• where experts go to learn about FDA
  • Ricardo Carvajal

    • On Geraniums, Synthetic Botanicals, and Body-Building: 11th Circuit Court of Appeals Upholds FDA Seizure of DMAASeptember 6th, 2019

      Claiming that DMAA (1,3-dimethylamylamine) is a “constituent” of geraniums, Hi-Tech Pharmaceuticals, Inc. sold DMAA as a dietary supplement, in products intended for body-builders.  The U.S. Food and Drug Administration seized the products, claiming that DMAA is a food additive because it is not generally recognized …

    • SCOTUS Makes it Easier for Government to Withhold Commercial or Financial InformationJune 26th, 2019

      In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government.  Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …

    • Consumers Encouraged to “Make Smart Choices” About CBD ProductsJune 24th, 2019

      FDA published a Consumer Update acknowledging the ubiquitous presence of CBD products in the marketplace, and providing the agency’s current perspective on questions regarding the regulatory status, safety, and quality of such products.  The Consumer Update follows closely on the heels of a recent statement issued jointly …

    • Hemp Producers, Rev Your EnginesMay 30th, 2019

      As we discussed in a prior posting, U.S.-based hemp production took a giant leap forward with passage of the 2018 Farm Bill, which directed USDA to establish a regulatory framework for the production of “hemp” as defined in that law.  USDA had signaled its intent to …

    • Setting Reasonable Expectations for FDA’s Public Hearing on CannabisMay 24th, 2019

      Yes, FDA’s upcoming public hearing on cannabis is important – and if you registered in time to get a spot in the room, we’ll see you there.  But as stated in the agency’s Federal Register notice announcing the hearing, “FDA does not intend for this hearing …

    • Hi-Tech Sues to Save DMHAMay 6th, 2019

      Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to …

    • Judge Says Lack of State and Federal Plans Means That the Farm Bill’s Interstate Commerce Protections for Hemp Don’t ApplyApril 9th, 2019

      We previously posted about what the Agricultural Improvement Act of 2018 (commonly referred to as the Farm Bill) did, and did not, do with respect to “hemp” and CBD products derived from hemp.  In that post, we noted that the Farm Bill did not preempt …

    • Farm Bill Creates Legal Framework for Hemp, But Challenges RemainDecember 21st, 2018

      In a rare display of bipartisanship in Washington, Congress has passed, and the President has signed, the Agricultural Improvement Act of 2018.  The agricultural legislation is far-ranging, but its most significant aspect from a controlled substance perspective is that it removes “hemp” as defined in the …

    • FDA on Gene-Edited Plants and Animals: “We’ve Got This”November 25th, 2018

      To the possible chagrin of those who think that FDA lacks jurisdiction over gene-editing of plants and animals, the Agency announced a Plant and Animal Biotechnology Innovation Action Plan that lays out actions the Agency is taking to help harness the potential benefits of the …

    • 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 …