Legal Challenge Filed w/FDA to Remove Monsanto's BGH from the Market
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LEGAL CHALLENGE FILED WITH FDA TO REMOVE MONSANTO'S BGH FROM THE MARKET
Long-term Human Health Studies Needed After New Information is Uncovered
Washington, D.C. (December 15) - The Center for Food Safety and more
than two dozen consumer groups announced today at an EMS Press Breakfast
that they have filed a petition to reverse the FDA's approval of bovine
growth hormone (BGH). Manufactured by the Monsanto Corporation, BGH is
injected into an estimated 15 to 30 percent of American dairy cows in
order to increase their milk production.
The petition asserts that new evidence not considered in the FDA's 1993
approval of the product shows that more testing is needed.
The petition asks FDA to remove BGH from the market until it is proven
safe. If the FDA will not remove BGH from the market, CFS said today it
will sue the agency.
"Today's petition demands the immediate withdrawal of Monsanto's bovine
growth hormone from the market," said Andrew Kimbrell, executive
director of the Washington-based Center for Food Safety. "It is clear
that the FDA put the interest of Monsanto above its duty to protect the
health of the American consumer when it approved BGH five years ago."
The petition cites mounting evidence that the original testing of BGH
was flawed. The plaintiffs contend that more testing is needed and
until testing is complete, BGH should be taken off the market.
In 1990 the FDA said BGH was "safe for human consumption." Part of its
findings were based on 90-day rat feeding studies in which they reported
"no toxicologically significant changes were noted . . . in rats
administered BGH orally." Based largely on this conclusion, FDA did not
toxicological tests usually required for a veterinary drug.
However in April of this year, researchers from Health Canada, the
Canadian equivalent to FDA, issued a report which contradicted FDA's
findings. Canadian researchers found studies showing that rats were
absorbing BGH after all. In fact, between 20 and 30 percent of the rats
were developing distinct immunological reactions. Additionally, cysts
formed in the thyroid of some male rats and infiltrated the prostate.
"These are toxicologically significant changes in the rats and they
should have triggered a full human health review, including assessment
of potential carcinogenic and immunological effects," said Michael
Hansen, a Ph.D. researcher with Consumer Policy Institute, a division of
It is unclear how or why these results were overlooked in the original
FDA review of BGH. MONSANTO SAYS IT SUBMITTED THE STUDIES TO THE FDA
WHILE THE AGENCY SAYS IT ONLY SAW SUMMARIES. [emphasis added!]
"We're going to go to the courts and say - you were lied to," said
Kimbrell. "Essentially it was fraud by the agency and fraud by Monsanto
in telling the court that there were no human health effects possible
from consuming these products made with BGH treated milk. We now know
that not to be true."
For five years American consumers have been consuming dairy products
without knowing about the potential health impacts recently uncovered by
Health Canada scientists. Monsanto has successfully suppressed other
information, including such basic information as product notification
that milk is, or is not, derived from BGH-treated cows.
"People have a right to this information. Threats of litigation,
threats to drop advertising, threats to discontinue business
relationships, and who knows what else have caused these stories to be
covered up," said Steve Wilson, an award winning television
investigative reporter who was fired along with his partner, Jane Akre,
after producing a series of reports critical of BGH. "Stories are just
not getting out. The whole strategy of keeping information away from
consumers and not labeling or disclosing what's in dairy
products is wrong," said Wilson. Their station, Fox-owned WTVT in
Tampa, never aired the series.
For more information, contact: Tom Lalley, Environmental Media Services
Andrew Kimbrell, Center for Food Safety - 202/547-9359
Michael Hansen, Consumers Union - 914/378-2000
John Stauber, PR Watch - 608/233-3346
Jane Akre and Steve Wilson - 727/799-7559
Jo Dufay, Council of Canadians - 613/233-4487