Wednesday, May 18, 2016

US - Take action to change to the predicate date for vapor products newly deemed as tobacco by the FDA

Updated - 05.18.16


CASAA is urging our members to support
both HR 2058 and the Cole-Bishop amendment.
We have updated our engagement to reflect this support.

Take Action - Send a Message

Currently, there are two pieces of legislation in Congress that would effectively change the predicate date for products deemed to be tobacco by the FDA. In January, CASAA updated our Call to Action for HR 2058 and issued a separate Call to Action regarding the Cole-Bishop amendment in April. We have also provided an up-to-date list of co-sponsors (updated 06.14.16) with an opportunity for people living in those districts to send thank you letters.

Both HR 2058 and the Cole-Bishop amendment are vehicles for language that would change the predicate date in the Tobacco Control Act (TCA) from February 15th, 2007 to the effective date of the deeming regulations (August 8th, 2016). This change would allow for all vapor products currently on the market to remain on the market without being subject to the burdensome and prohibitive pre-market FDA approval application process. If Congress does not act to change the predicate date established by the TCA, the wide variety of vapor products that adult smokers have come to rely on to live smoke-free will be swept off the market.

The first Call to Action for Cole-Bishop specifically targeted members of the House Appropriations Committee, so it was limited to those CASAA members whose representatives were on the committee. The amendment was successfully added to the Agriculture Appropriations bill and will be moving to the floor of the House for a full vote soon. Shortly prior to this vote, we will need to rally support in order to prevent opponents from stripping the amendment out.

CASAA will be issuing a new, strategically-timed Call to Action to support the Cole-Bishop amendment before the appropriations bill comes to a vote in the House. At this time, we are urging our members to support both of these pieces of legislation. We have updated our message to lawmakers in this Call to Action to reflect this support.

Take Action - Send a Message

In order to clarify the similarities and differences of these two pieces of legislation, we have provided a table below that outlines the provisions of each. While we prefer HR 2058, our current analysis is that the Cole-Bishop Amendment has a greater likelihood of moving forward at present than does HR 2058, which is why we are urging consumers to support both. These two pieces of legislation are not mutually exclusive. Moreover, HR 2058 is useful as it provides both backup legislation, should the Cole-Bishop section be stripped from the appropriations bill before it gets to the President, and makes the predicate date change a permanent part of the law. CASAA is urging support of both at this time.
HR 2058:

HR 2058
Cole-Bishop Amendment
- Changes the predicate date in the Food, Drug, and Cosmetics Act for products deemed to be tobacco by the FDA from February 15th, 2007 to the effective date of the deeming regulations (August 8th, 2016).
- Prohibits funds appropriated to HHS for the FDA from being used to enforce the February 15th, 2007 predicate date. Instead, the enforceable predicate date becomes August 8th, 2016

- Directs the Secretary of Health and Human Services (HHS) to issue a notice of proposed rulemaking (NRPM) within 12 months of the effective date of the deeming regulations August 8, 2017) to establish a product standard for vapor product batteries

- Prohibits vapor product advertising in newspapers, magazines, periodicals, or other publications other than adult publications

- Prohibits sales of vapor products through vending machines or displays that are not located in age restricted establishments where no one under the age of 18 is allowed to enter

- Requires labeling of vapor products to include the phrases:
• "Keep Out of Reach of Children"
• "Underage Sale Prohibited"
• An accurate statement of the nicotine content of the vapor product

- Requires all vapor retail establishments to register with the Secretary of HHS (see exceptions)

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