Cosmetics or Drugs?

Well the borderline is really thin and even the think tanks at FDA are hard pressed to draw a demarcation between the two. Both can be lethal if taken without any knowledge regarding the ingredients and their side effects..

• Much confusion exists about the status of cosmetic products having medicinal or drug-like benefits, says Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors. Although the FDA does not consider the term “cosmeceutical” to be a valid product class, Katz says it is used throughout the cosmetic industry to describe products that are marketed as cosmetics but that have drug-like effects. Tretinoin (retinoic acid), the biologically active form of vitamin A, for example, is not prohibited from use in cosmetics. However, when it is used topically for treating mild to moderate acne, sun-damaged skin, and other skin conditions, it is recognized by the FDA as a drug. This is because it acts deep at the skin’s cellular level by increasing collagen.

• According to the AAD, the answer to whether or not cosmeceuticals really work lies in the ingredients and how they interact with the biological mechanisms that occur in aging skin. The regulatory question the FDA faces when considering such products, Katz says, “is whether or not a manufacturer is making a structure or function claim.”

• The FDA uses different standards when evaluating the risks and benefits of products used for cosmetic treatments than for therapeutic uses of products. Steven K. Galson, M.D., M.P.H., acting director for the FDA’s Center for Drug Evaluation and Research, adds that products like tretinoin and Restylane that are not indicated for serious or life-threatening conditions are subject to close examination by the agency because of the benefit-to-risk ratio.

• “Because these products are for cosmetic purposes, they must be extraordinarily safe,” Galson says. This means that the FDA may allow someone to incur a greater risk from products that treat medical conditions, rather than from those that are intended for cosmetic purposes. “We generally won’t tolerate much risk for a drug whose primary use is cosmetic,” he says.

Cosmetic Industry has seen a very health evolution in the last decade with consumers becoming more proactive against spurious anti aging creams and beauty products.