FEC Filings Show Donald Trump’s New Acting FDA Commissioner Backed Barack Obama and Other Democrats

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Posted by Paul Blair on Tuesday, March 12th, 2019, 7:52 PM PERMALINK

At a hearing before the House Energy and Commerce Committee’s health subcommittee today, the Director of the National Cancer Institute Norman “Ned” Sharpless was announced as the next acting commissioner of the Food and Drug Administration. The current commissioner, Scott Gottlieb, recently announced that he was resigning to spend more time with his family. 

Publicly available records from the Federal Elections Commission reveal that Ned Sharpless has contributed thousands of dollars to Democrat candidates for federal office, including Barack Obama in both 2008 and 2012. A review of FEC filings show:

Sharpless has not been announced as President Trump's formal nominee and there may be other candidates under consideration for the position, which faces a Senate confirmation.

Earlier today, Americans for Tax Reform's Paul Blair issued a statement on Sharpless:

“As the head of the National Cancer Institute, Ned Sharpless knows firsthand the potential benefit of transitioning millions of adult smokers away from cigarettes with proven-effective and less harmful e-cigarettes. However long he’s in charge, I'm hopeful he’ll have less of an interest in scaring suburban moms and more of an interest in reducing the cancer and disease associated with cigarette use by preserving the ability of adults to access a wide range of vapor products. He can begin by fulfilling the perhaps forgotten promise of Scott Gottlieb to issue clear guidance on how to bring new reduced risk products to market.”

Photo Credit: Flickr: Greg Stokinger

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ATR Statement on Inclusion of Vapor Product User Fees in Trump's 2020 Budget

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Posted by Paul Blair on Monday, March 11th, 2019, 1:51 PM PERMALINK

In his 2020 “Budget for a Better America,” President Donald Trump is calling upon Congress to impose a new $100 million "user fee" on manufacturers of electronic cigarettes and vapor products. The proposal would raise the current Food and Drug Administration user fee cap of $712 million by $100 million and be indexed to inflation. Pushed in the name of “tackling the ‘epidemic of youth e-cigarette use,” this tax would further enable the FDA's anti-vaping spending spree and it flies in the face of public health, consumer choice, and the rest of the president’s tax and regulatory agenda. 

Americans for Tax Reform calls upon Congress to reject any and all efforts to impose new taxes on life-saving alternatives to cigarettes in the United States, including e-cigarettes. 

This announcement comes just one week after FDA Commissioner Scott Gottlieb announced his retirement from the agency, effective next month. Commissioner Gottlieb has been critical of the e-cigarette industry, threatening to force manufacturers to remove flavored e-cigarettes from convenience stores and other large retail chains. In response to the budget announcement, Gottlieb applauded the new tax, claiming that it would help the agency take “aggressive steps to reduce [e-cigarettes] appeal and access to kids.” 

People under the age of 18 are already prohibited by law from purchasing e-cigarettes. Raising the cost of producing and selling e-cigarettes will make the products less appealing to adults who smoke cigarettes, striking a blow to decades of efforts to improve public health by reducing cigarette use in the United States. 

The tobacco product user fee is currently calculated based on the amount of excise taxes that a manufacturer has paid. The FDA uses these resources to regulate the industry. In order to collect new user fees from a company, Congress would also have to pass a new national tax on e-cigarette companies. The proposal to impose $100 million in new user fees, indexed to inflation, would only be applied after Congress authorized a new excise tax on e-cigarettes, unless Title 21 of the Code of Federal Regulations was revised. 

This request would grease the skids for a national vapor tax and should be rejected without further consideration. 

ATR’s Director of Strategic Initiatives Paul Blair issued the following statement in response to a call for $100 million in user fees on e-cigarette manufacturers:

“FDA Commissioner Scott Gottlieb’s departure can’t come soon enough. His constant threats to remove e-cigarettes from convenience store shelves flies in the face of the President’s broader regulatory objectives and will ultimately harm public health. 

It’s unfortunate, however, that a proposed tax increase championed by Gottlieb has made its way into the President’s budget. We’re hopeful that Congress rejects this misguided assault on the life-saving potential of e-cigarettes and that the Senate replaces Gottlieb with someone who champions the cause of consumer freedom, innovation, and tobacco harm reduction.” 

