The Food and Drug Administration (FDA) is requesting (i) nominations for a non-voting industry representative to serve on the Food Advisory Committee and (ii) statements from organizations interested in participating in the selection process for the non-voting committee member. The Food Advisory Committee evaluates data and makes recommendations on such matters as food ingredient safety; food and cosmetic labeling; nutritional issues; and exposure limits for food contaminants. Organizations that want to participate in the process should express their interest in writing by January 7, 2015. Nomination materials must be received by the same date. See Federal Register, December 8, 2014. Issue 548
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has updated its online bisphenol A (BPA) information to reaffirm its conclusion that the substance is safe for approved food-packaging uses. According to the revised statement, agency experts in toxicology, analytical chemistry, endocrinology, epidemiology, and other fields completed “a four-year review of more than 300 scientific studies” without finding any information that would “prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.” “Based on FDA’s ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging,” said the agency. “FDA will also continue to consult with other expert agencies in the federal government, including the National Institutes of Health (and the National Toxicology Program), the Environmental Protection Agency, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention.” See…
The Pew Charitable Trusts Campaign on Human Health and Industrial Farming has published an issue brief concluding that gaps in the U.S. Food and Drug Administration’s (FDA’s) guidance for antibiotic use in livestock have allowed “some injudicious practices to persist.” Released in December 2013, FDA Guidance for Industry #213 aims to combat antibiotic-resistant bacteria by restricting the use of antibiotics in food animals for growth promotion. To this end, the agency asked drug companies to remove “feed efficiency” and “weight gain” indications from product labels and required veterinary oversight when these drugs are added to feed or water. After reviewing all 287 antibiotics affected by Guidance #213, Pew researchers reported that approximately one-quarter of these drugs “can be used in at least one species of livestock (chickens, turkeys, pigs or cattle) for disease prevention at levels that are fully within the range of growth promotion dosages and with no limit…
A federal court has granted summary judgment for the U.S. Food and Drug Administration (FDA) in a lawsuit brought by the Center for Science in the Public Interest (CSPI) and Mercury Policy Project (MPP) alleging that the agency has egregiously delayed a response to the organizations’ 2011 petition urging FDA to require the labeling of mercury levels in seafood. CSPI v. FDA, No. 14-0375 (D.D.C., order entered November 21, 2014). Additional information about the complaint appears in Issue 517 of this Update. Assessing precedent, the court noted six considerations relevant in evaluating agency delay and found that three were in question here. CSPI and MPP argued that FDA’s delay was unreasonable because statutorily, the agency has six months to approve, deny or tentatively respond to citizen petitions; while FDA technically complied with this regulation, they argued, the deadline “provides a framework within which to gauge FDA’s delay in issuing a…
The U.S. Food and Drug Administration (FDA) has finalized two rules under the 2010 Patient Protection and Affordable Care Act that require chain restaurants and vending machine operators to disclose calorie information on menus or at the point of purchase. Generating more than 1,100 public comments, the federal rules aim to standardize labeling requirements “to provide consumers with more nutritional information about the foods they eat outside of the home.” Effective December 1, 2015, the menu-labeling final rule applies to restaurants and similar retail food establishments with more than 20 locations, as well as food facilities in movie theaters, amusement parks and other entertainment venues. According to FDA, which narrowed the scope of the rule to focus on restaurant-style food, the new labeling provisions cover standard menu items, certain alcohol beverages and multi-serving dishes labeled on a per-serving basis, but exempt “condiments, daily specials, temporary menu items, and food that…
The Center for Science in the Public Interest (CSPI) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a rule that would require sesame seeds and sesame products to be disclosed on food labels in the same way that allergens, such as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy, are disclosed. CSPI asks that sesame be added to FDA’s list of allergens in its “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens” “to address both labeling and cross contact issues related to food manufacturing practices.” The petition includes letters from parents of purported sesame-allergic children “explaining why better labeling is so important for their families.” They claim that reactions to sesame have been severe and life-threatening. See CSPI News Release, November 18, 2014.
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and the Food and Drug Administration’s Center for Food Safety and Applied Nutrition have announced a January 13, 2015, public meeting in College Park, Maryland, to discuss draft U.S. positions for consideration during the 24th Session of the Codex Committee on Fats and Oils slated for February 9-13 in Melaka, Malaysia. Agenda items at the January meeting include a proposed draft standard for fish oils and discussion papers focusing on (i) cold pressed oils and (ii) amended standards for sunflower seed oils and high oleic soybean oil. See Federal Register, November 19, 2014. Issue 546
A federal court in Missouri has denied the motion to dismiss filed by a food-safety company responsible for auditing conditions at the Jensen Farms cantaloupe facility some six weeks before the U.S. Food and Drug Administration inspected the farm and found the Listeria strains associated with a nationwide outbreak that allegedly sickened the plaintiff. West v. Frontera Produce Ltd., No. 13-0943 (W.D. Mo., decided November 7, 2014). Primus Group, Inc. had argued that it owed no duty to the plaintiff, but the court disagreed, citing Missouri case law, which is consistent with the Restatement (Second) of Torts, Section 324A, allowing liability for third persons who render services that should be recognized “as necessary for the protection of a third person or his things.” According to the court, the plaintiff sufficiently stated a cause of action against the defendant, “given that Primus assumed a duty pursuant to contract and the performance of that duty…
The Center for Science in the Public Interest (CSPI) has submitted a request to the U.S. Food and Drug Administration (FDA) under the Freedom of Information Act for “the data collected by the Center for Veterinary Medicine under its Raw Milk Drug Residue Survey.” According to CSPI, FDA conducted the survey in 2012 “because excess and sometimes illegal drugs are more frequently found in animals from dairy farms at slaughter plants than animals coming from other sources.” CSPI’s review of drug testing reports in 2011 purportedly revealed that “animals coming from dairy farms accounted for 67 percent of reported drug residue violations at slaughter” and that, in some cases, “the reported residues were for drugs that are not approved for use in cattle.” While FDA informed consumer groups that it would make the raw data available when its report is released, it has yet to release the survey results. CSPI attorney…
The Center for Food Safety and two other public interest organizations have filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to overturn its approval of 11 animal drugs containing ractopamine hydrochloride on the ground that the agency failed to undertake the analysis purportedly required under the National Environmental Policy Act (NEPA) before approving them. Ctr. for Food Safety v. Hamburg, No. 14-4932 (N.D. Cal., filed November 6, 2014). The Center previously petitioned FDA to reduce the allowable levels of ractopamine, administered in animal feeds to boost growth and leanness in meat production, and to study its potential effects on human health and animal welfare. Information about the petition appears in Issue 466 of this Update. The complaint sets forth the effects these drugs allegedly have on livestock, like pigs, and on the environment. The plaintiffs claim that the company that makes ractopamine has acknowledged the “risk…
