Tag Archives FDA

The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) announced a number of developments in their work on organic food, poultry and food safety. FDA released an update on the implementation of the Food Safety Modernization Act (FSMA), announcing it will track outcomes for FSMA rules for inspections and recalls via the Food Safety Dashboard. One metric the agency will track is how quickly a company issues a public notice for a Class 1 recall for human and animal food. FDA has also released guidance on recall plans for its multipart guidance on “how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’” USDA updated the National Poultry Improvement Plan (NPIP) Program Standards to incorporate proposed changes published in April 2019, including the amendment of the testing…

The U.S. Food and Drug Administration has released guidance on the use of "medically important antimicrobials" in "food-producing animals." The guidance describes a voluntary process that "will help ensure new animal drugs containing antimicrobials of human importance are administered only under veterinary oversight and only for therapeutic uses." The agency will accept comments on the guidance until December 24, 2019.

A group of U.S. lawmakers, led by Reps. Chellie Pingree (D-Maine) and James Comer (R-Ky.), have urged the U.S. Food and Drug Administration to "quickly adopt a policy of enforcement discretion and to consider issuing an interim final rule to regulate [cannabidiol (CBD)] as a dietary supplement and food additive while simultaneously moving forward with a robust framework for evaluating the safety and accurate labeling of these products." The letter stated that the agency's "current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry. We are discouraged by FDA's estimation that a rulemaking process could span 3 to 5 years. We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors." In the U.S. Senate, Majority Leader Mitch McConnell (R-Ky.) reportedly took a different path in an effort to…

The U.S. Food and Drug Administration (FDA) has announced "A New Era of Smarter Food Safety," a public meeting "to get input from a broad cross-section of stakeholders on a modern approach the Agency is taking to strengthen its protection of the food supply." The meeting, which will be held October 21, 2019, is intended to "foster a dialogue with our domestic and international regulatory and public health partners, industry, consumers, academia, and others," and input will "be used to shape an FDA Blueprint for a New Era of Smarter Food Safety."

Denmark has reportedly passed a law that will ban per- and polyfluoroalkyl substances (PFAS) from cardboard and paper used for food packaging. "These substances represent such a health problem that we can no longer wait for the EU," Denmark's food minister is quoted as saying. Recycled paper may continue to be used if the PFAS compounds are separated from food with a barrier. PFAS compounds have come under scrutiny in both the United States and Europe as agencies research the effects of consuming the substances.

The U.S. Food and Drug Administration (FDA) has announced a public meeting to discuss the agency's "effort to modernize food standards of identity (SOI) and provide information about changes we could make to existing SOI, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to provide flexibility for the development of healthier foods." The meeting will be held September 27, 2019, and comments on the subject will be accepted until November 12.

The Center for Food Safety and Center for Environmental Health have filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to promulgate rules for a program to improve foodborne-illness detection as required under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Azar, No. 19-5168 (N.D. Cal., filed August 19, 2019). The organizations allege that FDA failed to create a laboratory accreditation program "whereby an increased number of accredited laboratories following model standards developed by the agency would be in place 'to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards.'" "FDA’s failure to implement FSMA’s laboratory accreditation provisions by their statutory deadlines is an abdication of the agency’s fundamental responsibilities," the complaint asserts. "Moreover, the agency’s unlawful withholding and unreasonable delay is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’s commands. This lawsuit therefore…

The U.S. Food and Drug Administration (FDA) has issued the first warning letter enforcing the Food Safety Modernization Act (FSMA) Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The letter targeted a company importing tahini that was recalled after purportedly causing a Salmonella outbreak. "Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk," the agency's announcement stated.

The U.S. Food and Drug Administration's Office of Nutrition and Food Labeling has released guidance providing "step-by-step instructions to manufacturers of retail food products marketed in the United States on how they may convert the previous units of measure for certain nutrients to the new units in the updated Nutrition Facts label." The guidance also "provides information that can help manufacturers understand and comply with relevant labeling requirements," according to the agency's announcement.

The U.S. Food and Drug Administration (FDA) has announced that soy leghemoglobin has been approved for use "as a color additive in ground beef analogue products" following a petition submitted by Impossible Foods. The announcement notes that the agency previously found soy leghemoglobin to be generally recognized as safe as a flavor additive. "FDA concurs with the petitioner that the genetic modifications made to generate the non-toxigenic and non-pathogenic production strain are well-characterized and the production process conforms to good manufacturing practice," the announcement states. "In addition to specification limits for lead, arsenic, mercury, and cadmium, we are requiring a specification for the minimum purity of soy leghemoglobin protein as a percent of the total protein in the color additive." The rule takes effect September 4, 2019, and objections can be filed until September 3.

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