Category Archives U.S. Government and Regulatory Agencies

The U.S. Food and Drug Administration (FDA) has announced the seizure of human and animal food products held by J and L Grocery LLC in insanitary conditions. A complaint filed in Arkansas federal court alleges that September and October 2018 FDA inspections "revealed insanitary conditions including multiple live and dead rodents, rodent nesting, live racoons, live cats, a dead possum, animal feces, and urine-stained products in and around the company’s seven warehouses and sheds used to store food, medical products and cosmetics." “The widespread insanitary conditions found at J and L Grocery is alarming and won’t be tolerated,” a press release quoted FDA Commissioner Scott Gottlieb as saying. “At this time, we’re unaware of adverse events associated with the use of products purchased at J and L Grocery. The work of our field force and the goals of our vigorous oversight efforts are to find these kinds of potential hazards…

The U.S. Food and Drug Administration (FDA) has released several reports and guidance documents on food-related issues, including draft guidance on reasonable serving sizes and a report on foodborne illnesses in restaurants. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics. This draft guidance details how food companies determine reasonable serving sizes for the nutritional panels on their products. Comments submitted before January 4, 2019, will be considered before FDA begins working on the final version of the guidance. Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Guidance for Industry. FDA has provided a series of questions and answers on quantifying added sugars, vitamins and minerals. Several questions focus specifically on calculating added sugars in fruit juices…

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the agency's Plant and Animal Biotechnology Innovation Action Plan. Gottlieb describes the plan as identifying priorities in three areas: (i) "advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways;" (ii) "strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology;" and (iii) "increasing engagement with domestic and international partners on biotechnology issues." The plan indicates that FDA will "adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them." The statement also announced that the agency's Center for Veterinary Medicine will host a webinar on genome editing in animals on December 3, 2018.

The U.S. Food and Drug Administration (FDA) has requested comments on "the prevalence and severity of sesame allergies in the United States and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient." The announcement cites a 2014 petition submitted by the Center for Science in the Public Interest requesting a "rule to require that sesame seeds and sesame products be regulated in a manner similar to the manner in which major food allergens are regulated."

The U.S. Food and Drug Administration (FDA) has announced the availability of two draft guidance documents involving standards for produce. One draft guidance "provides a broad range of recommendations on how to meet the requirements" for growing produce and "outlines how to determine whether produce or farms may be eligible for exemptions." The second guidance focuses on fresh-cut produce and methods for minimizing food-safety hazards. Comments on both guidance documents will be accepted until April 22, 2019.

The National Advertising Division (NAD) has referred The a2 Milk Company's claims that its products are "easier on digestion" to the U.S. Federal Trade Commission (FTC). The National Milk Producers Federation challenged the milk marketing, asserting "errors in study design, methodology, and population selection" as well as arguing that the results of the company's study are "clinically insignificant." The a2 Milk Company responded that the organization "selectively presents incomplete and outdated research and observations made without the benefit of recent research" but declined to participate further in the system of self-regulation.

Following a petition from several advocacy groups, the U.S. Food and Drug Administration (FDA) has deauthorized the use of seven synthetic substances used as flavoring in foods. The agency found that the advocacy groups provided data demonstrating that six ingredients cause cancer in animals—benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone and pyridine—and removed styrene from its food additives list, finding that it has been permanently abandoned in that use. In addition, FDA has banned the use of benzophenone as "a plasticizer in rubber articles intended for repeated use in contact with food." The rule took effect October 9, 2018.

The U.S. Food and Drug Administration (FDA) has solicited public input on questions related to plant-based substitutes for dairy products such as almond or soy milk. The agency's request for information (RFI) seeks responses on three points: "How do you use plant-based products?" "What is your understanding of dairy terms like milk, yogurt and cheese when they are used to label plant-based products?" "Do you understand the nutritional characteristics of plant-based products? Do you know how they’re different from each other? Do you know how their nutritional qualities compare with dairy products?" "The RFI opened today is an important step in our efforts to take a look at how we have been applying the Food Drug and Cosmetic Act with respect to food names and our existing standards of identity," FDA Commissioner Scott Gottlieb said in a statement. "The comments we receive will help inform the development of draft guidance…

U.S. Health and Human Services' National Toxicity Program has issued a research report on the toxicity of bisphenol A (BPA) in rats. The study "was designed to characterize and evaluate the toxicological potential of BPA following perinatal only or chronic exposure in rats under the conditions of a chronic, extended-dose response design." The report is one component of Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), which will issue a final report in the autumn of 2019 compiling the National Toxicity Program's results with reports from university researchers.

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