Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted October 5, 2007
FTC Charges Progesterone Cream Sellers with Making Unsubstantiated Claims
“Millions of women seek safe, effective alternatives to hormone replacement therapy,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection. “These companies violated their trust by making claims they just couldn’t prove.”
The Commission’s Complaints
According to the FTC’s complaints, the respondents claimed that their natural progesterone creams: 1) are effective in preventing, treating, or curing osteoporosis; 2) are effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer; and 3) do not increase the user’s risk of developing breast cancer and/or are effective in preventing or reducing the user’s risk of developing breast cancer. The complaints allege the respondents did not have substantiation for these claims and, in some cases, misrepresented that clinical testing proved the products were effective.
The products allegedly sold without proper health-claim substantiation 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.
The Consent Orders
The consent orders announced today settle the FTC’s charges against the following individuals and organizations: 1) Lawrence A. Jordan and Stephanie L. Jordan, individually and doing business as (d/b/a) Springboard and Pro Health Labs of Spring Valley, California; 2) Elation Therapy, Inc., and Robert Rutledge, individually and as an officer of Elation Therapy, Inc., of Marietta, Georgia; 3) Merilou Barnekow, individually and d/b/a Women’s Menopause Health Center of Surfside Beach, Texas; 4) The Green Willow Tree LLC, and Robert Burns individually and as a manager and member of The Green Willow Tree, LLC of Asheville, North Carolina; 5) Health Science International, Inc., and David Martin, individually and as an officer of Health Science International, Inc., of Port Orange, Florida; and 6) Shelly Black, individually and d/b/a Progesterone Advocates Network of Trabuco Canyon, California.
Under the terms of the orders, the respondents are required to have competent and reliable scientific evidence substantiating claims about the health benefits, performance, efficacy, safety, or side effects of any dietary supplement, food, drug, device, or health-related service or program, including claims that progesterone products are effective in mitigating, treating, preventing, or curing any disease. In addition, the orders prevent the respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Finally, the orders contain record-keeping and notification provisions designed to ensure the respondents comply with their terms. The orders will expire in 20 years.
The charges against Herbs Nutrition Corporation and Syed M. Jafry, individually and as an officer of Herbs Nutrition Corporation of Torrance, California, have not been settled, and the case will be tried by an administrative law judge at the Commission.
In the actions announced today, the FTC obtained all the relief necessary to protect consumers by focusing on some of the most egregious claims made by the online sellers of alternative HRT. The FTC staff is not aware of any competent and reliable scientific evidence to support claims that natural progesterone products are safe, or that they are effective in preventing osteoporosis, increasing bone density, or preventing, treating, or curing cancer, heart disease, or other diseases. When evaluating health-related claims for any product, it may be a good idea for consumers to talk to their primary care physician, pharmacist, or healthcare provider.
The Alternative HRT Web Surf
The FTC staff identified the respondents through an Internet search of Web sites advertising products that claimed they were natural alternatives to HRT and that they would prevent diseases such as cancer and osteoporosis. The FTC staff sent warning letters to 34 Web site operators informing them that they must have competent and reliable scientific evidence to support any health-related claims made for their products. The staff advised the marketers to revise or delete any false, misleading, or unsubstantiated claims.
The FTC’s letters noted that the staff was not aware of any competent and reliable scientific evidence to support claims that natural progesterone products are safe or are effective in preventing osteoporosis, increasing bone density, or preventing, treating, or curing cancer, heart disease, or other diseases. The U.S. Food and Drug Administration (FDA) sent letters to an additional 16 alternative HRT sellers, warning them that their business practices could be in violation of FDA law.
The FTC staff followed up with the online advertisers who received letters, and all except seven modified the claims on their Web sites. The Commission now has charged those seven sellers with violating the FTC Act, and has settled the charges against six of the seven sellers.