Welcome
Health Law & Business News

Altria Asks FDA to Delay Regulatory Deadline Due to Coronavirus

March 27, 2020, 12:23 AM

Altria Group Inc. sent a letter to the Food and Drug Administration Wednesday asking that a crucial regulatory deadline for some tobacco products be pushed back by eight weeks due to complications caused by the coronavirus pandemic.

Currently, companies must apply to the FDA by May 12 for authorization to keep selling certain tobacco products. Regulators, public-health groups and companies fought over the timing for years before settling on that date last year in federal court. The deadline applies to products such as e-cigarettes and nicotine pouches.

In the letter, which was reviewed by Bloomberg News, Altria asked that the FDA seek an extension from a federal judge in Maryland to coincide with the eight-week social-distancing period recommended by the U.S. Centers for Disease Control and Prevention to slow the spread of the coronavirus.

Altria’s employees, contractors and partners, such as analytical labs, have been working for months to prepare the applications, the company said in the letter. Altria said it is on track to meet the filing deadline, but that it and many of its partners have asked employees to work from home.

If an extension isn’t possible, Altria proposed the FDA allow companies to submit data and product samples after the deadline if the pandemic hinders their efforts.

“Although we make this request and raise these issues given these unprecedented times, we remain committed to working with the agency on these important product submissions,” Altria Senior Vice President Paige Magness said in the letter.

Michael Felberbaum, a spokesman for the FDA, said in a statement that the agency had received numerous inquiries from the industry expressing concern about the impact of Covid-19, the disease caused by the coronavirus, on the May 12 deadline.

“The FDA is currently engaged in internal discussions to determine how to best address this issue,” Felberbaum said. “We encourage manufacturers who have concerns about meeting the May 12 deadline for any reason to contact the FDA directly.”

The deadline is also especially important to the e-cigarette industry, which has been allowed to continue to sell some products pending FDA authorization but barred from introducing new ones. Altria holds a large stake in Juul Labs Inc., the largest U.S. vaping company.

Like at many businesses, the new coronavirus has disrupted operations at the Richmond, Virginia-based tobacco giant. Altria Chief Executive Officer Howard Willard contracted Covid-19. And the company halted production at its plant in Richmond last week after a second employee tested positive.

To contact the reporter on this story:
Angelica LaVito in New York at alavito@bloomberg.net

To contact the editors responsible for this story:
Drew Armstrong at darmstrong17@bloomberg.net

Timothy Annett, Nick Turner

© 2020 Bloomberg L.P. All rights reserved. Used with permission.

To read more articles log in. To learn more about a subscription click here.