The U.S. Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition has notified the Good Food Institute (GFI) that the agency has been unable to reach a decision on the advocacy group's March 2017 petition requesting recognition for commonly used—if technically inaccurate, per FDA definitions—food names such as "almond milk," "soymilk," "almond butter" and "cashew butter." The letter informs GFI that the agency was "not able to reach a decision on your petition within the first 180 days of its receipt, nor as of the date of this letter, because of other agency competing priorities."
Category Archives U.S. Government and Regulatory Agencies
A federal court has granted the U.S. Department of Commerce's motion for summary judgment in a lawsuit aiming to block implementation of the Seafood Import Monitoring Program, which will require importers to document the catch-to-table distribution chain. Alfa Int’l Seafood, Inc. v. Sullivan, No. 17-0031 (D.D.C., entered August 28, 2017). A group of seafood processing, distribution and retail companies argued that the agency violated federal law in promulgating the rule, alleging it was issued without proper authority or supporting evidence. Several environmental groups previously sought to intervene in the lawsuit to defend the rule, but the court denied their motion. The court found for the defendants on all issues, finding that Commerce's authority is broader than the plaintiffs asserted. The plaintiffs argued that the U.S. Food and Drug Administration has exclusive regulatory authority over food labeling, but the court pointed to other relevant authorities that can affect labeling, including the…
Shook Partners Lindsey Heinz and Katie Gates Calderon, with Associate Hillary Nicholas, have authored an article for Law360 discussing regulations related to the use of photography during a U.S. Food and Drug Administration (FDA) inspection of a production facility. "Despite the void of statutory authority, the FDA continues to instruct its inspectors to 'not request permission from management to take photographs during an inspection' and to instead simply begin taking photos and video," the authors explain. "Should a company object to these tactics, inspectors are encouraged to '[a]dvise management the U.S. Courts have held that photographs may lawfully be taken as part of an inspection.' However, the two cases the FDA cites in support of this assertion — Dow Chemical Co. v. U.S. and U.S. v. Acri Wholesale Grocery Co. — do not stand for the unequivocal proposition suggested by the FDA." Heinz, Gates Calderon and Nicholas advise companies to…
The Center for Food Safety has filed a lawsuit seeking to compel the U.S. Department of Agriculture (USDA) to proceed with the studies and public comment required to implement the 2016 Federal Bioengineered Food Disclosure Standards Act. Ctr. for Food Safety v. Perdue, No. 17-4967 (N.D. Cal., filed August 25, 2017). Passed by Congress in 2016, the act will require food producers to disclose the presence of any genetically modified organisms (GMOs). The complaint contends that USDA has failed to conduct the studies required by the act to inform its rulemaking, including a specific Congressional mandate to study whether digital or electronic disclosures would be an acceptable alternative to package labeling. If the agency finds no significant barriers to consumer access, food manufacturers could provide a QR code, website link or toll-free number for disclosures. However, the complaint alleges that USDA missed the July 29, 2017, deadline for completion of…
The U.S. Food and Drug Administration has made available industry guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.” Comments on the guidance may be submitted at any time. Issue 645
The U.S. Food and Drug Administration (FDA) has announced the availability of industry guidance titled, “Ultrafiltered Milk in the Production of Standardized Cheese and Related Cheese Products: Guidance for Industry.” The guidance advises manufacturers that FDA intends to exercise enforcement in the use of fluid ultrafiltered milk in cheese products. Issue 645
The U.S. International Trade Commission (USITC) has found a “reasonable indication” that domestic olive production has been injured by imports of Spanish olives sold at less than fair market value. In June 2017, two California olive producers filed a petition alleging that the imported olives, which are subsidized by the Spanish government, have damaged domestic producers. According to the petition, the number of domestic olive producers has fallen from 20 to two over the last few decades. The Department of Commerce initiated an investigation in July, and final determinations of penalties or duties due under the Tariff Act of 1930 are expected in early 2018. Issue 645
The U.S. Department of Agriculture, Food and Drug Administration and the Agricultural Marketing Service will sponsor three meetings in September and October 2017 to provide information and receive comments on U.S. positions to be discussed at upcoming Codex Alimentarius Commission meetings. On September 1, the agencies will discuss U.S. positions for the Committee on Fresh Fruits and Vegetables, which meets in Uganda on October 2-6, 2017. The public meeting to discuss positions for the Committee on Food Labeling is scheduled for September 13, before the committee meets in Paraguay on October 16-20, 2017. Finally, the agencies will hold a public meeting to discuss positions for the Committee of Food Hygiene on October 11, before the committee’s meeting in Chicago on November 13-17, 2017. Issue 645
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has announced that the agency will provide guidance on menu-labeling requirements before the end of 2017 in advance of the May 2018 compliance date. "This additional guidance will address concerns that were raised about challenges establishments faced in understanding how to meet their obligations under the new regulations," Gottlieb wrote in an August 25, 2017, statement. "We have been diligently working to address the comments we received, and to establish a sustainable framework for enabling establishments to effectively meet the new menu labeling provisions. These new policy steps should allow covered establishments to implement the requirements by next year’s compliance date." Issue 645
As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and Lindsey Heinz, with Associate Elizabeth Fessler, explain the debate in “Dairy Vs. Plant-Based ‘Milks’: A Regulatory Standoff." While Canada and the EU have both ruled that plant-based products cannot be called “milk,” the U.S. Food and Drug Administration (FDA) has yet to take determinative action to ensure that products using "milk" contain cow milk, though it does define the term as “obtained by the milking of one or more healthy cows." Although FDA has warned plant-based beverage manufacturers, the agency has not taken enforcement action against such products and has never ruled on a 1997 petition to allow the use of the term “soymilk.” Moreover, legislation has been introduced in both houses of Congress (H.R. 778; S.130) that…
