- Apr 2, 2009
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Clarifying the Impact of Cole-Bishop on the Vapor Industry
By Bill Godshall
Founder and Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
On December 20, Tony Abboud from the two-year-old Vaper Technology Association (VTA) sent out an e-mail (at the bottom of this document) denouncing the five-year-old American e-liquid Manufacturing Standards Association (AEMSA) for urging Congress to exclude the Cole-Bishop amendment from the 2018 federal spending bill. Tony’s e-mail also revealed letters VTA recently sent to Congress (which were cosigned by reps from SFATA, CASAA and AVA, but which have not been posted on their websites) urging Congress to include the Cole-Bishop amendment in the 2018 federal spending bill. Those letters are at
https://cqrcengage.com/vaportechnology/file/GIUKZgExZbo/Unified Vapor Letter to Chairman Aderholt - FINAL.pdf
https://cqrcengage.com/vaportechnology/file/5cr83oiqTk5/Unified Vapor Letter to Chairman Cochran - FINAL.pdf
Unfortunately for the vapor industry and vapers, VTA’s letters to Congress inaccurately claim that changing the TCA’s predicate date from 2/15/2007 to 8/8/2016 would let vapor companies make safety and quality improvements to Substantially Equivalent (SE) vapor products in the future, and falsely insinuate that enacting Cole-Bishop will ensure that “Americans continue to have access to the full range of vapor products”. The letters fail to reveal that Cole-Bishop would codify all of FDA’s disastrous Deeming Rule (except its predicate date) into federal law (including FDA’s Deeming of all vapor as tobacco products under Chapter 9 of the TCA), require FDA to issue a Final Rule for "a product standard for vapor products" "to include but not limited to" "characterizing flavors" and "batteries" by January 2021, and will make it far more difficult and costly to convince Congress to repeal and replace the Deeming Rule with reasonable and responsible vapor product standards. For reference, the Cole-Bishop language is Section 753 in the House Ag spending bill at:
https://appropriations.house.gov/uploadedfiles/bills-115hr-sc-ap-fy2018-agriculture-agriculture.pdf
Tony Abboud’s e-mail also contained a link to an inaccurate and misleading statement by VTA about Cole-Bishop (titled THE IMPORTANCE OF COLE-BISHOP & CHANGING THE PREDICATE DATE) at https://cqrcengage.com/vaportechnology/file/XOLQm3lTzSS/Cole Bishop One Pager December 2017 - FINAL.pdf
That document is reprinted below (in black), along with point by point responses by me (in blue).
WHY CHANGE THE PREDICATE DATE?
1. The vapor industry is at a critical juncture where manufacturing companies will be forced to spend tens of millions of dollars on PMTAs just to keep pre-8/8/16 products on the market.
While vapor policies are at a critical juncture, FDA’s Scott Gottlieb has allowed the 3 million vapor products already registered with FDA to be remain on the market until August 8, 2022.
2. Right now, vapor has NO grandfathered products since there were no vapor products on the market on February 15, 2007 (the current grandfather date).
In fact, several vapor companies marketed vapor products in the US on February 15, 2007, and some grandfathered products (e.g. Crown7 & Sottera) have been located and are available for sale. But the value of obsolete 2016 SE vapor products after August 8, 2022 is likely to be no greater than the present value of these obsolete 2007 vapor products, which were removed from the market a decade ago due to declining demand and many new/improved competitive products.
3. Cole-Bishop would change the February 15, 2007 grandfather date (aka "predicate date") to August 8, 2016, thereby allowing all pre-8/8 products to be grandfathered in and serve as “predicate products” going forward.
The predicate date change would only allow grandfathered 8/8/2016 vapor products to remain on the market AFTER 8/8/2022. But Cole-Bishop would also require FDA to issue a Final Rule for a TCA and Deeming Rule authorized tobacco product standard "for vapor products" "to include but not limited to" "characterizing flavors" and "batteries" by January 2021 (which would ban the sale of many/most/all of the 3 million vapor products more than a year before the Deeming Rule bans them on 8/8/2022).
Why is this important? Once we’ve established all those pre-8/8/16 products as predicate products, your company will save millions of dollars because they will be able to take advantage of the Substantial Equivalence (SE) pathway, rather than the Pre-Market Tobacco Application pathway (PMTA) to get NEW products approved.
Except that Cole-Bishop codifies all other disastrous provisions of FDA’s Deeming Rule (except for the predicate date change) into federal law, requires FDA to issue a Final Rule for a tobacco vapor product standard (that could ban nearly all vapor products) by January 2021. The only way a vapor company could generate any sales/revenue via the SE pathway is if consumer demand remains beyond 8/8/2022 for its obsolete 8/8/2016 vapor product(s), and if Cole-Bishop mandated FDA tobacco vapor standards let the product(s) to remain on the market beyond 2021.
