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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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Berta Camps Bisbal

Senior legal analyst
Berta has a law degree from the University of Barcelona and a Juris Doctor degree from Nova Southeastern University (Florida). She has worked as a faculty assistant in legal research in Florida, was a member of the Law Review, and has interned for a magistrate judge of the US District Court for the Southern District of Florida. Berta focuses on US legal analysis, including tracking all federal, state and local regulation. She runs our US interactive regulatory tracker product, following changing regulation on e-cigarettes in all 50 US states.

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