A U.S. federal court entered a consent decree of permanent injunction prohibiting Home Style Foods, Inc., and its owner and quality manager from selling food products until the company complies with federal regulations. U.S. Food and Drug Administration (FDA) inspections reportedly found Listeria monocytogenes in the company's food preparation area and documented violations of seafood safety regulations. “After repeated food safety violations, the FDA worked with the U.S. Department of Justice to obtain this injunction in order to prevent potentially contaminated food from reaching consumers. The company failed to take the appropriate corrective actions resulting in this action,” an FDA official said in a press release. “When a company fails to follow the law, the government will take action to protect the food supply."
Category Archives U.S. Government and Regulatory Agencies
The U.S. Codex Office has announced public meetings that will be held on February 21 and February 27, 2020, to discuss and receive comments on U.S. positions for upcoming Codex Alimentarius meetings. The February 21 meeting will focus on general principles, while the February 27 meeting will include discussions on pesticide residues.
The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in radiation oncology, reportedly promised to prioritize science, data and public health over political interests when directing the agency's policy.
The National Advertising Division (NAD) has found that Insurgent Brands LLC's RXBAR labels, which feature a brief list of ingredients on the front, communicate a substantiated claim about the main ingredients in the product and do not "convey misleading implied claims about weight and proportions of the protein bar inside." Kind Inc. challenged the labels, arguing that the labels—which primarily feature ingredients on a short, numbered list—do not imply that the list is in descending order by weight, as compared to the legally mandated ingredients list featured on the back of the packaging. NAD was unpersuaded by consumer perception surveys provided by Kind, finding "significant flaws" in the studies. The board noted that the listed "3 Egg Whites" on the front label are present in the product in the form of dehydrated egg white powder, as "appropriate for a packaged, shelf-stable bar." The board also found that "the dried egg…
The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol (CBD) products and other products containing ingredients derived from cannabis. The update clarified that FDA "is concerned that people may mistakenly believe that trying CBD 'can't hurt'" because the agency has "seen only limited data about CBD's safety and these data point to real risks that need to be considered." FDA warned that CBD may have potential to injure the liver, cause negative drug interactions and affect male reproductive health, safety risks the agency identified during its review for the drug form of CBD. FDA's update coincided with the release of several warning letters to CBD companies from the agency's Center for Drug Evaluation and Research. The letters warned companies that the language used to describe the benefits of CBD amounted to adulterated foods and misbranded drugs. Following the November 25, 2019, update, consumers filed several…
The U.S. Department of Justice has announced that Roy Tuccillo, Sr., his son Roy Tuccillo, Jr., and their food processing and distribution companies, Anchor Frozen Foods Inc. and Advanced Frozen Foods Inc., have pleaded guilty to conspiracy to commit wire fraud. The companies reportedly imported 113,000 pounds of squid and sold it as octopus to more than ten grocery stores. The father and son could face up to five years of imprisonment and fines up to $250,000, while their companies may be required to pay a fine of up to $500,000 and face five years of probation.
The Center for Food Safety (CFS) has filed a petition urging the U.S. Department of Agriculture (USDA) to provide transparency on the levels of drug residue in meat, poultry and egg products found as part of the agency's National Residue Program (NRP). The advocacy group specifically requests that all approved animal drugs be incorporated in the NRP; that the NRP use "the best available methods that provide for the lowest limits of detection and quantitation"; that USDA establish "clear definitions and parameters for minimum levels of applicability"; and that the agency "improve the NRP reporting mechanisms to provide publicly-available information on all samples with positive residues regardless of whether the levels detected exceed minimum levels of applicability or [U.S. Food and Drug Administration] tolerances."
The Government Accountability Office (GAO) has released a recommendation that the U.S. Food and Drug Administration (FDA) establish a process that ensures the agency tests at least one shipment of imported seafood before removing it from alert status. GAO reviewed 274 removal decisions between 2011 and 2018 and found that FDA did not conduct audits for 260, or 95%, of the decisions. "FDA officials said they conducted limited sampling because many import alert removal decisions can be supported by documentary evidence provided by firms," GAO announced. "Additionally, for certain violations that indicate a firm failed to meet regulatory or administrative requirements and may pose a public health hazard, an FDA directive establishes a goal for FDA staff to conduct a follow-up inspection within 6 months. However, GAO's review of removal decisions found that for 31 of the 32 firms that received such a finding, FDA did not conduct a follow-up…
In a letter to the U.S. Department of Agriculture (USDA), Sens. Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) have requested changes to the interim final rule on hemp production. Wyden and Merkley, who co-wrote the legislation that legalized hemp farming, passed along feedback from Oregon farmers, researchers and regulators, according to a press release. The letter cites five key complaints: Testing within 15 days of harvest may be "an impossible obstacle for growers to overcome" because it is insufficient time, "particularly if there are a limited number of registered laboratories with sufficient expertise to perform the necessary tests"; The requirement to submit hemp to laboratories registered with the Drug Enforcement Administration (DEA) could "cause tremendous bottlenecks and unnecessary delays," and the 2018 Farm Bill only granted USDA and the Food and Drug Administration "sole regulatory authority over hemp production"; "The interim final rule introduced a new requirement, contrary to the…
Sen. Kirsten Gillibrand (D-N.Y.) and Rep. Rosa DeLauro (D-Conn.) have sent a letter to the U.S. Department of Agriculture (USDA) urging the agency to "adopt a policy of greater transparency with respect to the microbiological testing" that the agency collects from meat slaughter and processing establishments. The letter cites a Salmonella outbreak in ground beef announced by the Centers for Disease Control and Prevention and notes that investigators "have not identified a single, common supplier" for the affected meat. DeLauro and Gillibrand urge USDA's Food Safety and Inspection Service to provide data on the samples it collects to "allow companies, government researchers and members of the scientific community to identify links between pathogenic strains" found in meat samples and in patients identified as affected by the Salmonella outbreak. The Congress members request answers to four questions before December 13, 2019, including an identification of which establishments had samples that resulted…
