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US FDA proposed rule – requirements for tobacco product manufacturing practice

Published: 14th April 2023 | No. pages: 12
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Description

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.

Reasons to buy

This TobaccoIntelligence regulatory report will provide you with:

  • A clear and detailed understanding of current regulatory requirements affecting this sector in a specific jurisdiction, enabling you to be confident your business and your products are compliant.
  • The ability to plan ahead for specific regulatory changes.
  • Strategic understanding of the policy climate within the jurisdiction, enabling you to forecast how it might affect business development.
  • Sources of further information, for example links to full texts of legislation and contact details for relevant government offices.

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?

Methodology

Our research is completely independent and original. It is conducted by TobaccoIntelligence’s multilingual legal analysis team, all specialists in this sector, and goes through a rigorous review and editing process before publication. Research draws on multiple sources, including: online and offline resources and data, specialist legal software, our own extensive databases and report archives, interviews with key stakeholders and government officials, and collaboration with local legal firms and on-the-ground professionals in the jurisdictions covered.

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Description

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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“ US FDA proposed rule – requirements for tobacco product manufacturing practice ”

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    “ US FDA proposed rule – requirements for tobacco product manufacturing practice ”