Category Archives Food and Drug Administration

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…

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. 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. 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."

The U.S. Food and Drug Administration (FDA) has issued an update for consumers on its 2018 study examining milk allergies and dark chocolate. "U.S. law requires manufacturers to label food products that are major allergens, as well as food products that contain major allergenic ingredients or proteins," the update notes. "Allergens contained in a food product but not named on the label are a leading cause of FDA requests for food recalls, and undeclared milk is the most frequently cited allergen. Chocolates are one of the most common sources of undeclared milk associated with consumer reactions." FDA advised consumers to interpret "may contain" disclosures as "likely to contain," even if the package is also labeled as dairy-free or vegan. "Unfortunately, you can’t always tell if dark chocolate contains milk by reading the ingredients list. FDA researchers found that of 94 dark chocolate bars tested, only six listed milk as an…

The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance that "outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products." The agency will accept comments on the guidance until September 21, 2020.

The U.S. Food and Drug Administration (FDA) has announced that it will resume domestic inspections of regulated facilities during the week of July 20, 2020, after pausing in March due to COVID-19. "To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining when and where it is safest to conduct prioritized domestic inspections," the agency states. "The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. We are also making the Advisory Level data available to our state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract." The agency also announced that the inspections will be pre-announced. "The FDA has also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced…

The U.S. Food and Drug Administration (FDA) has released a blueprint of plans to implement the Food Safety Modernization Act and a hub for the New Era of Smarter Food Safety. The blueprint focuses on four elements: (i) tech-enabled traceability; (ii) smarter tools and approaches for prevention and outbreak response; (iii) new business models and retail modernization; and (iv) food safety culture. "This document represents the thinking of FDA food safety experts, consumers, the food industry, technology firms, federal and state regulatory partners, our regulatory counterparts in other nations, and academia," the blueprint states. "Together, we envision a framework that will enable food to be traced to its source in seconds and will utilize new data analytical techniques to strengthen prevention of foodborne illnesses, alerting consumers in real time before contaminated or misbranded foods are consumed. We envision a framework in which education, communication, and democratization of data will enable…

The U.S. Food and Drug Administration (FDA) has published the results of its investigation into an outbreak of E. coli in November and December 2019 caused by romaine lettuce and other leafy greens from the Salinas Valley area of California. FDA found that nearby land used for cattle grazing was the most likely contributing factor associated with three outbreaks that stemmed from three distinctly different strains of E. coli.

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