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Agency Ignores Womens’ Opinions in Focus Group Research, Gets Chummy with Seafood Industry

Washington — Internal Food and Drug Administration (FDA) documents obtained by the Environmental Working Group (EWG) reveal that the agency is failing in its public health obligation to protect pregnant women and the developing fetus from the toxic effects of mercury. The FDA cites focus group research as a justification for its severely limited consumer advisory on fish that should be avoided by pregnant women. However, transcripts of the focus groups reveal that the agency knows its standards don’t protect the fetus, knows that adequate protection would mean adding tuna to the list of restricted fish, and knows that women want as much information as possible, preferably from their doctors.

“The FDA is ignoring the science on mercury and ignoring health information women want and need, while using focus groups as an excuse,” said Jane Houlihan, EWG’s Vice President for Research. “The problem is not FDA using focus groups to determine how it should communicate concerns about mercury in fish to women. The problem is the FDA using focus groups to determine if it should communicate concerns about mercury in fish to women.”

Both the U.S. Environmental Protection Agency (EPA) and the National Academy of Sciences (NAS) have recognized that mercury is a substantial public health problem, and recommend much stricter standards for allowable levels of mercury in fish than the FDA. The NAS estimates that every year approximately 60,000 children are born at a significantly increased risk of neurological effects from mercury because of the contaminated fish their mothers ate. The NAS is also concerned that, aside from the extremely high exposure cases, there is a broad, low-level mercury exposure potential that could push a greater percentage of the population into the group of children who struggle to keep up in school or who require remedial education. Furthermore, a 2001 Centers for Disease Control study found that 10% of reproductive-age American women already carry so much mercury in their blood that if they got pregnant it could pose a threat of neurological damage to the fetus.

FDA has said that too long a list of fish to avoid confuses women, and that tuna is safe for pregnant women and the developing fetus. The transcripts show a very different story. A top FDA scientist admits that FDA’s current mercury ’action level’ in seafood does not protect the fetus and also says that pregnant women need to limit their consumption of tuna to protect their babies from mercury damage. Yet the message FDA gave to the public only months later, after three private meetings with the tuna and seafood industry, claims that tuna is perfectly safe.

This particular project is an outgrowth of EWG’s earlier report, Brain Food, which was the first-ever computer analysis of mercury contamination in fish and the diets of American women. The report was based on information from 7 different government sources and 4 different agencies used to create a first-of-its-kind database on fish contamination that contains 53,000 records of mercury test results. This database with a list of 13 fish pregnant women should avoid altogether, based on our computer model that included variations in women’s weight, blood volume, diet, metabolism, and the level of mercury already in their blood.

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