossible to gain it back. Making overly ambitious claims about the benefits of a cosmeceutical may technically be legal, but it will eventually tarnish your brand image.

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