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This article is from the WebMD News Archive

Lip Enhancer Gets Kiss-Off From Doctors

Product Didn't Live Up to Its Claims, Say Plastic Surgeons
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WebMD Health News

May 20, 2005 -- Plastic surgeons at the University of Washington are giving a "thumbs down" to an over-the-counter lip enhancer.

They took before-and-after pictures of seven people who tried the unnamed lip balm for one to four months. There were no significant changes in lip size, says the study in the Archives of Facial and Plastic Surgery.

The lip enhancer was harmless; no negative side effects were reported. However, only one person said they would use the product again.

That's a turnaround from their enthusiasm before the experiment. Participants had consulted the university's cosmetic surgery center about lip enhancement and were "quite motivated to try this product," says researcher Sam Most, MD, in a news release.

Proven methods of lip enhancement include filler injections and plastic surgery, says Most.

What to Believe?

Because the lip enhancer is not named in the study, WebMD could not contact the product's maker for response. The Cosmetic, Toiletry, and Fragrance Association also declined comment on the study, which it had not seen.

Some products make medicinal-sounding claims and may need scrutiny, says Most.

"In an age of ever-increasing demand for facial enhancement, many such devices or 'cosmeceuticals' can be expected to come to market outside of U.S. Food and Drug Administration [FDA] regulation," says the study.

"Facial plastic surgeons have a responsibility to determine the efficacy of such products to provide unbiased, evidence-based advice to our patients. More studies such as this will likely be needed to study such products as they come to market," write the researchers.

Government Approval Not Required for Cosmetics

Cosmetics aren't regulated like drugs or medical devices, says the FDA. "Cosmetic products and ingredients are not subject to FDA pre-market approval authority, with the exception of color additives," says the FDA's web site.

However, the FDA says a cosmetic can be considered "misbranded" for reasons including false, misleading, or incomplete labeling. The FDA can take regulatory action if it has information showing that a cosmetic is adulterated or misbranded.

The FDA says it does not recognize the term "cosmeceuticals" and defines drugs as products that "cure, treat, mitigate, or prevent disease or that affect the structure or function of the human body," says the FDA.

"If a product has drug properties, it must be approved as a drug," says the FDA.