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  • Dietary Supplements

    • HP&M’s Food, Beverage & Supplement Wrap Up: February 2021March 4th, 2021

      Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Food & Beverage Transition: As of this writing, Janet Woodcock is Acting Commissioner of Food …

    • HP&M’s Food, Beverage & Supplement Wrap Up: January 2021February 8th, 2021

      Welcome to the latest edition of HPM’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. It’s been quite a January, hasn’t it? Food & Beverage Transition: As of this writing, Janet Woodcock is Acting …

    • ACI’s Dietary Supplements – Legal, Regulatory & Compliance – VIRTUAL ConferenceJune 2nd, 2020

      The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The virtual conference is scheduled to take place on June 23-24, 2020. This “must-attend” event for legal, regulatory, and compliance stakeholders in …

    • Affirmative Defenses: What’s Going to Stick to the Wall?March 11th, 2020

      The recent opinion in FTC v. Quincy Bioscience Holding Co., 2020 U.S. Dist. LEXIS 36424*(S.D.N.Y. Mar. 2, 2020) (background here) is a primer on affirmative defenses in an FTC Act case alleging deceptive advertising of a dietary supplement.  The FTC and State of New York …

    • CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary SupplementsNovember 27th, 2019

      FDA has repeatedly declared that cannabidiol (“CBD”) cannot be lawfully used in food or dietary supplements because FDA approved CBD as an active ingredient in an epilepsy drug before the first marketing of CBD as a dietary supplement or food.  This has not stopped the …

    • 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 …

    • ACI’s Annual Legal, Regulatory & Compliance Forum on Dietary SupplementsJune 3rd, 2019

      The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s  Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The conference is scheduled to take place at the InterContinental New York Times Square in New York, New York from June …

    • 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 …

    • FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement IndustryFebruary 15th, 2019

      On February 11, 2019, Dr. Gottlieb issued a statement that appears to build on statements from December 2018.   In December 2018, as part of remarks to the FDLI Enforcement, Litigation, and Compliance Conference, Dr. Gottlieb had alluded to FDA’s plans to step up its efforts …

    • ACI’s 6th Annual Legal, Regulatory & Compliance Forum on Dietary SupplementsMay 31st, 2018

      The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s 6th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The conference is scheduled to take place in Ney York, New York from June 18-20, 2018. This “must-attend” event for legal, …

    • 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 …

    • FDA Issues First Mandatory Recall Order, Exercising FSMA Authority Over Food Products Containing KratomApril 5th, 2018

      On April 3, 2018, FDA announced that it had issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC (Triangle). FDA issued this order based on its finding that several Triangle products contained kratom …

    • 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 …

    • FTC Staff Publishes Guidance for Multi-Level MarketersJanuary 17th, 2018

      On January 4, the Federal Trade Commission (FTC) announced the release of a new guidance by FTC staff concerning Multi-Level Marketing (MLM). The guidance, in the form of questions and answers, addresses issues relevant for businesses evaluating their compliance with the FTC Act. Multi-level marketing is …

    • Trailblazer Amarin Takes on a New Fight with ITC Complaint Against Synthetic Omega-3 Oil Manufacturers and Dietary Supplement DistributorsAugust 30th, 2017

      Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or successfully challenging FDA’s denial of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our …