
PRESS RELEASE
For Immediate Release
Dated: August 10, 2005 Brooke
Holve Public Relations Manager 917-755-4900
Youngevity
FDA Postpones
Decision on Lycopene/Cancer Health Claim for a Fifth Time SAN DIEGO, CALIFORNIA - The FDA has
requested a fifth extension on giving a decision on Youngevity’s
health claim petition on the link between lycopene and a reduced
risk of developing certain types of cancer until October 11, 2005.
Youngevity has compiled scientific studies indicating that
consumption of tomatoes, tomato-based products and lycopene supplementation
may reduce the incidence of prostate, lung and stomach cancers and
submitted these to the agency in 2003, along with its petition.
A decision was initially expected
on December 24, 2004. However in mid-December the agency informed
Youngevity that the decision would be delayed until February
11, 2005, again until April 12, 2005, again until June 12, 2005,
yet again until August 12, 2005 and finally they have requested
an additional 60 day extension. In recent months the agency has
asked for extensions in its review of seven other pending qualified
health claim petitions citing a lack of agency resources. In a letter dated July 7, 2005, U.S.
Senators Tom Harkin and Orrin Hatch wrote Dr. Lester Crawford, the
commissioner of the Food and Drug Administration (FDA) expressing
their concern about the length of time it takes to get an approval
for Qualified Health Claim Petitions. The letter specifically asked
how many petitions the FDA currently had, the length of time it
has taken to approve each one, how many full-time equivalents (FTEs)
are devoted to review them and the grade levels of the reviewers.
The senators offered the disposal of their staffs to meet with the
FDA to solve the problem.
“To say that we are disappointed by this fifth request for
an extension would be an understatement,” states Steve Wallach
of Youngevity. “Every extension further delays our
ability to get this important information out to the general public.
However, we look forward to getting approval on this lycopene/cancer
health claim petition in October.” Youngevity has submitted several
Health Claim Petitions to the FDA and is responsible for the authorized
Health Claim Petition for Selenium and its relationship to Cancer
Risk Reduction. Youngevity has helped to defend the Health
Claim Petition process through the courts and has submitted many
official comments to the FDA on behalf of the nutrition industry,
all in an effort to help consumers have more access to truthful
information in order to base a more informed decision regarding
their own health and wellness.
Youngevity is a leading designer of Dietary Supplements
and cutting edge personal care and wellness lifestyle products.
The company was founded in April of 1997 in San Diego, California
by Joel D. Wallach BS, DVM, ND, and Ma Lan MD, MS. Youngevity
markets its products worldwide, through a network of independent
distributors.
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