US FDA proposed rule: requirements for tobacco product manufacturing practice

The US Food and Drug Administration (FDA) has proposed a rule that would establish a unified regulatory framework for tobacco product manufacturing practice requirements in the US.

The rule would apply to manufacturers of finished and bulk tobacco products.

One of the main reasons for proposing this rule is cases of variability in e-liquid nicotine concentrations where there is a contradiction between what the label states and the product’s actual nicotine level.

This report looks at how the rule came to be proposed, who and which products it would apply to, and when it would go into effect.

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Table of contents

  1. Executive summary
  2. Introduction
  3. What is the purpose of this rule?
  4. What is the content of the rule?
  5. What set this proposed rule in motion?
  6. Who is subject to the rule?
  7. What products does it apply to?
  8. Are there differences between the categories or does it apply uniformly to all tobacco products?
  9. When will the rule become effective and what are the next steps?

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