SFATA Provides Guidance on Senate Appropriations Bill November 24 2015
SFATA Provides Guidance on Senate Appropriations Bill
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 December 11th, 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).
1. Check the list below to see if any US Senators on the committee are from your state.
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:
Senate Full Committee Members:
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.
If you have questions or concerns, please contact SFATA at firstname.lastname@example.org or call 202-559-8619.
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.
ED, President, SFATA