• where experts go to learn about FDA
  • Ricardo Carvajal

    • FDA Finalizes Guidance on Mosquito-Related Products (Including Genetically Engineered Mosquitoes)October 24th, 2017

      FDA finalized a guidance that clarifies FDA and EPA jurisdiction over mosquito-related products, including mosquitoes produced through the use of biotechnology.  FDA had issued the draft guidance as part of a batch of biotech-related documents that were released in the final days of the Obama administration …

    • Could The Delaney Clause Rear Its Head Yet Again?October 5th, 2017

      Occasionally we peruse FDA’s inventory of food and color additive petitions under review as a reminder of what might lie on the horizon.  The current list includes some that have gotten considerable attention, and others that have largely flown below radar.  Among the latter, one stands …

    • FDA Releases Food Safety Plan SoftwareAugust 22nd, 2017

      In a blog posting that cited the agency’s goal of educating while regulating, FDA released the Food Safety Plan Builder (FSPB) – a software program “designed to assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities …

    • Deregulatory Agenda Notwithstanding, the Enforcement Side of the House is Open for BusinessJuly 27th, 2017

      FTC and FDA issued a blog posting co-authored by senior officials that encourages the public to report potentially violative dietary supplements to one or both agencies.  The posting lists the following as circumstances that should prompt a report: “You bought a dietary supplement that didn’t work …

    • GMO Labeling And The ANPRM That Wasn’tJune 29th, 2017

      Earlier this week, USDA/AMS posted “Proposed Rule Questions Under Consideration” on its web page dedicated to the establishment of a National Bioengineered Food Disclosure Standard.  The posting asks for comment on 30 questions relating to different aspects of what such a standard might entail.  Most of …

    • Coalition of Consumer Advocates Challenges FDA’s GRAS Notification Final RuleMay 26th, 2017

      A coalition of consumer advocates filed a lawsuit challenging FDA’s final rule that formally established the GRAS notification system.  The complaint alleges that the rule “unlawfully subdelegates statutory authority to private parties,” that the “secret GRAS system is contrary to the FDCA,” and that the “criteria for …

    • To Reduce Regulatory Burdens, Citizen Petition Asks FDA to Permit Interstate Sales of Raw MilkMay 10th, 2017

      A citizen petition (Docket No. FDA-2017-P-2626) recently submitted to FDA asks the agency to exercise enforcement discretion with respect to the regulatory prohibition on interstate shipments of milk products that have not been pasteurized (21 CFR 1240.61).  There have been previous petitions asking FDA to allow the …

    • Interagency Food Safety Analytics Collaboration Issues New Strategic PlanMarch 31st, 2017

      The Interagency Food Safety Analytics Collaboration (IFSAC) has issued a strategic plan for the 5-year period beginning in 2017.  This is the second such plan issued by IFSAC, a collaboration between FDA, USDA/FSIS, and CDC that aims “to improve coordination of federal food safety analytic efforts …

    • FDA SOT Colloquium Explores Determination of Adversity in Food Chemical Safety EvaluationsMarch 21st, 2017

      On Monday, March 27, FDA and the Society of Toxicology (SOT) will present a colloquium (chaired by Bernadene A. Magnuson, PhD, Health Science Consultants, Inc., and Sabine Francke, DVM, PhD, CFSAN FDA) on Considerations for the Determination of Adversity in Food Chemical Safety Evaluations, the …

    • How to Name that Food: The Good Food Institute Petitions FDA for ClarityMarch 8th, 2017

      With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue. Although the issue …

    • FDA’s Draft Guidance on Listeria monocytogenes (In Case You Missed It)February 14th, 2017

      Just a few days before the presidential inauguration, FDA published a revised draft guidance on control of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods.  The significance of the guidance to the food sector is difficult to overstate.  Since FDA published the original draft guidance in February …

    • Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?December 8th, 2016

      There has been a spate of recent news articles about the potential use of the Congressional Review Act (CRA) to overturn final rules issued toward the end of the Obama Administration. That prompted us to see which of FDA’s recently issued final rules might be …

    • In a FSMA First, FDA Suspends a Food Facility’s RegistrationNovember 29th, 2012

      By Ricardo Carvajal & John R. Fleder – On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella.  Until the order …

    • Court Sides With Government in Case Alleging Adulteration, But Deems Injunction Request OverbroadSeptember 15th, 2011

      By Wes Siegner, John R. Fleder & Ricardo Carvajal – In U.S. v. Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues.  Although nominally a veterinary drug case, …

    • FTC Wins Summary Judgment Against Marketer of Weight Loss ProductsApril 27th, 2009

      By Ricardo Carvajal & John R. Fleder – In Federal Trade Commission v. Medlab, Inc., the United States District Court for the Northern District of California granted summary judgment on April 21, 2009, to the FTC in an action against a marketer of weight loss products, which …