 

Photo Credit: Flickr: Cafe Credit

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Indiana House Endorses Vape Tax

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Posted by Robert Wines on Thursday, February 21st, 2019, 1:03 PM PERMALINK

The Indiana House of Representatives recently voted to impose a new tax on the liquid contents of electronic cigarettes and vapor products. The 4 cents per-milliliter tax is now under consideration by the Senate. Americans for Tax Reform urges the Senate to reject this tax, which represents a threat to harm reduction and smoking cessation efforts in the state of Indiana.  

By imposing a tax on e-cigarettes, the Indiana House is assuring that adult smokers face even greater hurdles when trying to quit combustible cigarettes.  

The health impact to consumers of cigarettes is well known. Conversely, however, vapor products do not contain tobacco and lack combustion. A battery heats a liquid, that when aerosolized and inhaled is significantly less harmful than cigarette smoke. Public Health England determined that vapor products are at least 95% less harmful than combustible cigarettes. This is consistent with the growing global consensus on the reduced risk of these products. 

The reduced health risks involved in vaping have led many smokers to turn to the products as a quitting aid. Studying adult smokers, researchers published in the International Journal of Environmental Research and Public Health, determined that 40.8% of users were able to quit traditional cigarettes using a vapor product. Another 25.4% smoked less frequently because of the electronic alternative. 

E-cigarettes have even outpaced traditional treatment methods like nicotine patches and Nicorette gum. Comparing the efficacy of both, research published in the New England Journal of Medicine found that e-cigarettes were almost twice as effective as traditional cessation methods. However, the state of Indiana taxes items like the nicotine gum and patches at the rate of the general sales tax. Subjecting e-cigarettes with similar tax rates, which is present law, would make for sound tax and public health policy.

In attempting to tax e-cigarettes Indiana lawmakers are leveraging their constituents’ interests in quitting smoking for a boost in revenue streams. But in this vain attempt at bolstering the state’s general fund, the Indiana House is also leveraging its states small businesses while punishing consumers who make informed decisions about alternative products on the market.

As of 2016, the state of Indiana housed between 200 and 250 specialty vape shops. This figure pre-dates the last attempt at killing the industry, an onerous permit scheme designed to give monopoly control of the market to a select few businesses.  Imposing a new excise tax such as the one passed by the House would likely price a number of these shops out of business, slowing state commerce and losing any tax revenue from these already existing entities.

Tax hikes have negative consequences. After passing their own tax on vapor products, the Commonwealth of Pennsylvania lost over 100 of the state’s 400 vape shops. These businesses were forced to close their doors, as they could not sustain business while giving the government its cut. 

Before taking the route of the state House, the state Senate ought to consider the real-world effect of this bill. A few dollars extra in the state fund is not worth the blow to public health and small business.  

Photo Credit: Lindsay Fox

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ATR Leads Coalition Urging President Trump to Halt the FDA's Regulatory Assault on E-Cigarettes

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Posted by Paul Blair on Monday, February 4th, 2019, 12:30 AM PERMALINK

Today, Americans for Reform President Grover Norquist led a coalition of free market, limited government, and conservative organizations calling on President Donald Trump to halt the Food and Drug Administration's aggressive regulatory assault on businesses who sell electronic cigarettes and vapor products in the United States. In recent months, FDA Commissioner Scott Gottlieb has acted in a manner inconsistent with the president's regulatory agenda, pressuring manufacturers to remove products from store shelves, suggesting new rules that would ban products currently on the market, and failing to act on pending product applications of innovative alternatives to cigarettes. Even worse, he's promised to go further.

As the letter explains:

"FDA Commissioner Scott Gottlieb’s effort to curb the $6.6 billion electronic cigarette industry and an even larger reduced risk tobacco alternatives market is inconsistent with your clearly articulated deregulatory objectives and will destroy jobs, limit consumer freedoms, and harm public health."

From the 2016 campaign to President Trump's first set of executive orders, deregulation has been a top priority for this administration. That agenda has had a positive impact on taxpayers and the conomy. 