Unlike PMTA, the SE pathway is much less expensive and is legally available to all companies with predicate products. The standard for SE is that the new product must have the same characteristics as a predicate product or has different characteristics but does not raise different questions of public health. This standard is considered to be significantly less burdensome than the PMTA standard, i.e., that the product in question is appropriate for the public health.
So, rather than spending millions on highly subjective PMTAs – which few companies (big or small, tobacco or vapor) may get approved by the FDA – manufacturers could spend their dollars investing in new product innovation and substantial equivalence applications.
The TCA and all FDA Guidances for Substantially Equivalent (SE) tobacco products require all new tobacco products to be virtually identical to a predicate product. Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
The only exception is product label changes (due to a successful lawsuit by PM USA).
As stated above, Cole-Bishop mandated FDA vapor product standards would ban the sale of many/most/all 2016 vapor products in 2021 (a year before FDA’s Deeming Rule bans them), and the value of obsolete 2016 SE vapor products after 8/8/2022 is likely to be no greater than the present value of obsolete 2007 vapor products (especially if new black market vapor products that weren’t on the market on 8/8/2016 continue flooding the US market).
In sharp contrast to Cole-Bishop, a bill (HR 2194) introduced by Duncan Hunter (R-CA) at
https://www.congress.gov/bill/115th-congress/house-bill/2194/text?q=%7B%22search%22%3A%5B%22hr2194%22%5D%7D&r=1
would exempt vapor products from all of the disastrous provisions in FDA’s Deeming Rule (including its sales ban on new vapor products since 8/8/2016, its ban on truthful health claims since 8/8/2016, its prohibitively costly PMTA and MRTP requirements, and its 8/8/2022 vapor product sales ban), would require FDA to establish reasonable and responsible vapor product standards that most of the several thousand existing vapor manufacturers can afford to comply with, and would require FDA to evaluate and publicly reveal the different risk/benefit profiles for all types of tobacco/nicotine products.
Bottom-line Questions for Company Leaders and Financial Backers
· Do you want to lock in cash flow generated by all your pre-8/8 products by grandfathering?
· Do you want to your company to keep millions of dollars in your pocket?
· Wouldn’t you prefer to spend your money on innovating new products, not PMTAs?
· Do you want to have a chance to compete by bringing innovative products to market by proving them to be substantially equivalent to your pre-8/8 products?
· Do you want to continue building on success in Washington, D.C.?
The first two questions falsely assume that US consumer demand for many/most/all 2016 SE vapor products will exist after 8/8/2022, and that FDA will begin and continue to aggressively enforce the Deeming Rule’s ban on vapor products that weren’t on the market on 8/8/2016.
The third and fourth questions deceitfully claim Substantially Equivalent products can be “new” and “innovative”. By its definition in the TCA, SE products cannot be innovative or new.
The answer to the fifth question is that Congressional enactment of Cole-Bishop would almost certainly be the last time Congress considers vapor product legislation in the next decade (as that’s the way Congress actually works), and would likely ban millions of vapor products and destroy thousands of vapor companies a year before FDA’s Deeming Rule is scheduled to do so.
Frequently Asked Questions
What If We Don’t Support Cole-Bishop Now? Abandoning Cole-Bishop now would be a direct affront to the powerful Members of Congress who have stepped up to champion our issue. Blindsiding these champions or “walking away” will only make them less likely to want to help our industry going forward. In addition, it would make the vapor industry appear confused, fractured, and immature.
Many/most vapor companies and vaping advocates wisely abandoned the Cole-Bishop amendment this past summer after its text was changed (to require FDA to issue a Final Rule creating a tobacco standard "for vapor products" "to include but not limited to" "characterizing flavors" and "batteries" within three years), and after FDA’s Scott Gottlieb delayed the Deeming Rule’s vapor sales ban / PMTA deadline by four years (from 8/8/2018 until 8/8/2022).
While the predicate date change in Cole’s 2015 bill was a life preserver for vapor products to remain on the US market after FDA Deeming Rule’s 8/8/2018 original vapor sales ban, the huge changes to Cole-Bishop in June along with Scott Gottlieb’s four year delay of FDA’s vapor sales ban in July eliminated virtually all (and probably all) benefits Cole-Bishop previously provided the vapor industry, and would make it far more difficult for Congress and/or FDA to repeal and replace the Deeming Rule with reasonable and responsible vapor standards in the future.
Walking away from Cole-Bishop and advocating reasonable and responsible vapor product standards legislation (e.g. HR 2194) would inform Congress that FDA’s Deeming Rule MUST be repealed and replaced (at least for vapor products) in order for >99.9% of the ten thousand vapor companies in the US to stay in business beyond 8/8/2022, and in order for manufacturers to once again truthfully inform smokers and vapers that vaping is less harmful than smoking.
Cole-Bishop FAQ (continued)
Doesn’t the FDA’s Deadline Delay Solve This Problem? No. Anyone who thinks the delay is the answer is wrong. The delay only allows FDA time to come up with its foundational rules, aka regulations, for the various pathways to market, which may provide clarity but may not mitigate the burdens on manufacturers. Securing this change now will provide insurance against other potential negative changes that may come.
