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.
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.