FDA Launches ‘Substantive Review’ of Juul’s E-Cigarette Products

August 19, 2020

1 minute read

Juul Labs has announced that it has received notice from the Food and Drug Administration (FDA) that the company’s Premarket Tobacco Product Applications (PMTA) will enter the substantive review phase.

Last month, Juul Labs submitted PMTAs to the FDA for the company’s JUUL System — an electronic nicotine delivery system (ENDS) product. The company’s submission includes scientific evidence for the JUUL Device and JUULpods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0% and 3.0%, as well as information on data-driven measures to address underage use of its products.

The FDA will now begin a substantive scientific review of the applications.

Joe Murillo, Chief Regulatory Officer at Juul Labs said: “We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application.”

Following controversy over its alleged marketing to millennials, the company, under new CEO K.C. Crosthwaite, now says it is working with regulators and legislators to combat underage use and instead focus on transitioning adult smokers from combustible cigarettes.

MO) snapped up a 35% stake in Juul back in 2018 for a whopping $12.8 billion. Overall, Altria has recorded $8.6 billion in impairment charges on the investment.” data-reactid=”21″>Tobacco giant Altria Group (MO) snapped up a 35% stake in Juul back in 2018 for a whopping $12.8 billion. Overall, Altria has recorded $8.6 billion in impairment charges on the investment.

price target indicates 13% upside potential from current levels.” data-reactid=”22″>However despite this costly mistake, MO continues to score a cautiously optimistic Moderate Buy consensus from the Street. With shares down 13% year-to-date, the average analyst price target indicates 13% upside potential from current levels.

Nik Modi reiterated his buy rating on Altria after the company reported a better-than-expected quarter, supporting his view that cigarette volume declines are moderating.” data-reactid=”23″>RBC Capital’s Nik Modi reiterated his buy rating on Altria after the company reported a better-than-expected quarter, supporting his view that cigarette volume declines are moderating.

See MO stock analysis on TipRanks).” data-reactid=”24″>“The company is essentially hedged from the three biggest issues facing the CPG (consumer packaged goods) space today: 1) limited pricing power; 2) significant retail evolution (selling tobacco products is banned online); and 3) rising cost of goods/logistics (which comprise a very small percentage of COGs)” he explained. (See MO stock analysis on TipRanks).