[net-gold] TOBACCO CIGARETTES CIGARS AND SMOKING : MEDICAL: DISEASES: CANCER: Some E-Cigarettes Deliver a Puff of Carcinogens
- From: "David P. Dillard" <jwne@xxxxxxxxxx>
- To: Net-Gold -- Educator Gold <Educator-Gold@xxxxxxxxxxxxxxx>, net-gold@xxxxxxxxxxxxx, Net-Gold <Net-Gold@xxxxxxxxxxxxxxx>, NetGold <netgold@xxxxxxxxxxxxxxx>, K-12ADMINLIFE <K12ADMIN@xxxxxxxxxxxxxxxxxxx>, K12AdminLIFE <K12AdminLIFE@xxxxxxxxxxxxxxx>, MediaMentor <mediamentor@xxxxxxxxxxxxxxx>, Nabble Groups Net-Gold <ml-node+s3172864n3172864h56@xxxxxxxxxxxxx>, Net-Platinum <net-platinum@xxxxxxxxxxxxxxx>, Sean Grigsby <myarchives1@xxxxxxxxxxxxxxx>, Net-Gold <NetGold_general@xxxxxxxxxxxxxxxxx>, Temple Gold Discussion Group <TEMPLE-GOLD@xxxxxxxxxxxxxxxxxxx>, Temple University Net-Gold Archive <net-gold@xxxxxxxxxxxxxxxxxxx>, "Net-Gold @ Wiggio.com" <netgold@xxxxxxxxxxxxxx>, Health Lists -- Health Diet Fitness Recreation Sports <healthrecsport@xxxxxxxxxxxxxxx>, HEALTH-RECREATION-SPORTS-TOURISM@xxxxxxxxxxxxxxxxxxx, Sport-Med <SPORT-MED@xxxxxxxxxxxxxx>, sports-med@xxxxxxxxxxxxxxx, sport-med@xxxxxxxxxxxxxxxxxxx
- Date: Sun, 4 May 2014 17:14:28 -0400 (EDT)
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TOBACCO CIGARETTES CIGARS AND SMOKING :
MEDICAL: DISEASES: CANCER:
Some E-Cigarettes Deliver a Puff of Carcinogens
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Some E-Cigarettes Deliver a Puff of Carcinogens
By MATT RICHTEL
MAY 3, 2014
New York Times
http://www.nytimes.com/2014/05/04/business/
some-e-cigarettes-deliver-a-puff-of-carcinogens.html?ref=todayspaper
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A shorter URL for the above link:
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http://tinyurl.com/o95zlps
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Electronic cigarettes appear to be safer than ordinary cigarettes for one
simple and simply obvious reason: people dont light up and smoke them.
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With the e-cigarettes, there is no burning tobacco to produce myriad new
chemicals, including some 60 carcinogens.
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But new research suggests that, even without a match, some popular
e-cigarettes get so hot that they, too, can produce a handful of the
carcinogens found in cigarettes and at similar levels.
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A study to be published this month in the journal Nicotine and Tobacco
Research found that the high-power e-cigarettes known as tank systems
produce formaldehyde, a known carcinogen, along with the nicotine-laced
vapor that their users inhale. The toxin is formed when liquid nicotine
and other e-cigarette ingredients are subjected to high temperatures,
according to the study. A second study that is being prepared for
submission to the same journal points to similar findings.
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The long-term effects of inhaling nicotine vapor are unclear, but there is
no evidence to date that it causes cancer or heart disease as cigarette
smoking does. Indeed, many researchers agree that e-cigarettes will turn
out to be much safer than conventional cigarettes, an idea that
e-cigarette companies have made much of in their advertising.
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snip
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Nonetheless, the new research suggests how potential health risks are
emerging as the multibillion-dollar e-cigarette business rapidly evolves,
and how regulators are already struggling to keep pace. While the Food and
Drug Administration last month proposed sweeping new rules that for the
first time would extend its authority to e-cigarettes, the F.D.A. has
focused largely on what goes into these products currently, an
unregulated brew of chemicals and flavorings rather than on what comes
out of them, as wispy plumes of flavored vapor.
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The complete articles may be read at the URLs provided for each.
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F.D.A. Will Propose New Regulations for E-Cigarettes
By SABRINA TAVERNISE
APRIL 24, 2014
New York Times
http://www.nytimes.com/2014/04/24/health/
fda-will-propose-new-regulations-for-e-cigarettes.html
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A shorter URL for the above link:
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http://tinyurl.com/p2udpv4
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WASHINGTON The Food and Drug Administration will propose sweeping new
rules on Thursday that for the first time would extend its regulatory
authority from cigarettes to electronic cigarettes, popular nicotine
delivery devices that have grown into a multibillion-dollar business with
virtually no federal oversight or protections for American consumers.
