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FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

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On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies … Continue Reading

FDA Issues Draft Guidance on Reducing Microbial Hazards in Seed for Sprouting

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance, titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” This draft guidance document provides food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting. FDA reported that between January 1996 and August 2018, contaminated … Continue Reading

FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food

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  The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by FDA under 21 C.F.R. Part 117 and Part 507, respectively.  Meeting the “small business” definition has two main implications: (1) Certain small businesses (i.e., “farm mixed-type … Continue Reading

Louisiana Laws to Limit Use of Terms “Meat,” “Rice,” “Sugar” and “Milk” on Food Product Labels

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On June 11, Louisiana joined a growing number of states, including Missouri and Arkansas, that have enacted legislation aimed at protecting traditional agricultural products from the growing popularity of plant-based and cell-based meat products or riced vegetables. Louisiana Governor John Bel Edwards signed two bills into law aimed at prohibiting the use of common labeling … Continue Reading

Executive Order: Eliminate One-Third of Advisory Committees

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On June 14, President Trump issued an Executive Order on Federal Advisory Committees. The Executive Order (EO) directs executive departments and federal agencies to evaluate their current advisory committees established under section 9(a)(2) of the Federal Advisory Committee Act (FACA). As part of the review, each agency “shall, by September 30, 2019, terminate at least … Continue Reading

FDA Reiterates That Scientific Data and Safety Information are Required to Support a Regulation or Formal Enforcement Discretion Policy on the Use of CBD in Foods

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  Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Industry wants FDA to … Continue Reading

President Trump Issues Executive Order to Streamline Regulation of Genetically Modified Food

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On June 11, President Trump issued an Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products.  The purpose of the Executive Order (EO) is to employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment with an ultimate goal of facilitating innovation, … Continue Reading

FDA Updates Produce Safety FAQ

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On June 11, 2019, FDA updated its Frequently Asked Questions (FAQ) on FSMA to include additional questions and answers related to the Produce Safety Rule that the Agency received through the FSMA Technical Assistance Network (TAN). The FAQ covers a wide range of topics, from defined terms (e.g., “qualified end-use” and “retail food establishment”) to training … Continue Reading

Deadlines Set for FDA to Establish Reporting Requirements for “High-Risk” Foods

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The Food Safety Modernization Act (FSMA), enacted on January 4, 2011, set deadlines for the U.S. Food and Drug Administration (FDA) to (1) designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health; and (2) publish a notice of proposed rulemaking to establish recordkeeping requirements for facilities that … Continue Reading

FDA Deputy Commissioner Yiannis’ Remarks on World Food Safety Day

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June 7 marked the first ever celebration of the United Nations’ World Food Safety Day.  The theme for 2019 is that food safety is everyone’s business.   The United Nations has designated two of its agencies, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), to lead efforts in promoting food safety around … Continue Reading

USDA Removes Standard for “Jambalaya”

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On May 29, 2019, the USDA Food Safety and Inspection Service (FSIS) announced in a letter that it will remove the entry for Jambalaya from the Food Standards and Labeling Policy Book (Policy Book).  The change came in response to a 2013 petition from Zatarain’s, a Louisiana-based food company owned by McCormick & Company, Inc., … Continue Reading

OEHHA Confirms Final Carcinogen/Coffee Rule on Twitter

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In a tweet published on June 3, 2019 California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that its draft Proposition 65 regulation regarding listed carcinogens in coffee had been finalized and will become effective on October 1, 2019.  The regulation states that exposures to Proposition 65 carcinogens listed on or before March 15, 2019, … Continue Reading

FDA Publishes Draft Guidance to Assist in Developing Alternate Curricula to Satisfy Produce Safety Rule Requirements

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FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety Modernization Act (FSMA). As our readers may know, the Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of … Continue Reading

Upcoming Presentation on FDA’s 2018 Cyclosporiasis Outbreak Investigations Will Explore Recent Scientific Advances and Continuing Regulatory Challenges

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  Cyclosporiasis is an intestinal illness caused by the microscopic parasite Cyclospora cayetanensis. People can become infected with Cyclospora by consuming contaminated food or water. Past cyclosporiasis outbreaks in the U.S. have been mainly linked to consuming imported fresh produce like cilantro. C. cayetanensis, however, may be an emerging pathogen with an increasing incidence of occurrence and infection. … Continue Reading

Looking Ahead: Proposed Regulatory Actions by FDA and USDA in the Fall 2018 Unified Agenda

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The Executive Office of the President recently released the Spring 2019 Unified Agenda. As we described in our post for the release of the Fall 2018 Unified Agenda, twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top … Continue Reading

NuTek Withdraws “Potassium Salt” Citizen Petition

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NuTek Food Science—the company that filed a 2016 citizen petition to obtain FDA permission to label potassium chloride as “potassium salt”—has withdrawn its citizen petition.  The company made its decision based on FDA’s recent issuance of draft guidance authorizing the term “potassium chloride salt” as an alternative name for “potassium chloride” on food labels. NuTek’s … Continue Reading

USDA Updates FAQs Regarding BE Labeling

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As previously reported on this blog earlier this month, the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) posted Frequently Asked Questions (FAQs) and responses for manufacturers concerning its bioengineered (BE) food labeling rule (formally known as the National Bioengineered Food Disclosure Standard (NBFDS)). We pointed out in that blog that the FAQs were not … Continue Reading

FDA Endorses “Best If Used By” Label for Food

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Packaged food and beverage products for retail sale contain an array of date labels, such as “Use by,” “Best If Used By,” “Expires On,” etc. Ultimately, with few exceptions, such as labels for infant formula, data labels are not required on packaged foods. While manufacturers are prohibited from placing false or misleading information on a … Continue Reading

FDA Launches Menu Labeling Social Media Toolkit

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FDA has launched a social media toolkit to assist with consumer awareness of menu labeling information.  The toolkit features web badges that can be added to an organization’s website, a sample newsletter/blog, and social media messages for sharing on Facebook and Twitter. The new consumer-focused materials refer to FDA’s www.fda.gov/caloriesonthemenu website, which provides consumers with … Continue Reading
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