• where experts go to learn about FDA
  • Ricardo Carvajal

    • A Heavy Homework Assignment for Food Importers and ProducersFebruary 14th, 2018

      Barely a week apart, FDA announced the publication of a slew of guidance documents intended to further implement the food supply chain-related provisions of the Food Safety Modernization Act (FSMA).  In this posting, we look at the first set of documents, published on January 24. …

    • Vape Shops Challenge Constitutionality of FDA’s Deeming RuleFebruary 2nd, 2018

      Vape shops in several states have banded together in litigation challenging the constitutionality of FDA’s Deeming Rule (for background information on that regulation, see our prior posting here). Plaintiffs are pursuing the litigation simultaneously in several federal district courts – perhaps with the objective of …

    • Now Hear This: FDA Issues Draft Guidance on Public Warning and Notification of RecallsJanuary 29th, 2018

      FDA issued a draft guidance that addresses public warning and notification of recalls under the agency’s recall regulation at 21 CFR part 7, subpart C (see here and here).  Although the draft guidance extends to recalls of nearly all FDA-regulated products, it is of particular importance …

    • Up in Smoke? Will the Feds Ramp Up Enforcement Action Against Budding State Marijuana Industry?January 4th, 2018

      Federal law continues to prohibit the possession, cultivation or distribution of marijuana and prohibits operating a business for these purposes. A number of states continue to follow Federal law and prohibit the use of marijuana under any circumstance, but a growing majority of other states …

    • FDA Publishes Two Guidance Documents on GRASDecember 14th, 2017

      FDA recently published a guidance document reminding proponents of GRAS status of their obligations under the FFDCA and its implementing regulations (which we refer to as the “Reminder Guidance,” available here).  FDA also published a draft guidance document setting out best practices for convening a …

    • 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  FDA had issued the draft guidance as part of a batch of biotech-related documents that were released in the final days of the Obama administration …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 …