This is a straw man argument because nobody has said that FDA’s vapor sales ban delay (until 2022) solves anything except delaying the industry’s 2018 death sentence by four more years.
Besides, Cole-Bishop not only codifies FDA’s 8/8/2022 vapor prohibition date into federal statute, it requires FDA to issue Final Rule for a vapor standard that would likely ban most vapor products more than a year prior to FDA’s Deeming Rule.
Is Cole-Bishop Likely to Eliminate Flavors? No. This is a red herring. Cole-Bishop says NOTHING about banning flavors. On December 11, 2017, FDA sent to the Office of Management and Budget its Advanced Notice of Proposed Rule Making (ANPRM) regarding flavors. Cole-Bishop only tells FDA to do what FDA already has decided to do: conduct a regulatory process on flavors. The language sets out a timeline; however, agencies tend to operate under their own timelines when promulgating rules.
This is another strawman argument since nobody is claiming Cole-Bishop will ban all flavors. Rather, Cole-Bishop’s requirement that FDA propose and issue a Final Rule (by the end of 2020) establishing a standard for characterizing flavors in vapor products is very likely to ban many/most characterizing flavors in vapor products. In sharp contrast, FDA will be issuing an Advanced Notice of Proposed Rule Making (ANPRM) for flavorings for all newly Deemed tobacco products. ANPRMs are not formal regulatory proposals, are more like trial balloons to obtain more information about the issue, and typically do not result in a Final Rule being issued.
Will Cole-Bishop “speed up” the flavor regulation? No. It is extremely unlikely that FDA’s rulemaking process will completed by 2020 whether Congress dictates that or not. The science which they are required to develop takes time. Again, FDA just initiated its ANPRM on flavors which means they have elected to take the longest potential regulatory path on the issue. This first step is simply an information-gathering process, during which we as stakeholders must weigh in about the importance of flavors. There are plenty of “deadlines” set by Congress which FDA in its discretion does not meet.
It is disingenuous to lobby for legislation that requires FDA to issue a Final Rule for new vapor product standards in January 2021 (not just for flavorings, but for batteries and for any other vapor product standard FDA chooses), but then claim FDA is unlikely to comply with a Congressional mandate.
Won’t Congress Just “Mark Up” Cole-Bishop to Ban Flavors Before Passage? Again, no. Congress doesn’t “mark-up” the Appropriations package. Fact: the House Appropriations bill already went through mark up and our industry’s language predicate date language was included. Fact: the Senate Appropriations bill already has been “marked up” and does not include this language. House and Senate conferees will negotiate whether to include the predicate date section or not, and there is no reason to believe that negotiators would insert a flavor ban. FDA already is working on a rulemaking on this issue and Congress generally will not step in front of an agency in this way.
This statement only further confuses readers, as nobody is suggesting Congress might “mark up” Cole-Bishop.
Don’t We Have to Choose to Support HR 2194 Instead of Cole-Bishop? No. These two pieces of legislation are NOT mutually exclusive so why choose one over the other? Also, why tear down one strategy that the entire vapor industry has been working on for 3 years, and which is moving forward with support from powerful members of Congress, just to try something different? The biggest difference between HR 1136/Cole-Bishop and HR 2194 is their path. Cole-Bishop has been passed by the full House of Representatives via the House FY2018 Agriculture Appropriations bill. Cole-Bishop is currently in the mix for the must-pass spending package. HR 2194 has not been scheduled for a hearing and, unless a bill has the force of something like tax reform, there are not enough days on the Congressional calendar to pass a standalone bill in 2018.
As previously stated, if Congress enacts Cole-Bishop, it will be far more difficult and far more costly to convince Congress and/or FDA to enact/support HR 2194 (or any other proposal to repeal and replace FDA’s Deeming Regulation with reasonable and responsible vapor product standards that most vapor companies can afford to comply with). If Cole-Bishop is enacted, members of Congress will simply tell vapor companies and vapers “We just enacted legislation that codified virtually all of FDA’s Deeming Rule into federal law because you claimed that doing so would save the vapor industry. Why didn’t you tell us that the only benefit Cole-Bishop provides to vapor companies and vapers is to allow obsolete SE 2016 vapor products to remain on the market after 2022.”
Shouldn’t We Be Aiming Higher than Changing the Predicate Date? You can aim anywhere you want, but strong beliefs alone won’t achieve anything. There must be a viable industry strategy to hit any target. Changing the predicate date is an important first step in a longer-range plan to provide for sensible regulation of the vapor industry. Frankly, it is unlikely (at best) that a complete overhaul of the Tobacco Control Act will occur in a timeframe that will be helpful absent a predicate date change.
HR 2194 is a the only viable strategy introduced in Congress that would reestablish a thriving and sustainable vapor product market in the US. Enacting Cole-Bishop would not only codify virtually all provisions of the disastrous FDA Deeming Rule into federal law and ban the sale of many vapor products before FDA’s 8/8/2022 Deeming deadline, but would also make it far more difficult and far more expensive to enact HR 2194 (or a similar regulatory scheme) in the future.