"Your leadership, Orders, and deregulatory efforts have led to historic and important relief for the American people, with over $33 billion in savings alone through October of last year. Across every department and agency, your administration has not only identified harmful regulations but worked to untangle and repeal them, freeing consumers and businesses from the grip of government overreach. One glaring exception has been the Food and Drug Administration." 

President Trump's Executive Order 137771 not only directed agencies to eliminate two prior regulations for the creation of any new one, but it directed the Office of Management and Budget to create caps on and estimates for the cost of new rules imposed by agencies, like the FDA. For that reason, we suggest to the president:

"Consistent with your Executive Orders, an economic cost benefit analysis must be conducted that examines pending FDA guidance and potential new regulations with regards to this innovative industry."

Without an analysis on the economic impact of pressuring businesses to remove products from the retail distrubtion chain or failing to provide clarity on the government approval pathway for new products, FDA Commissioner Scott Gottlieb's actions will be inconsistent with the president's Executive Order, pro-jobs, and economic growth agenda. 

The growing body of scientific evidence suggests that e-cigarettes are at least 95% less harmful than traditional combustible cigarettes. Even further, a new study by the New England Journal of Medicine which found that e-cigarettes are twice as effective at getting smokers to quit as government-approved smoking cessation products like the nicotine patch. Given the high cost of cigarette use on public health expenditures across the United States, these products present adults aged 18 and over with real and increasingly effective choices that will save taxpayers billions of dollars and potentially save millions of lives. 

All of this comes at a cost of no longer being a leader on public health and missing out on investments in our economy. 

"Private sector initiative and sound public policy should not be held hostage by prohibitionist impulses. The FDA’s current efforts and attitude towards the e-cigarette industry make America a less appealing place to invest and do business. Countries around the world, including many throughout Europe have embraced this industry, encouraging doctors and medical professionals to recommend it to patients who smoke. Simply put, we are not a public health leader on the issue of utilizing the free market and innovation for tobacco harm reduction."

This broad coalition of limited government, free market, conservative, and consumer choice organizations is asking the president to pump the brakes on the FDA's new and pending regulatory efforts against an industry that is helping American smokers quit. 

A PDF of the letter and its signers can be found here. 

Photo Credit: Gage Skidmore

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Coalition Urges Congress to Rein in FDA Overreach as Part of FY18 Spending Bill

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Posted by Paul Blair on Monday, March 5th, 2018, 11:22 AM PERMALINK

Today, Americans for Tax Reform and a coalition of center-right public policy organizations and think tanks sent a letter to Congressional leadership and the chairmen of the House and Senate Appropriations Committees urging them to provide regulatory relief to thousands of small businesses that sell and millions of adult consumers that use vapor products in the United States. The Obama-era "Deeming Rule" stands to cripple a growing industry unless Congress acts to make a small staturoy change to the Tobacco Control Act for new products subject to the oversight given to the Food and Drug Administration by Congress in 2009. Inaction would not only strike a blow to innovation, but to public health as well. 

Below is a letter, which can also be read here

We, the undersigned organizations, urge you to provide regulatory relief from the Food and Drug Administration’s May 2016 “Deeming Rule” as part of the final FY18 omnibus appropriations package. Without a modernization of a provision of the Family Smoking Prevention and Tobacco Control Act, the Deeming Rule will kill tens of thousands of jobs in an industry that is helping many American adult smokers transition to lower risk alternatives to combustible to cigarettes.

Language and legislation sponsored by Congressmen Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) modernizes the “predicate date” for newly deemed tobacco products, providing regulatory certainty for small businesses against an onerous and retroactive pre-approval process imposed by the 2016 Rule. The Cole-Bishop Amendment to the current FY18 Agriculture Bill would provide additional substantive protections for adult consumers without preventing the FDA from imposing more appropriate regulations for the product category in the future.

Congressional action is necessary to prevent the loss of tens of thousands of jobs created in recent years. Most of these jobs are the result of domestic manufacturing and new retailers that are providing smokers with potentially effective smoking cessation and/or harm reduction choices that were not available ten years ago.

