The FDA Cracks Down
One of the most exciting components of the medical aesthetics industry is the rapid innovation in treatment products and protocols. Each season, a slew of new skincare-related product formulations and ingredients emerge in the marketplace and on the horizon. The challenge for patients and practitioners is separating the valid claims from the invalid. In a move that presents a double-edged sword for physicians, the United States Food & Drug Administration (fda.gov) has become aware of these concerns and is becoming more active in pursuing them. Its efforts may help to protect consumers from these bogus marketing tactics. At the same time, this push is placing practitioners in the crosshairs of FDA regulators charged with investigating online marketing claims.
The skin is the ultimate barrier, designed to protect our body and other organs against germs, disease and bacteria. The shortcoming of skincare topicals historically has been that this barrier makes it difficult to deliver active ingredients to the dermis where they may help the skin. Nanotechnology—by reducing the molecular size of active ingredients, enabling them to reach the dermis—may solve the delivery issue within a few short years. The question then becomes, will these topical products be categorized as cosmetics or as drugs?
Another exciting area of research is stem cell-based skincare solutions. Human stem cells are regenerative cells that can repair damage. There is a lot of valid anticipation as researchers continue to uncover their potential uses in a variety of medical specialties. Unfortunately, some manufacturers are capitalizing on the excitement surrounding stem cells by advertising what are essentially phyto- or plant-based ingredients as regenerative, stem cell-based skincare lines. Similarly, physicians are using “stem cell” to describe a number of cosmetic procedures that may or may not derive their actual benefits from the use of human stems cells. In short, the research has yet to catch up with the claims. These two advances—nanotechnology and stem cells—are helping to fuel the public and the FDA’s frustration with misleading marketing claims, and the FDA’s drive to clearly differentiate drugs vs. cosmetics.
It is important to note that many manufacturers and distributors use the term cosmeceutical, especially when referring to skincare lines that draw on science-based claims. The FDA does not recognize this term. There are only two categories for these products: drug or cosmetic.
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