Will Cole-Bishop Devastate the Industry? No. If that were the case, why would all of the major vapor industry and consumer associations, including AVA, CASAA and SFATA, be supporting it?
Cole-Bishop would most definitely devastate the vapor industry. But since NONE of the cosigners of Tony Abboud’s unity statement and letters to Congress have yet to provide ANY explanation for their action (despite repeat requests), I urge funders and members of SFATA, CASAA and AVA to ask why they still support legislation that codifies nearly all of FDA’s disastrous Deeming Rule into federal law.
Cosigners of the unity statement and Tony Abboud’s letters to Congress should also be asked why they have not been supporting the only bill in Congress (HR 2194) that would allow the vast majority of vapor products and companies to remain in business for future decades, that will allow new vapor products to be introduced into the market without spending tens/hundreds of millions of dollars for PMTA and MRTP applications, and that will allow vapor manufacturers to truthfully inform consumers that vapor products are less harmful than smoking cigarettes.
Can’t Cole-Bishop Be Easily Changed in Other Appropriations Bills? No. Cole-Bishop’s language says: “None of the funds appropriated or otherwise made available by this Act or any other Act with respect to any fiscal year…” Regardless, nothing that happens in Congress is easy.
Agreed. Cole-Bishop won’t change unless the tobacco industry lobbyists who have been behind the evolving legislation since 2015, and who have given money to VTA, want it changed. http://s2.q4cdn.com/129460998/files...-to-501(c)(4)-and-501(c)(6)-Organizations.pdf
Opinion | Big Tobacco Attacks Sensible F.D.A. Rules on Vaping
Opinion | E-Vapor Regulation
Tony Abboud’s December 20, 2017 e-mail is below.
FROM THE VTA BOARD OF DIRECTORS
On December 11, 2017, VTA along with the Consumer Advocates for Smoke-free Alternatives Association ("CASAA"), the American Vaping Association ("AVA"), and the Smoke Free Alternatives Trade Association ("SFATA"), issued our Unified Front Letter to the vapor industry advising that the time was close to step up and support our call to action to change the predicate date, as part of the pending FY 2018 Appropriations process.
That same day, the American E-Liquid Manufacturing Standards Association ("AEMSA") announced that it had taken a remarkable unilateral action that directly conflicted with the will of the overwhelming majority of the vapor industry. Specifically, AEMSA announced that it sent a letter to House and Senate leaders in the United States Congress, including Senate Minority Leader Chuck Schumer and House Minority Leader Nancy Pelosi, directly attacking a legitimate and important legislative strategy that VTA and every other advocacy organization has been pursuing for the past three years. In so doing, AEMSA purported to speak on behalf of the entire vapor industry in declaring to Congressional leaders that it would be a mistake to change the predicate date, andclaiming that our industry doesn't need additional short-term relief. In sending their letter, AEMSA demonstrated a complete disregard of the powerful Members of Congress who have graciously stepped forward to champion our industry.
In an effort to mitigate whatever damage AEMSA's letter may have caused, we were pleased send a Unified Vapor industry letter, from VTA, AVA, CASAA and SFATA, encouraging our Congressional leaders to do the right thing and change the predicate date. Here are examples of the Unified Vapor Letter (House) and the Unified Vapor Letter (Senate) that VTA's team delivered to the Hill on December 14, 2017.
Individuals and groups may disagree on policy and strategy. However, nothing gives one group license to undermine years of important relationship building and issue building in Congress simply because it has a "strong belief" in another approach. Similarly, nothing justifies one group tearing down a legitimate legislative strategy that could be enormously beneficial to small and mid-sized companies right now, based on the notion that they have a better idea and might be able to secure something better at some point in the distant future.
So, if someone tells you their way is better, if they promise a "permanent" fix, if they tell you that they can solve your entire problem, or tell you that they are going to take vapor out of the Tobacco Control Act, that's great. Just make sure you ask all the hard questions like, what is the strategy, who is the team that will execute it, how are you going to generate support in the House and Senate, and where are the funds coming from to make it happen? Absent answers to these questions, you are just being offered ideas and words.
To that end, our fights are not ideological and not hypothetical. They are real, they are present, and the clock is ticking. Effective advocacy requires that we engage in strategies that can bring relief to our industry, engage in battles that are winnable, and that we build on prior success. Our industry does not have the luxury of hope. We are in a pitched battle and if we are repeatedly distracted from singularly focusing on our real enemies, we'll wake up one day with a basket full of beliefs but no believers in government.
As we look forward to another year, we invite all of you to join our continuing efforts to level the playing field and secure a bright future for the vapor industry in the U.S. by working simultaneously with Congress and the Administration. For more information on why this one prong of our multi-pronged strategy is important to small, mid-sized and large companies alike, please read our Changing the Predicate Date Summary and FAQ.
Thank you,
VTA Board of Directors
By Bill Godshall
Founder and Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
On December 20, Tony Abboud from the two-year-old Vaper Technology Association (VTA) sent out an e-mail (at the bottom of this document) denouncing the five-year-old American e-liquid Manufacturing Standards Association (AEMSA) for urging Congress to exclude the Cole-Bishop amendment from the 2018 federal spending bill. Tony’s e-mail also revealed letters VTA recently sent to Congress (which were cosigned by reps from SFATA, CASAA and AVA, but which have not been posted on their websites) urging Congress to include the Cole-Bishop amendment in the 2018 federal spending bill. Those letters are at
https://cqrcengage.com/vaportechnology/file/GIUKZgExZbo/Unified Vapor Letter to Chairman Aderholt - FINAL.pdf
https://cqrcengage.com/vaportechnology/file/5cr83oiqTk5/Unified Vapor Letter to Chairman Cochran - FINAL.pdf
Unfortunately for the vapor industry and vapers, VTA’s letters to Congress inaccurately claim that changing the TCA’s predicate date from 2/15/2007 to 8/8/2016 would let vapor companies make safety and quality improvements to Substantially Equivalent (SE) vapor products in the future, and falsely insinuate that enacting Cole-Bishop will ensure that “Americans continue to have access to the full range of vapor products”. The letters fail to reveal that Cole-Bishop would codify all of FDA’s disastrous Deeming Rule (except its predicate date) into federal law (including FDA’s Deeming of all vapor as tobacco products under Chapter 9 of the TCA), require FDA to issue a Final Rule for "a product standard for vapor products" "to include but not limited to" "characterizing flavors" and "batteries" by January 2021, and will make it far more difficult and costly to convince Congress to repeal and replace the Deeming Rule with reasonable and responsible vapor product standards. For reference, the Cole-Bishop language is Section 753 in the House Ag spending bill at:
https://appropriations.house.gov/uploadedfiles/bills-115hr-sc-ap-fy2018-agriculture-agriculture.pdf
Tony Abboud’s e-mail also contained a link to an inaccurate and misleading statement by VTA about Cole-Bishop (titled THE IMPORTANCE OF COLE-BISHOP & CHANGING THE PREDICATE DATE) at https://cqrcengage.com/vaportechnology/file/XOLQm3lTzSS/Cole Bishop One Pager December 2017 - FINAL.pdf
That document is reprinted below (in black), along with point by point responses by me (in blue).
WHY CHANGE THE PREDICATE DATE?
1. The vapor industry is at a critical juncture where manufacturing companies will be forced to spend tens of millions of dollars on PMTAs just to keep pre-8/8/16 products on the market.
While vapor policies are at a critical juncture, FDA’s Scott Gottlieb has allowed the 3 million vapor products already registered with FDA to be remain on the market until August 8, 2022.
2. Right now, vapor has NO grandfathered products since there were no vapor products on the market on February 15, 2007 (the current grandfather date).
In fact, several vapor companies marketed vapor products in the US on February 15, 2007, and some grandfathered products (e.g. Crown7 & Sottera) have been located and are available for sale. But the value of obsolete 2016 SE vapor products after August 8, 2022 is likely to be no greater than the present value of these obsolete 2007 vapor products, which were removed from the market a decade ago due to declining demand and many new/improved competitive products.
3. Cole-Bishop would change the February 15, 2007 grandfather date (aka "predicate date") to August 8, 2016, thereby allowing all pre-8/8 products to be grandfathered in and serve as “predicate products” going forward.
The predicate date change would only allow grandfathered 8/8/2016 vapor products to remain on the market AFTER 8/8/2022. But Cole-Bishop would also require FDA to issue a Final Rule for a TCA and Deeming Rule authorized tobacco product standard "for vapor products" "to include but not limited to" "characterizing flavors" and "batteries" by January 2021 (which would ban the sale of many/most/all of the 3 million vapor products more than a year before the Deeming Rule bans them on 8/8/2022).
Why is this important? Once we’ve established all those pre-8/8/16 products as predicate products, your company will save millions of dollars because they will be able to take advantage of the Substantial Equivalence (SE) pathway, rather than the Pre-Market Tobacco Application pathway (PMTA) to get NEW products approved.
Except that Cole-Bishop codifies all other disastrous provisions of FDA’s Deeming Rule (except for the predicate date change) into federal law, requires FDA to issue a Final Rule for a tobacco vapor product standard (that could ban nearly all vapor products) by January 2021. The only way a vapor company could generate any sales/revenue via the SE pathway is if consumer demand remains beyond 8/8/2022 for its obsolete 8/8/2016 vapor product(s), and if Cole-Bishop mandated FDA tobacco vapor standards let the product(s) to remain on the market beyond 2021.
Unlike PMTA, the SE pathway is much less expensive and is legally available to all companies with predicate products. The standard for SE is that the new product must have the same characteristics as a predicate product or has different characteristics but does not raise different questions of public health. This standard is considered to be significantly less burdensome than the PMTA standard, i.e., that the product in question is appropriate for the public health.
So, rather than spending millions on highly subjective PMTAs – which few companies (big or small, tobacco or vapor) may get approved by the FDA – manufacturers could spend their dollars investing in new product innovation and substantial equivalence applications.
The TCA and all FDA Guidances for Substantially Equivalent (SE) tobacco products require all new tobacco products to be virtually identical to a predicate product. Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
The only exception is product label changes (due to a successful lawsuit by PM USA).
As stated above, Cole-Bishop mandated FDA vapor product standards would ban the sale of many/most/all 2016 vapor products in 2021 (a year before FDA’s Deeming Rule bans them), and the value of obsolete 2016 SE vapor products after 8/8/2022 is likely to be no greater than the present value of obsolete 2007 vapor products (especially if new black market vapor products that weren’t on the market on 8/8/2016 continue flooding the US market).
In sharp contrast to Cole-Bishop, a bill (HR 2194) introduced by Duncan Hunter (R-CA) at
https://www.congress.gov/bill/115th-congress/house-bill/2194/text?q=%7B%22search%22%3A%5B%22hr2194%22%5D%7D&r=1
would exempt vapor products from all of the disastrous provisions in FDA’s Deeming Rule (including its sales ban on new vapor products since 8/8/2016, its ban on truthful health claims since 8/8/2016, its prohibitively costly PMTA and MRTP requirements, and its 8/8/2022 vapor product sales ban), would require FDA to establish reasonable and responsible vapor product standards that most of the several thousand existing vapor manufacturers can afford to comply with, and would require FDA to evaluate and publicly reveal the different risk/benefit profiles for all types of tobacco/nicotine products.
Bottom-line Questions for Company Leaders and Financial Backers
· Do you want to lock in cash flow generated by all your pre-8/8 products by grandfathering?
· Do you want to your company to keep millions of dollars in your pocket?
· Wouldn’t you prefer to spend your money on innovating new products, not PMTAs?
· Do you want to have a chance to compete by bringing innovative products to market by proving them to be substantially equivalent to your pre-8/8 products?
· Do you want to continue building on success in Washington, D.C.?
The first two questions falsely assume that US consumer demand for many/most/all 2016 SE vapor products will exist after 8/8/2022, and that FDA will begin and continue to aggressively enforce the Deeming Rule’s ban on vapor products that weren’t on the market on 8/8/2016.
The third and fourth questions deceitfully claim Substantially Equivalent products can be “new” and “innovative”. By its definition in the TCA, SE products cannot be innovative or new.
The answer to the fifth question is that Congressional enactment of Cole-Bishop would almost certainly be the last time Congress considers vapor product legislation in the next decade (as that’s the way Congress actually works), and would likely ban millions of vapor products and destroy thousands of vapor companies a year before FDA’s Deeming Rule is scheduled to do so.
Frequently Asked Questions
What If We Don’t Support Cole-Bishop Now? Abandoning Cole-Bishop now would be a direct affront to the powerful Members of Congress who have stepped up to champion our issue. Blindsiding these champions or “walking away” will only make them less likely to want to help our industry going forward. In addition, it would make the vapor industry appear confused, fractured, and immature.
Many/most vapor companies and vaping advocates wisely abandoned the Cole-Bishop amendment this past summer after its text was changed (to require FDA to issue a Final Rule creating a tobacco standard "for vapor products" "to include but not limited to" "characterizing flavors" and "batteries" within three years), and after FDA’s Scott Gottlieb delayed the Deeming Rule’s vapor sales ban / PMTA deadline by four years (from 8/8/2018 until 8/8/2022).
While the predicate date change in Cole’s 2015 bill was a life preserver for vapor products to remain on the US market after FDA Deeming Rule’s 8/8/2018 original vapor sales ban, the huge changes to Cole-Bishop in June along with Scott Gottlieb’s four year delay of FDA’s vapor sales ban in July eliminated virtually all (and probably all) benefits Cole-Bishop previously provided the vapor industry, and would make it far more difficult for Congress and/or FDA to repeal and replace the Deeming Rule with reasonable and responsible vapor standards in the future.
Walking away from Cole-Bishop and advocating reasonable and responsible vapor product standards legislation (e.g. HR 2194) would inform Congress that FDA’s Deeming Rule MUST be repealed and replaced (at least for vapor products) in order for >99.9% of the ten thousand vapor companies in the US to stay in business beyond 8/8/2022, and in order for manufacturers to once again truthfully inform smokers and vapers that vaping is less harmful than smoking.
Cole-Bishop FAQ (continued)
Doesn’t the FDA’s Deadline Delay Solve This Problem? No. Anyone who thinks the delay is the answer is wrong. The delay only allows FDA time to come up with its foundational rules, aka regulations, for the various pathways to market, which may provide clarity but may not mitigate the burdens on manufacturers. Securing this change now will provide insurance against other potential negative changes that may come.