The Deeming Rule requires new products that did not exist on or before February 15, 2007 – the predicate date – to undergo a burdensome pre-market review process that achieves little in the way of protecting public health at a very high cost. The FDA’s own estimates found that the cost of completing and submitting the required Pre- Market Tobacco Application (PMTA) would exceed $300,000 per product and take at least 500 hours of time per application. At present, the deadline for the submission of PMTAs for each product manufactured in the United States is August 8, 2022.

When FDA Commissioner Scott Gottlieb extended the deadlines for the submission of PMTAs last year, he explained that it was done in part “to allow the FDA to encourage innovation that has the potential to make a notable public health difference—and to inform future policies and efforts that will protect kids and help smokers quit cigarettes.” Gottlieb has also argued that “there should be reduced harm products available to consumers to transition them off of combustible cigarettes,” consistent with the international consensus that vapor products are significantly less harmful than cigarettes. Without a statutory change to TCA by Congress, however, countless smoking cessation products currently on the market will be illegal in 2022. The ball is in Congress’s court and further inaction only stands to harm public health.

The onerous PMTA process required of every single vapor product on the market today was one that every single manufacturer of cigarettes in the U.S. avoided when the TCA was signed into law. Even if businesses could afford this investment, however, the process is designed to end in failure. Many small businesses produce hundreds of these products and would be forced to close their doors as a result of this retroactive federal rule.

The Cole-Bishop Amendment would not weaken the TCA or the ability of the FDA to impose additional product standards or regulations on new products in the future. In fact, the FDA is already moving forward on additional rulemaking for newly deemed products and this amendment would make the agency’s new regulatory objectives, which include preventing youth initiation, attainable. That is precisely why the efforts are bipartisan, because there is recognition that while regulations that protect consumers are important, the Rule imposed burdens that neither protect consumers, nor acknowledge that the consequence will be the new industry’s demise.

The millions of adult consumers who currently rely on these products as less harmful alternatives to smoking need your help today. The inclusion of the Cole-Bishop Amendment, as passed by the House Appropriations Committee, will provide significant regulatory certainty to tens of thousands of small businesses in the United States. We encourage Congress to adopt the language into the final FY18 omnibus budget.

Photo Credit: Flickr

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ATR Urges Utah Legislators to Reject Punitive Tax on Vapor Products

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Posted by Tyler Tate on Monday, February 26th, 2018, 10:16 AM PERMALINK

Recently, Utah Rep. Paul Ray introduced legislation (House Bill 88) to impose a whopping 86% excise tax on tobacco –free electronic cigarettes and vapor products. The tax, which was lowered to 29% in committee, serves as a harsh penalty on an estimated 110,000 Utahans who use e-cigarettes as a means for quitting or reducing their use of cigarettes.

The tax push comes at a time when the international consensus is that e-cigarettes are at least 95% less harmful than traditional combustible cigarettes. Unlike traditional cigarettes, e-cigarettes are free from tobacco, tar, and other carcinogens that make cigarettes harmful.

Over the past decade, e-cigarettes have emerged as an innovative and effective market solution that empowers smokers to quit tobacco use by transitioning towards a significantly less harmful alternative. Notably, this is a goal public health advocates have failed to achieve for decades.

A punitive excise tax on these life-saving products threatens to put them out of the reach of those who need them most. Lower and middle-income consumers compose the overwhelming majority of smokers, and many spend up to 25% of their income on tobacco. Imposing a regressive and steep excise tax on e-cigarettes directly hinders the ability of low and middle income consumers to afford to try a safer alternative to smoking tobacco.

Proponents argue these attempts to tax e-cigarettes are based on increasing public health, however, the real motivation is to preserve the massive windfall from exorbitant tobacco excise taxes. Since 1998, more than $500 billion has been transferred from consumers and businesses to the government from tobacco taxes and the federal Master Settlement Agreement with tobacco companies.

As consumers continue to switch to tobacco-free products, politicians have scrambled to replace revenues from tobacco taxes with e-cigarette taxes. Rather than pursue damaging tax hikes on life saving products, legislators should allow the free market to empower individuals to better their health.

Representative Paul Rey's attempt to hike taxes on 110,000 Utahans in 2018 comes as no surprise, considering he has pushed this tax every year for the last several years. Rep. Ray has also declined to sign the Taxpayer Protection Pledge, a written commitment to voters to oppose tax hikes.  

