This update includes FDA updates, USDA updates, and FDA warning letters, including guidance for inorganic arsenic in apple juice, a proposed rule for front-of-package nutrition labels in the U.S, and more.
FDA Updates
Final Guidance for Inorganic Arsenic in Apple Juice Now Available
June 1: FDA announced the availability of a final guidance for industry titled “Action Level for Inorganic Arsenic in Apple Juice.” The final guidance identifies the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice that was issued in draft by the agency in 2013. The final guidance comes after Consumer Reports tested 21 popular fruit juices and found elevated levels of cadmium, inorganic arsenic, and/or lead in 2018. FDA expects that the 10-ppb action level, though non-binding, will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency will continue its current practice of monitoring arsenic in apple juice samples, and if testing identifies inorganic arsenic in apple juice above 10 ppb, FDA will consider this action level, in addition to other factors, to determine whether to take enforcement action. A copy of the final guidance can be found here.
FDA Launched Webpage on Equivalence and Food Safety
June 5: The FDA has published a new webpage dedicated to equivalence for food safety. Equivalence is the process of determining whether a foreign regulatory counterpart’s food safety controls achieve at least the same level of public health protection measures required by U.S. law. The webpage explains how equivalence is determined, current equivalence determinations, and how regulatory authorities can submit a formal request for equivalence for FDA-regulated food products. The Equivalence and Food Safety webpage can be found here.
Comment Period Extended for Color Additive Petition
June 28: FDA is extending the comment period for a color additive petition submitted by Environmental Defense Fund, notice of which was published in the Federal Register on May 3, 2023. The petition requests that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods. The deadline to submit comments has been extended to September 1, 2023. More information and a link for submitting comments can be found here.
Comment Period Extended for Dietary Guidance Statements in Food Labeling
June 15: The FDA is extending the comment period for the draft guidance titled “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry,” that was published on March 27, 2023. The deadline to submit comments has been extended to September 25, 2023. More information can be found here.
New FSMA Food Traceability Rule FAQs Available
June 26: The FDA published new frequently asked questions (FAQs) and additional tools to provide industry with more information about FDA’s Food Safety Modernization Act (FSMA) Food Traceability Rule. The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. The FAQs regarding the Food Traceability Rule can be found here and more information can be found here.
Final Guidance for Quantitative Efficacy and Risk Information in DTC Advertisements
June 27: The FDA issued a final guidance for industry entitled, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The purpose of the guidance is to provide industry with recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs, as well as DTC promotional labeling for over-the-counter animal drugs. A copy of the final guidance can be found here.
FDA Testing Front of Food Package Nutrition Labels
June 14: The FDA is considering a proposed rule for front-of-package nutrition labels in the U.S. This proposed rule would require the front of food labels to display certain nutrition information to make it easier for consumers to make more informed dietary choices, which are intended to complement the nutrition facts label on packaged foods. FDA hopes to release a proposed rule on these labels by December 2023. More information can be found here.
FDA Warning Letters
Ready-to-eat Mandarin Oranges: A Chinese ready-to-eat (RTE) mandarin orange food manufacturing facility was issued a warning letter after FDA investigators found a serious violation of the Current Good Manufacturing Practices & Preventive Controls for Human Food Rule (“CGMP/PC Rule”). FDA determined that RTE mandarin oranges in light syrup in glass jars manufactured in the facility were adulterated because they were prepared, packed, or held under insanitary conditions.
Chewable Calcium with Vitamin D for Kids: A pharmaceutical company selling “Chewable Calcium 600 mg with Vitamin D for Kids in Orange Flavor” was issued a warning letter by FDA for misbranding of the product and selling the product, which FDA considers an unapproved new drug.
Ready to Eat Bread Rolls: FDA issued a warning letter to a RTE bread roll facility in Ohio for serious violations of the CGMP/PC Rule. FDA investigators determined the RTE buns processed at the facility are adulterated in that they were prepared, packed, or held under insanitary conditions.
A database of warning letters can be found here.
USDA Updates
New Guideline for Salmonella Control in Swine Slaughter and Pork Processing
June 1: The USDA Food Safety and Inspection Service (FSIS) updated its guideline for pork producers on controlling Salmonella in swine from pre-harvest through slaughter. The guideline covers pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage. It provides information on best practices that may be applied at slaughter facilities to prevent, eliminate, or reduce levels of Salmonella on swine at all stages of slaughter and dressing. It also contains best management practices for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products. A copy of the guideline can be found here.
Best Practices Guidance Available for Controlling Listeria in Delicatessens
June 20: FSIS released an updated guidance entitled “Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens.” The best-practices guidance discusses steps that retailers can take to prevent certain ready-to-eat foods that are prepared or sliced in retail delicatessens and consumed in the home from becoming contaminated with Listeria and thus a source of listeriosis. More information and a copy of the guidance can be found here.
FSIS Issues Updated Cell-Cultured Meat and Poultry Food Products Sampling Program
June 29: FSIS issued a notice of updates to the Cell-Cultured Meat and Poultry Food Products Sampling Program. The notice has been updated to reflect sampling of ready-to-eat products. The notice also provides instructions to inspection program personnel on how to collect cell-cultured meat and poultry food products and send samples to the FSIS Eastern Laboratory for microbiological, chemical residue, speciation testing, and pathology. More information can be found here.
Revised Directive for Responsibilities in Dual Jurisdiction Establishments
June 21: The directive for Responsibilities in Dual Jurisdiction Establishments provides instruction to FSIS inspection program personnel (IPP) about their roles and responsibilities regarding inspection, verification, documentation of findings, reporting and enforcement actions in establishments that operate under the jurisdiction of both FSIS and the FDA. FSIS revised this directive to reflect the updated Memorandum of Understanding between FSIS and FDA and to provide instructions to IPP in establishments that harvest cells for cell-cultured meat and poultry food products. More information can be found here.
USDA Considering Cracking Down on Animal-Raising Claims
June 14: USDA has launched a multi-step effort to strengthen standards used to substantiate animal-raising claims such as “raised without antibiotics,” “grass-fed,” and “free-range,” among others. This effort comes after petitions, comments, and letters requested USDA to reevaluate its oversight of how animal-raising claims are substantiated. To address concerns, FSIS, along with USDA’s Agricultural Research Service, will conduct a sampling project to assess antibiotic residues in cattle marketed with the “raised without antibiotics” claim. In addition, FSIS will be issuing a revised industry guideline to recommend companies strengthen the documentation they submit to substantiate animal-raising claims. More information can be found here.
This Regulatory Update covers information for June 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.