ARRA News Service
News Blog for social, fiscal & national security conservatives who believe in God, family & the USA. Upholding the rights granted by God & guaranteed by the U.S. Constitution, traditional family values, "republican" principles / ideals, transparent & limited "smaller" government, free markets, lower taxes, due process of law, liberty & individual freedom. Content approval rests with the ARRA News Service Editor. Opinions are those of the authors. While varied positions are reported, beliefs & principles remain fixed. No revenue is generated for or by this "Blog" - no paid ads - no payments for articles. Fair Use Doctrine is posted & used.
Blogger/Editor/Founder: Bill Smith, Ph.D. [aka: OzarkGuru & 2010 AFP National Blogger of the Year]
Contact: editor@arranewsservice.com (Pub. Since July, 2006)
    Home Page
   

One of the penalties for refusing to participate in politics is that you end up being governed by your inferiors. -- Plato (429-347 BC)

Friday, January 29, 2016

Congress Needs to Fix FDA Vapor Rule

by Phil Kerpen, Contributing Author: After a lengthy and heavily contested regulatory process, a final rule deeming vapor products to be subject to pervasive FDA regulation is currently in the White House Office of Management and Budget for a final review before it is published and takes effect this year. Leaks of the purported final rule suggest it remains deeply flawed and will impose a draconian, one-size-fits-all model that risks disrupting the fast-growing vapor industry and denying access to products that pose vastly less health danger than conventional tobacco cigarettes. Unfortunately, in the final negotiations over last year’s omnibus bill a provision addressing this issue was dropped, but that should not be the last word on the issue from Congress.

Mitch Zeller, the FDA’s top tobacco regulator, told Congress “If we could get all of those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.”

Indeed, vapor products are displacing regular cigarettes. The most recent data from the CDC show the percentage of the adult population that smokes has dropped six consecutive years, from 20.6 percent in 2009 to 14.9 percent in the first half of 2015. An estimated two million ex-smokers are using vapor products.

So we’re on the right track, and Zeller warned: “Let’s not lose our focus on what the primary cause is for those 480,000 avoidable deaths each year — it’s primarily burning, combusting cigarettes.”

Unfortunately, his agency is poised to do precisely that with its deeming rule.

“This is not really regulation. It’s prohibition,” says Boston University community health sciences professor Dr. Michael Siegel.

He’s referring to a feature of the rule that sets a grandfather date of February 15, 2007 – effectively denying grandfather status to nearly every vapor product on the market and forcing each to go through a lengthy approval process or be pulled from the market within 24 months.

That date and timeline were established by the Family Smoking Prevention and Tobacco Control Act, passed by Congress in 2009 – and it grandfathered all but the very newest cigarette products. By now deeming vapor products subject to regulation seven years later, the FDA is subjecting these safer products to more draconian regulation.

Jan Verleur, co-founder and CEO of VMR Products, a major manufacturer of vapor devices, said: “It’s essentially a death sentence for industry. It could be held up in litigation for many years.”

That’s only slight hyperbole.

Once the rule is final, manufacturers would be required to submit to the FDA, for each product, a Premarket Tobacco Application (PMTA) or a Substantial Equivalence (SE) report. The PMTA process is complex and expensive and would be challenging for all but the largest manufacturers – the major tobacco companies – to navigate. The SE choice depends upon showing that a predicate product is already approved, but vapor technology is new and rapidly evolving, ruling this option out. The investment driving that innovation would be chilled by time and expense of submitting every product for regulatory approval – and the agency already has a substantial backlog.

The solutions are simple but will require Congress to act quickly, because the rule currently sits at OMB and could be published any day. On the next appropriate must pass vehicle Congress should include language that either delays the rule completely or fixes its most egregious flaws – the imposition of an inappropriate grandfather date and an insufficient approval period. Failure to do so will result in regulating vapor more strictly than cigarettes, destroying thousands of small businesses, and, tragically, likely increasing tobacco-related sickness and death.
---------------------
Phil Kerpen is president of American Commitment. Follow him at (@kerpen) and on Facebook. He is a contributing author at the ARRA News Service.

Tags: Phil Kerpen, American Commitment, FDA, failed, fix, FDA Vapor Rule. Congress, To share or post to your site, click on "Post Link". Please mention / link to the ARRA News Service. and "Like" Facebook Page - Thanks!
Posted by Bill Smith at 10:00 AM - Post Link

0 Comments:

Post a Comment

<< Home


View U.S. National Debt

Don't miss anything!
Subscribe to the
ARRA News Service
It's FREE & No Ads!

You will receive a verification email
& must validate you subscribed!

You Then Receive One Email Each AM
With Prior Days Articles / Toons / More


Also, Join & leave conservative posts & comments on
Facebook.com/ARRANewsService


Recent Posts:
Personal Tweets by the editor:
Dr. Bill - OzarkGuru - @arra
#Christian Conservative; Retired USAF & Grad Professor. Constitution NRA ProLife schoolchoice fairtax - Editor ARRA NEWS SERVICE. THANKS FOR FOLLOWING!

