Lane Labs Violates Injunction With Unsubstantiated Fertil Male Claims – FTC

The Federal Trade Commission has filed civil contempt charges against dietary supplement marketer Lane Labs-USA alleging violations of a 2004 order requiring the firm to substantiate claims for all its products, FTC announces Jan. 29.

Lane Labs, company President Andrew Lane and his father, William Lane, Ph.D., have until March 12 to respond to FTC's motion for order to show cause why they should not be held in contempt of court for violating the previous order, according to an order issued by the U.S. District Court for the District of New Jersey.

William Lane's Short Hills, N.J.-based Cartilage Consultants firm is also named in the motion and was included in FTC's 2004 order. His research has stirred interest in the healing and protective properties of shark cartilage.

The 2004 order required Mahwah, N.J.-based Lane Labs to have "competent and reliable scientific evidence and to substantiate ad claims" and prohibits it from making "deceptive claims about tests, studies or research." FTC says.

The order led to a permanent injunction in 2004, which focused on Lane Labs' supplement and cosmetic products marketed as cancer therapies. The ruling came four years after the FTC filed a stipulated order in a separate case that required Lane Labs to pay $450,000 to fund a study on shark cartilage and cancer, and $550,000 in consumer redress (¹ (Also see "Lane Labs To Pay Consumer Restitution Under Permanent Injunction" - Pink Sheet, 19 Jul, 2004.), p. 9).

FTC's current motion concerns Lane Labs' Fertil Male , a dietary supplement claiming to enhance male fertility, and AdvaCAL ,a calcium supplement also sold as AAACa.

Lane Labs claims Fertil Male "helps support healthy sperm activity" through LMG , a "Peruvian plant root infused with HAI , a patented amino acid complex that appears to enhance absorption."

FTC says the studies claiming Fertil Male improves male fertility are "flawed."

Lane Labs also claims AdvaCAL is "clinically proven to build strong, healthy bones" and is "clinically proven to fight osteoporosis."

Lane Labs claims AdvaCAL also has fracture-reducing benefits.

"One chart indicates that there is a 100% fracture reduction for elderly patients over a three-year period," FTC says. "Other advertisements state that there were zero fractures per 1,000 patient years for AdvaCAL users compared with 357 for Calcium Carbonate users."

FTC says the claims are unsubstantiated and the studies are misrepresented. In addition, William Lane has violated the 2004 order by making "unsubstantiated representations as an expert endorser for AdvaCAL," according to the agency.

FTC seeks remuneration for consumers who have purchased Fertil Male and AdvaCAL. "The Defendants' sales - on the order of millions of dollars - translate into real losses for consumers," according to the motion.

The products were sold via the Internet, catalogs, direct mail, on infomercials and at retail; a one-month supply of Fertil Male and a 25-day supply for AdvaCAL are priced at $34.95 and $39.95, respectively.

Lane Labs says in a statement it is "shocked" by FTC's charges and does "not understand how the FTC's planned attempt to undermine accepted science serves the public or scientific community."

"AdvaCAL is supported by eight peer-reviewed papers in leading medical journals, dating back to 1995," Lane Labs says. "These journals are recognized by medical doctors and scientists worldwide."

Under the stipulated scheduling order submitted to Judge Dennis M. Cavanaugh Jan. 29, FTC must reply to Lane Labs rebuttal by April 9. The schedule also sets a proposed hearing for May 29 on the motion for order to show cause.

Recent FTC actions against companies making unsubstantiated claims include a $3.2 million settlement agreement with Bayer for misleading claims of its One-A-Day WeightSmart product (² (Also see "FTC Supplement Settlements Spotlight Bayer, Mark First Hoodia Action" - Pink Sheet, 8 Jan, 2007.), p. 4).

- Rebekah Moan