| U.S. Federal Trade Commission |
FTC News Release, Mar 17, 2004
Marketers of the Supplements “Focus Factor” and “V-Factor”
Agree to Settle FTC Charges and Pay $1 Million
Marketers of “Focus Factor,” a
dietary supplement that purports to improve concentration, and
“V-Factor,” a supplement that purports to enhance sexual
performance, have agreed to settle Federal Trade Commission
charges that they made numerous unsubstantiated advertising
claims for the products. In one complaint, the FTC charges
Vital Basics, Inc. of Portland, Maine, and its principals,
Robert Graham and Michael Shane (VBI respondents), with not
having adequate substantiation to back up claims they made
about the efficacy of “Focus Factor” and the safety of
“V-Factor Natural Pack.” The VBI respondents have agreed to a
consent order containing provisions designed to prevent them
from engaging in similar acts or practices in the future and
requiring the payment of $1 million in consumer redress. In
the other complaint, the FTC charges Creative Health
Institute, Inc. of Corinth, Texas, and its principal, Dr. Kyl
Smith (CHI respondents), with making unsubstantiated claims
about Focus Factor’s ability to improve users’ focus, memory,
mood, and concentration. The CHI respondents have also agreed
to a consent order designed to prevent similar practices in
the future and requiring the payment of $60,000 in consumer
redress.
Focus Factor is a dietary supplement that
contains, among other things, vitamins, minerals, botanicals,
and amino acids. Dr. Smith developed Focus Factor, and
advertised and sold it through Creative Health Institute from
at least 1997 to 2000. Since 2000, the VBI respondents have
advertised and sold Focus Factor, and the CHI respondents
participated in the advertising of the product. The
respondents allegedly marketed Focus Factor as improving the
focus, memory, and concentration of healthy adults;
alleviating stress and combating the fatigue, irritability,
and mood swings that healthy adults experience; making
children and teenagers feel more alert, focused, and mentally
sharp; improving students’ ability to concentrate and their
academic performance; improving senior citizens’ memory,
mental clarity, and energy; improving adults’ ability to
absorb information in books and to recall facts, figures, and
names; and as having the desired effects in as little as one
to 10 days. The Commission’s two complaints challenge these
claims as unsubstantiated.
V-Factor is a dietary supplement that
contains, among other things, yohimbine and L-argenine. The
VBI respondents allegedly marketed V-Factor as a male sexual
performance enhancer. The FTC alleges that the VBI respondents
did not have substantiation for their claim that V-Factor is
safe for virtually all men, and that they misrepresented that
a clinical study proved that V-Factor is safe and effective at
improving sexual response and function.
The
Commission’s complaints further allege that both sets of
respondents failed to disclose that certain endorsers who
appeared in Focus Factor advertising had material connections
with the product. In addition, the FTC alleges that the VBI
respondents: (1) represented that consumer endorsements were
made without compensation, and failed to disclose that
consumer endorsements were solicited with a promise of a free
6-month supply of Focus Factor to those individuals whose
testimonials were used in advertising; and (2) misrepresented
that certain radio infomercials were independent radio
programs, not paid commercial advertising.
The proposed consent agreement with the VBI
respondents prohibits any representation about the safety,
performance, benefits or efficacy for any food, drug or
dietary supplement for:
- the brain or any mental functions or
processes;
- sexual response, function, enhancement,
or performance; or
- the treatment, cure, mitigation, or
prevention of any disorder;
unless the respondents possess and rely upon
competent and reliable evidence substantiating that
representation. In addition, the proposed settlement prohibits
them from making unsubstantiated safety claims for V-Factor or
any product containing yohimbine; misrepresenting the
existence, contents, validity, results, conclusions, or
interpretations of any test; failing to disclose material
connections with endorsers; and misrepresenting the nature of
paid advertising. Finally, the settlement requires the VBI
respondents to pay $1 million in consumer redress.
The proposed consent agreement with the
CHI respondents prohibits them from making any
representation about the benefits, performance, or efficacy
for any food, drug or dietary supplement for:
- the brain or any mental functions or
processes;
- stress, anxiety, energy, mood, or
behavior;
- academic or business performance;
- longevity, age-related memory impairment,
or dementia; or
- the treatment, cure, mitigation,
alleviation of the symptoms, prevention, or reduction in the
risk of any mental, brain, or central nervous system disease
or disorder;
unless they possess and rely upon competent
and reliable evidence substantiating that representation. The
proposed settlement further requires that they clearly and
prominently disclose any material connections with endorsers.
Finally, the proposed settlement requires the CHI respondents
to pay $60,000 in consumer redress.
The Commission vote to place
the two proposed consent agreements and complaints on the
public record was 5-0. Announcements regarding the
two proposed consent agreements will be published in the
Federal Register shortly. The agreements will be subject to
public comment for 30 days, until April 16, 2004, after which
the Commission will decide to make them final. Comments should
be addressed to the FTC, Office of the Secretary, 600
Pennsylvania Avenue, N.W., Washington, D.C. 20580.
The text in this article was prepared by the U.S. Federal Trade Commission.