Category Archives U.S. Government and Regulatory Agencies

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has completed the 2016 sunset process for five synthetic and two non-synthetic (natural) substances on the National List of Allowed and Prohibited Substances that governs the use of synthetic and nonsynthetic substances in organic production, processing and handling. Per the National Organic Standards Board’s recommendations, AMS has renewed approvals for the following synthetic substances used in organic crop production: (i) ferric phosphate for use as slug bait; and (ii) hydrogen chloride for delinting cotton seed for planting. It has also renewed approvals for the following non-agricultural ingredients used in or on organic products: (i) L-malic acid; (ii) any food grade bacteria, fungi, and other microorganism; (iii) activated charcoal from vegetative sources, for use only as a filtering aid; (iv) peracetic acid/peroxyacetic acid when used in wash and/or rinse water according to Food and Drug Administration limitations, for use as a sanitizer…

A Delaware cheese company and two individual defendants have pled guilty to a misdemeanor violation of the federal Food, Drug, and Cosmetic Act for distributing adulterated ricotta, queso fresco and fresh cheese curds in several neighboring states. U.S. v. Roos Foods, Inc., No. 16-0013 (D. Del., information filed January 22, 2016). Roos’ cheese was connected to a 2014 outbreak of Listeria that caused five adults and three newborns to contract listeriosis. The criminal information alleged the company produced the cheese in unsanitary conditions, including the “[f]ailure to clean food-contact surfaces as frequently as necessary to protect against contamination of food” and “failure to store raw materials or ingredients in a manner that protects against contamination.” In their agreement with the U.S. Food and Drug Administration (FDA), the defendants agreed to an injunction preventing them from processing or distributing food products until they undergo an FDA inspection and facility testing by…

The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and U.S. Food and Drug Administration are convening a March 7, 2016, public meeting in College Park, Maryland, to evaluate draft positions for consideration at the 10th Session of the Codex Committee on Contaminants in Food slated for April 4-8 in Rotterdam, The Netherlands. Agenda items for the March 7 meeting include papers about maximum levels for methylmercury in fish and mycotoxins in spices; and discussions of a draft Code of Practice to prevent and reduce arsenic contamination in rice and proposed draft maximum levels for cadmium in cocoa and cocoa-derived products. See Federal Register, February 11, 2016.   Issue 594

Led by the Vermont Maple Sugar Makers’ Association (VMSMA), the maple syrup industry has penned a February 15, 2016, letter asking the U.S. Food and Drug Administration (FDA) to take enforcement action “concerning misrepresentative labeling of food products whose labels incorrectly indicate the presence of maple syrup.” The signatories—which include the International Maple Syrup Institute and North American Maple Syrup Council, as well as several state organizations—identify several instant oatmeal, natural sweetener and other products that allegedly violate Food, Drug and Cosmetic Act regulations by using the word “maple” in their product descriptions without containing maple syrup. Drawing parallels to the agency’s conclusion that Hampton Creek’s Just Mayo® eggless sandwich spread was mislabeled because “mayo” has “long been used and understood as shorthand or slang for mayonnaise,” the letter argues that the term “maple” “has long been used and understood to refer to ‘maple syrup.’” As VMSMA opines, “This unchecked…

The U.S. Department of Agriculture (USDA) has finalized standards that seek to reduce Salmonella and Campylobacter in ground chicken and turkey products, as well as raw chicken breasts, legs and wings. Part of the Food Safety and Inspection Service’s (FSIS’) effort to revamp the poultry inspection system, the new rules require routine sampling throughout the year rather than infrequent sampling on consecutive days, and authorize the agency to publicize facility results online. “Over the past seven years, USDA has put in place tighter and more strategic food safety measures than ever before for meat and poultry products. We have made strides in modernizing every aspect of food safety inspection, from company record keeping, to labeling requirements, to the way we perform testing in our labs,” said USDA Secretary Tom Vilsack in a February 4, 2016, news release. “These new standards, in combination with greater transparency about poultry companies’ food safety…

