CSPI red flags Natrol's Promensil to regulators

The vociferous and often controversial group has denounced Natrol's red-clover dietary supplement, Promensil, saying it is deceptively marketed to women for the relief of hot flashes, night sweats and mood swings.

CSPI maintains most of the research on the supplement points to its ineffectiveness, but Natrol upholds the science behind the product.

The case highlights efforts of groups lying outside the federal regulatory circle that are trying to draw attention to practices they say hurt both consumers and other industry members.

"Natrol's ads for Promensil are some of the most dishonest we've seen for a dietary supplement in a while," said CSPI senior nutritionist David Schardt.

"It's a shame that companies like this exploit the desire of women to find a safe, effective alternative to estrogen for the relief of their symptoms during menopause."

Known in the industry as being 'hardline', CSPI is not necessarily representative of the newer brand of watch dog funded by industry itself and trying to help the US Food & Drug Administration (FDA) red flag the marketing practices of certain dietary supplement manufacturers.

"We have long had confidence in the significant body of clinical research indicating Promensil provides benefits for menopausal women by offering a unique isoflavone ratio that is a safe alternative to HRT [hormone replacement therapy] ," said Michael Yatcilla, vice president of research and development for Natrol, in a written response.

"Promensil can help relieve the frequency and severity of hot flashes, and promote breast and heart health, as well as emotional well-being."

Australian biotech company Novogen launched Promensil in Australia in 1997, and the product is sold in the US by California-based Natrol.

CSPI said it is urging the FDA and the Federal Trade Commission (FTC) to crack down on the product's advertising and labeling.

Among these advertising campaigns for Promensil are a television ad citing the product as the "only supplement proven to reduce menopause symptoms" .

In addition, CSPI calls into question advertising in women's magazines claiming "22 clinical studies can't be wrong" in proving Promensil works.

Natrol on the other hand is underscoring that medical practitioners recommend their product.

"The design of a clinical treatment protocol by practicing OB/GYN physicians adds new support recommending the use of Promensil," said Yatcilla.

"These clinicians, who are concerned about the realities of patient compliance, safety and therapeutic value, have found that Promensil represents a valuable addition to any physician's menopause treatment options."

Industry-led groups have been cropping up of late for the purpose of policing themselves and weeding out those dietary supplement manufacturers carrying out illegal marketing practices.

At stake has been industry credibility as companies say such advertising practices damage consumer confidence in the industry as a whole.

The Council for Responsible Nutrition and the National Advertising Division (NAD) of the Council of Better Business Bureaus have teamed together to encourage industry to bring to their attention cases of false or harmful advertising.

CSPI has highlighted the fact that the Dietary Supplement Education Alliance's campaign director is Natrol executive chairman, Elliott Balbert.

The Alliance is initiating an advertising campaign to publicize a positive face of the industry to consumers to counter negative media attention.