November 10, 2005

U.S. warns sellers of “alternative” hormone treatments

WASHINGTON (Reuters) - U.S. regulators said on Thursday
they had issued warnings to dozens of companies that are
promoting unproven "alternative" hormone therapies for


The government sent letters to about 50 firms and Web sites
that market supplements and creams as alternatives to hormone
replacement therapy, warning them against making baseless
claims that the treatments can help with serious diseases such
as cancer, heart disease and osteoporosis.

"It's particularly troublesome when these claims provide
false hope to patients with serious or life-threatening
conditions," Margaret Glavin, the Food and Drug
Administration's associate commissioner for regulatory affairs,
said in a statement.

Hormone Replacement Therapy (HRT) aims to replace hormones
diminished by menopause and is prescribed to women to relieve
menopause symptoms such as hot flushes, night sweats and mood

However, millions of women have stopped taking the therapy
and sought alternatives after learning in recent years that HRT
can raise the risk of heart attack, stroke, breast cancer and
other serious conditions.

The FDA said it sent 16 letters to companies marketing
alternative therapies, telling them that it considers the
products unapproved new drugs, which require FDA approval
before they can be sold.

Many of the alternatives claim to be either natural
progesterone creams or dietary supplements that contain
plant-based hormones.

Among the unproven claims cited in the warning letters, the
FDA said, are that the therapies can reverse
osteoporosis-related bone loss and increase bone density;
reduce or arrest the growth of cancer cells; protect against
fibroids, ovarian, and endometrial cancers; and treat various
forms of arthritis.

The Federal Trade Commission, meanwhile, said it sent
warning letters to 34 Web site operators making similar kinds
of claims.

The FTC, which enforces U.S. consumer protection laws,
warned in its letters that some claims made on the Web sites
"may be false or unsubstantiated and therefore may violate the

The agency said it "is not aware of any competent and
reliable scientific evidence to support claims that the types
of products advertised could prevent, treat, or cure cancer,
heart disease, or other diseases, prevent osteoporosis, or
increase bone density."