Action Links!
State Upper & Lower House Members
State Attorney Generals
State Governors
The White House
US House of Representatives
US Senators
GrassFire
NumbersUSA
Ballotpedia

Facebook Accts - Dr. Bill Smith
Pages:
ARRA News Service
Arkansans Against Big Government
Alley-White Am. Legion #52
Catholics & Protestants United Against Discrimination
End Taxpayer Funding of NPR
Overturn Roe V. Wade
Prolife Soldiers
Project Wildfire 4 Life
Republican Liberty Caucus of Arkansas
The Gold Standard
US Atty Gen Loretta Lynch, aka Eric Holder, Must Go
Veterans for Sarah Palin
Why Vote for Hillary (Satire)
FB Groups:
Arkansas For Sarah Palin
Arkansas Conservative Caucus
Arkansas County Tea Party
Arkansans' Discussion Group on National Issues
Blogs for Borders
Conservative Solutions
Conservative Voices
Defend Marriage -- Arkansas
FairTax
FairTax Nation
Arkansas for FairTax
Friends of the TEA Party in Arkansas
Freedom Roundtable
Pro-Life Rocks - Arkansas
Republican Network
Republican Liberty Caucus of AR
Reject the U.N.

Patriots
Exchange
Links

Request Via
Article Comment

Links to ARRA News
A Patriotic Nurse
Agora Associates
a12iggymom's Blog
America, You Asked For It!
America's Best Choice
ARRA News Twitter
As The Crackerhead Crumbles
Blogs For Borders
Blogs for Palin
Blow the Trumpet Ministry
Boot Berryism
Cap'n Bob & the Damsel
Chicago Ray Report - Obama Regime Report
Chuck Baldwin - links
Common Cents
Conservative Voices
Diana's Corner
Greater Fitchburg For Life
Lasting Liberty Blog
Liberal Isn't Amy
Marathon Pundit
Patriot's Corner
Right on Issues that Matter
Right Reason
Rocking on the Right Side
Saber Point
Saline Watchdog
Sultan Knish
The Blue Eye View
The Born Again Americans
TEA Party Cartoons
The Foxhole | Unapologetic Patriot
The Liberty Republican
The O Word
The Path to Tyranny Blog
The Real Polichick
The War on Guns
TOTUS
Twitter @ARRA
Underground Notes
Warning Signs
Women's Prayer & Action
WyBlog

Editor's Managed Twitter Accounts
Twitter Dr. Bill Smith @arra
Twitter Arkansas @GOPNetwork
Twitter @BootBerryism
Twitter @SovereignAllies
Twitter @FairTaxNation

Editor's Recommended Orgs
Accuracy in Media (AIM)
American Action Forum (AAF)
American Committment
American Culture & Faith Institute
American Enterprise Institute
American Family Business Institute
Americans for Limited Government
Americans for Prosperity
Americans for Tax Reform
American Security Council Fdn
AR Faith & Ethics Council
Arkansas Policy Foundation
Ayn Rand Institute
Bill of Rights Institute
Campaign for Working Families
CATO Institute
Center for Individual Freedom
Center for Immigration Studies
Center for Just Society
Center for Freedom & Prosperity
Citizens Against Gov't Waste
Citizens in Charge Foundstion
Coalition for the Future American Worker
Competitive Enterprise Institute
Concerned Veterans for America
Concerned Women for America
Declaration of Am. Renewal
Eagle Forum
FairTax
Family Research Council
Family Security Matters
Franklin Center for Gov't & Public Integrity
Freedom Works
Gingrich Productions
Global Incident Map
Great Americans
Gold Standard 2012 Project
Gun Owners of America (GOA)
Heritage Action for America
David Horowitz Freedom Center
Institute For Justice
Institute for Truth in Accounting
Intercollegiate Studies Institute
Judicial Watch
Less Government
Media Reseach Center
National Center for Policy Analysis
National Right To Work Foundation
National Rifle Association (NRA)
National Rifle Association (NRA-ILA)
News Busters
O'Bluejacket's Patriotic Flicks
OathKeepers
Open Secrets
Presidential Prayer Team
Religious Freedom Coalition
Renew America
Ron Paul Institute
State Policy Network
Tax Foundation
Tax Policy Center
The Club for Growth
The Federalist
The Gold Standard Now
The Heritage Foundation
The Leadership Institute
Truth in Accounting
Union Facts



Blogs For Borders

Reject the United Nations

Presidential Prayer Team

Thousands of Deadly Islamic Terror Attacks Since 9/11


FairTax Nation on FaceBook
Friends of Israel - Stand with Israel
Blog Feeds
Syndicated - Get the ARRA News Service feed Syndicated!
ARRA Blog Feed

Add to Google Reader or Homepage

Add to The Free Dictionary

Powered by Blogger


  • To Exchange Links - Email: editor@arranewsservice.com!
  • Comments by contributing authors or other sources do not necessarily reflect the position the editor, other contributing authors, sources, readers, or commenters. No contributors, or editors are paid for articles, images, cartoons, etc. While having reported on and promoting principles & beleifs beliefs of other organizations, this blog/site is soley controlled and supported by the editor. This site/blog does not advertise for money or services nor does it solicit funding for its support.
  • Fair Use: This site/blog may contain copyrighted material the use of which has not been specifically authorized by the copyright owner. Such material is made available to advance understanding of political, human rights, economic, democracy, and social justice issues, etc. This constitutes a 'fair use' of such copyrighted material as provided for in section Title 17 U.S.C. Section 107 of the US Copyright Law. Per said section, the material on this site/blog is distributed without profit to readers to view for the expressed purpose of viewing the included information for research, educational, or satirical purposes. Any person/entity seeking to use copyrighted material shared on this site/blog for purposes that go beyond "fair use," must obtain permission from the copyright owner.
  • © 2006 - 2020 ARRA News Service
Creative Commons License
Creative Commons Attribution Noncommercial Share Alike 3.0 Unported License.