Now that the FDA deeming regulations have been sent to the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OMB/OIRA) the response from the business community for meetings with OMB/OIRA has been overwhelming. Initially intending to cease taking appointments by Dec. 11, OMB/OIRA has extended the date to accommodate additional requests. We hope they will continue to extend the date until all requests have been met.
In the interim, we turn our attention to other action items; specifically to preserve the language regarding the FDA’s grandfather date in Sec. 747 of the House Agriculture appropriations bill in any final funding bill.
The February 15, 2007 grandfather date acts as a de-facto ban on vapor products and has the potential to severely reduce the amount of products on the market today.
Do not be misled! The appropriations language does NOT defund the FDA. The FDA would receive the full funding of the bill, but would be prohibited from using any of the funds to implement February 15, 2007 as the deeming date. The language specifically states:
“SEC. 747. For each tobacco product, which the Secretary of Health and Human Services, by regulation under section 901(b) of the Federal Food, Drug, and Cosmetic Act, deems to be subject to chapter IX of such Act, none of the funds made available in this Act or any other Act may be used to treat any reference in sections 905 and 910 of such Act to February 15, 2007, as other than a reference to the effective date of the regulation under which a tobacco product is deemed subject to the requirements of such Act pursuant to section 901(b)(1) of such Act, and any reference in such sections to 21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act as other than a reference to 21 months after the date of such final deeming regulation.”
The House has already included this language in their version of the appropriations bill but the Senate version does NOT contain this type of language so they would need to “recede” to the House provision in the final conference (where they work out differences in the two bills and agree on final language to send to the President).
2. Contact them and request they support inclusion of the Cole bill language currently in Section 747 of the House Agriculture Appropriations bill in the final enacted bill.
Without a change to the grandfather date, the FDA Deeming Regulation would:
- Cost >$20 million to submit each ENDS (Electronic Nicotine Delivery System) Pre-Market Tobacco Application that FDA would actually accept for review. FDA has claimed previously that it estimated a cost of just $333,554 per PMTA
- Ban the sale of >99.9% of nicotine vapor products to adults
- Put >99% of estimated 10,000 vapor companies (including vape shops) out of business
- Put 50,000+ vaping industry employees out of work
- Create a monopoly or oligopoly of just one or several legal (i.e. FDA approved) electronic nicotine delivery systems (ENDS) manufacturers and products – with large tobacco companies the most likely winners
- Create a multibillion dollar black market for totally unregulated vapor products
- Force millions of vapers to go back to smoking cigarettes, switch to an FDA approved ENDS, or buy totally unregulated vapor products from newly created black markets
- Protect cigarettes and threaten the lives of millions of vapers and smokers
Senate Full Committee Members:
|Cochran, Thad (MS) , Chairman
McConnell, Mitch (KY)
Shelby, Richard C. (AL)
Alexander, Lamar (TN)
Collins, Susan M. (ME)
Murkowski, Lisa (AK)
Graham, Lindsey (SC)
Kirk, Mark (IL)
Blunt, Roy (MO)
Moran, Jerry (KS)
Hoeven, John (ND)
Boozman, John (AR)
Capito, Shelley Moore (WV)
Cassidy, Bill (LA)
Lankford, James (OK)
Daines, Steve (MT)
|Mikulski, Barbara A. (MD), Ranking Member
Leahy, Patrick J. (VT)
Murray, Patty (WA)
Feinstein, Dianne (CA)
Durbin, Richard J. (IL)
Reed, Jack (RI)
Tester, Jon (MT)
Udall, Tom (NM)
Shaheen, Jeanne (NH)
Merkley, Jeff (OR)
Coons, Christopher A. (DE)
Schatz, Brian (HI)
Baldwin, Tammy (WI)
Murphy, Christopher (CT)
Despite the tremendous support shown for HR 2508, there is no guarantee that it will pass, so we must put our efforts everywhere that can be helpful.
Please feel free to share this guidance with others who may not be SFATA members. We know this is a stressful time and we know that working in unison and cooperatively the best bet we have as an industry to survive this and other challenges that will come our way.