TrimFast to Recall Product Linked to Health Problems (Update1)
1/21/99 19:10 (New York)
TrimFast to Recall Product Linked to Health Problems (Update1)
(Adds comment from FDA, details on health risks.)
Washington, Jan. 21 (Bloomberg) -- TrimFast Group Inc., a
nutrition products company, will recall its Revivarant after an
ingredient in the product was linked to serious health problems
and one death, the U.S. Food and Drug Administration said.
The FDA said it has asked other companies that sell products
containing the ingredient, known as gamma butyrolactone, or GBL,
to begin recalls as well. The agency said it's ``considering all
potential regulatory actions'' if the recalls don't happen.
The products are marketed under a variety of names,
including Renewtrient, Revivarant, Blue Nitro, Blue Nitro
Vitality, GH Revitalizer, Gamma G and Remforce, the agency said.
The products, some of which are marketed as dietary supplements,
are advertised for uses ranging from bulking up to enhancing sex
or reducing stress, the FDA said.
``We consider it an illegally marketed unapproved drug,''
said Joseph Levitt, director of the FDA's food branch. ``We need
to take action.''
The body converts GBL into a potentially dangerous drug
known as GHB, once hyped as a body building aid. While GHB is
under study for use in treating legitimate ailments, it has never
won FDA approval, and the agency and Justice Department have
taken action against what they say is improper promotion and
marketing of it.
The FDA said it has received 55 reports of health problems,
including one death, among users of products containing GBL. In
19 cases, people became unconscious or comatose, the FDA said.
Consumers should throw out any products they have containing
GBL, the FDA said. The products are sold over the Internet or in
health stores or fitness centers, and the FDA may not have a
complete list, the agency said.
Officials from Tampa, Florida-based TrimFast weren't
available for comment. The announcement came after the close of
U.S. markets. Company shares fell 9/16 to close at 4 1/2.
--Kristin Jensen in the Washington newsroom (202) 624-1843 with
reporting from Kristin Reed in Washington / mfr/ba |
