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Legal Challenge Filed with FDA to Remove Monsanto's rBGH from the Market

December 16, 1998

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 recombinant bovine growth hormone (rBGH). Manufactured by the Monsanto Corporation, rBGH 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 does 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 require human 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 Consumers Union.

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.

“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:

  • 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
  • Tom Lalley, Environmental Media Services – 202-463-6670

To view petition, click HERE.