From The Tribune staff reports
WASHINGTON, D.C. — Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products across the country.
Electronic cigarette used for vaping
In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.
To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods, the administration stated. However, the agency added that “here is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.”
The FDA recommends against modifying or adding substances to tobacco products.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action.
The CDC lists several dangers to the use of e-cigarettes by young people, including:
- Some of the ingredients in e-cigarette aerosol could also be harmful to the lungs in the long-term. For example, some e-cigarette flavorings may be safe to eat but not to inhale because the gut can process more substances than the lungs.1
- Defective e-cigarette batteries have caused some fires and explosions, a few of which have resulted in serious injuries.
- Children and adults have been poisoned by swallowing, breathing, or absorbing e-cigarette liquid through their skin or eyes. Nationally, approximately 50% of calls to poison control centers for e-cigarettes are for kids 5 years of age or younger.
