• where experts go to learn about FDA
  • Riëtte van Laack

    • GAO Report: USDA/FSIS Should Update Some of Its Food Safety StandardsMay 4th, 2018

      In 2015, Senators D. Feinstein, R. Durbin and K. Gillibrand asked GAO to investigate the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) pathogen standards for meat and poultry products and identify any steps that FSIS could make to address food safety. …

    • FDA Denies Petition to Ban Caffeine Because the Requested Action Is Not Necessary; Issues Guidance InsteadApril 27th, 2018

      In 2014, the Center for Science in the Public Interest (CSPI) filed a Citizen Petition requesting that FDA ban the retail distribution of highly concentrated caffeine marketed as a dietary supplement and specify limits on the forms in which caffeine may be sold.   On April …

    • What is Beef? Round TwoApril 20th, 2018

      As we previously reported, the United States Cattlemen’s Association (USCA) filed a Petition with the Food Safety and Inspection Service (FSIS), asking that FSIS establish formal definitions of “meat” and “beef” that exclude what petitioners call lab grown meat and products prepared from plant or …

    • The Food Labeling Modernization Act Is Back Again…April 12th, 2018

      On April 2, Rep. Frank Pallone, Jr. introduced the Food Labeling Modernization Act (FLMA) of 2018, an updated version of the FLMA of 2015. As we previously reported, the FLMA of 2015 was an updated version of the FLMA of 2013. The FLMA of 2018 differs …

    • Got Skim Milk? Dairy Farmer Sues FDA Over its Skim Milk RequirementsApril 10th, 2018

      On April 5, 2018, the Institute for Justice (IJ), on behalf of South Mountain Creamery (South Mountain), filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the Middle District of Pennsylvania, stating that the Agency is violating …

    • Second Circuit Affirms Preemptive Effect of Organic Food Production Act; a Clear Case of Conflict PreemptionApril 4th, 2018

      For anyone not familiar with the legal framework governing “organic” claims, first a brief summary. The Organic Food Production Act of 1990 (OFPA) established a process for organic certification by the United States Department of Agriculture Agricultural Marketing Service, National Organic Program (NOP). Under the …

    • Alliance for Natural Health Asks FDA to Fix IND GuidanceMarch 30th, 2018

      In September 2013, FDA issued a final guidance addressing when, according to FDA, companies need an Investigational New Drug Application (IND) for clinical studies in humans. The final guidance created quite a stir, as it included several sections that had not been included in the …

    • The Wait is Over: USDA Withdraws the Organic Livestock and Poultry Practices RuleMarch 21st, 2018

      On March 12, 2018, the USDA announced its decision to withdraw the Organic Livestock and Poultry Practices (OLPP) final rule that was published on January 19, 2017. As previously discussed, the OLPP was essentially an animal welfare rule, establishing minimum indoor and outdoor space requirements for …

    • GAO Report Confirms the Obvious: Food Safety Has Been Driving the Bus at FDA’s FVM ProgramMarch 13th, 2018

      On March 5, 2018, GAO released to the public a report titled “Food Safety and Nutrition: FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities.” The report confirms that FDA’s Food and Veterinary Medicine (FVM) Program has been primarily preoccupied with …

    • FDA Issues Final Guidance on Dietary Fiber and Guidance Regarding Implementation of the 2016 Nutrition Labeling RulesMarch 2nd, 2018

      On March 1, 2018, FDA announced the release of several guidance documents: final guidance on Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as Citizen Petition; final guidance on Reference Amounts Customarily Consumed: List of Products …

    • FSIS Proposes Egg Products HACCP Rule That Expands JurisdictionFebruary 19th, 2018

      On February 13, 2018, the USDA Food Safety and Inspection Service (FSIS) published a proposed rule that would amend the egg products inspection regulations. The proposal had been announced on January 9, 2018. The 48-page proposal (including the preamble) covers more than a change in …

    • Traditional vs Clean Meat: Cattlemen Ring the Bell for Round 1February 15th, 2018

      Clean or cultured meat are terms used for animal muscle produced by growing cells directly rather than via the rearing and slaughtering of an animal. The idea of growing meat (or muscle) from cells outside the body (in vitro) to produce a product that replicates …

    • FDA Publishes First Installment of Guidance Regarding Preventive Controls Requirement for Animal FoodFebruary 6th, 2018

      On Monday, January 21 (amid the government shutdown) the Center for Veterinary Medicine of the Food and Drug Administration (CVM) released a draft guidance document addressing Subpart C of the Agency’s regulation titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food …

    • USDA and FDA Announce Intent to Improve and Increase Coordination and CollaborationFebruary 5th, 2018

      On January 30, 2018, Dr. Gottlieb of FDA and Secretary Perdue of the USDA announced that they had signed a formal agreement to make the coordination and collaboration between the two agencies more efficient and effective. The USDA has jurisdiction over most meat, poultry, catfish, and …

    • Proposed Legislation to Reform the OTC Drug Monograph SystemFebruary 1st, 2018

      On January 17, 2018, in an effort to overhaul the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey introduced bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315. As readers of this blog know, the current monograph system, which …