ATR strongly urges Utah legislators to protect Utah e-cigarette consumers and public health by rejecting House Bill 88. ATR’s letter to the Utah Taxation & Revenue Committee can be found here.

Photo Credit: Wikimedia Commons

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Podcast with IWF on Vaping and the Rugulatory Assault its Consumers Face

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Posted by Paul Blair on Monday, June 19th, 2017, 1:28 PM PERMALINK

In a recent podcast with Julie Gunlock of the Independent Women's Forum, Americans for Tax Reform's Paul Blair discussed the politics and policies surrounding the government's regulatory war against vapor products. What exactly is an electronic cigarette and what is vaping? Topics covered include a conversation about tobacco harm reduction and the role that innovation is playing in the tobacco product space that may help smokers transition to less harmful alternatives. 

Learn more about ATR's work in vapor issues at www.stopvapetaxes.org and feel free to sign up for Paul's monthly newsletter Vapor News and Views

Photo Credit: Vaping360.com

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Democrats Claim Credit for Killing Budget Provision That Would Have Saved Vapor Industry and Consumers

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Posted by Paul Blair on Monday, May 1st, 2017, 8:01 AM PERMALINK

Early Monday morning, the FY17 Omnibus Budget to fund the federal government through October was rolled out by leaders of both parties. Notable among the policies and priorities missing from the agriculture budget was a House Appropriations Committee-passed provision that would have saved tens of thousands of business and millions of U.S. consumers from government overreach. Democrats were quick to take credit in a press release explaining the provisions they ensured were kept out included those that protected small vapor businesses and consumers from crippling regulations imposed last year. 

The May 2016 “Deeming Rule” imposed by the Obama Administration’s Food and Drug Administration (FDA) expanded the list of tobacco products subject to burdensome rules established by the Family Smoking Prevention and Tobacco Control Act to include tobacco-free vapor products and electronic cigarettes.

As we recently explained in a letter to House and Senate leadership:

"The Rule requires new products that did not exist on or before February 15, 2007 – the predicate date – to undergo a burdensome pre-market review process that achieves little in the way of protecting public health at a very high cost. The FDA’s own estimates found that the cost of completing and submitting the required Pre-Market Tobacco Application (PMTA) would exceed $300,000 per product and take at least 500 hours of time per application. At present, the deadline for the submission of PMTAs for each product manufactured in the United States is August 8, 2018...

Estimates from the startup industry suggest 99% of all businesses would be wiped out unless Congress or the Administration rein in the Deeming Rule’s burdensome barriers to approval for new products."

In their FY17 Omnibus Appropriations Act press release, House Democrats claimed credit for ensuring an important provision that would have grandfathered in products currently being used by smokers to quit was not included, noting, “The Omnibus does not include a House provision allowing thousands of unregulated tobacco products to escape full FDA review.”

Setting aside for a moment that the products are not unregulated, the provision referenced is the Cole-Bishop Amendment to the Agriculture Appropriations Bill, bipartisan language that passed the Appropriations Committee by a vote of 31-19 last Spring. Stand-alone legislation, House Resolution 1136, also has the support of both Democrats and Republicans and would modernize the 2007 predicate date to August of 2016, ensuring that products being used by smokers to quit when the regulation took effect will remain available beyond net year.

As we explain:

"The Cole-Bishop Amendment and House Resolution 1136 would not weaken the TCA or the ability of the FDA to impose additional product standards or regulations on new products in the future. That is precisely why the efforts are bipartisan, because there is recognition that while regulations that protect consumers are important, the Rule imposed burdens that neither protect consumers, nor acknowledge that the consequence will be the new industry’s demise."

This minor statutory change would ensure that products known to be at least 95% less harmful than cigarettes were not treated more harshly than their combustible counterparts and made illegal by August of next year. Every cigarette on the market avoided the type of regulatory regime established by Obama’s FDA when the Tobacco Control Act passed in 2009. 

