US FDA Proposes Rule Over Record-Keeping For Vape Makers

By Dayeeta Das
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US FDA Proposes Rule Over Record-Keeping For Vape Makers

The US Food and Drug Administration has proposed rule for e-cigarette makers, requiring them to maintain records related to the legal marketing status of their products.

When finalised, the rule would also help to ensure that e-cigarette applications by manufacturers contain information on the product's potential public health benefits and harms, the FDA said.

The agency's proposal follows a rise in popularity of the e-cigarettes among the youth and a widening outbreak of severe lung-related illnesses tied to vaping that has affected possibly 530 people.

Application Deadline

A US District Court judge in Maryland in July issued an order that would require makers of tobacco products, including e-cigarette makers, to file the applications by 12 May 2020.

Juul Labs Inc, the market leader in the US e-cigarette market, was warned by the FDA over marketing its vapes as safer than traditional cigarettes.


The Federal Trade Commission is investigating the marketing practices of e-cigarette maker Juul Labs Inc.

The proposed rule also establishes procedures which the FDA would follow when reviewing the premarket tobacco product applications.

News by Reuters, edited by ESM. Click subscribe to sign up to ESM: European Supermarket Magazine.

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