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  • Dietary Supplements

    • 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 …

    • 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 …

    • For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget PlanMay 23rd, 2017

      Cue up “For The Love of Money” by The O’Jays (and theme song of The Apprentice) . . . The Trump Administration’s Fiscal Year 2018 Budget Proposal is out! On May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year …

    • FTC Announces Settlement with Herbalife; Consent Decree Sets Parameters for a Legal Multilevel Marketing BusinessJuly 20th, 2016

      By Riëtte van Laack –   Last week, FTC announced a settlement agreement with Herbalife International of America Inc., Herbalife International, Inc. and Herbalife Ltd. (Herbalife) under which Herbalife is to pay 200 million dollars and restructure its business (see FTC press release here). In the Complaint …

    • ACI & CRN Co-Sponsor Forum on Dietary SupplementsMay 12th, 2016

      The American Conference Institute’s 4th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements will be presented in collaboration with the Council for Responsible Nutrition, and is scheduled for June 27-28 in New York.  The Forum will feature presentations on policy initiatives, federal and state …

    • The Next Wave for Probiotics?April 25th, 2016

      By Ricardo Carvajal – The would-be marketer of a probiotic suppository submitted a citizen petition (Docket No. FDA-2016-P-1133) to FDA asking the agency to “amend the definition of dietary supplement under the present statutory authority [of DSHEA] and to treat probiotic suppositories the same as oral probiotic …

    • Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary SupplementsMarch 10th, 2016

      By Jenifer R. Stach & Wes Siegner – If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice. On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney …

    • FDA Broadens Arsenal in Fight Against KratomJanuary 7th, 2016

      By Ricardo Carvajal –  FDA announced the seizure of dietary supplements purportedly containing kratom, which the agency describes as “a botanical substance that could pose a risk to public health and have the potential for abuse.”  The seizure followed on the heels of an administrative detention – a …