Botox Cosmetic

FDA Warning

The FDA may regulate products by approving them or not, but they do not control how each product is used. Approved products are sometimes used for purposes other than those stated on the product label.

Botox Cosmetic is currently being used by some practitioners to treat facial wrinkles other than those specified by the FDA. Consumers need to be aware that these “off-label” uses have not been independently reviewed by the agency, and may not be safe. Without proper research and studies, there is no way to determine what long-term results or risks might be involved.

Ella L. Toombs, M.D., a dermatologic medical officer in the FDA's Office of Cosmetics and Colors, says “Careful deliberation, investigation and evaluation are undertaken by the agency before any prescription product is approved. Drugs like Botox are subject to a greater level of scrutiny because of the benefit-to-risk ratio.” In other words, the FDA may allow a greater risk ratio for patients with serious or life threatening medical conditions, as opposed to patients who are being treated for cosmetic purposes.

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