The Natural Resources Defense Council (NRDC) has joined the Center for Science in the Public Interest and other consumer groups in petitioning the U.S. Food and Drug Administration (FDA) to remove several chemicals from food contact materials. The first food additive petition asks FDA to promulgate a new rule “prohibiting the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be used in food contact articles,” and to amend existing regulations to ban the use of potassium perchlorate in food container sealing gaskets. Citing “the well-recognized toxicity of perchlorate,” the petition alleges that dietary exposure can impair fetal and infant development, especially when pregnant or nursing women do not consume enough iodine. A second petition urges the agency to revoke approval for “the use of long-chain perfluorocarboxylate [PFC] oil and grease repellents in paper and paperboard.” Noting that FDA has already asked some domestic manufacturers to…
Category Archives Food and Drug Administration
A California federal court has granted in part and denied in part a motion for summary judgment in a lawsuit alleging that Mott’s violated the U.S. Food and Drug Administration’s (FDA’s) and California’s Sherman Law standards on the use of “no sugar added” on food packaging. Rahman v. Mott’s LLP, No. 13-3482 (N.D. Cal., order entered October 14, 2014). The plaintiff alleged that Mott’s 100% Apple Juice included a “no sugar added” label but failed to follow the additional FDA regulations requiring “a statement that the food is not ‘low calorie’ or ‘calorie reduced’ (unless the food meets the requirement for a ‘low’ or ‘reduced calorie’ food) and that directs consumers’ attention to the nutrition panel for further information on sugar and calorie content.” Mott’s moved for summary judgment on four grounds: the plaintiff (i) did not suffer damages as a result of purchasing the apple juice, (ii) lacked standing…
The U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR) for November 6-7, 2014, at NCTR’s research campus in Jefferson, Arkansas. Public sessions of the two-day meeting will include the NCTR director’s update on scientific initiatives; a report from the National Toxicology Program on opportunities for collaboration; and discussions of specific research needs from representatives of the Center for Veterinary Medicine, Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. Individuals interested in making presentations during the meeting should express interest in doing so by October 22 while those wishing to submit data or views in writing should do so by October 30. See Federal Register, October 9, 2014. Issue 540
The U.S. Court of Federal Claims has ruled that the U.S. Food and Drug Administration (FDA) is not required to compensate tomato growers for a regulatory taking after incorrectly warning the public in 2008 that a Salmonella outbreak was linked to tomatoes. Dimare Fresh Inc. v. U.S., No. 13-519 (Fed. Cl., order entered September 18, 2014). The growers argued that FDA had “appropriated a benefit” through the seizure of tomatoes, but “[a] regulatory takings claim is not plausible and cannot proceed when the government action at issue has no legal effect on the plaintiff’s property interest,” the court said. “Advisory pronouncements, even those with significant financial impact on the marketplace, are not enough to effect a taking of property under the Fifth Amendment.” The growers were attributing independent consumer behavior to FDA, the court found, and the argument that consumer advisories alone constituted takings had no support in case law.
