Category Archives U.S. Government and Regulatory Agencies

The U.S. Department of Agriculture's (USDA's) Agricultural Marketing Service has released the final National Bioengineered Food Disclosure Standard (NBFDS), which will require food manufacturers, importers and other entities to indicate on a product's label whether it was made with genetically modified organisms (GMOs). The rule applies to food products in which the predominant ingredient is subject to the federal Food, Drug, and Cosmetic Act; "[a] multi-ingredient food product that contains broth, stock, water, or similar solution as the first ingredient, and a meat, poultry, or egg product as the second ingredient on the food label would also not be subject to the NBFDS," according to the announcement. The rule takes effect February 19, 2019, and mandatory compliance with the rule begins on January 1, 2022.

The U.S. Food and Drug Administration (FDA) has established January 1, 2022, as "the uniform compliance date for food labeling regulations that are published on or after January 1, 2019, and on or before December 31, 2020" to help "minimize the economic impact of label changes." The agency also issued technical amendments to the Nutrition Facts Label Final Rule that correct errors in sample labels and inadvertent omissions of preexisting provisions.

The U.S. Department of Agriculture (USDA) has reallocated responsibilities between its agencies, resulting in the elimination of the Grain Inspection, Packers, and Stockyards Administration (GIPSA). The Agricultural Marketing Service will absorb GIPSA's previous responsibilities as well as some program areas formerly overseen by the Farm Service Agency. The rule took effect November 29, 2018, finalizing changes initially announced in September 2017.

The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have announced after "several thoughtful discussions" that both agencies "should jointly oversee the production of cell-cultured food products derived from livestock and poultry." The agencies' statement announces a "joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation" that will transition "during the cell harvest stage" to USDA, which "will then oversee the production and labeling of food products derived from the cells of livestock and poultry." "This regulatory framework will leverage both the FDA’s experience regulating cell-culture technology and living biosystems and the USDA’s expertise in regulating livestock and poultry products for human consumption," the announcement concludes. "USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products. Because our agencies have the statutory authority necessary to appropriately regulate cell-cultured food products derived…

The National Organic Standards Board (NOSB) has announced a meeting to be held April 24-26, 2019, that will include a discussion and vote on recommendations for updates to U.S. organic standards. The deadline to submit written comments is April 4, 2019, with the same deadline applying to those who intend to provide oral comments at the meeting in person or via webinar.

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.