A German court has reportedly ordered the city of Hamburg to compensate a Spanish vegetable grower falsely linked to a 2011 E. coli outbreak that sickened more than 4,000 people in 16 countries. Vegetable cooperative Frunet asserted that it suffered €2.3 million in damages as a result of its incorrect identification as the source of the outbreak, which was later traced to fenugreek sprouts. The amount of the award has not been confirmed. See Think Spain, October 25, 2015. Meanwhile, the U.S. Court of Appeals for the Federal Circuit has affirmed a lower court’s decision that the government does not owe tomato growers compensation after the U.S. Food and Drug Administration (FDA) publicly attributed a 2008 Salmonella outbreak to red tomatoes, then later traced it to jalapeno and serrano peppers. DiMare Fresh, Inc. v. U.S., No. 15-5006 (Fed. Cir., order entered October 28, 2015). “The problem with the Tomato Producers’ contention…
Category Archives U.S. Government and Regulatory Agencies
The Center for Science in the Public Interest (CSPI) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) to compel the agency to act on the advocacy group’s 2005 citizen petition requesting regulations about the use of salt as a food additive. Ctr. for Sci. in Pub. Interest v. FDA, No. 15-1651 (D.D.C., filed October 8, 2015). The petition called for FDA to revoke salt’s status as generally recognized as safe, amend prior approvals of salt use, require food manufacturers to reduce sodium levels in processed foods, and mandate labeling messages about the health effects of salt in foods containing more than half an ounce of the substance. The complaint alleges that while “[n]early all Americans consume more sodium than is safe,” “[c]onsumers can exert relatively little control over their sodium intake by adjusting discretionary use of salt” because such use amounts to only 5 to 10…
Three federal agencies are convening an October 30, 2015, public meeting in Silver Spring, Maryland, to discuss a July 2015 memorandum issued by the Executive Office of the President (EOP) directing the agencies to clarify their roles in the oversight of biotechnology products, develop long-term regulatory strategies and commission an independent study of the biotech landscape. The EOP memo defines biotechnology products as those “developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” The meeting will include presentations by representatives of the Department of Agriculture, Environmental Protection Agency and Food and Drug Administration (FDA) about each agency’s current approach to biotech product regulation. Information about registration, oral presentations and viewing the meeting via live webcast is available on FDA’s website. See Federal Register, October 16, 2015. Issue 581
A California federal court has denied the U.S. Department of Agriculture’s (USDA’s) motion to dismiss a lawsuit brought by environmental organizations challenging USDA’s issuance of a guidance document about the use of pesticides in compost without first having solicited public comment. Ctr. for Envt’l Health v. Vilsack, No. 15-1690 (N.D. Cal., order entered September 29). The Center for Food Safety (CFS), Center for Environmental Health and Beyond Pesticides challenged USDA’s actions on Administrative Procedures Act (APA) grounds, arguing the agency violated federal procedures by not allowing a formal rulemaking and public comment period about a guidance document permitting the use of compost with pesticides in the production of organic food. The court found that the organizations had sufficiently stated their claim under the APA and had standing to sue. “The agency’s unilateral action to allow compost contaminated with pesticides in organic production was contrary to federal rulemaking requirements as well…
The U.S. Food and Drug Administration (FDA) has issued a final rule allowing “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits.” Mica-based pearlescent pigments are currently approved as color additives in many foods and beverages, including distilled spirits containing “not less than 18 percent and not more than 23 percent alcohol by volume.” Effective November 5, 2015, the new rule permits the use of these pigments at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, while finding that “certification of mica-based pearlescent pigments prepared from titanium dioxide is not necessary for the protection on the public health.” “Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that…
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and the U.S. Food and Drug Administration have announced an October 19, 2015, public meeting in Washington, D.C., to discuss draft U.S. positions for review at the 47th Session of the Codex Committee on Food Hygiene (CCFH) slated for November 9-13 in Boston, Mass. Among other things, CCFH is responsible for prioritizing topics related to microbiological risk assessments and drafting basic hygiene provisions applicable to all food. Agenda items for October 19 include proposed draft guidelines for controlling nontyphoidal Salmonella in beef and pork meat and a discussion paper about revising the Code of Hygienic Practice for Fresh Fruits and Vegetables. See Federal Register, August 25, 2015. Issue 579
The Center for Food Safety (CFS) has filed a lawsuit against the U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) alleging that the agency has routinely failed to respond to Freedom of Information Act (FOIA) requests for records related to genetically engineered (GE) crops. Ctr. for Food Safety v. Animal & Plant Health Inspection Serv., No. 15-1377 (D.D.C., filed August 25, 2015). CFS asserts that APHIS has unlawfully delayed its responses to at least 29 FOIA requests or appeals related to its decision to withdraw proposed regulations that would update existing management of GE crops. “APHIS has a track record of irresponsible and inadequate regulation of GE crops,” CFS Staff Attorney Cristina Stella said in an August 25, 2015, press release. “In the absence of thorough government oversight, public access to information about these crops becomes all the more critical. This lawsuit is necessary to stop…
Weeks after the U.S. Food and Drug Administration (FDA) sent Hampton Creek Foods a letter warning that its Just Mayo is misbranded because it does not contain eggs, emails obtained through the Freedom of Information Act reportedly indicate that the American Egg Board (AEB) and a public relations firm made a concerted effort to remove Just Mayo from the market. The emails reportedly detail the actions the group undertook, including a complaint to FDA, an attempt to convince Whole Foods to stop selling Just Mayo, aid to Unilever in its litigation against Hampton Creek, and payments to food bloggers who post about how “real and sustainable foods, like eggs,” fit into their lifestyles. Details about Unilever’s lawsuit against Hampton Creek appear in Issue 549 of this Update. Public health attorney Michele Simon posted the emails on her blog, alleging that AEB likely broke laws during its attempt to quash Hampton…
The U.S. Food and Drug Administration has issued draft guidance for industry titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11.” When finalized, the guidance is intended to assist chain establishments with 20 or more locations (e.g., grocery stores, quick service restaurants, pizza delivery outlets, convenience stores, movie theaters, fast food restaurants) comply with menu-labeling requirements for standard menu items, including self-service offerings. See Federal Register, September 16, 2015. Issue 578
The U.S. Food and Drug Administration (FDA) has issued five warning letters to the distributors of pure powdered caffeine, citing two fatalities linked to caffeine toxicity as evidence that the products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers.” Equating 1 teaspoon of pure caffeine to 25 cups of coffee, FDA also warns consumers not to purchase or use powdered caffeine as “it is nearly impossible to accurately measure pure powdered caffeine with common kitchen measuring tools and you can easily consume a lethal amount.” In particular, the agency plans to “aggressively monitor the marketplace” for pure powered caffeine being sold as a dietary supplement. The warning letters not only find the products adulterated under the Federal Food, Drug, and Cosmetic Act, but argue that labeling directs consumers to use difficult measurements such as one-sixteenth of a teaspoon. “Consumers are unlikely to have…