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The regulatory blueprint, with broad implications for public health, the
tobacco industry and the nations 42 million smokers, would also cover pipe
tobacco and cigars, tobacco products that have long slid under the
regulatory radar and whose use has risen sharply in recent years. The new
regulations would ban the sale of e-cigarettes, cigars and pipe tobacco to
Americans under 18, and would require that people buying them show photo
identification to prove their age, measures already mandated in a number
of states.
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The e-cigarette industry is fighting for the right to exist, despite all
the evidence that it is significantly safer than tobacco cigarettes.
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Once finalized, the regulations will establish oversight of what has been
a market free-for-all of products, including vials of liquid nicotine of
varying quality and unknown provenance. It has taken the agency four years
since Congress passed a major tobacco-control law in 2009 to get to this
stage, and federal officials and advocates say it will take at least
another year for the rules to take effect and possibly significantly
longer if affected companies sue to block them.
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If it takes more than a year to finalize this rule, the F.D.A. isnt doing
its job, said Matthew Myers, president of the Campaign for Tobacco-Free
Kids, an advocacy group.
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Thursdays release of the blueprint which is hundreds of pages long is
sure to set off a frantic lobbying effort in Washington as affected
industries try to head off the costliest, most restrictive regulations.
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Members of the Smoke Free Alternatives Trade Association, one of the
e-cigarette industry trade groups, descended on Washington in November,
and reported holding nearly 50 meetings with congressional officials to
help them learn more about the negative impact inappropriate regulation
could have on this nascent industry, the group said in a statement.
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The industry has several trade associations, and a number of them have met
with Obama administration officials about the regulations over the past
several months, according to public records and industry group statements.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA-2014-N-0189]
RIN 0910-AG38
https://s3.amazonaws.com/public-inspection.
federalregister.gov/2014-09491.pdf
OR
http://tinyurl.com/l6o3mxm
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Deeming Tobacco Products To Be Subject to th e Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco
Control Act; Regulations on the Sale and Distribution of Tobacco Products
and Requi red Warning Statements for Tobacco Products AGENCY: Food and
Drug Administration,
HHS. ACTION:
Proposed rule.
SUMMARY:
The Food and Drug Administration (FDA) is proposing to deem products
meeting the statutory definition of "tobacco product," exce pt accessories
of a proposed deemed tobacco product, to be subject to the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco
Control Act provides FDA authority to regulate cigarettes , cigarette
tobacco, roll-your- own tobacco, smokeless tobacco, and any other to bacco
products that the Agency by regulation deems to be subject to the law.
Option 1 of the proposed rule would extend the Agency's "tobacco product"
authorities in the FD&C Act to all other categories of products, except
accessories of a proposed deemed tobacco product, that meet the statutory
definition of "tobacco product" in the FD&C Act. Option 2 of the pr oposed
rule would extend the Agency's "tobacco product" authorities to all ot her
categories of pr oducts, except premium cigars and the accessories of a
proposed deemed tobacco product, that meet the statutory definition of
"tobacco
2
product" in the FD&C Act. FDA also is propos ing to prohibit the sale of
"covered tobacco products" to individuals under the age of 18 and to
require the di splay of health warnings on cigarette tobacco, roll-your
own tobacco, and covered tobacco product packages and in advertisements.
FDA is taking this action to addr ess the public health conc erns
associated with the use of tobacco products. DATES: Submit either
electronic or written comments on the proposed rule by [INSERT DATE 75
DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Submit comments
on information collection issues under the Paperwork Reduction Act of 1995
(the PRA) by [INSERT DATE 30 DAYS AFTER DA TE OF PUBLICATION IN THE
FEDERAL REGISTER], (see the "Paperwork Reduction Act of 1995" section).
ADDRESSES: You may submit comments, iden tified by Docket No.
