| U.S. Federal Trade Commission |
FTC News Release, Oct 5, 2007
FTC Charges Seven Online Sellers of Alternative Hormone Replacement Therapy
with Failing to Substantiate Products’ Health Claims
The Federal Trade Commission today announced complaints against seven online
sellers of alternative hormone replacement therapy (HRT) products, alleging that
they made health claims for their natural progesterone creams without supporting
scientific evidence. Six of the sellers have signed consent orders barring them
from making such unsubstantiated claims in the future. The seventh did not
respond to staff’s repeated contacts, and the case will now be heard by an
administrative law judge.
“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.
Consumer Information
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.
The Commission vote authorizing the filing of an administrative complaint
against respondents Herbs Nutrition Corporation and Jafry was 5-0. The vote
authorizing the filing of administrative complaints and consent orders settling
the charges against the remaining respondents was 5-0. The consent orders will
be subject to public comment for 30 days, beginning today and continuing through
November 7, 2007, after which the Commission will consider whether to make them
final.
NOTE: The Commission authorizes the filing of a complaint
when it has “reason to believe” that the law has or is being violated, and it
appears to the Commission that a proceeding is in the public interest. A
complaint is not a finding or ruling that the defendants have actually violated
the law.
NOTE: A consent agreement is for settlement purposes only
and does not constitute an admission of a law violation. When the Commission
issues a consent order on a final basis, it carries the force of law with
respect to future actions. Each violation of such an order may result in a civil
penalty of $11,000.
The text in this article was prepared by the U.S. Federal Trade Commission.