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
Category Archives Food and Drug Administration
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…
In the absence of action by the U.S. Food and Drug Administration (FDA), consumer-advocacy and dairy trade groups are disputing whether plant-based beverages, such as those made from soy or almonds, can be called “milk.” The Good Food Institute (GFI) sent a July 31, 2017, letter to FDA requesting action on a 1997 citizen petition filed by the Soyfoods Association of America seeking recognition of the term “soy milk.” The National Milk Producers Federation (NMPF) answered with a statement the same day, saying the effort to alter food-labeling standards “falsely suggests that the products are nutritionally equivalent.” Although FDA has previously issued letters to producers of plant-based beverages warning that their use of the term “milk” is improper because such products do not contain dairy, the agency has never responded to the 1997 petition. NMPF argued that GFI “is mistaken” for trying to revive the 1997 petition and that “[n]othing…
Sen. Chuck Schumer (D-N.Y.) has urged the U.S. Food and Drug Administration to launch a formal investigation into "Coco Loko," a "snortable chocolate" product that contains stimulants akin to those found in energy drinks. He argues that the product "isn't even pure chocolate" and is "chock full of concentrated energy drink ingredients masked and marketed under the innocence of natural and safe chocolate candy." “I can’t think of a single parent who thinks it is a good idea for their children to be snorting over-the-counter stimulants up their noses,” Schumer said in a July 10, 2017, press release. “This product is like cocaine on training wheels.” Issue 640
The U.S. Food and Drug Administration (FDA) has announced it will hold a public advisory committee meeting of its Science Board on June 26, 2017, in Silver Spring, Maryland. The Science Board will hear an update on FDA’s biotechnology activities related to animals and plant-derived food as well as a report from the National Antibiotic Resistance Monitoring System Review Subcommittee. Written submissions of data, information or opinions may be made on or before June 19, 2017. Issue 638
The U.S. Food and Drug Administration (FDA) has announced that it will postpone the deadline for food companies to use a revised Nutrition Facts label on packaged foods and beverages that includes added-sugar content and emphasizes calorie content. The FDA guidance document on the changes was updated to note that it received feedback from industry and consumer groups about the compliance dates. "As a result, the FDA intends to extend the compliance dates to provide the additional time for implementation," the guidance documents states. "The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace." Issue 638
The Center for Science in the Public Interest (CSPI) and National Consumers League have filed a lawsuit alleging the U.S. Food and Drug Administration’s (FDA’s) decision to delay implementation of rules requiring chain restaurants and food sellers to display nutritional information violated the Administrative Procedure Act. Ctr. for Sci. in the Pub. Interest v. Price, No. 17-1085 (D.D.C., filed June 7, 2017). The plaintiffs allege that the agency “repeatedly delayed” the compliance date for the nutritional labeling rules, which were originally scheduled to take effect in December 2015. One day before the revised enforcement date in May 2017, FDA announced that compliance would be delayed until May 2018. The plaintiffs request that the court vacate the delay. Additional details on the delay announcement appear in Issue 633 of this Update. “The Trump administration’s delay of menu labeling ill serves consumers, who need and want better information about their food choices,” CSPI Director of Nutrition Policy Margo G. Wootan said in a June…
Five public advocacy groups have filed suit against the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) seeking to vacate FDA’s “Substances Generally Recognized as Safe” (GRAS) rule, which allegedly allows “potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug and Cosmetic Act (FDCA).” Ctr. for Food Safety v. Price, No. 173833 (S.D.N.Y., filed May 22, 2017). The plaintiffs argue that the GRAS rule allows manufacturers to certify that a substance is GRAS without notice to FDA or the public, although the rule gives them the option to notify the agency about certification. However, they allege, the Food Additives Amendment to the FDCA requires food additives to go through an FDA approval process. FDA allowed manufacturers to begin using the proposed rule’s optional notification…
Syfrett Feed Co., a Florida manufacturer of medicated animal feeds, has entered into a consent decree to control its production process and comply with federal laws before resuming medicated feed operations. U.S. v. Syfrett Feed Co., Inc., No. 17-14038 (S.D. Fla., order entered May 4, 2017). The court entered the decree after the U.S. Food and Drug Administration (FDA) filed a complaint alleging the company failed to adequately identify and store the drugs it used or prevent contamination of drugs and feeds as well as mislabeled and misbranded feeds. According to the complaint, 17 horses had to be euthanized after eating the company’s horse-pellet food. Syfrett manufactures feeds for cattle, poultry, pigs, sheep, goats and exotic animals, but has agreed to discontinue production of the horse feed connected to the animal deaths. “Animal feed manufacturers that fail to comply with labeling and good manufacturing requirements for medicated animal feeds jeopardize…
