Category Archives Food and Drug Administration

In a speech at the National Food Policy Conference in Washington, D.C., U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly summarized the agency’s plans, including (i) defining “healthy” for use with a food-labeling icon, (ii) implementing delayed updates to nutrition labels, and (iii) creating a strategy for reduction in salt consumption. Gottlieb reportedly said FDA will explore possible changes to nutrient-content claims. “People eat foods, not nutrients,” he is quoted as saying. “This is why we’re asking the important question of whether a modernized definition of ‘healthy’ should go beyond nutrients to better reflect dietary patterns and food groups, like whole grains, lowfat dairy, fruits and vegetables and healthy oils.” FDA will also propose short-term, voluntary targets for salt and sodium reduction from the current average daily intake of 3,400 milligrams to no more than 3,000 milligrams. “There remains no single more effective public health action related to…

U.S. Rep. Rosa DeLauro (D-Conn.) has sent a letter asking the U.S. Government Accountability Office (GAO) to examine the regulatory framework for cell-cultured food products. According to the letter, such food products include lab-grown meat and “animal-free” milk that can be produced from fermented yeast and proteins in cow’s milk. DeLauro requested a “comprehensive review” of the unique challenges in safety oversight, the regulations and labeling requirements that may already exist, and a determination on whether federal agencies have begun preparing for the product’s commercialization. “While not yet commercially available, the potential introduction of this new type of product into the nation’s food supply and economy raises many important questions,” DeLauro said in the letter. “To date, it remains unclear exactly how cell-cultured food products should be regulated . . . More information is needed for Congress to address this emerging sector in the United States and to ensure it…

The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) will sponsor a public meeting April 6, 2018, in Washington, D.C., to provide information and receive public comment on U.S. draft positions for the Codex Committee on Methods of Analysis and Sampling meeting to be held in Budapest, Hungary, May 7-11, 2018. The committee is responsible for defining criteria and serving as a coordinating body for groups working on analysis, sampling and quality assurance systems applicable to foods.

The U.S. Food and Drug Administration (FDA) has proposed to allow the import of raw bivalve molluscan shellfish—including clams, mussels, oysters and scallops—harvested in the Netherlands and Spain by officially acknowledging that the EU food-safety system provides "at least the same level of sanitary protection as the United States' system and is therefore equivalent." The United States and the European Commission have not yet reached equivalence findings on food labeling requirements, maximum levels for food additives, maximum pesticide residue limits, drug residue limits or limits on other contaminants. "These critical determinations are a result of a multi-year, in-depth and cooperative review of shellfish safety systems in the U.S. and the EU, in which technical experts on both sides of the Atlantic have concluded that many of the safety controls in the EU and the U.S are equivalent," FDA Commissioner Scott Gottlieb said in a statement. "Both governments recommended these actions…

The National Toxicology Program, part of the Public Health Service of the U.S. Department of Health and Human Services (HHS), has issued for peer review a draft research report of a two-year study of the effects of bisphenol A (BPA) on rats. According to a press release issued by the U.S. Food and Drug Administration (FDA), the study was conducted by senior scientists at FDA’s National Center for Toxicological Research as part of a collaborative effort by FDA and the National Institutes of Health to investigate concerns about possible developmental effects of relatively low exposure to BPA. FDA reports that it found “minimal effects” of BPA on rats but identified areas that “may merit further research, such as the increase in occurrence of mammary gland tumors at one of the five doses.” FDA also noted that its “comprehensive review” of the report supports the agency’s determination that currently authorized uses…

Alleging unfair trade restrictions, the Vietnamese government has asked the World Trade Organization (WTO) to consult with the United States to discuss limitations on catfish imports. Vietnam alleges that a recent move to shift import inspections from the U.S. Food and Drug Administration to the U.S. Department of Agriculture subjects shipments of Vietnamese catfish (Siluriformes Pangasius) to unfairly stringent food safety rules. Vietnam argues that it has “objectively demonstrated” that its food safety standards “achieve the appropriate level” of safety demanded by the United States. If the requested consultations do not achieve a quick resolution, WTO may authorize Vietnam to ask for a formal adjudication.

The U.S. Food and Drug Administration (FDA) has released the 2017 edition of the FDA Food Code, a set of model regulations and advice for the reduction of foodborne illnesses, including suggested uniform standards for retail food safety, inspections and audits. The Code includes (i) a requirement for a person in charge of the establishment to be a “Certified Food Protection Manager”; (ii) an added section regarding the use of bandages, finger cots and stalls; (iii) standardized cooking times and temperatures for “intact and non-intact” meat and poultry; and (iv) updated procedures for operation during extended water or electrical outages.

The U.S. Food and Drug Administration (FDA) is soliciting public comment on whether the agency should continue to collect information about foodborne illnesses in restaurants. The proposal would extend studies of risk factors, preparation practices, employee behavior and the effects of regulation and food safety management systems on occurrences and outbreaks. FDA began a study of full-service and fast food restaurants in 2013; its current data collection will end in 2018, and the proposed collection would extend to 2022. Public comment will be accepted through April 9, 2018.

One day after the U.S. Food and Drug Administration (FDA) issued draft guidance on proposals to expedite product warnings and recalls, FDA and other health officials testified before the House Subcommittee on Oversight and Investigations about the results of an audit faulting the agency for the failure of the recall process to ensure food safety. Conducted by the Office of Inspector General of the Department of Health and Human Services, the audit identified a two-month average delay between when FDA notified companies of issues and when companies took action. During the hearing, Rep. Greg Walden (R-Ore.) reportedly displayed a snack container he had brought to a 2009 hearing on a nationwide Salmonella outbreak traced to products manufactured by the Peanut Corp. of America (PCA). PCA executives are serving federal prison terms for their roles in the outbreak, and a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit…

Panera Bread has reportedly petitioned the U.S. Food and Drug Administration (FDA) to establish a clear definition of the term “egg” after learning that agency rules dictate that “no regulation shall be promulgated” to define eggs. The company asserts that under existing regulations, restaurants can sell processed substances containing artificial flavorings, gums, coloring and fillers as "eggs." Panera’s director of wellness and food policy said in a press release, “Panera and our competitors use the FDA definitions to guide our product descriptions and names. But in the case of ‘eggs,’ we have no guidance. Brands can say they offer an egg sandwich, but sell an egg product that contains multiple additives.”

Close