Tag Archives citizen petition

Panera Bread has reportedly petitioned the U.S. Food and Drug Administration (FDA) to establish a clear definition of the term “egg” after learning that agency rules dictate that “no regulation shall be promulgated” to define eggs. The company asserts that under existing regulations, restaurants can sell processed substances containing artificial flavorings, gums, coloring and fillers as "eggs." Panera’s director of wellness and food policy said in a press release, “Panera and our competitors use the FDA definitions to guide our product descriptions and names. But in the case of ‘eggs,’ we have no guidance. Brands can say they offer an egg sandwich, but sell an egg product that contains multiple additives.”

The U.S. Food and Drug Administration (FDA) has denied a February 9, 2012, petition filed by the Center for Science in the Public Interest (CSPI) that requested “a performance standard of non-detectable as determined by the best available method of detection for Vibrio vulnificus in molluscan shellfish intended for raw or processed raw consumption.” Citing V. vulnificus as “the leading cause of seafood-associated deaths in the United States,” the petition notes that FDA already enforces a zero tolerance standard for V. vulnificus in ready-to-eat fish and a non-detectable standard of less than 30 most probable numbers per gram (MPN/g) for post-harvest processed shellfish. According to CSPI, the Food Safety Modernization Act directs the agency to set performance standards for significant foodborne contaminants. In rejecting the petition, FDA notes that other strategies—including state adherence to and federal oversight of control measures designed to manage V. vulnificus risk—have effectively reduced oyster-associated V.…

The Center for Science in the Public Interest (CSPI) has petitioned the U.S. Department of Agriculture (USDA) for "a Label on Processed Meat and Poultry Products Warning the Public that Frequent Consumption May Increase the Risk of Colorectal Cancer." Citing the International Agency for Research on Cancer's finding that smoked, salted and/or cured bacon, hot dogs, ham, sausages and similar products are "carcinogenic to humans," CSPI argues that epidemiological studies backed by "mechanistic evidence" support the alleged link between processed meat and an increased risk of colorectal cancer. The group also points to similar conclusions drawn by the World Cancer Research Fund International, American Institute for Cancer Research, Imperial College London and the American Cancer Society, the latter of which "advises the public to 'minimize consumption of processed meats such as bacon, sausage, luncheon meats, and hot dogs' based on evidence that the risk of colorectal cancer increases by 15…

The U.S. Food and Drug Administration (FDA) has opened a docket and released industry guidance on the use of the term “healthy” in the labeling of human food products. Responding to Kind LLC’s citizen petition asking the agency to align its nutrient content claim regulations with federal dietary guidance, FDA invites “public comment on the term ‘healthy’, generally, and as a nutrient content claim in the context of food labeling.” Current regulations reportedly establish “the parameters for use of the implied nutrient content claim ‘healthy’ or related terms… on the label or in labeling of a food to suggest that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions, and the claim is made with an explicit or implicit claim or statement about a nutrient.” Among other things, the conditions take into…

Several consumer-protection groups, including the Natural Resources Defense Council (NRDC) and the Center for Science in the Public Interest (CSPI), have filed a citizen petition with the U.S. Food and Drug Administration (FDA) urging the agency to withdraw approval of seven antibiotics for disease prevention and growth-promotion use in livestock and poultry. “The use of medically important antibiotics in livestock production for growth-promotion or disease-prevention purposes is not shown to be safe,” the September 13, 2016, petition asserts. “FDA’s voluntary program will not end these drug uses. FDA must immediately begin proceedings to withdraw approval for these uses.” The day before the groups filed the petition, FDA announced a comment period about therapeutic uses of medically important antimicrobials. The agency seeks information about (i) “[t]he underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases”; (ii) “[m]ore targeted antimicrobial…

A June 10, 2015, petition filed by consumer and environmental groups asks the Food and Drug Administration (FDA) to ban the following synthetic substances widely used in baked goods, ice cream and beverages: (i) benzophenone (also known as diphenylketone); (ii) ethyl acrylate; (iii) eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol); (iv) myrcene (also known as 7-methyl-3-methylene- 1,6-octadiene); (v) pulegone (also known as p-menth-4(8)-en-3-one); (vi) pyridine; (vii) styrene; and (viii) trans,trans-2,4-hexadienal. Signed by the Center for Science in the Public Interest, National Resources Defense Council, Center for Environmental Health, Environmental Working Group, Center for Food Safety, Consumers Union, and Improving Kids’. Environment, the petition claims that the flavorings are not safe for use in human food under the Delaney Clause of the Food Additives Amendment Act (21 U.S.C. § 348 (c)(3)(A)) because the National Toxicology Program and other agencies have linked them to animal or human cancers. The…

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 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. Food and Drug Administration (FDA) has denied two citizen petitions asking the agency to prohibit the use of aspartame as a non-caloric sweetener. Dated July 16, 2002, the first petition argued that the Public Health Security and Bioterrorism Preparedness Response Act authorizes FDA to recall dangerous chemicals without manufacturer approval. Citing studies conducted by the European Ramazzini Foundation (ERF), the second petition urged FDA to revoke approval for the sweetener under the Delaney Clause in section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act, which provides that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” Responding to these claims, FDA reasoned that the first petition and subsequent comments…

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…

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