SFATA hosted a 2.5 hour conference call this afternoon and tried to answer questions about the 500-page document we all know as “The Deeming.” Experts participating in the call asked for a week or so to decipher more of the complex material and then prepare materials for a member webcast later this month.
A few key points:
- Rules will go into effect August 10, 2016 (90 days after final rule published, expected to be May 10, 2016).
- The latest new product and innovation as we’ve seen it will stop on the effective date. Products not already marketed here on August 10, 2016 will not be allowed on the market without FDA authorization.
- Minimum age and identification and vending machine restrictions are effective August 10, 2016.
- Health warning requirements are effective 24 months after final rule published.
- Companies must submit SE (substantially equivalent), SE Exemption or PMTA (new tobacco product) applications for all newly deemed products.
- Companies are allowed 12, 18 or 24 months from effective date to submit, depending on pathway selected.
- Any products not authorized within 12 months of application deadline must be pulled from shelves or choose another path (time permitting).
- “Grandfathered” products must have been on the market on the actual date February 15, 2007. Products on the market prior to, but not ON this date are not grandfathered.
- Free samples to consumers are forbidden in any context.
- It appears face-to-face sales only is not standard regulation as of yet (pg 310, comment 219).
A lot was discussed, but bottom line is the best course of action at this point is to try and get the law changed.
Now more than ever we ALL need to focus our attention and resources on three people – our two state senators and our district’s congressman (specific to your state, of course). SFATA will be providing talking points soon and we will pass those along. End consumers can also find a wealth of information at CASAA.
We’re also urged to Tweet, Facebook and write our local media about the issues. Post on your state representatives’ social media pages, email them studies of relevance (please vet materials first for credibility).
This industry’s small businesses have been very slow in reaching out to each other to create a strong, unified force. THIS HAS TO CHANGE! It will be IMPOSSIBLE for any single entity or individual to move this forward alone. We need to share data, consider standards and organize resources. There won’t be any proprietary anything left to protect if businesses don’t pull together and consumers don’t work their representatives.