The recent actions and announcements by the FDA regarding the measures it is taking or plans to take in order to stem the tide of teen vaping has many public health experts worried that the agency is overreacting to the events surrounding electronic cigarettes. Consequently, the Attorney General for Iowa, the chair of the Advisory Board of the Center for Health Law and other experts have written a letter to the FDA cautioning it to think carefully about any step that they plan to take or risk causing worse public health problems down the road. For example, they suggest that the agency should distinguish between teens who vape regularly/daily from those who do it once in a while, and then design measures to address regular use rather lumping occasional use with daily use. Similarly, the experts ask the FDA to establish whether daily vapers among adolescents aren’t smokers as well who need e-cigarettes in order to reduce or switch from combustible cigarettes. This letter is a good reminder that one shouldn’t use a sledge hammer to swat a fly. Will the FDA listen to the voice of reason?
Scott Gottlieb, the FDA Commissioner tweeted days ago that he will meet the top executives of electronic cigarette companies. The FDA chief also hinted that his discussions with the companies was prompted by actions that seem to show that those companies are backtracking on the promises that they made to the public and to the agency. The Director feels that companies have an obligation to stem the teen vaping “epidemic” even before the regulator issues specific directives on what the companies should do in this regard. The meeting may therefore be geared towards pushing the companies to implement what they promised to do. This would be akin to self-regulation during this time when the FDA hasn’t put in place a detailed regulatory framework for the electronic cigarette industry. Industry watchers can only hope that the meeting produces positive results that protect public health without stifling the vaping industry unnecessarily.
In the wake of FDA statistics that put the number of teens who are vaping at about 3.6 million, the South Central Public Health District in Twin Falls, Idaho, plans to conduct classes to educate teens about vaping and the dangers that those teens face if they take up the habit. The classes will be conducted at two different venues, and they are free for anyone (18-years or older) to attend. The school district took this unprecedented step to fill the knowledge gap in order to reduce the number of teens who vape thinking that it is harmless pastime.
Young people risk becoming addicted to nicotine in addition to exposing themselves to developmental challenges since their brains are still growing. The first classes were held a few days before Christmas at the two venues. The school district also revealed that they want to educate parents as well, but it wasn’t clear whether the classes organized for the teens would also be open to parents. One would hope not, since the presence of parents may prevent some of the teens from opening up about their concerns while those adults are around. All in all, this effort is to be commended if it can attain the objective of helping the teenagers to make informed choices regarding electronic cigarettes.
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.
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.
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.
Juul Labs is slated to announce its plans to stop retailing the majority of its flavored “Juul pods” in most brick and mortar stores as a response to the FDA’s call that electronic cigarette manufacturers reveal their plans on curbing teen vaping. Juul’s plan comes hot on the heels of an announcement by Altria a few weeks ago that the company would no longer sell flavored vapes until the teen vaping issue is resolved or the FDA designs clear rules on flavored e-cig products. Juul will continue to sell those fruity flavors on its online stores since, it says, sufficient age-verification technology can prevent access by minors. The big question on the mind of people hearing this yet-to-be announced plan by Juul Labs is, “Are they pulling the trigger just because they have got wind of the restrictions due to be announced by the FDA or they are doing it from the goodness of their hearts?” We can only hope that the remedial measures aren’t coming too late to save teens before they are addicted to nicotine.
In a move that is expected to be announced soon, the FDA plans to restrict the sale of flavored electronic cigarette products in all gas stations and convenience stores across the US. This decision comes at a time when government data paints a gloomy picture showing that teen vaping has increased by 77 percent since last year. The FDA will only allow tobacco shops and vape shops to sell flavored e-cigs. However, menthol and mint-flavored e-cigs will continue to be sold in convenience stores as well as gas stations. This exception is intended to avoid giving combustible cigarettes an advantage since menthol and mint-flavored tobacco cigarettes can be sold at gas stations and convenience stores. Refillable e-cigs will not be affected by the ban. Only prepackaged e-liquid pods will be restricted. The regulator also wants online stores to implement strict age-verification systems in order to prevent minors from purchasing e-cigs.
This decision is likely to be criticized by both sides of the aisle. Pro-vaping groups may protest that it will get harder for adults who want to switch to e-cigs to access those products. In contrast, those opposed to vaping are likely to say that the FDA should have imposed a total ban on the manufacture and sale of flavored e-cigs. The coming weeks will show how this matter pans out once the official FDA restrictions are announced.
Amid intense pressure from the FDA and legislators, some electronic cigarette makers are turning to self-regulation. They probably fear that they could lose their businesses if the FDA clamps down on them. Altria, one of the leading e-cig makers, has announced that it will stop making some of its flavored products until the FDA brings clearer rules on flavored e-cigs or the issue of teen e-cig use is conclusively addressed. The flavored products to be affected by this announcement are pod-based (similar to Juul pods). They constitute 20 percent of the products made by Altria. Other electronic cigarette makers are yet to make any decisions about their flavored products as they await the outcome of the investigations being conducted by the FDA on the matter. One can only hope that the attempts to stop minors from using electronic cigarettes don’t turn into a widespread witch-hunt targeting the vaping industry as a whole.