To ease producer burdens under the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has revised four proposed rules related to produce safety; preventive controls for human food and animal food; and the foreign supplier verification program. After receiving feedback from consumers and industry stakeholders, the agency has (i) updated water quality testing provisions; (ii) exempted farms with less than $25,000 in sales from produce-safety rules; (iii) addressed the use of spent grains in animal food by clarifying that brewers and distillers subject to the human-food rules do not need to comply with all animal-food rules; and (iv) granted importers more flexibility under the proposed foreign-supplier verification program “to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.” FDA has requested comments on the proposed changes by December 15, 2014. “Ensuring a safe and high-quality food supply is one of the FDA’s…
The Natural Resources Defense Council (NRDC) and other groups have requested that the Second Circuit Court of Appeals reconsider its decision that the U.S. Food and Drug Administration (FDA) is not required to begin proceedings to withdraw approval of certain antibiotics in livestock feed. NRDC Inc. v. FDA, No. 12-2106 (2d Cir., petition filed September 8, 2014). Additional details about the Second Circuit’s split ruling appear in Issue 531 of this Update. According to a news source, the petitioners contend that the panel majority overlooked FDA’s initial findings that the use of antibiotics in animal feed is unsafe and “writes the withdrawal provision out of the Food and Drug Act.” FDA considered the safety of penicillin and tetracyclines in animal feed in 1977, but never conducted adversarial hearings with industry as purportedly required under the law, opting instead to seek the voluntary withdrawal of animal feed with antibiotics from the market. See Law360,…
The Food and Drug Administration (FDA) is reportedly taking measures to bolster intra-agency program processes based on a comprehensive review of the scientific capacity and management of the Chemical Safety Program across the Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM). FDA plans to address improvements in the principal categories of science, communication and collaboration, and training and expertise. Among other things, the agency intends to (i) update the agency’s Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook); (ii) establish consistent methodologies for safety and risk assessments within and across CFSAN offices and between CFSAN and CVM; (iii) increase collaboration on emerging issues with other federal agencies; and (iv) create an experts database to help identify potential collaborators both inside and outside the agency. See FDA Constituent Update, August 28, 2014. Issue 537
Recent legislation (S.B. 2718) introduced by U.S. Sen. Robert Menendez (D-N.J.) and U.S. Rep. Bill Pascrell (D-N.J.) has called for energy drink guidelines as part of a wider initiative to ensure children’s safety in athletics. According to a September 8, 2014, press release, the Supporting Athletes, Families and Educators to Protect the Lives of Athletic Youth Act (SAFE PLAY Act) combines previous legislative efforts to address “concussions, cardiac arrests, heat-related illness, and consumption of energy drinks.” The bill would require the Department of Health and Human Services, Food and Drug Administration (FDA) and Centers for Disease Control and Prevention to (i) “develop information about the ingredients used in energy drinks and the potential side effects of energy drink consumption,” and (ii) “recommend guidelines for the safe use of energy drink consumption by youth, including youth participating in athletic activities.” Although the proposed guidelines would cover all liquid dietary supplements and…
U.S. Food and Drug Administration (FDA) researchers recently presented dietary exposure assessments for 4-methylimidazole (4-MEI) at the 248th American Chemical Society (ACS) National Meeting held August 10-14, 2014, in San Francisco. Contributing to FDA’s review of available toxicological data for 4-MEI found in Class III and IV Caramel colors produced using ammonium compounds, the scientists analyzed 4-MEI levels of caramel-containing foods and beverages using liquid chromatography-tandem mass spectrometry, then relied on intake data from the National Health and Nutrition Examination Survey (NHANES) to estimate dietary exposure levels for the following U.S. population groups: (i) “the U.S. population aged 2 years or more”; (ii) “infants (< 1 year old)”; (iii) “children aged 1 year”; (iv) “children aged 2-5 years”; (v) “children aged 6-12 years”; and (vi) “teenage boys aged 12-18 years.” According to the presentation poster, the caramel-containing food categories contributing more than 1 percent “to the cumulative dietary exposure to 4-MEI…
Discussing the expedited approval process for food additives that took effect 17 years ago, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Michael Taylor recently told Washington Post reporter Kimberly Kindy that the agency does not have “the information to vouch for the safety of many of these chemicals.” According to the August 17, 2014, article, the number of additives in the food supply has increased to 9,000 from 800 over a 50-year span, in part because a voluntary certification system dependent on industry safety data has eclipsed FDA’s independent review process. Under the Generally Recognized as Safe (GRAS) scheme, companies need only submit a summary of their safety research to FDA, shortening time to approval even for new and novel food additives. In particular, the Post highlights how a mycoprotein marketed as “Quorn” achieved GRAS status despite one undisclosed study allegedly showing that 5 percent of test…