This is a straw man argument because nobody has said that FDA’s vapor sales ban delay (until 2022) solves anything except delaying the industry’s 2018 death sentence by four more years.
Besides, Cole-Bishop not only codifies FDA’s 8/8/2022 vapor prohibition date into federal statute, it requires FDA to issue Final Rule for a vapor standard that would likely ban most vapor products more than a year prior to FDA’s Deeming Rule.
Is Cole-Bishop Likely to Eliminate Flavors? No. This is a red herring. Cole-Bishop says NOTHING about banning flavors. On December 11, 2017, FDA sent to the Office of Management and Budget its Advanced Notice of Proposed Rule Making (ANPRM) regarding flavors. Cole-Bishop only tells FDA to do what FDA already has decided to do: conduct a regulatory process on flavors. The language sets out a timeline; however, agencies tend to operate under their own timelines when promulgating rules.
This is another strawman argument since nobody is claiming Cole-Bishop will ban all flavors. Rather, Cole-Bishop’s requirement that FDA propose and issue a Final Rule (by the end of 2020) establishing a standard for characterizing flavors in vapor products is very likely to ban many/most characterizing flavors in vapor products. In sharp contrast, FDA will be issuing an Advanced Notice of Proposed Rule Making (ANPRM) for flavorings for all newly Deemed tobacco products. ANPRMs are not formal regulatory proposals, are more like trial balloons to obtain more information about the issue, and typically do not result in a Final Rule being issued.
Will Cole-Bishop “speed up” the flavor regulation? No. It is extremely unlikely that FDA’s rulemaking process will completed by 2020 whether Congress dictates that or not. The science which they are required to develop takes time. Again, FDA just initiated its ANPRM on flavors which means they have elected to take the longest potential regulatory path on the issue. This first step is simply an information-gathering process, during which we as stakeholders must weigh in about the importance of flavors. There are plenty of “deadlines” set by Congress which FDA in its discretion does not meet.
It is disingenuous to lobby for legislation that requires FDA to issue a Final Rule for new vapor product standards in January 2021 (not just for flavorings, but for batteries and for any other vapor product standard FDA chooses), but then claim FDA is unlikely to comply with a Congressional mandate.
Won’t Congress Just “Mark Up” Cole-Bishop to Ban Flavors Before Passage? Again, no. Congress doesn’t “mark-up” the Appropriations package. Fact: the House Appropriations bill already went through mark up and our industry’s language predicate date language was included. Fact: the Senate Appropriations bill already has been “marked up” and does not include this language. House and Senate conferees will negotiate whether to include the predicate date section or not, and there is no reason to believe that negotiators would insert a flavor ban. FDA already is working on a rulemaking on this issue and Congress generally will not step in front of an agency in this way.
This statement only further confuses readers, as nobody is suggesting Congress might “mark up” Cole-Bishop.
Don’t We Have to Choose to Support HR 2194 Instead of Cole-Bishop? No. These two pieces of legislation are NOT mutually exclusive so why choose one over the other? Also, why tear down one strategy that the entire vapor industry has been working on for 3 years, and which is moving forward with support from powerful members of Congress, just to try something different? The biggest difference between HR 1136/Cole-Bishop and HR 2194 is their path. Cole-Bishop has been passed by the full House of Representatives via the House FY2018 Agriculture Appropriations bill. Cole-Bishop is currently in the mix for the must-pass spending package. HR 2194 has not been scheduled for a hearing and, unless a bill has the force of something like tax reform, there are not enough days on the Congressional calendar to pass a standalone bill in 2018.
As previously stated, if Congress enacts Cole-Bishop, it will be far more difficult and far more costly to convince Congress and/or FDA to enact/support HR 2194 (or any other proposal to repeal and replace FDA’s Deeming Regulation with reasonable and responsible vapor product standards that most vapor companies can afford to comply with). If Cole-Bishop is enacted, members of Congress will simply tell vapor companies and vapers “We just enacted legislation that codified virtually all of FDA’s Deeming Rule into federal law because you claimed that doing so would save the vapor industry. Why didn’t you tell us that the only benefit Cole-Bishop provides to vapor companies and vapers is to allow obsolete SE 2016 vapor products to remain on the market after 2022.”
Shouldn’t We Be Aiming Higher than Changing the Predicate Date? You can aim anywhere you want, but strong beliefs alone won’t achieve anything. There must be a viable industry strategy to hit any target. Changing the predicate date is an important first step in a longer-range plan to provide for sensible regulation of the vapor industry. Frankly, it is unlikely (at best) that a complete overhaul of the Tobacco Control Act will occur in a timeframe that will be helpful absent a predicate date change.
HR 2194 is a the only viable strategy introduced in Congress that would reestablish a thriving and sustainable vapor product market in the US. Enacting Cole-Bishop would not only codify virtually all provisions of the disastrous FDA Deeming Rule into federal law and ban the sale of many vapor products before FDA’s 8/8/2022 Deeming deadline, but would also make it far more difficult and far more expensive to enact HR 2194 (or a similar regulatory scheme) in the future.
