FTC goes after nutraceutical HRT

The federal agency alleges the marketers of natural progesterone creams advertised their products without supporting scientific evidence to support their claims.

The case is a further demonstration of FTC's conviction to at least appear to be going after false marketing in the nutraceutical category.

"Millions of women seek safe, effective alternatives to hormone replacement therapy," said Lydia Parnes, director of FTC's Bureau of Consumer Protection.

"These companies violated their trust by making claims they just couldn't prove."

Six of the sellers have signed consent orders preventing them from making similar unsubstantiated claims in the future.

However, according to FTC, one of the marketers did not respond and as such the case will be passed on to the attention of an administrative law judge.

Bad publicity surrounding the effects of HRT has caused many women to begin looking beyond Western medicine and towards dietary supplements or alternative healthcare products to relieve the symptoms associated with menopause.

Once the standard therapy for menopausal symptoms in the US, HRT became the center of controversy in July 2002 when a National Institutes of Health study showed that taking hormone replacement therapy could increase the risk of heart attack, stroke or breast cancer.

In July 2005 the International Agency for Research on Cancer, a United Nations agency, changed the classification of hormonal menopause therapy from "possibly carcinogenic to humans" to "carcinogenic to humans" .

Women experiencing, or imminently facing, menopause represent a sizeable consumer segment in the US.

The onset of natural menopause occurs between the ages of 40 and 58, with a median of 47.5 years, says the American Menopause Society.

In 2000, the category of women between the ages of 45 and 54 alone represented 13.4 percent of the female population, or 36.6 million women, according to the US Census from that year.

Among the claims the alternative HRT marketers made, says FTC, was that their progesterone creams can prevent, treat, or cure osteoporosis; prevent or reduce the risk of estrogen-induced uterine cancer; and are effective in preventing or reducing the risk of developing breast cancer.

These marketers came to the attention of the federal body when staff conducted an Internet search for websites advertising products claiming to be natural alternatives to HRT and to prevent diseases such as cancer and osteoporosis.

FTC in turn sent warning letters to 34 of these website operators.

The products in question include: Probalance and Probalance plus transdermal creams; Elation therapy natural progesterone cream; Preserve progesterone cream; Progesta care plus; Est progesterone cream; Restored balance progesterone cream; Serenity for women natural progesterone cream; Nature's precise cream; Eternal woman progesterone cream; and Pro-gest body cream.