The U.S. Food and Drug Administration (FDA) has warned Nashoba Brook Bakery that it has misbranded its granola by listing “Love” as one of its ingredients. The warning letter informed the company that “'love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.” “Intervening material” refers to information that is not required in FDA labeling and can distract from required content. The letter also cited the bakery for health and sanitary violations as well as misbranding violations for whole-wheat products that contain corn meal.
Category Archives U.S. Government and Regulatory Agencies
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…
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 Organic Trade Association has filed a lawsuit to compel the U.S. Department of Agriculture (USDA) to implement the Organic Livestock Rule, which was scheduled to take effect on March 18, 2017. Organic Trade Ass’n v. U.S. Dep’t of Agric., No. 17-1875 (D.D.C., filed September 13, 2017). After 10 years of public process and hearing, USDA published the final rule in January 2017 along with formal recommendations from the National Organic Standards Board (NOSB) resulting from consultations required by the Organic Foods Production Act (OFPA). On January 20, 2017, former White House Chief of Staff Reince Priebus issued a memorandum to federal agencies directing them to temporarily postpone effective dates for regulations that had been published but had not yet taken effect. The complaint alleges that public comment should have been permitted on whether the Priebus memo applied to the Organic Livestock Rule because its standards affect only those who…
The National Advertising Division (NAD) has ruled that Mizkan America, Inc. provided a reasonable basis for its advertising claim that “consumers prefer the taste of Ragú Homestyle Traditional over Prego Traditional.” The Campbell Soup Co., which makes Prego, challenged the ad on the grounds that Mizkan’s consumer survey methodology was flawed. Both parties conducted a taste test of the products; the Mizkan test reportedly showed a consumer preference for Ragú while the Campbell test showed no preference. The Mizkan test included testing of all tomato-based sauces, while Campbell limited its test to traditional-style sauces. NAD found the Campbell test “overly restrictive” and that its results were not “stronger or more persuasive” than those of Mizkan.
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…
Following a Center for Food Safety lawsuit seeking information on requirements in the 2016 Federal Bioengineered Food Safety Disclosure Standards Act, the U.S. Department of Agriculture (USDA) has released a study identifying potential challenges to implementation of electronic disclosure of genetically modified organism (GMO) content on food labels. The study considered whether consumers or retailers would have sufficient access to smartphones or broadband internet to easily obtain ingredient information, purportedly finding that about 85 percent of consumers experience technical challenges scanning digital links such as QR codes and less than 40 percent of small retailers provide in-store Wi-Fi access.
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.
