FDA Warns Marketers About False Claims

Nov. 10, 2005 -- The FDA and the Federal Trade Commission (FTC) have sent warning letters to marketers of unapproved "alternative hormone therapies" promoted for treatment or prevention of numerous diseases including cancer, heart disease, and osteoporosis.

The FDA sent warning letters to 16 dietary supplement and hormone cream marketers. The FTC sent warning letters to 34 web site operators.

"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," states an FDA news release.

The letters also warn the companies that their marketing claims may be illegal.

FDA's Warning Letters

The FDA says the marketers who got the letters 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, says the FDA.

"FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims," says Margaret Glavin, the FDA's associate commissioner for regulatory affairs, in a news release.

"It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions," Glavin continues.

FDA's Letter List

The companies that got the FDA warning letters are:

• All Natural Pain Relief Inc.
• Bio-Health
• BuyInnovations.com
• CHS International Research Ltd.
• ComCore 21 Corporation
• Greatest Herbs on Earth
• HMS Crown Inc.
• Healthworks 2000
• Healthy Days Inc.
• Heba Laboratories LLC
• Herbal Fields Supplements
• Nutriteam Inc.
• One Life USA
• Suzanne's Natural Foods
• The Way Up
• Tip Top Vitamins

Marketers have 15 days to respond to the FDA.

FDA's Warning Letters

The FDA's warning letters advise the firms that, under the federal Food, Drug, and Cosmetic Act, 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 or dietary supplements, it claims to affect the structure or function of the body (for products other than foods or dietary supplements).

The letters further state that the FDA considers the products in question 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

FTC's Letters

The FTC's warning letters state that the FTC is unaware of any competent and reliable scientific evidence to support the claims made by the marketers.

The letters also state the law prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims.