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?
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.
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.
The U.S. Food and Drug Administration has written letters to 21 e-cig manufacturers asking for information that would help the regulator to determine whether some of the products marketed by the companies in question are on the market illegally. The FDA ruled that any electronic cigarette product which was to be introduced on the market after August 8, 2016 needed to get clearance (premarket approval) from the FDA while those already on the market could continue as the makers prepared to undergo the premarket approval process come 2022. However, the media had reports of new products on sale yet such products aren’t approved by the FDA as required by law. The call for information is therefore designed to identify those products which could have been rebranded (due to the sale of their parent companies and other factors) and those which are new (and therefore non-compliant). We await the outcome of that investigation.
Juul Labs, the manufacturer of Juul electronic cigarettes, have been under scrutiny by the FDA and Congress regarding why Juul products are so popular among teens and the youth. The FDA went on to describe teen vaping as an “epidemic” and the agency threatened to ban the sale of any flavored e-cigarette juice or product which is seen as appealing to teens and the youth. Juul Labs has responded by cooperating with the regulator as well as increasing its expenditure on lobbying by 167 percent in the third quarter of this year when that spending is compared to what was spent in the second quarter of this year. According to Juul’s declaration, it spent $560,000 on lobbying while the second quarter cost for lobbying was just $210,000. The e-cig maker appears to be in a fight for its very life. It will be interesting to look back and judge whether the lobbying had any effect in softening the rate at which regulators clamped down on different e-cig manufacturers.
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.