Isis Breast Enhancement System Safety, Efficacy Questioned By FTC

Vital Dynamics promoted its Isis Breast Enhancement System as free of side effects after receiving "hundreds of reports of negative side effects," according to a Federal Trade Commission complaint.

"In truth and in fact, there are reported side effects for the Isis system...including reports of allergic reactions, nausea and headache," the complaint filed in Los Angeles district court Dec. 26 states. "Therefore, the making of the representations...constitutes a deceptive practice and the making of false advertisements."

Canoga Park, Calif.-based Vital Dynamics, doing business as Isis, has sold the Isis Breast Enhancement System via a toll-free number since 1999, the complaint says.

The product, which consists of a dietary supplement and topical cream, was promoted as enhancing breast size up to one cup size or more in six months. FTC notes a six-month supply has sold for between $199 and $599.

Both the supplement and cream contain saw palmetto, chaste tree, fenugreek, fennel and black cohosh. The supplement also contains dong quai, hops, wild yam, blessed thistle, damiana, methylsulfonylmethane, royal jelly, scullcap, curcubita pepo pumpkin seed and lycium Chinese herb extract. The cream's other ingredients include ma huang, comfrey, white willow bark, passion flower, horsetail, cayenne, bilberry, guarana and pueraria mirifica.

The complaint maintains Vital Dynamics made unsubstantiated claims for the product over the radio, in magazine ads, in transcripts for telemarketing scripts, on Internet video sidebars, in infomercials and on ¹ the product's Web site. One such claim cited by FTC states the Isis System will give "you fuller, firmer, shapelier breasts naturally - not surgery, no big medical bills."

Another claim says "Isis blends age-old herbs into a patent-pending formula that works internally and externally to deliver the desired results to your breast," adding it "awakens estrogen receptor sites which may have been dormant since puberty."

A claim on the product Web site says "Isis pushes beyond your inherited potential by helping stimulate the pituitary gland, which is responsible for the production and release of growth hormones that help promote the growth of breast cells and tissue."

Along with alleging Vital Dynamics made unsubstantiated claims and misrepresented the Isis System's safety, FTC maintains the firm distorted its refund policy.

Although Vital Dynamics promises a 90-day risk-free guarantee, FTC notes the firm "placed impediments in the path of those seeking to obtain such a refund."

For example, FTC states consumers seeking refunds were directed to obtain a return authorization code from the firm, but "many consumers seeking to contact the company for a return authorization are unable to get through...to obtain such an authorization number."

"Many consumers who...obtain refunds... have done so only after complaining to a Better Business Bureau or a state governmental agency," FTC adds.

In a stipulated final order filed with the court the same day, Vital Dynamics President & Treasurer Geoffrey Knight, Vice President & Secretary Mark Berman and Vice President Allen Smith are required to pay $16,667 each in consumer redress.

If the court finds the defendants misrepresented their finances, they would have to repay the $22 mil. in gross revenue garnered by Isis System from 1999-2002, according to ² FTC's Dec. 26 press release.

The defendants are permanently enjoined from implying in any way that Isis is a safe and effective method for firming, toning and enhancing breasts without side effects unless such claims are based on sound, reliable evidence. The same guidelines also apply to claims made by the defendants for any other products they may sell.

The order also prohibits the defendants from "misrepresenting...that any entity will refund costs...[by] failing to disclose any material condition, qualification, requirement or limitation to a refund."

Breast enhancement supplements have recently gotten attention from the Council of Better Business Bureaus' National Advertising Division as well. In separate cases, Wellquest International challenged claims made by CP Nutritionals and Shoreline Enterprises that their products tone and enlarge breasts.