It was very challenging for those who tuned in this week to listen to the FDA’s webinar “Live Deeming Rule Q&A: How Can My Business Comply?” covering the new (and final) regulations to sit still. Despite the presenter’s efforts to provide guidance in a nice, calm manner, the message that the situation is dire came crashing through.
For context, it’s important to remember what the FDA is and what mission they pursue:
“The Tobacco Control Act takes a comprehensive approach—grounded in rigorous, timely science and the law—to improve public health, especially for the next generation.”
“CTP uses a comprehensive approach as the best way to end the negative health effects of tobacco use. This includes defining policy, issuing regulations, conducting research, educating Americans on regulated tobacco products, and making decisions on whether new products and claims can be marketed— including reviewing and evaluating applications and claims before the products are allowed on the market.
This cohesive, comprehensive approach can help us reach our goals of:
- preventing people from starting to use tobacco products
- encouraging tobacco users to quit
- reducing the harm caused by tobacco use
As we work to protect the public’s health, we will use the full power of the law to protect consumers from the dangers of tobacco use.”
The FDA did a very good job of closing any potential loopholes and it was obvious that viewers had gotten past tying find any and had moved to asking more pointed and direct questions.
Below is a brief takeaway, as well as the current situation regarding legislative efforts and litigation status.
Things that require a PMTA:
- Any non-grandfathered product on the market as of August 8th, 2016
- Removing a single ingredient or changing the nicotine level to a new one
- Making a label change that renders it “distinct” from the old one
- Introducing the same flavor/strength e-liquid under a new brand
- New configurations for an existing product, i.e., a new bottle size
- In the event that the FDA does not get to a filed PMTA within the
- compliance period (36 months from August 8, 2016), the product in question will have to be removed from the shelves until such time that a determination is made.
- There are no registration fees with FDA. Costs come from the cost of tests and putting together the actual application
- The PACT Act applies only to cigarettes and smokeless products
- Manufacturers have 24 months to comply with filing PMTA’s for their products. After that products are considered to be non-compliant
- Manufacturers have 25 months to stop shipping and distributing existing products
- Owner/operators have until 12/31/16 to register their establishment with FDA (renewed annually)
- A list of all covered (i.e., tobacco products) must also be registered (updated twice a year for adjustments to products)
- Whoever labels and packages the final product is the one that has to file the PMTA
- If raw material is intended to be used in the production of a nicotine product, (VG/PG) it is considered a tobacco product and the correct procedures must be followed
So where are we as an industry?
Litigation proceeds; five lawsuits have been filed:
- The Right to be Smoke-Free Coalition (bundled with Nicopure)
- Lost Art Liquids
- Larry Faircloth (R) West Virginia
- Cyclops Vapor 2 LLC, Tiger Vapor LLC, Karma S Clouds, LLC dba Operation Vapor
FDA has until August 16, 2016 to respond to the lawsuits by Nicopure and The Right to be Smoke-Free Coalition and Judge Amy Berman Jackson has scheduled a hearing for October 19. It’s likely we’ll see a decision in the lower court by the end of the year but whatever side loses will file an appeal thus continuing the legal battle. Moreover, if that battle isn’t settled before the end of the compliance period, all rules take effect everyone not granted a PMTA or SE is out of luck and time.
On the legislative front we have HR 2058 (The Cole Act) and The Cole-Bishop Amendment. In truth, HR2058 is a far better alternative for the vapor and e-cig industry because all it does it move the predicate from February 15, 2007. The Cole-Bishop Amendment moves the predicate date but also adds regulations in addition to those already specified by the final regulations and implements them sooner.
Neither of these solutions fixes the long-term and inescapable challenges created by the final deeming rule, which means we have to keep working toward the thing that does. Finding the right vehicle (maybe it’s HR2058), gaining the right critical mass and pushing the right pressure points is the only strategy we have.
Congress has gone home for the summer and will soon turn their attention to the presidential conventions and then the election, which means we need to execute our strategy with the right tactics.
Cynthia Cabrera provides government affairs and business consulting, including business development to the vapor and electronic cigarette industry. Cynthia has worked on legislative affairs for the vapor industry since 2011 and is the former Executive Director for SFATA. You can reach her at The Cating Group, via email email@example.com or by calling 844-6CATING.