Pulling Off The Cosmeceutical Tightrope Act; Industry Consultant Offers Tips

Success in the cosmeceuticals game takes a keen knowledge of the fine lines and subtle distinctions that separate cosmetics from drugs, according to Wen Schroeder, president of Seki Cosmeticals.

In planning a marketing approach, makers of cosmeceuticals need to have a clear idea of the level of performance they intend to promise consumers, Schroeder said Sept. 19 at the HBA Regulatory Summit.

"You need to decide right in the beginning what exactly you are going to claim, so that [you can] determine which regulatory sandbox [you] are playing in," she said.

Now a consultant to the cosmetic, chemical and pharma industries, Schroeder held positions at Kimberly Clark in regulatory affairs and product development before going to Seki Cosmeticals.

Companies whose cosmeceutical claims stray too far from traditional cosmetic territory should be prepared to comply with regulations for over-the-counter drugs, Schroeder said.

Negotiating the thin line between the two regulatory regimes is particularly challenging, she noted, because cosmeceutical makers are being pulled in two directions by regulators and consumers.

While regulators maintain that only drugs can claim to alter the function of skin, consumers increasingly are calling for cosmetics that do more than just cover up blemishes. Consumers "want performance, they want more bioactives, they want more functional, they want to veer towards more of a drug," Schroeder said.

But by giving consumers what they want, "are we gradually becoming cosmetic medicines without proper licensing? That's one thing that's worth looking at," she added.

Tricks Of The Trade

Cosmeceuticals are "one of the most controversial topics in the industry," Schroeder maintained. Enticing consumers without running afoul of regulations requires that claims appearing on product packaging be carefully crafted.

"Claims must be related to general cleansing, beautifying, promoting attractiveness or altering appearances," Schroeder said. "Do not imply therapeutic effect unless you are willing to go that route, and try not to suggest that your product will provide structure or function-altering effect."

Schroeder gave some examples of the subtleties to which cosmeceutical companies must be sensitive if they want to escape being roped into the pharmaceutical space and forced to produce clinical substantiation for their claims.

She noted that marketers are free to claim that their cosmeceutical slows or reverses the appearance of aging, not aging itself. Firms can also advertise that a cosmetic product moisturizes and hides blemishes and age spots.

But claiming that a cosmetic "works on a cellular level" or that it bleaches or de-pigments the skin is not acceptable to regulators - even if the ingredients do indeed have that effect, Schroeder said.

Formulating products with vitamins also could invite intervention from regulators if done indelicately. Schroeder explained that it is acceptable to indicate on packaging that a product contains a vitamin provided there is no specific reference to its nutritional effect.

The notation must abide by certain expectations as well. For instance, a personal-care company cannot list "vitamin E" among its product's ingredients; tocopherol, the International Nomenclature Cosmetic Ingredient name, must be used, so as to avoid implying that the ingredient has any therapeutic effect, Schroeder said.

Complicating matters is the fact that marketers of cosmetics have to fit their products into regulatory schemes that differ from country to country.

Regulatory approaches across the globe tend to belong to one of two camps, Schroeder said. The "narrow" camp - which encompasses the U.S., Australia and Canada - holds that cosmetics can have no physiological effect.

On the other hand, Japan and the European Union allow some specific physiological effects, she said. For example, in the EU, an antiperspirant is classified as a cosmetic, while it is both a cosmetic and an OTC drug in the U.S.

- Molly Laas ([email protected])