The U.S. Food and Drug Administration (FDA) has banned the import of genetically engineered (GE) salmon just two months after deeming AquaBounty Technologies, Inc.’s AquAdvantage® salmon safe for human consumption. Issued in compliance with the Fiscal Year 2016 Omnibus Appropriations Act, the January 29, 2016, import alert directs that “any shipment of suspected or known GE salmon or product composed in whole or in part of GE salmon should be promptly forwarded to the District Compliance Branch.” Although AquaBounty Technologies produces GE salmon at fish farms based in Canada and Panama, the company has not yet sold its product in the United States. But after FDA ruled that the salmon posed no environmental or human health risks, U.S. Sen. Lisa Murkowski (R-Alaska) moved to block confirmation proceedings for the next FDA commissioner until the agency required labeling for all products containing GE salmon. “This is a huge step in our…

The Center for Science in the Public Interest (CSPI) has published a report criticizing the U.S. Food and Drug Administration’s (FDA’s) lack of action on food dyes. Titled Seeing Red: Time for Action on Food Dyes, the report points to studies allegedly linking food-dye consumption to behavioral issues in children—particularly those diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD)—concluding that FDA “has failed to protect or even inform consumers of the risks of dyes to children.” “We estimate that over half a million children in the United States suffer adverse behavioral reactions after ingesting food dyes, with an estimated cost exceeding $5 billion per year, using information cited by the U.S. Centers for Disease Control and Prevention and a recent meta-analysis sponsored by an arm of the food industry,” states CSPI. “A study of food labels in one supermarket found that more than 90 percent of child oriented candies, fruit-flavored snacks, and…

The U.S. Food and Drug Administration (FDA) has extended from February 16 to February 22, 2016, the comment period regarding requirements for fermented and hydrolyzed foods or those containing fermented or hydrolyzed ingredients that carry the “gluten-free” claim. The proposed rule would apply to foods such as sauerkraut, yogurt, pickles, cheese, green olives, vinegar, and FDA-regulated beers. Intended to address the uncertainty of interpreting test methods in terms of intact gluten, the finalized rule would mandate manufacturers to maintain records demonstrating: (i) “the food meets the requirements of the gluten-free labeling final rule prior to fermentation or hydrolysis”; (ii) “the manufacturer has adequately evaluated its process for any potential gluten cross-contact”; and (iii) “where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.” The agency also intends to evaluate the compliance of distilled…

The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and the U.S. Food and Drug Administration are convening a February 16, 2016, public meeting in College Park, Maryland, to discuss draft U.S. positions for consideration at the 48th Session of the Codex Committee on Food Additives (CCFA) in Xi’an, China, on March 14-18. Among other things, CCFA is responsible for establishing or endorsing permitted maximum levels of individual food additives, proposing risk assessments to the Joint FAO/WHO Expert Committee on Food Additives and recommending labeling standards for food additives. Agenda activities for the February 16 meeting will include discussion of a paper about the use of specific food additives in wine production; draft revisions to the food category 01.1 “Milk and dairy-based drinks”; and use levels for paprika extract. See Federal Register, January 11, 2016.   Issue 590

The U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) have published the 2015-2010 Dietary Guidelines for Americans, which now emphasize overall dietary patterns as opposed to nutrient quotas. Explaining that “people do not eat food groups and nutrients in isolation but rather in combination,” the guidelines offer the following “overarching” recommendations: (i) “follow a healthy eating pattern across the lifespan”; (ii) “focus on variety, nutrient density, and amount”; (iii) “limit calories from added sugars and saturated fats and reduce sodium intake”; (iv) “shift to healthier foods and beverage choices”; and (v) “support healthy eating patterns for all.” Among other things, the Dietary Guidelines specify that a healthy diet includes a variety of dark green, red, orange, and starchy vegetables as well as legumes; whole fruits; grains and whole grains; fat-free or low-fat dairy products and/or fortified soy beverages; a variety of proteins, such as seafood, lean meats,…

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