American electronic cigarette company, Juul Labs Inc., received a marketing denial order from the U.S. Court of Appeals for the D.C. Circuit. The court got in on a temporary administrative stay and noted its purpose as a way to provide enough opportunity for the petitioner’s emergency motion for stay. The forthcoming action is pending court review and should not be interpreted as a ruling on the motion’s merits.
JUUL Ban
On June 24, the U.S. Food and Drug Administration ordered a JUUL ban on all its products currently sold in the market. The agency has issued a marketing denial order (MDO), which means that the company is ordered to stop the selling and distribution of all its products. Aside from this, the company is called to remove its products already on the market or face enforcement actions.
The products include the JUUL device and four variants of the JUUL pods. These are its Virginia tobacco-flavored pods with 5% and 3% nicotine concentrations and its menthol-flavored pods with 5% and 3% nicotine concentrations. The agency asks retailers to communicate with JUUL if they have any questions about this order.
Commercial and Not Personal Use
According to FDA Commissioner Robert M. Califf, M.D., this action from the FDA is a welcome progress to ensure the agency’s commitment to meeting public health standards. The agency must ensure that all e-cigarettes and electronic nicotine delivery systems on the market meet these standards.
Califf added that the agency uses dedicated resources to review products from companies holding a significant market share. They are aiming to see if these products play a major role in the rise of young people getting into vaping.
However, these MDOs only apply to commercial sales, distribution, and importation of these products. They are not geared toward individual possession or use. He assured that the FDA has no power or will to enforce against personal consumer possession and use of any JUUL products or other similar goods.
Why the JUUL Ban?
The FDA reviewed JUUL’s premarket tobacco product applications (PMTAs). And they found that these do not have sufficient evidence with regards to the toxicological profile of their products. These do not show that marketing these products is appropriate for public health protection.
Additionally, a few of the company’s study findings have raised concerns that lead to insufficient and conflicting data. This includes the issue of genotoxicity and the potentially harmful chemicals that come from JUUL’s proprietary e-liquid pods. The FDA has not addressed correctly and overlooked these to complete a full toxicological risk assessment for the products in the company’s applications.
Today, the FDA has yet to receive clinical data to suggest an immediate hazard with the use of JUUL devices or pods. The MDO is enough to show that the agency found evidence about the products’ toxicological risks. The FDA does not recommend modification or addition of substances to tobacco products.
They are also encouraging JUUL users to report any unexpected health problems arising from using JUUL products. They are requested to go directly to the FDA via its Safety Reporting Portal and seek medical advice if needed.
To ensure that JUUL Labs, INC. complies, the FDA assures distributors and retailers that they will ensure the company’s compliance. The FDA noted that all new tobacco products out on the market have premarket authorization and are subject to enforcement actions. The agency also assures that companies with MDOs are on top of their enforcement priorities.
The FDA is working to complete its review for similar cases by the Sept. 9, 2020, deadline.
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