Tag Archives FDA

In an effort to remove regulations no longer "necessary to ensure that these products meet consumer expectations," the U.S. Food and Drug Administration (FDA) has proposed to revoke the standards of identity and quality for frozen cherry pie and French dressing. "The proposal is part of the FDA’s Nutrition Innovation Strategy," constituent updates on the proposed revocations state. "One of the goals of the NIS is to modernize food standards to maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation to produce more healthful foods. The FDA believes it is important to take a fresh look at existing standards of identity in light of marketing trends and the latest nutritional science." The agency's Fall 2020 agenda also indicated an intention to amend the standard of identity for yogurt and revoke the standards of identity for lowfat and nonfat yogurt, but that final rule has…

The U.S. Food and Drug Administration (FDA) has issued final guidance on the use of potassium chloride on food labels. The guidance advises "food manufacturers of its intent to exercise enforcement discretion for the name 'potassium salt' in the ingredient statement on food labels as an alternative to 'potassium chloride' to better inform consumers that it is a salt substitute." "Potassium chloride, in some instances, can be used as a partial substitute for sodium chloride (referred to as 'salt') in food processing and manufacturing," the constituent update notes. "Providing this enforcement discretion may help facilitate consumers’ choices to decrease their sodium consumption, if manufacturers use potassium chloride as a substitute ingredient for some sodium chloride."

The U.S. Food and Drug Administration (FDA) has warned Frito-Lay Inc. about "serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" because its investigators found potato chips to be misbranded "in that the finished product labels did not declare a major food allergen (milk)" in addition to being "prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health." The warning applied to Ruffles Cheddar & Sour Cream Potato Chips packaged with labels for the wrong type of chips, the Ruffles Original variety, at one facility. At another facility, the company reportedly failed to implement "allergen preventive control procedures to significantly minimize or prevent allergen cross-contact," which require the company to "verify that all visible evidence of prior seasoning is removed" after producing Lay's Limón Flavored Potato Chips.

The U.S. Food and Drug Administration (FDA) has filed a lawsuit seeking to enjoin Valley Processing Inc. from introducing adulterated food into interstate commerce. USA v. Valley Processing Inc., No. 20-3191 (E.D. Wa., filed November 6, 2020). FDA alleges Valley Processing's juice products "have been found to contain inorganic arsenic and patulin, both toxins which pose a health risk to consumers." The products were supplied to the U.S. Department of Agriculture's school lunch program, "providing approximately 2,964,000 apple juice servings to schoolchildren every year." FDA allegedly found "grossly insanitary conditions" during inspections in 2016, 2017, 2018 and 2019, including barrels containing "grape juice concentrate that was several years old" and "contaminated by filth and mold, thus not suitable for human consumption." Investigators "also discovered that Defendants processed the 'bottoms' of stored grape juice concentrate. The 'bottom' of juice concentrate is the leftover sludge that accumulates at the bottom of the…

The U.S. Food and Drug Administration (FDA) has issued draft guidance "encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels." The guidance notes that "sesame can, in some circumstances (such as when ground and used in a spice blend), be declared in an ingredient statement as simply 'spice' or 'flavor,' so its presence may not be obvious to consumers." While FDA has not required sesame to be labeled, "we recommend that manufacturers, as a voluntary matter, clearly declare sesame in the ingredient list when it is used in foods as a 'flavor' or 'spice' in a parenthetical following the spice or flavor, such as 'spice (sesame),' 'spices (including sesame),' 'flavor (sesame),' or 'flavors (including sesame).' If a term is used for a food that is or contains sesame, such as tahini, we recommend that sesame be included in a parenthesis, e.g. 'tahini (sesame)' in the…

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…

Close