This is a revised version of this press release, originally issued Nov. 10, 2005. Revisions were made later that same day.

FDA NEWS RELEASE

FDA Issues Warning Letters to Marketers of Unapproved 'Alternative Hormone Therapies'
Items promoted for treatment or prevention of cancer, heart disease, and osteoporosis

The Food and Drug Administration (FDA) today announced that the agency has taken action against a number of firms marketing unapproved "Alternative Hormone Therapies" because the products these firms are selling are unapproved new drugs that have not been found safe and effective to treat or prevent certain serious or life-threatening diseases or conditions.

FDA issued Warning Letters to 16 dietary supplement and hormone cream marketers who are making unproven claims that tout the benefits of their "alternative hormone therapy" products in treating or preventing serious diseases, including cancer, heart disease, and osteoporosis, and in affecting the structure or function of the body. These alternative therapies are often promoted as "natural" or "safer" treatments that can be used in place of approved hormone treatments. Marketers have 15 days to respond to FDA.

"FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims. It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions," said Margaret O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.

In the Warning Letters, FDA advises the firms that, under the federal Food, Drug, and Cosmetic Act (FDCA), a product is considered to be a drug if it claims to diagnose, cure, mitigate, treat or prevent disease or, for products other than foods and dietary supplements, if it claims to affect the structure or function of the body. The Warning Letters further state that FDA considers these products to be "new drugs" that require FDA approval before marketing.

Examples of the unproven claims cited in the Warning Letters include:

• reversing osteoporosis-related bone loss and increasing bone density
• reducing, arresting, or inhibiting the growth of cancer cells
• protecting against fibroids, ovarian, and endometrial cancers
• treating various forms of arthritis

The FDA letters also advise the marketers that advertising claims are governed by the FTC Act and other laws enforced by FTC.

As part of the joint effort, FTC is also issuing letters notifying 34 websites that are promoting "alternative hormone therapy" products with similar claims that the FTC is unaware of any competent and reliable scientific evidence to support the claims. As stated in these letters, the FTC Act prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. For more information, visit the FTC website at www.ftc.gov.

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