FDA proposes rule over record-keeping for vape makers

(Reuters) – The U.S. Food and Drug Administration on Friday issued a proposed rule for e-cigarette makers, requiring them to maintain records related to the legal marketing status of their products.

When finalized, 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 U.S. 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 May 12, 2020.

Juul Labs Inc, the market leader in the U.S. 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.