In the wake of the release of the 2018 National Youth Tobacco Survey, the FDA has announced tough measures to curb what it calls an “epidemic” of youth vaping. Teen vaping reportedly increased by 78 percent over the past year, and this has the FDA worried. Consequently, FDA Commissioner Scott Gottlieb, M.D., announced that flavored e-cig products would no longer be sold in places that minors can access, such as convenience stores. The ban doesn’t apply to mint and menthol products because combustible tobacco cigarettes are still being sold in places with no age restrictions. The FDA didn’t want to give combustible cigarettes an advantage over e-cigarettes. Furthermore, the regulatory agency is planning to revise its timeline for the premarket approval of flavored products instead of waiting until 2021 as it had initially planned. The agency also plans to announce enhanced age-verification measures for the online sale of vaping products. Websites will be expected to comply with those guidelines as soon as they become available. One can only hope that the steps being taken by the FDA can put an end to the growing trend of minors using nicotine products.
Month: December 2018
Altria Eyeing a Minority Stake in Juul
The Wall Street Journal published a news item revealing that combustible cigarette maker Altria is having discussions with Juul Labs in order to acquire a significant minority stake in the electronic cigarette giant. It is widely expected that the outcome of those talks will be announced in a few weeks. But why would Juul be reversing its earlier distance from “Big Tobacco” firms in its marketing efforts? Juul has the lion’s share of the e-cig market (75 percent) and it has come under intense pressure from regulators regarding the popularity of its products among teens. Teaming up with Altria could be a mutually beneficial arrangement in which Juul Labs benefits from the decades Altria has in dealing with tough regulatory scrutiny and pressure, while Altria stands to line its coffers with earnings from the sale of Juul products. Interestingly, both companies announced separately in recent weeks that they were halting the sale of some of their flavored e-cigarette products in light of concerns over teen vaping. How will this new deal affect the future of both companies?
Juul Sues Makers of Copycats
Juul Labs has initiated lawsuits against several companies that it claims are infringing on its copyright. Some suits were filed with the International Trade Commission while others were filed in district courts. In total, more than 30 companies are affected by the suits. Most of the said companies are based abroad, with China and Uruguay taking the largest share of the companies listed in those complaints. The ITC (International Trade Commission) cannot award monetary damages in case Juul Labs wins the cases. However, the suits in the district courts can result in monetary awards, so that could explain why mirror suits were filed in these courts too. Juul claims that those look-alike products aren’t subjected to any controls and can endanger public health since minors can access them. In response, some of the companies cited are saying that Juul is using underhand tactics to lock out any competition in order to raise the price of its products. All that is left is for the competent entities to listen to both sides and decide appropriately.
FDA to Hold Public Hearing on Teen Vaping and Addiction Therapy
The FDA has announced that it plans to hold a public hearing on December 5. This public hearing is intended to share the how FDA intends to curb the wave in teen vaping and smoking, and what measures have been put in place to stop teen initiation into nicotine use as well as help those who are already addicted and want to break the habit. The FDA also wants to use the public hearing as an opportunity to receive input from different sections of the public, such as the medical community and other stakeholders, regarding the best ways to deal with the threat to public health as a result of the use of nicotine-containing products by minors. This announcement comes at a time when the available data shows that gains aren’t being made to keep teens off tobacco and ENDS (electronic nicotine delivery system) products. It is every parent’s wish that his or her child is protected from nicotine addiction, and the kids already addicted get all the help they need. The public hearing will show how far this can be attained realistically.
FDA Warns Electric Lotus LLC Over Improper E-Liquid Packaging
The US FDA has written a warning letter to Electric Lotus LLC warning it about how it been packaging its e-liquids in a way that can mislead kids into thinking that those e-liquids are common consumer products. One product is labelled as “Cereal Treats Crunch” and it resembles the cereal products made by Cinnamon Toast Crunch. The e-liquids were also faulted for having cartoon characters on their packages, a move that can be regarded as targeting kids. The FDA also noted that Electric Lotus brought its products to the market after August 8, 2016. This means that those products should have been subjected to premarket approval by the FDA, but the company didn’t seek that approval. The FDA has therefore given Electric Lotus LLC 15 days (starting on November 29 when the warning letter was written) within which to file its response to the concerns raised. Otherwise additional measures, such as an injunction and/or seizures of the products in question would be undertaken. It remains to be seen whether Electric Lotus will wiggle out of the tight spot into which it has found itself.