The Center for Science in the Public Interest (CSPI) has filed a regulatory petition with the Food and Drug Administration (FDA), asking the agency to prohibit two types of caramel coloring used in cola, beer, soy sauce, and other foods. According to CSPI, “the artificial brown coloring in colas and some other products is made by reacting sugars with ammonia and sulfites under high pressure and temperatures,” resulting in “the formation of 2-methylimidazole [2-MI] and 4-methylimidazole [4-MI], which in government-conducted studies caused lung, liver, or thyroid cancer or leukemia in laboratory mice or rats.”

The consumer watchdog is thus urging FDA to prohibit Caramel III and
Caramel IV food colorings because both are made with ammonia. Experts
with ties to the National Toxicology Program (NTP) have also penned a letter
in support of this request, citing several NTP animal studies finding “’clear
evidence’ for carcinogenicity” of both 2-MI and 4-MI. “[T]he phrase ‘caramel
coloring’ is misleading when used to describe colorings made with ammonia
or sulfite,” concludes CSPI in a February 16, 2011, press release. “The terms
‘ammonia process caramel’ or ‘ammonia sulfite process caramel’ would be
more accurate, and companies should not be allowed to label any products
that contain such colorings as ‘natural.’” See Reuters, February 16, 2011.

Meanwhile, a coalition of industry organizations has submitted a letter to
California Governor Jerry Brown (D) to express concerns about actions taken
by the Office of Environmental Health Hazard Assessment (OEHHA) as former
Governor Arnold Schwarzenegger (R) left office. According to the February
11, 2011, letter, “These actions cast doubt on OEHHA’s use of best available
science [and] signal a bias toward selective use of scientific methodologies,
data and assumptions that yield the lowest possible health reference levels,
yet are unlikely to provide any real-world public health benefits.”

The coalition includes groups such as the California Chamber of Commerce,
California Restaurant Association and American Chemistry Council. They ask
Brown to suspend all pending OEHHA decisions until “necessary appointments
are made and the appropriate administration staff can engage in
discussions with OEHHA, Cal/EPA and other affected agencies to evaluate
whether these actions are truly based on the best available science, and how
best to mitigate the impacts that would follow from their incorporation in
state environmental regulatory decisions.”

OEHHA administers the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65) under which consumers must be notified about products containing known carcinogens or reproductive toxins. Among the issues specifically raised in the letter is a recently adopted final Prop. 65 listing of 4-MI as a carcinogen that would require colas and other products containing the coloring to bear a cancer warning label. According to the coalition, “No other government on earth currently requires or recommends product warnings for [4-MI].”

The coalition suggests that the timing of this and other OEHHA actions could
indicate “a desire by OEHHA to avoid executive oversight,” and appear to
“contribute significantly to the counter-productive regulatory environment
you cited during the gubernatorial campaign.”

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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