We are concerned because the FDA does not adequately monitor methylmercury levels in commercial fish supplies. These levels may change over time, but the FDA does not collect data to determine if this is happening. Surveillance is essential.

We are concerned because the current FDA advisory is incomplete. The advisory should be revised to include information about tuna. Although the levels of methylmercury in tuna, and especially canned tuna, are lower than the fish that are included in the current advisory, the amount of tuna consumed is typically so much higher that a public health perspective requires that the FDA widely disseminate risk information about fresh tuna and canned tuna.

We are concerned because FDA's dissemination of information about methylmercury exposure has not reached most consumers. Even health-conscious consumers are unaware of the overall risks of methylmercury in fish, and don't know which fish pose the greatest problems.

More than a year and a half ago, I participated in a small meeting of consumer groups with Joe Leavitt about the FDA's plans regarding an advisory for methylmercury. It was an excellent meeting. The major focus of the discussion, as I recall it, was that the FDA was planning to include a warning about fresh tuna in its advisory, but not canned tuna. Most of the consumer groups strongly urged that canned tuna be included in the advisory. We also discussed the various ways that this information would need to be provided to consumers: on fresh fish sold in supermarkets or fish markets, on cans of tuna, and on restaurant menus. So, imagine my surprise when neither canned tuna nor fresh tuna were included in the advisory, and when the FDA made no apparent effort to inform consumers of these risks at the time when it would do the most good: when they are either buying fish in a market or ordering it in a restaurant.

Based on the National Academy of Sciences (NAS) report on the potential adverse effects of chronic methylmercury exposure, we are convinced that the FDA must do more to protect vulnerable populations (pregnant women, women who might become pregnant, nursing mothers, and young children) from the risk of that exposure. In our experience, NAS is very cautious, so when they suggest that 60,000 newborns each year may be at risk for neurological problems due to methylmercury, we take that estimate very seriously -- even though it is just an estimate.

I am trained in epidemiology, so I strongly believe that better data would be preferable for making important health decisions. The American public relies on the FDA to require or to collect data so that we will better understand the risks of exposure to methylmercury in the fish that we eat, or want to eat. The epidemiological research suggests that methylmercury in fish can potentially pose very serious problems, especially for the developing fetus. There are two ways to be exposed to high levels of methylmercury through the consumption of fish. One is to eat swordfish, shark, and a few other types of fish that are highest in methylmercury. The other is to consume large quantities of fish that have moderate amounts of methylmercury, such as fresh tuna, canned tuna, and halibut.

Tuna Should Be Included in the Advisory
American women eat a lot of tuna -- canned and fresh. Using government data, the U.S. Tuna Foundation estimates that on average, the 1% of women who eat the most tuna eat almost 7 oz/week. This is just a little less than the 9 oz that FDA scientists considered the upper limit of what is safe for pregnant women, according to documents that have been made publicly available. What about the top half of one percent consumers of canned tuna? That is still a large number of women.

Canned tuna is a convenience food, because you can buy it now and eat it any time, and virtually anyone in the U.S. can afford it. Last week, the CVS stores offered cans of brand-name tuna for 44 cents. There aren't many "main courses" that are that inexpensive, and most of them - such as hot dogs or bologna-- are perceived to be rather unhealthy. This makes canned tuna especially appealing to low-income women, including pregnant women and mothers of young children.

If you believe that an FDA advisory should reflect the science, then I think you will agree that a very popular fish such as tuna needs to be included in the advisory. If scientists at the FDA believe that the level of methylmercury in canned tuna is not sufficient to warrant an advisory, they need to prove that by providing current data. It is not enough to say that the evidence is unclear. They need to collect the data needed to support or refute concerns about methylmercury in canned tuna and fresh tuna.

Vulnerable Populations and Risks and Benefits in the Advisory
The current FDA Advisory is entitled "An Important Message for Pregnant Women and Women of Childbearing Age Who May Become Pregnant About the Risks of Mercury in Fish." At the bottom of the page it mentions, almost casually, that "it is prudent for nursing mothers and young children not to eat these fish as well." Obviously,
those warnings deserve more attention.

Most foods have risks and benefits. Cheese provides calcium, but can also be high in fat. Juices provide vitamins, but pediatricians warn parents of young children to limit their juice consumption. So, it makes some sense to include both sides -- benefits and risks -- for fish as well. But it will be difficult to do that succinctly.

How should the FDA get the word out?
Just as important as the Advisory information is the dissemination of that information to the general public. The FDA advisory needs to reach more people. For example, how many people know that the FDA believes pregnant women and women who might become pregnant should limit their consumption of cooked store-bought fish to an average of 12 ounces a week? I asked several health-conscious, fish-eating types, and none of them were aware of it. In fact, I asked a pediatrician who teaches at a major university and is active in the American Academy of Pediatrics -- a man who does not eat red meat and considers himself very health-conscious. He barely knew what methyl mercury is, and certainly knew nothing about the 12 ounce limit for pregnant women.

What efforts has the FDA or the fish industry made to get information from the FDA advisory into women's magazines, parenting magazines, or other publications that are read by women of reproductive age? Why not have PSA's on TV, where they can reach even more pregnant women and mothers of young children? And, since the FDA advisory states that fish consumption should be limited to an average of 12 ounces per week for pregnant women and women who might become pregnant, why not place that information directly on menus and on all fish products that are sold, including canned tuna?

The Importance of Warning Information
In the absence of complete information about the levels of methylmercury contamination of fish, we believe that the FDA should warn vulnerable populations not to eat swordfish, shark, king mackerel, tilefish, and fresh tuna, since they have been previously shown to contain unsafe levels of methylmercury. We believe that the risks outweigh the potential benefits since at-risk consumers can simply switch from eating swordfish, shark, and fresh tuna, to other fish and seafood that have equal nutritional benefits but are not contaminated with methylmercury. We also believe that consumers should be advised to limit their consumption of tuna.

I realize that the companies involved fear that people will stop eating tuna. They were probably concerned by the focus groups that were conducted, which indicated that consumers wanted to know which fish were unsafe and which were safe, rather than more nuanced information.

However, focus groups do not necessarily predict what people will do in the real world. Millions of Americans still eat hot dogs, despite warnings about nitrites. We eat processed foods despite warnings about high salt content. We still eat fresh fruits and vegetables, despite warnings about pesticides. After the initial shock -- which would probably result in a drop in consumption -- consumers will look for a way to continue to modify their eating habits to conform to clearly stated warnings. If this is handled correctly, consumers will understand that limiting tuna consumption is not the same as avoiding it altogether. We manage to get that message out on a lot of other foods -- ice cream, alcoholic beverages, cake, and cookies, for example. I think consumers can understand it when the food is tuna, or other fish.

Labels
When consumers purchase swordfish, shark, king mackerel, tilefish, and fresh tuna that is either prepackaged or packaged at a fish counter, the package should bear a label that tells pregnant women, women who might become pregnant, nursing mothers, and young children not to eat it. At restaurants, a similar warning should be on menus if those items are served.

Labels are also needed for canned tuna. We urge that the FDA advise vulnerable populations to consume canned tuna infrequently (less than one 6-oz can per week) until a more comprehensive analysis of the methylmercury content of canned tuna can be performed. We also urge that analyses be conducted as soon as possible.

Our recommendations are consistent with the precedents that have been set to provide clear warnings for pregnant women and children, even in the absence of data establishing specific risks. For example, warning labels are used to caution pregnant women not to consume any alcoholic beverages, even though research has not established that occasional consumption is dangerous.