Category Archives Issue 476

The European Food Safety Authority’s (EFSA’s) Scientific Committee has issued an opinion “that clarifies the scientific criteria for identifying an endocrine disruptor.” Requested by the European Commission, the opinion addresses “the testing and assessment of endocrine active substances (EASs) and endocrine disruptors (EDs)” by adopting the World Health Organization’s definition for EDs, which must meet the following three criteria: “the presence of (i) an adverse effect in an intact organism or a (sub)population; (ii) an endocrine activity; and (iii) a plausible causal relationship between the two.” The opinion also identifies “a reasonably complete suite of standardized assays for testing the effects of EASs [that] is (or will soon be) available for the oestrogenic, androgenic, thyroid and steroidogenic modalities in mammals and fish” known to be sensitive to endocrine disruption. The Scientific Committee has stressed, however, that not all EASs are EDs, ultimately advocating “a risk assessment approach” that evaluates substances…

According to the Food and Drug Administration (FDA), a federal court has approved a consent decree with Clifton, New Jersey-based Butterfly Bakery, Inc. over claims that it distributed misbranded food products, such as muffins and snack cakes. United States v. Butterfly Bakery Inc., No. 13-669 (D.N.J., order entered March 5, 2013). Under the agreement, the bakery will be unable to process or distribute food until it complies with the Food, Drug, and Cosmetic Act. FDA and state testing apparently showed that foods labeled as “sugar free” contained sugar, and some products contained three times the amount of declared or labeled sugar and two times the amount of fat or saturated fat. See FDA News Release, March 13, 2013.

Two agricultural organizations have filed a citizen petition with the Food and Drug Administration (FDA) seeking to ban the use of antibiotics in ethanol production so that the leftover mash, known as “distillers grains with solubles (DGS),” which is fed to livestock, does not add to the levels of antibiotics used in the production of poultry and meat in the United States and thus contribute to the development of “superbugs,” that is, bacteria resistant to multiple antibiotics. In re Ctr. for Food Safety, No. __, (FDA, filed March 15, 2013). In the alternative, the petitioners request that FDA adopt regulations that deem antibiotics sold to ethanol producers for DGS production as new animal drugs, require drug sponsors to seek FDA approval for their use and ban the sale of antibiotics that have not been approved as new animal drugs. According to the Center for Food Safety and Institute for Agriculture…

A group of physicians, researchers and public health experts has urged Food and Drug Administration (FDA) Commissioner Margaret Hamburg to consider the purported adverse health effects, particularly for children and adolescents, posed by energy drinks containing high levels of caffeine, apply existing generally recognized as safe standards to such beverages and require manufacturers to provide caffeine content on product labels. In their March 19, 2013, letter, the signatories cite their own and others’ research to claim that an increase in the consumption of products with added caffeine has been associated with fatalities and injuries, increased emergency room visits, cardiovascular complications, seizures, childhood obesity, and risky behaviors when combined with alcohol. They contend that while caffeine’s effects on adults are known, safe levels for teenagers have not been sufficiently shown. In a related development, several energy drink companies, including Monster Beverage, have reportedly changed their product labels to declare the caffeine…

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