Tuesday, 17 September, 2019

FDA accuses Juul of illegally advertising its products as safe

Juul’s Marketing of Device May Have Violated Law FDA Says Melania Trump ‘Deeply Concerned’ About Teen Vaping as Severe Lung Illness Cases Grow to 450
Emmett Howard | 12 September, 2019, 02:58

Swiftly on the heels of incendiary national news stories like this one in the New York Times about the growing number of cases of serious vaping-related lung illnesses, the Food and Drug Administration issued a warning letter to SF-based Juul Labs saying the company has already violated federal regulations with its marketing claims.

"The law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful", acting FDA Commissioner Ned Sharpless said in a statement. "JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth".

The in-school presentations central to the FDA's latest concerns came to light during a Congressional hearing held July 24 and 25, titled "Examining JUUL's Role in the Youth Nicotine Epidemic".

Last week, Rep. Raja Krishnamoorthi, chairman of the House Oversight Subcommittee on Economic and Consumer Policy, asked the FDA in a letter to take "appropriate enforcement action" against Juul.

"FDA has determined that JUUL adulterated its products.by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution". If Juul's actions fail to appease the FDA, the company could face penalties and potentially have its products seized.

The agency also pointed out troubling aspects of testimony about a "Switching Program" presentation to the Cheyenne River Sioux Tribe Health Committee, in which Juul representatives made similarly unsubstantiated claims.

The FDA had also threatened to fine the company for its practices and even went as far as to threaten possible seizures of its products if it does not immediately rectify its marketing practices. "The alternative for adult smokers".

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"T$3 hat testimony revealed JUUL engaged in a wide variety of promotional activities and outreach efforts to persuade potential customers, including youth, to use JUUL products", the agency wrote in its letter of concern.

The agency previously requested documents from JUUL Labs in April 2018 to examine the reportedly high rates of youth use and the youth appeal of JUUL products.

Kelly Henning from Bloomberg Philanthropies and former youth e-cigarette user Phillip Fuhrman are live from NY to explain the action they're taking to address this public health crisis.

In response to the FDA's accusations, a Juul spokesperson mentioned in an interview that the company was still reviewing the contents of the two letters.

The FDA has been under fire recently by parents and health NGOs over its negligence to investigate the recent respiratory illnesses and deaths associated with vaping especially among the youth.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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