Internal documents reveal that the FDA is failing in its public health obligation to warn pregnant women about mercury in tuna.
Mercury is toxic to the developing fetal brain and is a poison of growing concern to health authorities nationwide. When the U.S. Food and Drug Administration's latest health advisory for mercury in seafood was issued in January 2001, the agency came under immediate fire from independent scientists and public health activists for failing to adopt the recommendations of a National Academy of Sciences study on mercury (NAS 2000), and for not providing pregnant women with complete information on what fish to avoid during pregnancy - particularly tuna.
Speaking to the press in May 2001, Dr. Robert Goyer, chairman of the NAS committee on mercury toxicity, criticized the Agency's health advisory for mercury, saying "The F.D.A. should be providing people with the best information and let them be the judge. The F.D.A. has stopped short of what it should have done."
Newly-available, internal FDA documents obtained by the Environmental Working Group (EWG) reveal that FDA, under pressure from the seafood industry, is deliberately withholding critical information from pregnant women on mercury-contaminated tuna and other fish, and using "focus group" sessions as a justification.
In May of 2001, FDA's Director of the Division of Risk Assessment, Michael Bolger, told the press that the agency had conducted focus groups and concluded that if women were given a more comprehensive list of fish that should be avoided or eaten only in moderation during pregnancy, they would simply not eat fish at all. To investigate this claim, the Environmental Working Group (EWG) obtained and analyzed 1,036 pages of focus group transcripts under the Freedom of Information Act.
We found that the word-for-word account of focus group discussions flatly contradicts Bolger's assertion. We also found compelling evidence that the agency is failing to protect the public from mercury-contaminated seafood. Internal FDA focus group transcripts considered together with publicly available FDA documents, show that the agency is failing to regulate mercury levels in seafood, has shut down its mercury monitoring program, has not issued an enforceable limit for mercury in fish, and has not implemented the mercury education program that it promised.
1. "Focus groups" are small groups selected from a broader population and interviewed through facilitator-led discussions, for opinions and emotional responses about a particular subject. Focus groups are a common market research tool. Results are qualitative and are not statistically significant.
Stunning admissions by FDA official in focus group transcripts
FDA's own focus group transcripts directly refute Dr. Bolger's claim that women would stop eating seafood if given detailed information on mercury levels. In fact, when presented with draft health advisories, an overwhelming majority of the participants said that they would keep eating fish but avoid those with high mercury levels (30 of 37 individual comments) - exactly the behavior that the FDA was aiming for (Table 1 and Table 2).
But beyond what FDA officials were told by consumers are several stunning admissions FDA officials made to participants during those same sessions. EWG's detailed review of 1,036 pages of word-for-word transcriptions of 11 FDA-sponsored focus groups in Denver, Boston, and Calverton, Maryland conducted in October and November 2000, reveals:
1. FDA is withholding from pregnant women information on their need to limit consumption of tuna in order to protect their babies. The agency's January 2001 advisory contains no mention of tuna, yet in the documents obtained by EWG, a senior FDA scientist reveals that:
"... the dilemma that we have is that to lower the action levels, so they're protective of fetuses, it would actually put the availability of certain kinds of fish in question. We would lose some fish." Then he is asked: "Like King Mackeral [sic], shark, and swordfish?" He replies, "Well, those in particular, but also tuna." (emphasis added, Macro International, Inc. 2000i - Boston, November 8, 8 pm, pg 65).
2. Seafood that is technically "safe" according to FDA's mercury action level is actually endangering public health. A senior FDA scientist admits to a Boston focus group that supposedly safe seafood could put a fetus at risk for neurological damage: "... the action levels that we have in place for fish are not protective enough for this - the fetuses..." (Macro International, Inc. 2000i - Boston, Nov 8, 8 pm, pg 65).
FDA scientists acknowledge the health risks during the focus groups. At one point during the focus groups, a woman whose child has Attention Deficit Hyperactivity Disorder pressed an FDA scientist: "I mean, now you find a lot of Attention Deficit Disorder and they're really not saying where it is coming from... But maybe it could be coming from eating too much fish - you know - I mean, is that a possibility?" The scientist replies, "Yes, that's why we're - yes, that is a possibility. That is why we're interested in this." "So my daughter is on medication, now, because I ate fish... ," she asks. FDA's scientist responds, "- now that we have this research, that now is a possibility." (Macro International, Inc. 2000i - Boston, Nov 8, 8 pm, pp 70-71)
3. FDA initially mentioned tuna in its draft mercury advisory but then dropped it after three meetings with the seafood industry. The agency's draft focus group materials contained warnings for pregnant women such as: "Tuna steaks can be eaten three times a month... You can eat one and a half six-ounce cans of tuna every week with no problems." (see, for example, Macro International, Inc. 2000j - Calverton, MD, Nov 14, 6 pm, pp 32). At the Calverton session, an FDA senior scientist reiterates the potential hazards tuna poses to pregnant women and extends the warning to toddlers and even adult males:
"The advice for pregnant women is once a month or less for things like king mackerel, tuna steaks, whatever." (Macro International, Inc. 2000k - Calverton, MD, Nov 14 2000, 8 pm, pp 45-46)
"It is prudent, particularly for pregnant women to avoid these high mercury fish and moderate their tuna fish consumption..." (Macro International, Inc. 2000j - Calverton, MD, Nov 14, 6 pm, pg 72).
"I have a fifteen month old and he loves tuna. I would want to know, should I be limiting the amount of tuna that I give him?" asks a focus group member. FDA's scientist replies, "It would be, you know, prudent to cut back if he's eating more than a can and a half a week." She asks for clarification: "So, it's the same can and a half for a fifteen month old as it is for him, you know, for an adult male?" He replies, "That is our - yes. It would be the same. It depends on how much you're doing." (Macro International Inc. 2000k - Calverton, MD, Nov 14, 8 pm, pp 48-49).
While crafting language for the advisory, FDA met privately three times - September 25, November 6, and November 22, 2000 - with Chicken of the Sea, StarKist, Bumble Bee, U.S. Tuna Foundation, and National Food Processors Association (FDA 2000a, 2000b, 2000c). The agency's final advisory, issued January 12, 2001, was stripped of any reference to tuna (FDA 2001a).
4. FDA official admits that the agency will rely on the seafood industry, not doctors, to educate women about the hazards of mercury in fish.
The seafood industry, however, has yet to warn women of the potential dangers of mercury. In fact, the industry used a recent study on the benefits of fish consumption (specifically, of Omega 3 fatty acids) to promote tuna consumption for pregnant women: "...this new study adds to the long list of startling health benefits scientists believe Omega-3s fatty acids provide to pregnant women and small children. The most convenient, economical source of Omega-3s for moms and kids is, quite simply, canned tuna!" (U.S. Tuna Foundation, 2001). This press release provides a clear indication that the tuna industry has no plan to protect its customers from the dangers of mercury by steering them toward safer fish.