Regulatory Issues: Natural acrylamide in food faces FDA scrutiny

In an op-ed piece in the October 17 issue of the San Francisco Chronicle, Attorney General Lockyer explained the reason he filed suit prior to OEHHA issuing final regulations and further proposals addressing acrylamide in food: “Since the discovery [of acrylamide in food], some food manufacturers started exploring better cooking methods, but some manufacturers instead have launched a major disinformation campaign about California law. They are even twisting the FDA's glacial pace on addressing this health crisis into an endorsement for the status quo. They're doing what they always do when called upon to stop concealing facts: The junk-food industry is peddling junk science. People have the right to make their own choices, for themselves and their families, based on truthful information. Few manufacturers voluntarily alert the public to the cancer-causing chemicals in their products. That is why right-to-know laws like Prop. 65 are critical.”

Possible Federal Preemption

Attorney General Lockyer had filed a lawsuit in San Francisco Superior Court in June 2004 seeking Proposition 65 warnings on canned and packaged tuna products containing mercury and mercury compounds, which are listed as carcinogens and reproductive toxins. On August 12, two weeks before the acrylamide lawsuit was filed, then-FDA Commissioner Lester Crawford sent a letter to Attorney General Lockyer concerning the FDA’s position on Proposition 65 mercury warnings.

Commissioner Crawford stated, “FDA believes that such warnings are preempted under federal law… The [Federal Food, Drug, and Cosmetic] Act provides broad authority to the FDA to regulate the labels of food products. However, rather than requiring warnings for every single ingredient or product with possible deleterious effects, FDA has deliberately implemented a more nuanced approach… taking action in instances of adulterated and misbranded foods and, only under exceptional circumstances, requiring manufacturers to provide warnings on their labels. As part of this deliberate regulatory approach, FDA has required warnings only in those instances where there is clear evidence of a hazard, in order to avoid overexposing consumers to warnings, which could result in them ignoring all such statements, and hence creating a far greater public health problem… 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."

Although the mercury and acrylamide cases differ in some respects, there are multiple similar issues. Given the FDA’s conclusion that federal law preempts Proposition 65 warnings for mercury in tuna, and its serious concerns as expressed to OEHHA in May regarding the possibility of Proposition 65 warnings for acrylamide in food, an FDA preemption challenge to the acrylamide lawsuit may be imminent.

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Leslie T. Krasny is a partner at the law firm of Keller and Heckman LLP, San Francisco office. She specializes in food and drug law, with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology and advertising. She is a member of the California Bar and holds a master’s degree in cell and molecular biology.