The U.S. Department of Agriculture and Food and Drug Administration have announced a June 18, 2013, public meeting in Washington, D.C., to provide information and receive public comments on agenda items and draft U.S. positions for discussion at the 36th Session of the Codex Alimentarius Commission in Rome on July 1-5. Agenda items include (i) a report by the chair of the 68th session of the executive committee; (ii) revocation of existing Codex standards and related texts; (iii) “Amendments to the Codex Standards and Related Texts”; (iii) “Financial and Budgetary Matters”; and (iv) chair and vice chair elections and coordinator appointments. See Federal Register, April 23, 2013.
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Several dozen trade associations representing the interests of food and beverage producers, processors, shippers, and retailers have submitted their concerns about the Obama administration’s proposed 2014 Food and Drug Administration (FDA) budget, which includes $59 million in food facility registration and inspection fees to fund FDA activities under the Food Safety Modernization Act (FSMA). In their April 17, 2013, letter to the chair and ranking member of the Senate Appropriations Subcommittee for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, the industry groups call for FDA to submit requests for FSMA implementation funding through the appropriations process, “rather than seeking authorization of new regulatory taxes, which Congress has repeatedly rejected.”
U.S. Sen. Barbara Boxer (D-Calif.) and Rep. Peter DeFazio (D-Or.) have introduced companion bills (S. 809; H.R. 1699) that would amend the federal Food, Drug, and Cosmetic Act to require the makers of genetically engineered (GE) foods and foods with GE ingredients to include this information on their labels. Noting that the Food and Drug Administration stated in 1992 that such labels were unnecessary because GE foods were not “materially” different from other foods, Boxer characterized this approach as antiquated and said, “Common sense would indicate that GE corn that produces its own insecticide—or is engineered to survive being doused by herbicides—is materially different from traditional corn that does not. Even the U.S. Patent and Trademark Office has recognized that these foods are materially different and novel for patent purposes.” One Republican representative has agreed to co-sponsor the legislation; the remaining support is from Democratic senators and representatives. According to…
A federal court in California has ordered Bumble Bee Foods, LLC to produce “documents dating back to 2004 regarding the marketing and labeling strategies for the products [plaintiff] purchased and for products with the same Omega-3 label or with nearly identical labels” in a putative nationwide consumer-fraud class action. Ogden v. Bumble Bee Foods, LLC, No. 12-1828 (N.D. Cal., order entered April 16, 2013). The named plaintiff seeks to represent class members who purchased products she did not buy and purchased a product made by a separate company that is not a defendant in the case. According to the court, the discovery dispute was about whether Bumble Bee “must produce discovery on all of its products . . . from eight years prior to the initiation of this lawsuit . . . [and involving] King Oscar.” The court determined that it was not appropriate to consider whether the named plaintiff has…
A federal court in California has decided that some consumer-fraud claims brought by an animal rights group and a company that makes vegan faux foie gras against Hudson Valley Foie Gras (HVFG) over statements that the defendant’s product is “the humane choice” may proceed. Animal Legal Def. Fund v. HVFG, L.L.C., No. 12-5809 (N.D. Cal., order entered April 12, 2013). While California prohibits the production of foie gras, which involves force-feeding ducks, the law does not prevent out-of-state producers, such as New York-based HVFG, from marketing in the state or shipping its product there. While the court reportedly acknowledged that a definition for “humane” is “hard to pin down,” it found that the plaintiffs might be able to prove use of the term by HVFG false if the production process is shown to cause ducks an undue amount of pain. The court dismissed the Animal Legal Defense Fund from the lawsuit…
A federal court in California has granted in part and denied in part the defendants’ motion to dismiss the first amended complaint in a putative class action alleging that the companies falsely label and market Splenda Essentials with Antioxidants®, Splenda Essentials with Fiber® and Splenda Essentials with B Vitamins®. Bronson v. Johnson & Johnson, Inc., No. 12-4184 (N.D. Cal., order entered April 16, 2013). Dismissed with leave to amend were claims brought under the Unfair Competition Law, False Advertising Law and Consumers Legal Remedies Act to the extent that the claims include statements made on the defendants’ website or in print ads. The court found that the plaintiffs failed to allege that they relied on these statements when purchasing the products. Also dismissed with leave to amend are claims about the Fiber and B Vitamins products because the plaintiffs relied on lack of scientific substantiation theories which cannot be asserted…
The European Commission (EC) has released the results of its investigation into beef products contaminated with horsemeat, reporting that 5 percent of tested products were contaminated with horse DNA and 0.5 percent of tested horse carcasses were contaminated with the pain reliever phenylbutazone (bute). The investigation apparently involved 7,259 tests carried out by 27 member states in addition to 7,951 tests conducted by food business operators, including producers, processors and distributors. Based on these results, the Commission has reiterated the European Food Safety Authority’s (EFSA’s) assessment that bute contamination poses a low risk to consumers. “Today’s findings have confirmed that this is a matter of food fraud and not of food safety,” said EU Commissioner for Health and Consumers Tonio Borg. “Restoring the trust and confidence of European consumers and trading partners in our food chain following this fraudulent labeling scandal is now of vital importance for the European economy…
The National Toxicology Program (NTP) recently released its peer-reviewed report on the toxicology and carcinogenesis of Ginkgo biloba, “an herbal remedy and dietary supplement purported to improve memory and brain function.” Based on long-term studies in which researchers “deposited solutions of Ginkgo biloba extract in corn oil directly into the stomachs of male and female mice and rats five times a week for two years,” the report concluded that animals exposed to Ginkgo biloba extract “experienced increased rates of a variety of lesions in the liver, thyroid, and nose” as well as “increased incidences of cancers of the thyroid gland… in male and female rats and male mice and liver cancers in male and female mice.” Citing these studies, the Center for Science in the Public Interest (CSPI) has since issued a warning to consumers, advising them to avoid a number of products, including energy drinks, that list ginkgo as…
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly informed Senate appropriators that the agency would extend for 120 days the comment period for two proposed rules—one relating to fresh produce and the other to food processors issued in January 2013 to implement the Food Safety Modernization Act (FSMA). According to Hamburg, “We appreciate that these are complex rules, the proposed rules, to go through and analyze, and we do intend to extend the comment period so that we can hear all of the concerns and address them fully, and I think it’s a reasonable request.” Hamburg also reportedly indicated that a rule requiring restaurants to post calorie information is a “high priority” for the agency, but hesitated when asked if it would be issued by October 1, at the start of the new fiscal year. See CQ Healthbeat News, April 18, 2013.
The Food and Drug Administration (FDA) has issued a proposed rule that would add selenium to the list of nutrients required in infant formula as well as establish minimum and maximum levels for the mineral in this context. Under the proposed rule, which recognizes selenium as an essential nutrient, infant formula labels would also need to list the amount per 100 kilocalories of formula. According to FDA, the selenium content of soil varies widely by geographic region, leading to either chronic selenium toxicity or dietary deficiencies that can result in diseases such as cardiomyopathy. Recognizing that formula “is intended to be the sole source of nutrition for infants,” FDA has proposed “2.0 µm selenium/100 kcal as the minimum level for selenium in infant formulas and 7.0 µm selenium/100 kcal as the maximum level.” The agency will accept comments on the proposed rule until July 1, 2013. See Federal Register, April 16,…