FDA-2014-N-0189 and/or Regulatory Information Number (RIN) 0910-AG 38, by
any of the following methods, except that comments on information
collection issues under the PRA must be submitted to the Office of
Information and Regulatory Affairs, Offi ce of Management and Budget (OMB)
(see the "Paperwork Reduction Act of 1995" section). Electronic
Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal:
http://www.regulations.gov
. Follow the instructions for submitting comments. Written Submissions
Submit written submissions in the following ways:
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Mail/Hand delivery/Courier (for paper subm issions): Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name,
Docket No. FDA- 2014-N-0189, and RIN 0910-AG38 for this rulemaking. All
comments received may be posted without change to
http://www.regulations.gov
, including any personal information provided. For additional information
on submitting comments, see the "Comments" heading of the SUPPLEMENTARY
INFORMATION section. Docket: For access to the docket to read b ackground
documents or comments received, go to
http://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the "Search" box and fo llow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers La ne, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Gerie Voss, Office of Regulations, Center
for Tobacco Products, Food and Drug Administra tion, 9200 Corporate Blvd.,
Rockville, MD 20850-
3229, 877-287-1373,
CTPRegulations@xxxxxxxxxxx
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SUPPLEMENTARY INFORMATION:
Table of Contents
Executive Summary
I. Legal Authority
II. Background for Deeming All Tobacco Pr oducts To Be Subject to the FD&C
Act
III. Continuum of Nicoti ne-Delivering Products
IV. Deeming Tobacco Products To Be Subject to the FD&C Act
A. Public Health Benefits of Deeming
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B. The Sottera Decision
C. Options for Premium Cigars and Re quest for Comments Regarding Scope
D. Request for Comments Regard ing Regulation of E-Cigarettes
E. Request for Comments Regarding Components, Parts, and Accessories
V. Basis for Additional Provisions
A. Addictive Nature of Products
B. Health Risks of Products
C. Consumer Confusion and Misinformati on About Certain Covered Tobacco
Products
D. Use as Starter Products or Dual Use With Other Tobacco Products
VI. Proposed Minimum Age and Identification Restrictions
A. Effectiveness of Proposed Restri ctions and Section 906(d) Standard
B. Application to Proposed Vending Machine Restrictions
VII. Proposed Required Warning Statements
A. Requiring Health Warnings Is Appropriate for the Protection of the
Public Health
B. Effectiveness of Warnings
C. Proposed Addictiveness Warning
D. Age of Initiati on for Cigar Smokers
E. Proposed Required Warning Statements for Small and Large Cigars
VIII. Description of the Proposed Rule
A. Proposed Part 1100--Tobacco Pro ducts Subject to FDA Authority
B. Proposed Changes to Part 1140--Cigar ettes, Smokeless Tobacco, and
Covered Tobacco Products
C. Proposed Part 1143--Required Warning Statements
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IX. Paperwork Reduction Act of 1995
A. Existing Burdens Associated With Tobacco Products Currently Subject to
the FD&C Act (i.e., Cigarettes, Cigarette Tobacco, Roll-Your-Own Tobacco,
and Smokeless Tobacco) With Approved OMB Control Numbers
B. Burdens Associated With Tobacco Products Currently Subject to the FD&C
Act But Not Yet Approved by OMB
C. New Collections of Information That Apply Only to Proposed Deemed
Tobacco Products
X. Executive Order 13132; Federalism
XI. Environmental Impact
XII. Analysis of Impacts: Summary
XIII. Request for Comments
A. General Information About Submitting Comments
B. Public Availability of Comments
C. Information Identifying the Person Submitting the Comment
XIV. References
Executive Summary
Purpose of the Proposed Rule Cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco were immediately covered by FDA's tobacco
product aut horities in chapter IX of the FD&C Act (21 U.S.C. 387 through
387u) when the Tobacco Control Act went into effect. For other kinds of
tobacco products, FDA has authority to issue regulations to bring them
under the law by "deeming" them to be subject to such authoriti es.
Consistent with the statute, once a tobacco
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product is deemed, FDA may put in place "restrictions on the sale and
distribution of a tobacco product," including age-rela ted access
restrictions and advertis ing and promotion restrictions, if FDA
determines the restrictions are appropriate for the protec tion of the
public health. The proposed rule has two purposes: (1) To deem pr oducts
that meet the definition of "tobacco product" under the law except a
ccessories of a proposed deemed tobacco product and subject them to the
tobacco control authorities in the FD&C Act and (2) to apply specific
provisions that are appropriate for the protection of the public health to
deemed tobacco products. To satisfy these purposes, FDA is proposing two
options (Option 1 and Option 2), which would provide two alternatives for
the scope of the deeming pr ovisions and, consequently, the application of
the additional specific provisions.
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Sincerely,
David Dillard
Temple University
(215) 204 - 4584
jwne@xxxxxxxxxx
http://workface.com/e/daviddillard
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