Category Archives Legislation, Regulations and Standards

Responding to public comments solicited in April 2014, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued revised guidance for identifying, controlling and labeling allergens and other ingredients of public health concern through hazard analysis and critical control point (HACCP) plans, sanitation standard operating procedures (SOPs) or other prerequisite programs. Geared toward meat and poultry products, the guidance seeks to ensure “that product labels declare all ingredients, as required in the regulations, and that the product does not contain undeclared allergens or other undeclared ingredients.” See Federal Register, November 16, 2015.   Issue 585

The U.S. Food and Drug Administration (FDA) plans to set requirements for fermented and hydrolyzed foods or those containing fermented or hydrolyzed ingredients and 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 foods by using scientifically valid methods to determine the absence…

In conjunction with its decision to approve the first genetically engineered (GE) animal for human consumption, the U.S. Food and Drug Administration (FDA) has published final labeling guidance for foods derived from GE crops and draft labeling guidance for GE salmon. Titled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants,” the final guidance document seeks to assist “food and feed manufacturers that wish to voluntarily label their plant-derived food products or ingredients (for humans or for animals) as having been made with or without bioengineering.” In addition, the agency’s draft labeling guidance—“Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon”—describes the preferred labeling terms for products marketed as containing or avoiding transgenic salmon. Emphasizing that such labeling should be “truthful and not misleading,” the agency recommends that manufacturers wishing to identify their products as not derived from GE ingredients use…

The U.S. Food and Drug Administration (FDA) has released its determination that genetically engineered (GE) salmon produced by AquaBounty Technologies, Inc., is as safe to eat as conventional salmon and will have little effect on the environment. Containing genes from Pacific Chinook salmon and ocean pout that accelerate growth and maturation, AquAdvantage® salmon is the first GE animal approved for human consumption. After spending more than a decade reviewing data on food safety and environmental impacts, the agency apparently concluded that (i) “the inserted genes remained stable over several generations of fish,” (ii) “food from the GE salmon is safe to eat by humans and animals,” (iii) “the genetic engineering is safe for the fish,” and (iv) “the salmon meets the sponsor’s claim about faster growth.” FDA also found that the multiple containment measures taken by land-based production facilities are sufficient to prevent the fish from mixing with wild populations.…

The U.S. Department of Justice (DOJ) and U.S. Food and Drug Administration (FDA) have announced the latest developments in civil and criminal actions taken against 117 dietary supplement manufacturers and distributors as the result of a year-long investigation into allegedly tainted products. According to a November 17, 2015, DOJ press release, an 11-count indictment alleges that weight-loss and workout supplement manufacturer USPlabs LLC “engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients.” The indictment claims the products in question were sold to retailers across the nation, with USPlabs asserting that it used natural plant extracts “when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.” “The joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely…

U.S. Sen. Chuck Schumer (D-N.Y.) is urging the U.S. Food and Drug Administration (FDA) to investigate the increased availability of caffeinated foods in light of a new peanut butter product containing 150 mg of caffeine per 2-tablespoon serving. “The FDA should take immediate action and investigate whether this caffeine product should be pulled from shelves,” Schumer said. “To think that peanut butter, one of the snacks most closely associated with children, might have to be stored in the medicine cabinet as opposed to the kitchen cabinet should serve as a jolt to the FDA.” See Press Release of Sen. Chuck Schumer, November 8, 2015. According to the manufacturer’s website, STEEM Caffeinated Peanut Butter contains no artificial sweeteners and “as much caffeine as two cups of coffee, so stick with the normal serving suggestions for the best effect.” The site cautions that feeding the  product to domestic animals could “lead to…

Citing citizen petition and federal court requests for the agency to define “natural” for use in food labeling and determine if food products containing genetically engineered ingredients and high-fructose corn syrup may be labeled as “natural,” the U.S. Food and Drug Administration (FDA) is soliciting information and comments about use of the term in the labeling of human food products. More specifically, FDA seeks responses to questions that include the following: (i) Should the agency define natural through rulemaking? (ii) Should the agency prohibit use of the term in food labeling? (iii) If the agency defines natural, what foods should be permitted to bear the term? (iv) Should certain production practices, e.g., salting, irradiating, be considered in defining the term? (v) Should natural be applied only to “unprocessed” foods? (vi) Should the way an ingredient is produced or sourced affect whether a product containing that ingredient be labeled natural? and…

The U.S. Food and Drug Administration (FDA) has filed three final rules under the Food Safety Modernization Act (FSMA) on produce safety, foreign supplier verification programs (FSVPs) and accredited third-party certification, all slated for publication in the November 27, 2015, edition of the Federal Register. The agency will also hold a webinar series to discuss the new rules, which are intended to “establish enforceable safety standards for the production and harvesting of produce on farms and make importers accountable for the safety of the food they bring into the U.S.” The produce safety rule addresses, among other things, (i) the quality and testing of agricultural water, (ii) biological soil amendments such as raw manure and stabilized compost, (iii) food safety requirements for sprouts, (iv) the management of domesticated and wild animals, (v) health, hygiene and worker training, and (vi) sanitation standards for equipment, tools and buildings. FDA also describes hazard…

Police in Turin, Italy, are reportedly investigating seven companies, including Bertolli, Carapelli and Santa Sabina—for allegedly selling “Extra Virgin” olive oils (EVOOs) that fail to meet EU standards to be labeled as such. The investigation was reportedly launched after consumer magazine Il Test notified the police of its taste-test results. The police then hired the Italian customs agency to test 20 of the most popular brands of EVOO in a laboratory, finding that nine brands from seven companies were lower quality oil. “For months now we have been increasing quality controls. In 2014 our inspectors carried out 6,000 checks and confiscated oil worth 10 million euros,” Agriculture Minister Maurizio Martina told The Telegraph. “It’s vital to protect a sector as important as that of olive oil.” See The Telegraph, The Guardian and The Local, November 11, 2015.   Issue 584

The Animal Legal Defense Fund (ALDF) has filed a lawsuit against the U.S. Department of Agriculture (USDA) alleging a violation of the Administrative Procedure Act (APA) based on USDA’s lack of response to ALDF’s 2011 rulemaking petition requesting mandatory labeling on foie gras produced through the forced feeding of ducks or geese. Animal Legal Def. Fund v. U.S. Dep’t of Agric., No. 15-5063 (N.D. Cal., San Francisco Div., filed November 5, 2015). ALDF argues that force-fed foie gras products are mislabeled because USDA certifies them as “[i]nspected for wholesomeness” despite the fact that force-feeding “induces a metabolic disease and commonly results in the onset of all of the conditions mentioned in [USDA’s Poultry Products Inspection Act].” The organization seeks a declaration that USDA has violated the APA and an injunction compelling the agency to substantively respond to the petition. “The USDA is responsible for ensuring that all poultry products that…

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