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FDA Commissioner Scott Gottlieb questioned by U.S. House reps on vaping regs

On Wednesday, FDA Commissioner Scott Gottlieb appeared before the House Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies. Topics ranged from sesame seeds to Chinese tilapia to e-cigarettes. Here are some interactions relative to our fight, as well as a few comments from the AVA below:

  • Appropriations Chairwoman Lowey says that the issue of tobacco hangs over FDA’s head. She accused FDA of letting thousands of products hit the market leading to today’s “epidemic,” with a specific mention of JUUL.
    • JUUL’s products were legally on the market on August 8, 2016, the date FDA began regulating vaping products. While the FDA has been, to say the least, lax in their enforcement of their ban on new, post-8/8/2016 products, this cannot be blamed on JUUL. Indeed, JUUL has acted where the FDA has failed, having filed dozens of lawsuits seeking to take illegal copycat products off the market.
  • Gottlieb: “We see an opportunity for these products to help adults transition to less harmful alternatives…” and “we will be taking very aggressive steps moving forward.”
  • Gottlieb claims that a FDA’s analysis estimated that 10-20% of JUUL’s sales are to youth, an analysis Gottlieb mentioned was not conducted with the rigor necessary to make the data or claims public. In Lowey’s personal experience and conversations with teens, “60% say they’re using JUUL.”
    • Research has repeatedly shown that youth tend to vastly overestimate the percentage of their friends and peers who are smoking cigarettes, drinking alcohol, using marijuana, etc. The same is true with vaping products, as one study published last year in Tobacco Control demonstrated. With the data continually showing that this overestimation is very common, the results of nationwide surveys of tens of thousands of youth should be taken more seriously than the anecdotes of individual teenagers.
  • Lowey: “What would it take for the FDA to ban flavors altogether?” Gottlieb indicated that would not be happening right now but said the youth use issue poses an “existential threat” and that “I am willing to pull them off the market” if youth use trends continue.
  • Rep. Aderholt asked Gottlieb about raising federal age to purchase to 21. Gottlieb said he and the FDA agree that would be helpful.
  • Gottlieb said he would be coming out with new guidance for the online verification of legal age to purchase requirements and mentioned signature at delivery, utilized in wine/liquor sales.
    • The people who order wine online are unlikely to be of the same social class or employment situation as those who order vaping products online. We are concerned that requiring ID at delivery would be unnecessarily burdensome, as those with 9 am – 5 pm jobs will be essentially cut off from easy and legal access to online orders. There are better ways to police this activity in this modern technology era, including mandatory FDA registration of online retailers and advanced third-party age verification.
    • Until the the FDA actually cracks down on the illegal sales happening every single day on public forums like eBay, it should not take steps to radically transform online sales of vaping products.
  • Subcommittee Chairman Bishop (of Cole/Bishop notoriety) expressed concerns about the costs to small businesses with complying with FDA rules and Gottlieb conceded that they are cognizant of those costs, without providing a clear answer on how they’re going to address them with pending 2022 PMTA deadlines.
    • Rep. Sanford Bishop (D-GA) is a true champion of small businesses in his district. We are hopeful he will continue to press Gottlieb about the need to provide a pathway for small- and medium-sized businesses to remain open.
  • Rep. DeLauro spoke angrily about Altria and JUUL, claiming there are “no rules” or “oversight” of e-cigarettes. She went on to explain that e-cigarette companies are making modified risk claims without FDA approval. Her example? Companies like Altria and JUUL have quoted Gottlieb’s remarks on the potential harm reduction benefits of adults switching from cigarettes to e-cigarettes.
    • Neither Altria nor JUUL quotes Commissioner Gottlieb on any material designed to sell vaping products. Consistent with the First Amendment, companies are permitted to quote government officials when communicating with the public about their company and their mission.
  • “There are radio ads about harm reduction!” Rep. DeLauro proclaimed.
    • Rep. DeLauro is likely referencing radio ads JUUL has been running that highlight the company’s mission of eliminating combustible cigarettes and stories of smokers that have switched to JUUL. Nothing in these ads violate the law and product ads come with a federally-mandated warning that JUUL contains nicotine. It is clear that for some members of Congress, any advertising by JUUL is unacceptable.

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