Will Cole-Bishop Devastate the Industry? No. If that were the case, why would all of the major vapor industry and consumer associations, including AVA, CASAA and SFATA, be supporting it?
Cole-Bishop would most definitely devastate the vapor industry. But since NONE of the cosigners of Tony Abboud’s unity statement and letters to Congress have yet to provide ANY explanation for their action (despite repeat requests), I urge funders and members of SFATA, CASAA and AVA to ask why they still support legislation that codifies nearly all of FDA’s disastrous Deeming Rule into federal law.
Cosigners of the unity statement and Tony Abboud’s letters to Congress should also be asked why they have not been supporting the only bill in Congress (HR 2194) that would allow the vast majority of vapor products and companies to remain in business for future decades, that will allow new vapor products to be introduced into the market without spending tens/hundreds of millions of dollars for PMTA and MRTP applications, and that will allow vapor manufacturers to truthfully inform consumers that vapor products are less harmful than smoking cigarettes.
Can’t Cole-Bishop Be Easily Changed in Other Appropriations Bills? No. Cole-Bishop’s language says: “None of the funds appropriated or otherwise made available by this Act or any other Act with respect to any fiscal year…” Regardless, nothing that happens in Congress is easy.
Agreed. Cole-Bishop won’t change unless the tobacco industry lobbyists who have been behind the evolving legislation since 2015, and who have given money to VTA, want it changed. http://s2.q4cdn.com/129460998/files...-to-501(c)(4)-and-501(c)(6)-Organizations.pdf
Opinion | Big Tobacco Attacks Sensible F.D.A. Rules on Vaping
Opinion | E-Vapor Regulation
Tony Abboud’s December 20, 2017 e-mail is below.
FROM THE VTA BOARD OF DIRECTORS
On December 11, 2017, VTA along with the Consumer Advocates for Smoke-free Alternatives Association ("CASAA"), the American Vaping Association ("AVA"), and the Smoke Free Alternatives Trade Association ("SFATA"), issued our Unified Front Letter to the vapor industry advising that the time was close to step up and support our call to action to change the predicate date, as part of the pending FY 2018 Appropriations process.
That same day, the American E-Liquid Manufacturing Standards Association ("AEMSA") announced that it had taken a remarkable unilateral action that directly conflicted with the will of the overwhelming majority of the vapor industry. Specifically, AEMSA announced that it sent a letter to House and Senate leaders in the United States Congress, including Senate Minority Leader Chuck Schumer and House Minority Leader Nancy Pelosi, directly attacking a legitimate and important legislative strategy that VTA and every other advocacy organization has been pursuing for the past three years. In so doing, AEMSA purported to speak on behalf of the entire vapor industry in declaring to Congressional leaders that it would be a mistake to change the predicate date, andclaiming that our industry doesn't need additional short-term relief. In sending their letter, AEMSA demonstrated a complete disregard of the powerful Members of Congress who have graciously stepped forward to champion our industry.
In an effort to mitigate whatever damage AEMSA's letter may have caused, we were pleased send a Unified Vapor industry letter, from VTA, AVA, CASAA and SFATA, encouraging our Congressional leaders to do the right thing and change the predicate date. Here are examples of the Unified Vapor Letter (House) and the Unified Vapor Letter (Senate) that VTA's team delivered to the Hill on December 14, 2017.
Individuals and groups may disagree on policy and strategy. However, nothing gives one group license to undermine years of important relationship building and issue building in Congress simply because it has a "strong belief" in another approach. Similarly, nothing justifies one group tearing down a legitimate legislative strategy that could be enormously beneficial to small and mid-sized companies right now, based on the notion that they have a better idea and might be able to secure something better at some point in the distant future.
So, if someone tells you their way is better, if they promise a "permanent" fix, if they tell you that they can solve your entire problem, or tell you that they are going to take vapor out of the Tobacco Control Act, that's great. Just make sure you ask all the hard questions like, what is the strategy, who is the team that will execute it, how are you going to generate support in the House and Senate, and where are the funds coming from to make it happen? Absent answers to these questions, you are just being offered ideas and words.
To that end, our fights are not ideological and not hypothetical. They are real, they are present, and the clock is ticking. Effective advocacy requires that we engage in strategies that can bring relief to our industry, engage in battles that are winnable, and that we build on prior success. Our industry does not have the luxury of hope. We are in a pitched battle and if we are repeatedly distracted from singularly focusing on our real enemies, we'll wake up one day with a basket full of beliefs but no believers in government.
As we look forward to another year, we invite all of you to join our continuing efforts to level the playing field and secure a bright future for the vapor industry in the U.S. by working simultaneously with Congress and the Administration. For more information on why this one prong of our multi-pronged strategy is important to small, mid-sized and large companies alike, please read our Changing the Predicate Date Summary and FAQ.
Thank you,
VTA Board of Directors
