On October 4, the FDA released its final rule on PMTA. There is still a lot of confusion over where the industry stands in the eyes of the FDA and the CTP. This leaves many in the vaping industry confused: where do they stand in the eyes of regulators? Without clear guidance, how can the industry proceed forward? Here is an aggregation of PMTA news for this edition of State of Vape.
Turning Point Brands Go Back Under FDA Review
Since the final ruling, many brands are challenging PMTA denials and marketing denial orders (MDOs). This includes appeals to federal circuit appeals courts, which could lead to an eventual showdown in the Supreme Court. Turning Point Brands managed to have its products go back under FDA review, which is good news for the industry, yet just one of many battles that could get tied up in the courts for months (if not years) to come.
Vaping360’s Jim McDonald has also reported that 27 other vaping manufacturers and distributors have followed Turning Point Brands’ lead. As of this writing, only Turning Point Brands has been successful in having the FDA rescind their initial denial. This will certainly increase the caseload of these appeals courts, which may give the vaping industry time to prepare a more powerful case—even one that might reach the Supreme Court.
FDA Authorizes First Vaping Product
The FDA’s main reason for banning vape products is because of their appeal to youth. However, vapers themselves (and the vaping industry) have found common ground with their opponents in restricting the purchase of vaping products to those 21 and older. Vapers have also reported great success with flavors in helping them reduce their reliance on nicotine.
The Vuse Alto is the first vaping product to get marketing authorization from the FDA. However, the Vuse Alto is tobacco-only and the manufacturer is R.J. Reynolds Vapor Company, which is a division of Reynolds American Inc., a subsidiary of British American Tobacco. Giving approval to the Vuse Alto means that the FDA has chosen Big Tobacco over the smaller vaping manufacturers and distributors.
What makes this an interesting choice for marketing authorization is that the Vuse Solo has very high nicotine content (48mg). While this is close to the upper limit of nicotine content of most nicotine salts (generally 20mg-50mg), most vapers who vape regular vape juice usually purchase vape juice that contains 3mg-6mg of nicotine. This once again poses the question of whether the FDA and the CTP are concerned about the effects of nicotine use on vapers, or are targeting tobacco industry disruptors who seek to innovate and assist customers in reducing their nicotine use.
Youth Vaping Decreases in 2021
As we previously mentioned, many tobacco control advocates point to youth using vaping products as a reason to ban them. However, the Centers for Disease Control and Prevention (CDC) published a report earlier this month about youth vaping being down more than 40%. This is the second year in a row that youth vaping has declined.
While some may point to vaping excise taxes and other measures (i.e. raising the age to buy vaping products to 21) taken to limit or eradicate youth access, the methodology of the survey, which was done entirely online, has also been called into question. Online surveys are easily manipulated, and the COVID-19 pandemic has also cut back on in-person interaction between students, with vaping as a popular social activity. As we previously covered in another State of Vape blog, there have been reports of high school parking lots littered with JUUL pods and other vaping products.
A New FDA Chief?
To throw yet another wrench into the confusion of PMTA, FDA acting commissioner Janet Woodcock is set to have a permanent replacement by mid-November as required by law. As we know, the FDA is under the Department of Health and Human Services (HHS), which is headed by vaping opponent Xavier Becerra.
The leading candidate to replace Woodcock is Robert Califf. Califf was the FDA commissioner during the issuance of the Deeming Rule in 2016, and had been publicly critical of vaping after he left the post. We will discuss this further in a later State of Vape.
What This Means For Your Business
The constant changes in the vaping industry are definitely stressful for any vape shop owner. As a business owner, you have the power to inform your customers about these changes. The last thing we want you to do is pass on the cost to your customers, which is already happening in many states that are imposing vaping excise taxes. As the 2022 midterms come around, you and your customers have the power to take action against heavy-handed regulation that will limit access to alternative nicotine products.
If you have any questions, comments, or concerns, feel free to talk to your eJuices.co account manager or sales representative. We’re looking forward to speaking with you and helping your business succeed.