U.S. Reps. Raúl Grijalva (D-Ariz.), John Conyers (D-Mich.) and Lucille Roybal Allard (D-Calif.) have circulated a request to their colleagues that they join a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking that the agency take action on two citizen petitions, pending before the agency for some eight years, seeking a rule that sugary beverages “carry a rotating series of health messages on their labels in order to educate consumers on the health risks of sugar overconsumption.” The first petition was filed in 2005 by the Center for Science in the Public Interest. See “Ask the FDA to Review Petitions on Sugary Beverages,” October 22, 2013.
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has extended until December 16, 2013, the period for submission of comments, scientific data and other information related to its risk assessment of human salmonellosis associated with the consumption of tree nuts. Originally published in the July 18 Federal Register, the assessment seeks to quantify the public health risk associated with eating tree nuts potentially contaminated with Salmonella and evaluate the impact of interventions to prevent contamination with the bacterium or to reduce contamination levels. Additional information about the risk assessment appears in Issue 491 of this Update. See Federal Register, October 4, 2013.
The U.S. Food and Drug Administration (FDA) has extended until November 12, 2013, the period for submission of comments, scientific data and other information related to its draft guidance titled “Arsenic in Apple Juice: Action Level.” Originally published in the July 15 Federal Register, the guidance proposes an action level of 10 parts per billion for inorganic arsenic in apple juice, which FDA considers “protective of human health and achievable with the use of good manufacturing practices.” The U.S. Environmental Protection Agency has set the same level for arsenic in drinking water. FDA extended the deadline in response to a request “to allow interested persons additional time to submit comments.” More details about the proposed rule appear in Issue 490 of this Update. See Federal Register, September 13, 2013.
The U.S. Food and Drug Administration (FDA) has reported that after testing 1,300 samples of rice and rice products for the presence of arsenic, the agency has determined that although the levels varied significantly depending on the product tested, the amount of detectable arsenic is “too low” to cause any “immediate or short-term adverse health effects.” The new findings represent the latest of the agency’s ongoing efforts to manage possible arsenic-related risks associated with the consumption of rice in the United States. FDA has apparently been monitoring arsenic levels in rice for more than 20 years and has seen no evidence of change in levels of total arsenic in rice. The agency’s next step will be to use new tools that provide greater specificity about different types of arsenic present in foods to analyze the effect of long-term exposure to low levels of arsenic in rice. It plans to conduct…
According to a news source, the federal court that heard a challenge to the U.S. Department of Agriculture’s (USDA’s) revision to its country-of-origin labeling (COOL) rules to comply with a World Trade Organization ruling stated during the hearing that it would issue a decision on the plaintiffs’ request for a preliminary injunction within 14 days. Am. Meat Inst. v. USDA, No. 13-1033 (D.D.C., oral argument held August 27, 2013). Additional information about a dispute that has split trade associations representing different parts of the meat production industry appears in issues 490 and 495 of this Update. The organizations seeking the injunction reportedly argued that “[t]his is a regulation the agency concedes is a de minimis benefit . . . for a de maximus cost.” They contend that the new rules violate their First Amendment rights and could put them out of business. A USDA attorney apparently argued that the new…
According to a news source, U.S. Food and Drug Administration (FDA) personnel have experienced significant delays in obtaining visas from China to staff food and drug inspection offices in that country. One staff member reportedly withdrew his application after waiting nine months for approval to work in China. The delays are seen as a setback for the agency’s efforts to improve supply chain safety; FDA planned to use $10 million in additional appropriations to increase its food inspection staff from two to nine and its drug inspection unit from just one to 11. FDA currently has three offices in the country—in Beijing, Shanghai and Guangzhou—staffed with eight U.S. civil servants and five Chinese nationals. An FDA spokesperson said, “We believe that timely issuance of visas for FDA staff will be beneficial to both the U.S. and China, and that it’s in China’s best interest to issue these visas and move…
The Food and Drug Administration (FDA) has apparently filed a petition submitted by the Dean Foods Co. and the WhiteWave Foods Co. “proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D2 and vitamin D3 as nutrient supplements in food.” In particular, the petition seeks to amend (i) 21 C.F.R. 172.39 “to provide for the safe use of vitamin D2 as a nutrient supplement in edible plant-based food products intended for use as alternatives to milk and milk products,” and (ii) 21 C.F.R. 172.80 “to provide for the safe use of vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted.” FDA has also noted that because the action will not have any significant effect on the human environment, there is no need to undertake an environmental assessment or prepare an environmental impact statement. See Federal Register,…
The Food and Drug Administration (FDA) has announced plans to prepare an environment impact statement (EIS) for a proposed rule that would establish standards for the growing, harvesting, packing, and holding of produce for human consumption. According to an August 16, 2013, FDA press release, the agency determined that an EIS was necessary based on public feedback and its own analysis, and will now begin a scoping process “designed to determine relevant issues that will influence the scope of the environmental analysis.” FDA will accept comments on the EIS scoping process until November 15, 2013. Additional details about the proposed produce standards appear in Issue 466 of this Update. See Federal Register, August 19, 2013.
The Food and Drug Administration (FDA) has announced an upcoming public meeting slated for September 19-20, 2013, in Washington, D.C., to discuss regulations proposed under the Food Safety Modernization Act (FSMA) that would establish Food Supplier Verification Programs as well as new rules for accrediting third-party auditors and certification bodies. Intended to ensure “that imported food meets the same safety standards as food produced domestically,” the proposed rules would (i) require importers “to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by [FMSA],” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies currently rely.” FDA will accept advanced registrations from individuals who wish to participate in person by September 10, 2013. Additional details about the proposed rules appear in Issue 492 of this Update. See Federal Register, August 16, 2013.
Four years after filing a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a prohibition on the use of partially hydrogenated oils containing artificial trans fat in food for human consumption, 98-year-old University of Illinois Emeritus Professor of Comparative Biosciences Fred Kummerow has filed a lawsuit seeking an order compelling an agency response to his petition and a declaration that its failure to ban trans fats violates the Food, Drug, and Cosmetic Act. Kummerow v. Hamburg, No. 13-2180 (C.D. Ill., filed August 9, 2013). The complaint details the history of the ingredient’s invention and research, including the plaintiff’s own, demonstrating its “harmful effects,” including inhibition of an enzyme necessary to prevent blood clots in the arteries and veins. The plaintiff also distinguishes between artificial and natural trans fats, noting that he does not seek a ban on the latter. According to the complaint, Kummerow learned in 2004…
