The U.S. Food and Drug Administration (FDA) has announced that it has issued "the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011." Fortune Food Product Inc. will be prohibited from "growing, harvesting, packing and holding sprouts and soy products at or from their facility, or any other facility, until certain requirements are met. The consent decree requires the defendants to, among other things, take corrective actions and notify the FDA before such operations may resume." “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk,” an agency official is quoted as saying in the September 15, 2020, press release. “This action demonstrates the agency's commitment to pursuing and taking swift action against those who repeatedly disregard these food…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Department of Agriculture has announced that it will provide an additional 30 days for public comments on the interim final rule (IFR) that established the Domestic Hemp Production Program. According to the announcement, "Comments are solicited from all stakeholders, notably those who were subject to the regulatory requirements of the IFR during the 2020 production cycle." The deadline for comments on the rule is October 8, 2020.
The U.S. Food and Drug Administration (FDA) has announced that it will not initiate enforcement actions for the updated Nutrition and Supplement Facts label requirements in 2021 against food manufacturers with less than $10 million in annual food sales. The updated requirements are scheduled to take effect January 1, 2021. "Although the compliance date will remain in place, the FDA will not focus on enforcement actions during 2021 for these smaller food manufacturers," the announcement states. "This additional flexibility includes manufacturers of packages and containers of single-ingredient sugars, regardless of the size of the manufacturer."
The U.S. Drug Enforcement Administration (DEA) has proposed a rule that would codify the legalization of hemp cultivation and related definitions passed in the 2018 Farm Bill into the Controlled Substances Act. The amendments include (i) modifying federal rules to state that "the definition of 'Tetrahydrocannabinols' does not include 'any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o'"; (ii) removing from Schedule V a "drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol [] derived from cannabis and no more than 0.1% (w/w) residual tetrahydrocannabinols"; (iii) removing import and export controls on these substances; and (iv) modifying federal rules by "stating that the definition of 'Marihuana Extract' is limited to extracts 'containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis.'"
The U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) has announced a virtual public meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI) on September 24-25, 2020. The objectives are "for the Committee to review and advise about the steps FSIS should take to ensure better control of artisanal, shelf-stable ready-to-eat (RTE) fermented, salt-cured, or dried products that rely on multiple hurdles for lethality" and to "review and advise whether the Agency should continue not to test boxed beef primal and sub-primal products for Shiga toxin-producing E. coli (STEC), if they are intended for intact cuts." USDA also announced the appointment of 10 new members to NACMPI, as well as an additional member to the National Advisory Committee on Microbiological Criteria for Foods.
U.S. Sen. Chuck Schumer (D-N.Y.) has called on the U.S. Department of Agriculture (USDA) to "delay the issuance of a U.S. Domestic Hemp Production Program final rule until 2022 and allow hemp growers and producers across the country and in Upstate New York to continue to operate under the 2014 Farm Bill pilot program regulations until that time." Schumer's press release includes the letter he sent to Secretary Perdue. "[A]s industrial hemp farmers and businesses explore the full benefits of the 2018 Farm Bill, they have experienced serious difficulty integrating the Interim Final Rules into their operations. Particularly in the current COVID climate, I see many farmers and processors in New York struggle with incorporating these changes into the existing state Pilot Programs. In a time when farmers and producers struggle with economic uncertainty, the implementation of the Interim Final Rules will create costs without the support of offsetting revenues."…
The U.S. Food and Drug Administration (FDA) has issued a final rule establishing requirements for "gluten-free" labeling for foods with fermented or hydrolyzed ingredients. Under the rule, FDA will evaluate compliance based on records manufacturers will be required to maintain because the agency "knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins." The rule takes effect October 13, 2020.
The U.S. Department of Agriculture (USDA) is accepting comments on the Agricultural Marketing Service's proposed amendments to organic regulations concerning oversight and enforcement of the production, handling and sale of organic agricultural products. The proposed rule would require the use of National Organic Program Import Certificates for all organic products entering the United States and "[r]educe the types of uncertified entities in the organic supply chain that operate without USDA oversight—including importers, brokers, and traders of organic products." The proposed amendment also contains provisions that would clarify "the method of calculating the percentage of organic ingredients in a multi-ingredient product" and "conditions for establishing, evaluating, and terminating equivalence determinations with foreign government organic programs, based on an evaluation of their organic foreign conformity systems." Comments will be accepted until October 5, 2020.
The U.S. Food and Drug Administration (FDA) has announced that several manufacturers of per- and polyfluoroalkyl substances (PFAS) have agreed to phase out the use of the material on food packaging, such as fast-food wrappers, to-go boxes and pizza boxes. The phase-out will begin in January 2021 and will occur over three years, with an additional 18 months anticipated to exhaust existing stocks of paper and paperboard products containing PFAS. The announcement coincides with a report from Toxic-Free Future purportedly finding PFAS in the packaging of several restaurants.
The U.S. Food and Drug Administration (FDA) has issued final guidance on inorganic arsenic in rice cereals for infants that sets the action level at 100 micrograms per kilogram, or 100 parts per billion. "FDA has made the determination that this level is achievable based on sampling and testing results," the guidance states. "This guidance applies to all types of infant rice cereals (e.g., white-rice, brown-rice, organically grown, and conventionally grown). Though not binding, the action level for inorganic arsenic in infant rice cereals is intended to encourage manufacturers to reduce levels of inorganic arsenic in their products, thus reducing the possible risk for infants fed rice cereal."
