TCS Daily

The Warning Label We Need

By John Luik - October 6, 2005 12:00 AM

Editor's note: This is the final article in a series on the alleged link between acrylamide in food and cancer in humans. See part 1, part 2, part 3, and part 4.

FDA believes that warning language for acrylamide in foods could confuse consumers, by creating unnecessary public alarm about the safety of the food supply and by diluting overall messages about healthy eating.

-- Food and Drug Administration Letter to California Office of Environmental Health Hazard Assessment (OEHHA), May, 2005

If you believe California Attorney General Bill Lockyer and the Center for Science in the Public Interest, food-based acrylamide causes 180 cancers each year in residents of the Golden State. That's why Lockyer has gone to court to force food vendors and manufacturers to slap cancer warning labels on all of the state's chips and fries, in order, he claims, to provide consumers with "the information we need to make informed decisions..." But Lockyer's move has four small but significant problems.

The first of these is that the science is somewhat uncooperative. Whatever CSPI and Lockyer might say about rats and WHO, and whatever junk science trick they pull, they simply can't get around the very clear epidemiological evidence that acrylamide is not associated with an increased risk of cancer in human populations. As leading acrylamide researcher Lorelei Mucci of Harvard said some two years ago, "It's very reassuring to know that when we looked in detail at the effects of consuming foods containing high levels of acrylamide we found no increased risk for three major cancers."

The second problem for Lockyer is the political one that attaches to his use of the now notorious Proposition 65 to sue the food companies over acrylamide. Referred to variously as the "trial lawyers' bonanza" or the "bounty-hunter's charter," Proposition 65 dates from a ballot initiative in 1986 which requires the governor to publish a list each year of all chemicals known to the state to cause cancer, birth defects or other reproductive harms. As part of the initiative's "bounty-hunter" provision, any citizen can sue a company for failing to disclose the presence of a listed chemical, regardless of whether the concentration is sufficient to effect human health. Violators can be fined $2500 per day, per violation and the plaintiff is allowed to keep 25% of the total fine. Nice work for the state's litigation bar.

As Walter Olson, writing in the Wall Street Journal (7/27/05) noted, Proposition 65 has turned California into the "shakedown state."

        "Identical practices [setting up fake consumer groups that are nothing 
        more than lawyer-controlled fronts] are seen in the parallel bounty-
        hunting subculture spawned by the state's Proposition 65 law, under 
        which lawyers have sued manufacturers for failing to warn of the claimed 
        toxic emissions given off by brass darts, Christmas lights, hammers, 
        mineral oil, billiard cue chalk and picture frames, not to mention French 
        fries and chocolate..... One lawyer filed 400 Proposition 65 claims against 
        candle makers, on the ground that their products emit toxic fumes when 
        burned; the consumer group he represented turned out to have his mother 
        as its only officer."

The third problem facing the AG is the Food and Drug Administration. Lockyer's problem grows out of the fact that the FDA has taken a science-based approach to the issue of warning consumers about health risks rather than the evidence-deficient one pursued by Lockyer and Proposition 65. And given a conflict between the two, Lockyer's warnings would be preempted under federal law.

Lockyer, using Proposition 65, is suing seafood processors for failing to warn California consumers that the tuna they are selling contains methylmercury, a chemical known to the state to cause cancer. In an August 12, 2005 letter to Lockyer, FDA Commissioner Lester Crawford told Lockyer that the state cannot require such warnings on tuna products for because the FDA's approach takes precedence and because Lockyer's warnings are not scientifically accurate. Crawford wrote:

        "...the Proposition 65 warnings purport to convey factual information, 
        namely that methylmercury is known to cause cancer and reproductive 
        harm. However, it is done without any scientific basis as to the possible 
        harm caused by the particular foods in question, or as to the amounts 
        of such foods that would be required to cause this harm. Stated differently, 
        these warnings omit facts which are necessary to place the information 
        in its proper context."

Lockyer's methylmercury warnings run afoul of the FDA precisely because they do not establish a scientific basis for harm for the particular food in question. And the same problem -- lack of scientific evidence of harm -- applies to Lockyer's proposed acrylamide warnings.

As the FDA in a May letter (From the Director of Plant and Dairy Foods Division) to OEHHA noted: "FDA believes that warning language for acrylamide in foods could confuse consumers, by creating unnecessary public alarm about the safety of the food supply and by diluting overall messages about healthy eating." So far from informing consumers by providing them with accurate scientific information, as Lockyer claims, the FDA believes that the acrylamide warnings will confuse and alarm them, create unnecessary worries and work against public health by diluting messages about healthy eating.

Lockyer's fourth problem then is that his warnings will actually work against the public health interest which is allegedly his focus. With Lockyer's acrylamide warnings consumers are likely to make worse, not better food choices, as well as expose themselves to greater risks. This happens in three different ways.

First, once acrylamide is labeled a carcinogen, consumers will attempt to avoid it not only in fries and chips but in foods that, while containing acrylamide, also contain essential nutrients. As Barbara Petersen, a former researcher with the FDA observed in a 2004 presentation to the American Chemical Society conference, since "virtually all of the foods associated with acrylamide contribute important nutrients... to the diet", avoiding consumption of these foods will have a negative nutritional impact.

Second, in order to avoid the cancer label on their products, companies may attempt to remove acrylamide through lowering the temperatures at which foods are cooked, (acrylamide only forms at certain temperature levels), something that could increase the risk of disease from undercooked foods. Consumers, in preparing their own foods, will be tempted to do the same. And many people may well decide to avoid a number of healthy foods in which acrylamide forms, if they are only "safe" if boiled, rather than fried, baked, broiled or grilled.

Third, by requiring warnings where there is no scientific justification, warnings proliferate, consumers are overexposed to warnings -- what warnings experts refer to as warning fatigue -- and as a result all warnings lose their effectiveness. As FDA Commissioner Crawford observed in his August letter to Lockyer:

        "...FDA is unwilling to require a warning statement in the absence of clear 
        evidence of a hazard...[as the agency] is concerned that it would overexpose 
        consumers to warnings. As a result, consumers may ignore, and become 
        inattentive to, all such statements."

Former FDA official Henry Miller, warned of the same loss of effect when he noted that "When you have too much information, and it doesn't discriminate, it does not inform."

Indeed, if Lockyer's approach of warning about naturally-occurring carcinogens like acrylamide that do not pose a health hazard were to become standard practice, then virtually all supermarket foods would have to carry some warning. "Nature abounds in chemicals that cause cancer at high dose in animal tests, including hydrazines in mushrooms, the safrole in black pepper, and alfatoxins in peanut products," says Elizabeth Whelan of the American Council on Science and Health. "If we were to label every food containing something that causes cancer in rodents, few foods would be spared. A supermarket, with everything labeled, might as well have 'abandon all hope ye who enter here' emblazoned on its welcome mat."

The phantom acrylamide scare has been with us now for three years, fueled by a heady mixture of bad science, lazy and sensationalist reporting, political opportunism and the avarice of the plaintiffs bar. Perhaps as Bill Lockyer suggests it really is time to provide consumers -- Californian and elsewhere -- the "information we need to make informed decisions". In that spirit the warning should read:

Junk Science at Work! Be Very Skeptical of all California Warning Labels

John Luik is writing a book about health policy.


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