After the FDA issued the marketing authorization announcement for the first e-cigarette, it shocked the U.S. e-cigarette industry. Chris Howard, vice president, general counsel and Chief Compliance Officer of independent innovative brand e-alternative solutions, as a professional, talked about the FDA's regulatory policy on e-cigarettes. The following is the full text.
Over the past 10 years, we have taken a roller coaster together. We have experienced the same ups and downs and share the hope that reducing damage will eventually prevail. Then, in the course of the past few weeks, so many marketing reject orders (MDOs) suddenly ended. Not surprisingly, several people question whether the steam industry can recover.
Recent FDA actions
In terms of its value, the recent actions of the U.S. Food and drug administration should not surprise anyone in the steam industry. We have known for years that it is not easy to be part of a highly regulated market segment. In fact, FDA clearly expressed its expectations in its 2016 draft pre marketing tobacco product application guide entitled electronic nicotine delivery system (ends).
In conclusion, this document shows that obtaining marketing orders for steam products requires scientific expertise, extensive data development and very strong funds.
In other words, the reason why the FDA made such a wide denial has aroused many doubts. More specifically, FDA provided the following reasons in its press release of August 26, 2021:
In view of the well-documented and shocking threat to public health caused by the use of flavored ends by adolescents, the agency reviewed the applications affected by this action to determine whether there is sufficient scientific evidence of specific products to prove sufficient benefits to adult smokers to overcome the risks posed to young people. Based on the existing scientific evidence and the agency's experience in pre-market review, the evidence that these products are beneficial to adult smokers may take the form of randomized controlled trials or longitudinal cohort studies, although the agency does not rule out other types of possibilities. If it is strong and reliable, the evidence is sufficient.
The main question we need to think about is whether this balance of interests exceeds the FDA's criteria for evaluating whether the product is suitable for protecting public health. According to section 910 of the tobacco control act, which describes appropriate review criteria, this balance appears to be one of many aspects of the application that FDA needs to consider.
Applicable to the protection of public health
Section 910 of the tobacco control act sets out FDA review criteria for new tobacco products:
... whether the marketing of tobacco products submitted for application is suitable for protecting public health shall be determined according to the risks and benefits to the whole population (including users and non users of tobacco products), and shall be taken into account——
(A) Increased or reduced likelihood of existing users of tobacco products ceasing to use such products;
(B) People who do not use tobacco products are more or less likely to start using such products.
Obviously, the risk of young people starting to use flavored ends products is related to the possibility that smokers generally stop using them. There is no doubt that FDA has determined that the evidence related to part (a) - stop - must exceed part (b) and start. In the FDA's own words, this risk balance is reflected in the data of clinical studies or longitudinal studies, indicating that the smoking cessation (or conversion) results of adults using flavored ends exceed the risk of teenagers starting to use tobacco products.
However, although it seems clear, there are still many problems around this analysis. For example, how much more must adults quit smoking than teenagers? What if the smoking cessation rates of tobacco varieties and seasoning varieties are the same or similar? When examining the balance between risk and benefit, has the FDA considered the reduction in the use of tobacco products by young people due to the recent change in the age of purchasing tobacco products to 21?
These questions are likely to have no answers for a long time. Many committed companies have begun to strive to meet FDA's outstanding requirements for clinical research and / or longitudinal data, but the development of data will take several months. Obviously, this may cause significant damage to the already fragmented market, and even greater potential damage to smokers seeking alternatives to combustible cigarettes.
Flavor is essential to reduce harm
Despite the turmoil of the past few weeks, the FDA is arguably the largest advocate for harm reduction. Given the agency's desire to provide adult smokers with a choice away from traditional combustible cigarettes, it is clear that there are ways to restore flavor.
Together with other industries and many public health researchers, I believe that the elimination of all flavoring products will have a negative impact on harm reduction in the United States. Some e-cigarette users will undoubtedly smoke combustible cigarettes again. Smokers who may have transitioned to ends products may now choose not to do so.
In a study conducted by my company e-alternative solutions, we demonstrated that adults prefer taste and that taste helps adults transition from combustible cigarettes to less potentially harmful alternatives. Existing literature documenting studies conducted by others also supports this claim. In addition, anecdotal stories are easy to find on Twitter and several other social media forums.
Although it may not be seen from the recent actions of FDA, I do not believe that seasoning ends will be banned in the United States. Although the threshold seems high, I hope and expect that for the sake of adult smokers in this country, we will see flavored ends in the American market again. In other words, it may take time for the agency to issue market orders for seasoning steam products.
The FDA's recent decision may prompt many people to appeal, some to appeal, and at least two lawsuits are known to have been filed. FDA appears ready to address these initiatives and is giving priority to those who do not comply with MDO and / or sell steam products that have not been pre market reviewed. Although these activities are ongoing, many people will begin longitudinal research and hard work to identify alternative methods to show FDA that taste plays a decisive role in the efforts of adult smokers to switch from combustible cigarettes.
Eventually, we will have to wait for the rest of the story to unfold. It is hoped that FDA will be ready to work directly with mature manufacturers to ensure that flavored ends can continue to play a role for adult smokers seeking alternatives.