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FDA to Evaluate Minimally or Non-Addictive Cigarette Product Standard, Also Plans to Look at Flavors and Premium Cigars

Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels (Nicotine ANPRM).  Gottlieb’s announcement comes nearly eight months after the Agency unveiled its planned tobacco regulatory policy shift to place nicotine, and the issue of addiction, at the center of FDA’s tobacco regulatory efforts, which we discussed here.
In addition

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Food Regulatory Update: FDA Moving Forward With Nutrition Facts and Menu Labeling Rules, Plans to Redefine “Healthy” and Encourage “Clean Labels”

In remarks at the National Food Policy Conference (NFPC) in Washington, D.C. on March 29, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., detailed the Agency’s wide-ranging plans on a number of food regulatory initiatives.
More specifically, and as detailed in FDA’s Nutrition Innovation Strategy, which Commissioner Gottlieb unveiled at the NFPC, the Agency plans to, among other things:
  • Implement the new Nutrition Facts Label and menu labeling;
  • Modernize food label claims,

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Pennsylvania Medical Marijuana Permit Applications Now Live, Deadline to Submit is May 17

Earlier today, the Pennsylvania Department of Health (DOH), Office of Medical Marijuana (OMM), which oversees the Commonwealth’s medical marijuana program, initiated phase II of its licensing process. OMM is now accepting applications for grower/processor permits and dispensary permits. Applications may be submitted between April 5, 2018 and May 17, 2018. OMM is also accepting applications for certification of Academic Clinical Research Centers (ACRC), which must be submitted by May 3, 2018.
OMM is expected to issue 13 additional grower/processor permits and 23 additional dispensary permits in phase II, which will

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FDA Update: Agency Seeks to Strengthen Public Warning and Notification of Recalls, Exercises FSMA Enforcement Discretion

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things:
  • Issued a Draft Guidance to strengthen public warning and notification of recalls of foods, drugs, medical devices, and cosmetics (Recall Draft Guidance); and
  • Released a Guidance outlining key areas where the Agency intends to exercise enforcement discretion in four of the rules that implement aspects of the FDA Food Safety Modernization Act (FSMA) (FSMA Enforcement Discretion Guidance).

Recall Draft Guidance
On January 17, 2018, FDA

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Attorney General Sessions Rescinds Obama-Era Policies That Allowed State-Authorized Cannabis Activity to Flourish, Including Cole Memo

Earlier today, Attorney General Jeff Sessions issued a memorandum to all U.S. Attorneys in which he rescinded, effective immediately, several previous U.S. Department of Justice (DOJ) guidance documents* related to marijuana enforcement. The most notable of these now-rescinded memoranda is the 2013 Cole Memorandum (Cole Memo).
By way of background, in 2013, Deputy Attorney General James Cole directed U.S. Attorneys to utilize their resources prudently, and to use discretion before prosecuting those using medical marijuana in compliance with their state’s laws. The Cole Memo

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FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and oversight of innovative digital health tools. The first two documents are draft guidances, “Clinical and Patient Decision Support Software” (CDS Draft Guidance) and “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” (Medical Software Policies Draft Guidance), and the

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Menu Labeling Update: FDA Issues New Guidance, Plans to Implement Rule in May 2018

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). In the Draft Guidance, FDA addresses comments it received on the May 2017 interim final rule (IFR) extending the compliance date for the Menu Labeling Final Rule (Menu Labeling Rule or the Rule) from May 5, 2017 to May 7, 2018.
By way of background, the Agency’s Menu Labeling Rule (discussed here, here, and here) requires restaurants and

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FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

​Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products sold online that allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication.
These actions were not surprising given FDA Commissioner Scott Gottlieb’s recent testimony

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Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device Development Tool

​Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA Commissioner Scott Gottlieb, M.D. More specifically, the Agency:
Device Change Final Guidances
As their names suggest, the Device Change Guidance applies to medical device changes broadly, whereas the Software Guidance focuses on software-specific changes and complements the broader Device Change Guidance. The Guidances, drafts of which were

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FDA Agrees to Enforce Menu Labeling Rule in May 2018, Delays New Nutrition Facts Label Compliance Deadline Until January 2020

​As discussed previously, earlier this year, the U.S. Food and Drug Administration (FDA or the Agency) delayed its Menu Labeling Rule (the Rule) until May 7, 2018.  FDA’s announcement in May came just one day before the Rule was set to go live.
By way of background, the Rule (discussed here, here, and here) requires restaurants and “similar retail food establishments” (e.g., convenience stores and grocery stores) that are part of a chain of 20 or

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FDA Commissioner Touts Seamless Clinical Trials, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., spent considerable time addressing how “seamless” clinical trials and more widespread use of modeling and simulation could help combat the costs of both drug development and new drugs.  This is not the first time that Gottlieb has addressed the challenges of bringing new products to market and drug costs (see here and here). 
Commissioner Gottlieb

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