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Senior Alert
FDA Issues Warnings to Marketers of Unapproved
'Alternative Hormone Therapies'
Items promoted to seniors for treatment or prevention
of cancer, heart disease, and osteoporosis
Nov. 16, 2005 - The Food and Drug Administration
has announced 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. The advertising targets older women.
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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 until November 25 to respond.
"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.
FDA Warning Letters went to -
All Natural Pain Relief Inc. (PDF)
Bio-Health
HTML
PDF
BuyInnovations.com (PDF)
CHS International Research Ltd. (PDF)
ComCore 21 Corporation (PDF)
Greatest Herbs on Earth (PDF)
HMS Crown, Inc.
HTML
PDF
Healthworks 2000 (PDF)
Healthy Days, Inc. (PDF)
Heba Laboratories, LLC (PDF)
Herbal Fields Supplements (PDF)
Nutriteam, Inc. (PDF)
One Life USA
HTML
PDF
Suzanne's Natural Foods (PDF)
The Way Up (PDF)
Tip Top Vitamins (PDF)
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