Tag Archives FDA

The U.S. Food and Drug Administration (FDA) has issued final guidance on the declaration of allulose in food. "The guidance describes FDA's views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and the caloric content of allulose," according to the announcement. "The guidance also announces our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose when calculating declarations on Nutrition and Supplement Facts labels." The agency also announced a request for comments on "the nutrition labeling of sugars that are metabolized differently than traditional sugars," such as allulose, D-tagatose and isomaltulose. According to the announcement, "Some sugars (e.g., allulose, D-tagatose, isomaltulose) do not have all of the same effects in the body as…

The U.S. Food and Drug Administration (FDA) has announced a voluntary pilot program that will assess third-party food safety audit standards for the Preventive Controls for Human Food and Produce Safety requirements set forth under the Food Safety Modernization Act (FSMA). The agency also released a guidance document with further information about the program. "We are launching this pilot program because we expect that FDA alignment determinations would create efficiencies for industry if they have confidence that the third-party standards used to audit their suppliers adequately consider the FDA’s food safety requirements," the announcement states. "Similarly, we expect that it would be helpful for FDA investigators to know that the standards used to audit a supplier were aligned with FDA regulations. This could help investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supply-chain verification requirements for audits."

The U.S. Food and Drug Administration (FDA) has announced the results of a study examining 52 dark chocolate products, determining that four of the products had potentially hazardous levels of milk allergens. "The agency found the 12 samples from the four products to have milk allergen levels ranging from 600 ppm to 3,100 ppm," the announcement states. "The agency determined that, at these levels, the four products held the potential to cause severe reactions in consumers with milk allergy. The FDA took action as warranted to address each of these positives."

The U.S. Food and Drug Administration will host three virtual public meetings to discuss the proposal of additional traceability records required for high-risk foods. All three meetings "will cover the same agenda items and are intended to facilitate and support the public's evaluation and commenting process." The meetings will be held November 6, November 18 and December 2, 2020.

The U.S. Food and Drug Administration (FDA) has released a proposed update to traceability recordkeeping requirements for foods considered "high risk" as sources of foodborne illness. The proposed rule would apply to entities that manufacture, process, pack or hold foods on the Food Traceability List and would require companies to "establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods." The rule reflects the terms of a settlement FDA reached with the Center for Food Safety in a lawsuit intended to compel the agency to meet requirements set forth in the Food Safety Modernization Act. "The availability of the traceability records that are set out in the proposed rule would also help limit the scope of recalls and in some instances, allow the FDA to better target consumer advice, avoiding blanket alerts…

Several advocacy groups, including the Environmental Defense Fund, American Academy of Pediatrics, Center for Food Safety and Consumer Reports, have submitted a citizen petition urging the U.S. Food and Drug Administration (FDA) to "define key terms essential to consider the cumulative effect of a food additive, food contact substance, generally recognized as safe substance, or color additive, taking into account any chemically- or pharmacologically-related substances in the diet, when assessing safety as required by law." The petition asserts that "FDA and food manufacturers have not taken into account the many chemicals we consume in our daily diet that are similar in structure or affect similar function(s) of organs in the body when making safety determinations for new additives, despite the Congressional mandate and the agency’s own regulations." The organizations argue that "one of almost 900 safety determinations conducted by food manufacturers and submitted to FDA for review as Generally Recognized…

The U.S. Food and Drug Administration (FDA) has announced that it has issued "the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011." Fortune Food Product Inc. will be prohibited from "growing, harvesting, packing and holding sprouts and soy products at or from their facility, or any other facility, until certain requirements are met. The consent decree requires the defendants to, among other things, take corrective actions and notify the FDA before such operations may resume." “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk,” an agency official is quoted as saying in the September 15, 2020, press release. “This action demonstrates the agency's commitment to pursuing and taking swift action against those who repeatedly disregard these food…

The U.S. Food and Drug Administration (FDA) has announced that it will not initiate enforcement actions for the updated Nutrition and Supplement Facts label requirements in 2021 against food manufacturers with less than $10 million in annual food sales. The updated requirements are scheduled to take effect January 1, 2021. "Although the compliance date will remain in place, the FDA will not focus on enforcement actions during 2021 for these smaller food manufacturers," the announcement states. "This additional flexibility includes manufacturers of packages and containers of single-ingredient sugars, regardless of the size of the manufacturer."

A consumer has filed a putative class action alleging that Panera Bread Co., or St. Louis Bread Co., markets its products as "100% clean" but sells products with ingredients "that are artificial, chemical, and/or synthetic preservatives, sweeteners, flavors, and colors." Sally v. Panera Bread Co., No. 20-1068 (St. Louis Cir. Ct., filed August 13, 2020). The complaint asserts that multiple products contain preservatives, including ascorbic acid, citric acid, potassium sorbate and tocopherols. "[A] preservative as defined by the FDA is a substance that 'tends' to prevent or retard the deterioration of foods," the complaint states. "Thus, it is not necessary that it function as a preservative in every single instance for it to qualify as a preservative according to the FDA's definition, so long as this is its general tendency." The plaintiff seeks class certification, refunds, injunctive relief, punitive damages, attorney's fees and costs for an alleged violation of the Missouri…

The U.S. Food and Drug Administration (FDA) has issued a final rule establishing requirements for "gluten-free" labeling for foods with fermented or hydrolyzed ingredients. Under the rule, FDA will evaluate compliance based on records manufacturers will be required to maintain because the agency "knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins." The rule takes effect October 13, 2020.

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