Understanding the FDA’s Final Tobacco Product Deeming Regulation

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
60 minutes
Product Description

FDA’s Final Tobacco Product Deeming Regulation, Affected Products, Compliance Timeline, Challenges and Opportunities for the Industry

As part of its goal to improve public health and protect future generations from the risks of tobacco use, the U.S. Food and Drug Administration (FDA) has extended its regulatory authority under the Family Smoking Prevention and Tobacco Control Act to cover all products that meet the statutory definition of “tobacco product.”

This webinar by Food and Drug Law attorney Will Woodlee will provide an overview of the long-awaited final version of the FDA’s so-called tobacco product deeming regulation, which will subject cigars, pipe tobacco, electronic cigarettes, and other tobacco products to FDA regulation under the Federal Food, Drug, and Cosmetic Act.

In this session, Mr. Woodlee will explain the authorities under which FDA will regulate such products, provide a breakdown of the various compliance periods for newly applicable requirements, and highlight potential challenges and opportunities for affected industry members. Key concepts will include FDA’s implementation of requirements for:

  • Labeling (including warnings);
  • Establishment registration and listing;
  • Submission of health documents;
  • Harmful and potentially harmful constituent data;
  • Ingredient information; and
  • Premarket review of “new tobacco products” and “modified risk tobacco products.”

The webinar will also cover new restrictions on the promotion and sale of deemed products that apply not only to manufacturers but also to distributors and retailers of such products.

Key Takeaways

  • What products does the deeming regulation cover?
  • What requirements will apply to covered products?
  • Which entities in the distribution chain have responsibility for compliance with these new federal requirements?  When must they comply?
  • How does the regulation impact new product launches and flavors?
  • How does the new federal regulation impact enforcement of current and future state and local laws?
  • What does the deeming regulation mean for retailers?

Who Should Attend

  • Employees of cigars, pipe tobacco, electronic cigarettes, novel nicotine products, and related product:
    • Manufacturers
    • Distributors
    • Retailers
  • Attorneys
  • Regulatory affairs specialists
  • Marketing professionals serving the industry  
  • Investors
  • Entrepreneurs
  • Academics
  • Government employees interested in learning more about regulation of the category

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About Our Speaker

Will Woodlee

Will Woodlee is a partner in the law firm of Kleinfeld, Kaplan, and Becker, LLP, in Washington, DC. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco product, and consumer product companies on regulatory and advertising law matters. In 2015, Super Lawyers named Mr. Woodlee a "Rising Star" of the Washington, DC, metro area's “Food & Drugs” bar....   More Info
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