• by Karlene Lukovitz  @KLmarketdaily, January 5, 2009

The Food and Drug Administration has released a final rule requiring that foods and cosmetics that contain insect-based colorings, called carmine or cochineal extract, list these by name on labels.

Currently, the FDA allows these colorings, which are extracted from the dried bodies of cochineal beetles, to be included under the terms "artificial colors" or "color added" on labels. The new rule, published in Monday's Federal Register, takes effect 24 months from that date.

The extracts, used by some food and cosmetics manufacturers as an inexpensive means of producing color-fast reddish and orange hues, have been found to produce allergic reactions such as sneezing, difficulty in breathing, hives, headaches and anaphylactic shock in some individuals, according to medical documentation cited by the Center for Science in the Public Interest (CSPI).

CSPI petitioned the FDA 10 years ago, in August 1998, to require clear labeling disclosure, conduct scientific studies--and, if appropriate, ban the colorings. The new rule was proposed in January 2006, and the commentary period ended in May 2006.

While there is "no complete list" of foods and beverages in which the colorings are used, they are known to be ingredients in some fruit drinks, yogurts, ice creams and candies, according to CSPI Executive Director Michael F. Jacobson. Data on the colorings' use in cosmetics is even less available, although the FDA has cited the awareness of at least one instance in which such ingredients in a cosmetic led to an allergic reaction, according to Jacobson.

While describing the new rule as "useful progress," CSPI maintains that it falls short. The center contends that the colorings should have been banned because "the only way people can determine that they are sensitive to them is to suffer repeated reactions, including potentially life-threatening anaphylactic reactions." At minimum, CSPI contends, the FDA should have required that labeling specifically indicate that these colorings are "insect-based" in order to provide clear disclosure not only for potential allergic reaction purposes, but for "vegetarians, Jews who try to keep Kosher, and anyone else who might not care to eat extracts of six-legged critters."

Will CSPI continue to press for that clearer labeling disclosure or a ban? "I think the ballgame is over at this point," Jacobson tells Marketing Daily. "The FDA has decided that it's OK for people to suffer allergic reactions."

Asked about CSPI's assessment of the FDA regulatory climate going forward under the incoming Obama administration, Jacobson said: "The Republicans have been adamantly opposed to regulation. The Obama administration certainly understands that there is an important role for government to improve health and safety." This change in policy climate and the appointment of a new FDA commissioner will result in the FDA being "a more vigorous watchdog," he predicts.