A U.S. Government Accountability Office (GAO) study has criticized the U.S. Food and Drug Administration (FDA) and the Department of Agriculture’s Food Safety Inspection Service (FSIS) for their failure to ensure that imported seafood does not contain unsafe levels of antibiotic or other drug residues. According to the GAO, about 90 percent of the seafood eaten in the United States is imported, and about half of imported seafood is raised on fish farms where producers treat fish to prevent infections and foodborne illnesses. GAO makes five main recommendations: (i) FDA should pursue agreements with exporting countries to test for “drugs of concern” and residue levels; (ii) FSIS should conduct onsite audits of fish farms instead of limiting visits to government offices, commercial food processing facilities and food testing labs; (iii) FSIS should require exporting countries to include residue-monitoring plans in equivalence determinations; (iv) FDA and FSIS should collaborate to develop…
Category Archives Food and Drug Administration
A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA) fails to adequately conduct or follow up on food-safety inspections required by the 2011 Food Safety Modernization Act (FSMA). OIG reportedly found that while FDA is “on track” to meet inspection timeframes for the initial mandate, future inspection timeframes are two years shorter and FDA may not be able to meet them. The report also stated that FDA did not always take action when it found significant safety violations and that the agency “commonly relied on facilities to voluntarily correct the violations” instead of taking advantage of FSMA administrative tools. FDA “consistently failed to conduct timely followup inspections” to ensure facilities made the necessary corrections, the report noted. In addition, “inaccuracies” in domestic facility data caused FDA to attempt inspections at the…
The U.S. Food and Drug Administration (FDA), the Center for Science in the Public Interest (CSPI) and the National Consumers League have filed a joint motion to stay a lawsuit intended to compel the agency to implement the delayed menu labeling rule required by the Affordable Care Act. Ctr. for Sci. in the Pub. Interest v. Price, No. 17-1085 (D.D.C., filed September 15, 2017). FDA has agreed to: (i) confirm in the Federal Register on or before December 31, 2017, that the compliance date of the rule is May 7, 2018; (ii) publish draft or final guidance by December 31, 2017; and (iii) announce by “rule, guidance, public statement, publically-available document, or otherwise,” if the compliance date could or will be extended past May 2018. If FDA fails to meet those terms, the advocacy groups may move for, and FDA will not oppose, expedited hearing of the lawsuit. Additional details appear…
The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing minimum standards for the growing, harvesting, packing and holding of raw produce for human consumption. Compliance dates are staggered but will affect large operations first. The key requirements include: (i) establishment of criteria for microbial water quality based on the presence of E. coli; (ii) rules governing the use of raw manure and compost; (iii) testing and corrective-action requirements for cultivation of sprouts; (iv) rules for assessment of contamination by domestic livestock and wild animals; (v) measures for worker training, health and hygiene; and (vi) standards for equipment, tools and buildings. Qualified exemptions and variances are also included for small farms, tribes and foreign countries that export food to the United States.
The U.S. Food and Drug Administration (FDA) has announced the approval of a qualified health claim that baby food with ground peanuts can reduce the development of peanut allergies. On the labels of foods suitable for infant consumption that contain ground peanuts, companies can now include the claim that "for most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age." "The new claim on food labels will recommend that parents check with their infant’s healthcare provider before introducing foods containing ground peanuts. It will also note that the claim is based on one study," Commissioner Scott Gottlieb said in a September 7, 2017, statement. "The FDA will continue to monitor the research related to peanut allergy. If new…
Implementing an executive order titled "Reducing Regulation and Controlling Regulatory Costs," the U.S. Food and Drug Administration (FDA) has opened a comment period to identify "existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations." FDA will accept comments related to "general regulatory and information collection requirements that affect multiple FDA Centers and/or Offices" and "products regulated by the Center for Food Safety and Applied Nutrition" until December 7, 2017.
The U.S. Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition has notified the Good Food Institute (GFI) that the agency has been unable to reach a decision on the advocacy group's March 2017 petition requesting recognition for commonly used—if technically inaccurate, per FDA definitions—food names such as "almond milk," "soymilk," "almond butter" and "cashew butter." The letter informs GFI that the agency was "not able to reach a decision on your petition within the first 180 days of its receipt, nor as of the date of this letter, because of other agency competing priorities."
Shook Partners Lindsey Heinz and Katie Gates Calderon, with Associate Hillary Nicholas, have authored an article for Law360 discussing regulations related to the use of photography during a U.S. Food and Drug Administration (FDA) inspection of a production facility. "Despite the void of statutory authority, the FDA continues to instruct its inspectors to 'not request permission from management to take photographs during an inspection' and to instead simply begin taking photos and video," the authors explain. "Should a company object to these tactics, inspectors are encouraged to '[a]dvise management the U.S. Courts have held that photographs may lawfully be taken as part of an inspection.' However, the two cases the FDA cites in support of this assertion — Dow Chemical Co. v. U.S. and U.S. v. Acri Wholesale Grocery Co. — do not stand for the unequivocal proposition suggested by the FDA." Heinz, Gates Calderon and Nicholas advise companies to…
The U.S. Food and Drug Administration has made available industry guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.” Comments on the guidance may be submitted at any time. Issue 645
The U.S. Food and Drug Administration (FDA) has announced the availability of industry guidance titled, “Ultrafiltered Milk in the Production of Standardized Cheese and Related Cheese Products: Guidance for Industry.” The guidance advises manufacturers that FDA intends to exercise enforcement in the use of fluid ultrafiltered milk in cheese products. Issue 645
