• where experts go to learn about FDA
  • OTC Drugs and Cosmetics

    • Grandma, What White Teeth You Have! But it’s Still Such a Gray AreaMarch 30th, 2021

      Tooth whiteners – drugs or cosmetics or both?  In the case of certain tooth whiteners, the regulatory status remains gray, apparently with no prospect of illumination from the Agency. As we reported back in 2014, FDA’s interest in the regulation of peroxide-containing tooth whiteners began in …

    • FDA Issues Warning Letters for CBD-containing OTC Analgesic DrugsMarch 29th, 2021

      For more than five years now, FDA has pursued action regarding cannabidiol (CBD) products.  FDA has taken the position that CBD is not a lawful food or dietary ingredient.   But despite the agency’s strong statement about CBD, FDA has acted, primarily through Warning Letters (WLs), …

    • ACI’s Advanced Legal, Regulatory, and Compliance Forum on OTC Drugs (Virtual Conference)February 4th, 2021

      The American Conference Institute (“ACI”) is sponsoring its Advanced Legal, Regulatory, and Compliance Forum on OTC Drugs Conference on February 26, 2021 (Eastern Time).  Like a lot of conferences over the past year, the ACI conference format has changed from a live, in-person event to …

    • OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the TableJanuary 11th, 2021

      That did not take long.  As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees.  Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened?  Well, …

    • FDA Announces OTC Monograph Drug User Fees for Manufacturers for FY2021December 30th, 2020

      As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law.  This law amended the FDC Act to include, among other things, an OTC monograph drug user fee program, under which FDA is authorized to assess and …

    • GAO Report on Over-the-Counter DrugsAugust 10th, 2020

      Under the Sunscreen Innovation Act (SIA), GAO was to review and report on FDA’s regulation of sunscreens and other over-the-counter (OTC) drugs.  In late July, 2020, GAO issued its report on its performance audit conducted from July 2019 through July 2020.  The report focuses on …

    • OTC Monograph Reform Becomes Law; HP&M Issues Summary and AnalysisApril 8th, 2020

      Amidst the onslaught of regulatory and legislative announcements and changes occurring daily during this unprecedented time, a long-awaited (in some quarters) legislative change quietly and finally became law.   On March 27, 2020, President Trump signed into law the CARES Act which includes an array of …

    • Not Dead Yet – Far from It: OTC Monograph Reform Back on Congress’ RadarJune 27th, 2019

      We knew it would be back. It was never dead, though perhaps forgotten by some (never us), but OTC Monograph Reform is back in the public eye again.  Lawmakers appear to be taking to heart CDER Director Janet Woodcock’s remarks last week in which she urged …

    • FDA Issues Another “Final” Rule on Antiseptics; Defers Action on Three Active Ingredients for Use in Consumer Antiseptic RubsApril 17th, 2019

      Last week FDA issued a final regulation regarding consumer antiseptic rubs.  In 2016, FDA had proposed that 28 active ingredients, including triclosan, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs.   FDA requested but did not receive …

    • Ain’t No Sunscreens When It’s Done (Almost): FDA Issues Proposed Monograph on Sunscreens with Only the Oldies but Goodies Categorized as GRASEFebruary 27th, 2019

      Back in 2014, The Sunscreen Innovation Act (“SIA”) amended the Federal Food, Drug, and Cosmetic Act with the goal of accelerating the review of sunscreen ingredients that had been proposed for addition to the sunscreen monograph.  Although the original focus of the SIA was on …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • FDA Takes First Step on Path to Monograph for Antiseptics for Food HandlersDecember 10th, 2018

      On Dec. 6, FDA announced that it is formally seeking data, comments and information related to the assessment of safety and effectiveness of food handler antiseptic drug products (rubs and washes) for over-the-counter (OTC) use. Although this is a positive development, judging from the questions …

    • Relief At Last? DC Circuit Rules on Rx PEG-3350 ANDAsNovember 1st, 2018

      Only ten years after initiating the withdrawal process, FDA approval for prescription PEG-3350 is officially withdrawn. The D.C. Circuit issued an unpublished opinion this week affirming FDA’s April 2018 Order withdrawing approval for several PEG-3350 ANDAs and denying requests for a hearing by the affected …

    • PEG 3350 Rx ANDA Holder Gets Things Moving in the D.C. CircuitMay 7th, 2018

      On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit. The Petition seeks review of a final FDA order published in the Federal Register on …

    • Proposed Legislation to Reform the OTC Drug Monograph SystemFebruary 1st, 2018

      On January 17, 2018, in an effort to overhaul the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey introduced bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315. As readers of this blog know, the current monograph system, which …