FDA Comments Deeming Regulation

FDA Comments Deeming Regulation

This afternoon I attended a meeting with CTP Director Mitch Zeller regarding the deeming regulation (“FDA Comments on Deeming Regulation”). CTP Director Zeller made the following comments on the deeming regulation:

  • Flavors of e-liquids – concern about health benefits for adults versus the appeal to youth;
  • Flavors and PMTAs – questions on impact on initiation of smoking, cessation of smoking combustable cigarettes, and consumer perceptions research will be a key component;
  • Burden of entering the market – exemption applications the least burdensome in terms of cost and time, Substantial Equivalence application in the middle, and PMTAs the most burdensome in terms of time and cost;
  • Enforcement – once in effect the FDA will conduct manufacturing inspections and market surveillance;
  • Enforcement during review – if an application is under review the FDA will assess whether to exercise enforcement discretion;
  • Cigars – no public health basis to exempt premium cigars
  • Cigars with no packaging – placards with all the warnings at the register sufficient for compliance and in lieu of individual labels;
  • Cigars free samples – free samples requires consuming or leaving the store, not touching smelling, etc.;
  • PMTA flexibility – the cost will depend on novelty, complexity and risks. Can bridge from the current literature and overtime from other applications.

Overall FDA comments on the deeming regulation showed an open and flexible approach to compliance. The important point, one that is emphasized elsewhere on this blog, is to engage with the FDA early, register during the period to comply for extend approval time, and begin work on approvals. CTP Director Zeller estimates 70% of vape shops engage in manufacturing – this places a large number of companies within the requirements of the new deeming regulation. There are a number of lawsuits and amendments in Congress that many in industry are hopeful for, but those should not be the basis to delay compliance. The FDA is showing every intention of moving forward with and developing the deeming regulation fully.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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