Without immediate action by the Secretary of Health and Human Services or the Food and Drug Administration, tens of thousands of businesses and jobs will be killed by next year. This will limit the availability of reduced risk products to millions of U.S. adult consumers, representing the greatest setback in public health in decades. This isn't the first time that out-of-touch House Democrats have claimed credit for punishing businesses trying to help consumers quit smoking but they should absolutely be ashamed of themselves.

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Coalition Urges Congress to Rein in FDA's Overreach as Part of FY17 Spending Package

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Posted by Paul Blair on Monday, April 24th, 2017, 7:22 PM PERMALINK

Today, in a letter to GOP leadership in the House and Senate, as well as the Appropriations Chairman, Americans for Tax Reform and thirteen other free market groups urged Congress to rein in the Food and Drug Administration's May 2016 "Deeming Rule" as part of the FY17 appropriations package. Without immediate action, rules imposed by President Obama's FDA on an expanded list of "tobacco products" will force thousands of new businesses to close their doors by August of 2018. 

As a result of the Rule, which redefined tobacco products subject to regulations imposed by the Family Smoking Prevention and Tobacco Control Act (TCA), every manufacturer of tobacco-free vapor products - large and small - will have to submit what is called a Pre-Market Tobacco Application (PMTA), retroactive and burdensome pre-approval process designed to prevent new products from hitting the market. This will harm public health, stifle innovation, and kill jobs. 

Below is the letter, which can also be read here. 

We, the undersigned organizations, urge you to provide regulatory relief from the Food and Drug Administration’s May 2016 “Deeming Rule” as part of the final FY17 omnibus appropriations package. Without a modernization of a provision of the Family Smoking Prevention and Tobacco Control Act (TCA), the Deeming Rule will kill tens of thousands of jobs in an industry that is helping many American smokers transition to lower risk alternatives to combustible cigarettes.

Language and legislation sponsored by Congressmen Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) modernizes the “predicate date” for newly deemed products, providing urgent relief to small businesses from an onerous and retroactive pre-approval process imposed by last year’s Rule. House Resolution 1136 and the Cole-Bishop Amendment to the current FY17 Agriculture Bill would provide additional substantive protections for adult consumers without preventing the FDA from imposing more appropriate regulations for the product category in the future.

Congressional action is necessary to prevent the loss of tens of thousands of jobs created in the last four years. Most of these jobs are the result of domestic manufacturing and new retailers that are providing smokers with potentially effective smoking cessation and/or harm reduction choices that were not available ten years ago. 

The Deeming Rule requires new products that did not exist on or before February 15, 2007 – the predicate date – to undergo a burdensome pre-market review process that achieves little in the way of protecting public health at a very high cost. The FDA’s own estimates found that the cost of completing and submitting the required Pre-Market Tobacco Application (PMTA) would exceed $300,000 per product and take at least 500 hours of time per application. At present, the deadline for the submission of PMTAs for each product manufactured in the United States is August 8, 2018.          

There are tens of thousands of vapor products that would have to be processed by the FDA and the Center for Tobacco Products in the months following August of next year, a nightmare for the agencies and small businesses involved. That is, if businesses could even afford an attempt at compliance. Estimates from the startup industry suggest 99% of all businesses would be wiped out unless Congress moves soon to rein in the Deeming Rule’s burdensome barriers to approval for new products.

This onerous process required of every single vapor product on the market today was one that every single manufacturer of cigarettes in the U.S. avoided when the TCA was signed into law. Even if businesses could afford this investment, however, the process is designed to end in failure. Many small businesses produce hundreds of these products and would be forced to close their doors as a result of this retroactive federal rule.

In his confirmation hearing as FDA Commissioner two weeks ago, Dr. Scott Gottlieb concluded, “There should be reduced harm products available to consumers to transition them off of combustible cigarettes.” Dr. Gottlieb recognizes what numerous international health agencies and bodies have – that vapor products are substantially less harmful than cigarettes and should be embraced by the government as low-risk alternatives for smokers. Without a statutory change to TCA by Congress, however, these tens of thousands of smoking cessation products will be illegal in August of next year.

Time is of the essence for many of these businesses, which cannot afford to wait for an administrative delay in deadlines or delayed Congressional action on the 2016 Deeming Rule. The millions of consumers who currently rely on these products as less harmful alternatives to smoking need your help today.

