• where experts go to learn about FDA
  • Ricardo Carvajal

    • Citing Delaney Clause, FDA Revokes Food Additive Approval of Six Artificial Flavoring SubstancesOctober 14th, 2018

      As we previously speculated might come to pass, FDA announced that it is amending the food additive regulation for synthetic flavoring substances and adjuvants (21 C.F.R. § 172.515) to remove six substances found to induce cancer in animals, namely benzophenone, ethyl acrylate, eugenyl methyl ether …

    • FDA Seeks Information on Labeling and Consumer Use of Certain Plant-Based ProductsSeptember 28th, 2018

      FDA published a notice requesting information on how consumers use plant-based products whose names include terms such as “milk,” “yogurt,” and “cheese,” and how consumers understand those terms when used in such product names.  The notice seeks data and evidence in five major areas, namely: (A) the …

    • FDA Adopts New Policy on Release of Retailer Lists During Human and Animal Food RecallsSeptember 27th, 2018

      FDA announced the establishment of a new policy that provides for the release of lists of retailers that may have received a food subject to a recall.  Historically, FDA has not released such information because it is considered confidential commercial information.  FDA now has concluded that …

    • Whither Regulation of Animal Cell-Cultured Foods?July 10th, 2018

      To anyone with an interest in that question, FDA’s public meeting later this week is a can’t miss event.  Perhaps the most critical issue facing this nascent industry is the need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction …

    • USDA Publishes Proposed Rule for National Bioengineered Food Disclosure StandardMay 4th, 2018

      USDA announced the publication of its much awaited proposed rule establishing a National Bioengineered Food Disclosure standard as mandated by Congress almost two years ago (for more on that law, see our prior posting here).  The rule is scheduled to publish in the Federal Register on …

    • 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 …

    • 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 …

    • 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 …