"If something that is being implanted into the body could
have health consequences, we're concerned about it," says Stephen P. Rhodes, M.S., chief of the FDA's Plastic and
Reconstructive Surgery Devices Branch. "Wrinkle fillers affect the structure of the face and could have such health
consequences."
Facing Facts
Under the Federal Food, Drug and Cosmetic Act, the FDA legally defines products by their intended uses. Drugs are
defined as products intended for treating or preventing disease and affecting the structure or any function of the
body. A medical device is a product that also is intended to affect the structure or function of the body, but
which does not achieve its primary intended purposes through the chemical action of a drug--nor is it dependent on
being metabolized.
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