The Cole-Bishop Amendment and House Resolution 1136 would not weaken the TCA or the ability of the FDA to impose additional product standards or regulations on new products in the future. That is precisely why the efforts are bipartisan, because there is recognition that while regulations that protect consumers are important, the Rule imposed burdens that neither protect consumers, nor acknowledge that the consequence will be the new industry’s demise.

The inclusion of the Cole-Bishop Amendment, as it passed the House Appropriations Committee, will provide significant regulatory certainty to tens of thousands of small businesses in the United States. We encourage Congress to adopt the language into the final FY17 omnibus budget. 

The letter and its signers can be read and found here. 

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ATR Urges HHS Secretary Tom Price to Provide Regulatory Relief to Emerging Vapor Market

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Posted by Paul Blair on Wednesday, March 22nd, 2017, 12:09 PM PERMALINK

In a letter to Health and Human Services Secretary Tom Price, ATR president Grover Norquist today asked for an immediate two-year delay of pending pre-market review requirements imposed by the Food and Drug Administration's May 2016 "Deeming Rule." The Rule applies to vapor products, electronic cigarettes, and premium cigars. Absent immediate action by Congress or the Administration to roll back the FDA's new rules, more than ten thousand new businesses in the United States will be required to comply with an application process so expensive and onerous that over the next two years more than 95% of vapor product manufacturers and retail small businesses will be forced to shut down. 

The C.D.C. estimates that more than 9 million U.S. adult consumers use vapor products, which are at least 95% less harmful than cigarettes, according to the Royal College of Physicians and other leading public health organizations. 

Under the new rules, new smoke-free vapor products will be subject to the regulatory review process established in the 2009-passed Tobacco Control Act. From the letter:

"In 2009 when Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA)... the FDA was granted authority to impose new regulations upon tobacco products such as cigarettes, smokeless and roll-your-own tobacco. A “predicate date” of February 15, 2007 was established whereby products on the market at or before this date were exempt from pre-market FDA review. That look-back period was just over two years when the TCA was signed in 2009. The look-back period for newly deemed products is ten years. 

The FDA’s May 2016 Deeming Rule requires products which did not exist in 2007 – such as vapor products – to undergo the pre-market review process set up in the TCA. The process was designed to make it extraordinarily difficult to introduce new products to market, which is why it was supported by organizations like the Campaign for Tobacco-Free Kids."

There were a number of new requirements established in the FDA's May 2016 Rule. 

"The most significant of the requirements imposed by the FDA’s new Deeming Rule is a requirement that all manufacturers of vapor products submit every product currently available to consumers for pre-market review, a process that every single manufacturer of cigarettes in the United State avoided when the TCA was signed into law. The Pre-Market Tobacco Application (PMTA) requires businesses to spend in excess of $300,000 per product and at least 500 hours of time per application. Even if businesses could afford this investment, the process is designed to end in failure. Many small businesses produce hundreds of these products and would be forced to close their doors as a result." 

ATR is requesting a two-year delay in the PMTA filing deadline for newly deemed products. 

I am asking you to delay the PMTA filing deadline by at least two years as Congress considers an alternative approach to regulating these very low risk products. There are multiple efforts with bipartisan support aimed at addressing the issues I’ve outlined, including the Cole-Bishop Amendment to the FY17 House Agriculture Appropriations Bill and House Resolution 1136, also sponsored by Congressman Tom Cole (R-Okla.). It is paramount that Congress acts this year to modernize the February 2007 predicate date for newly deemed products on the market. 

The FDA is an agency of HHS and its commissioner reports to the Secretary of HHS. 

With the emergence of smoke-free vapor products, millions of U.S. adults have successfully quit smoking traditional cigarettes with a variety of products that did not exist in 2007. ​Imposing this retroactive and onerous set of pre-market review rules upon reduced risk products is illogical and stands to harm decades of efforts to reduce the harm assocaited with cigarette use. The original Act was designed to make it extremely difficult to introduce new tobacco products, and not a single cigarette on the market today was forced to go through this review process. ATR strongly encourages HHS and the FDA to rein in this overreach with immediate action to delay all future filing and application deadlines imposed by the FDA's Deeming Rule. 

The full letter can be read here.

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