US regulatory report: synthetic nicotine products – what’s next?

The new US federal legislation has brought synthetic nicotine products under the oversight of the US Food and Drug Administration (FDA), meaning all synthetic nicotine products have to go through a premarket tobacco product application (PMTA) process. This has led to several questions this report addresses, such as: what the new federal legislation means for synthetic nicotine products; what the concerns were that spurred this legislation; what the next steps will be for synthetic nicotine products; whether there any products that currently do not fit the definition, or whether all products will fall under FDA oversight, and a look into enforcement to see how the market is really going to play out.

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Table of contents

  1. How is synthetic nicotine currently regulated?
  2. What does the new federal legislation mean for synthetic nicotine products?
  3. Where did the loophole come from?
  4. What were the concerns that spurred the legislation?
  5. What are the next steps for synthetic nicotine products? Is there any hope?
  6. Are there any products that currently do not fit the definition, or would all products fall under FDA oversight?
  7. A look into enforcement: how is the market really going to play out?

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