Tag Archives: FDA

State AGs Want Role in Regulation of CBD-Containing Products

Many, including state regulators, are closely watching the U.S. Food and Drug Administration (FDA) as it works through the challenges associated with regulating cannabidiol (CBD) products.  Under the Federal Food, Drug and Cosmetic Act (FD&C Act), CBD cannot lawfully be added to a food or marketed as a dietary supplement; however, industry has been pressuring … Continue Reading

FDA Publishes Final Rule on Tolerances for Animal Drugs in Food

On July 10 FDA finalized its rule on Updating Tolerances for Residues of New Animal Drugs in Food.  This rule was originally proposed in 2012 with a revision proposed in 2016.  The rule will become effective September 9. As described in the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Update, the new … Continue Reading

FDA Holds Ground in Challenge over GE Animal Regulatory Authority

As previously reported on this blog, on June 11, the President issued Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products, ensuring coordination across federal regulatory agencies for biotechnology products. Referring to gene-edited crops and animals, the executive order told regulators to use their existing powers “to exempt low-risk products of agriculture biotechnology from … Continue Reading

Updated FDA Advice on Fish Consumption for Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children

On July 9, 2019 the Food and Drug Association (FDA) announced the availability of “Advice about Eating Fish: For Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children.”   The update follows a 2019 congressional directive mandating that the original 2017 version, “Advice about Eating Fish,” be updated in a manner consistent with … Continue Reading

Upcoming Public Workshop to Provide Update on FDA’s Predictive Toxicology Roadmap

Adequate toxicological data – often involving the sacrifice of laboratory animals – are necessary for reaching a safety decision on the products that are subject to FDA’s regulatory review.  FDA’s Predictive Toxicology Roadmap, published in December 2017, is a six-part framework for integrating predictive toxicology methods into the Agency’s safety and risk assessments.  FDA’s initial … Continue Reading

Bill Introduced to Protect State Cannabis Programs from Federal Interference

As previously reported on this blog, while the 2018 Farm Bill removed hemp from the Controlled Substances Act, its passage did not affect FDA’s authority to regulate cannabidiol (CBD) or other hemp products in FDA-regulated products. In December 2018, FDA released a statement clarifying that it is illegal to sell a food or dietary supplement that … Continue Reading

FDA Adds New Ingredients to Dietary Supplement Ingredient Advisory List

On June 25, Frank Yiannis, Deputy Commissioner, Food Policy and Response, Food and Drug Administration (FDA), announced via Twitter that FDA has added octopamine and N-Methyltyramine to the Dietary Supplement Ingredient Advisory List (the “List”).  Inclusion in the list indicates that FDA believes that the ingredient may not be legally marketed based on a preliminary … Continue Reading

San Francisco Passes Law Ban on E-Cigarettes Sales

On Tuesday, June 25th, San Francisco’s City’s Board of Supervisors voted unanimously in favor of an ordinance to effectively ban e-cigarette sales in the city. As previously reported on this blog, the measure was initially announced in March of this year, with City Attorney Dennis Herrera noting in a statement that “FDA has failed to … Continue Reading

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

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

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

  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

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

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

  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

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

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

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

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

OEHHA Confirms Final Carcinogen/Coffee Rule on Twitter

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

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

  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
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