The FDA Deeming Clarification Act of 2017 (HR 1136) was introduced on Thursday, February 16th. Republican Tom Cole of Oklahoma (4th district) and Democrat Sanford Bishop of Georgia (2nd district) have built on previous legislative attempts from 2015 and 2016. HR 1136 is an updated version of HR 2058 and the Cole/Bishop amendment.
Last June, CASAA’s legislative coordinator, Alex Clark, along with representatives from vapor trade associations met with Representative Cole to discuss threats to vapor products if the predicate date was not modernized. An additional point discussed was the battery standards language contained in the Cole/Bishop Amendment (an amendment that could potentially still be added in through the appropriations process for 2017). We are pleased that HR 1136 addresses the most pressing of those concerns; specifically, Section 3(c) which states that manufacturers who make changes to devices in order to bring them into compliance with a battery standard created by the FDA would not be subject to submitting to the PMTA process in order to keep those devices on the market.
HR 1136 is the product of years of effort from all stakeholders. Modernizing the predicate date is a necessary first step to developing appropriate regulation for this life-saving product category while we continue to work towards long-term solutions. No one legislative, judicial, scientific, or public relations effort will accomplish our ultimate goal; different efforts and strategies are required to keep moving the ball forward. Looking to the future, fair regulatory treatment of vapor products is part of the larger campaign to change the tobacco control culture in the United States. Ultimately, policy makers, regulators, and public health advocates must change their abstinence-only approach to one of comprehensive harm reduction in order to humanely reduce the morbidity and mortality associated with smoking cigarettes.
In the coming weeks and months, CASAA will continue working cooperatively with other vapor organizations to develop campaigns in support of passing HR 1136. However, for those who are chomping at the bit to get started, this week is an excellent time to engage in face-to-face engagement with lawmakers.
Your representative will likely be back in their district from February 20th through 24th. This is a great time to make contact through their district offices and set up meetings. In some cases, your reps will be holding town hall meetings. Although there are other issues that have grabbed national attention, in lieu of being able to set up a personal meeting, addressing your representative at a town hall meeting can be just as effective.
How to speak at a town hall meeting:
Town halls are a time for your lawmakers to answer questions about policies and legislation that affects you. So you’ll want to frame your brief presentation in the form of a question.
- Briefly, tell your story.
- The FDA deeming regulations will limit or, in some cases, completely prohibit your access to life-saving vapor products.
What is the solution:
- HR 1136, introduced by representatives Cole [R-OK] and Bishop [D-GA], would modernize the 2007 predicate date in the Tobacco Control Act (TCA) for vapor products. This would allow most vapor products to remain on the market without being required to undergo the prohibitive PMTA process. Cigarette makers were given similar consideration when the TCA was passed in 2009. We are asking for equal treatment.
- The FDA will still have the authority to regulate vapor products. In fact, this bill would explicitly grant FDA more authority than is already given to them by the TCA.
What is “the ask”:
- Can we count on your support of HR 1136 and will you sign on as a co-sponsor?
As we move forward, we will have more opportunities to engage with lawmakers to urge support for HR 1136.