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Dec 24, 2012
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Can one of my American brothers explain to me the logic behind the February 15, 2007 deeming date?
I mean, if you believe that tobacco should be regulated to protect the health of the citizenry, then regulate it all? What is the logic behind saying that blends realeased after a certain date should be closely (and expensively) scrutinized from a health perspective, but those in the market on or before that date get a pass?
I realize that I will get some replies to the effect that logic has nothing to do with it, but surely Congress and the FDA have at least tried to ascribe some logic to the arbitary dividing line, however thinly veiled (or even illogical) that logic may be to you or I. Was the date written on a cocktail napkin and pulled out of a hat at some drunken Washington party?

 

bobpnm

Lifer
Jul 24, 2012
1,543
10,400
Panama City, Florida
2009 law. Family Smoking Prevntion and Tobacco Control Act. The are citing this law as their authority. 2007 must be significant date for some reason.

 

jitterbugdude

Part of the Furniture Now
Mar 25, 2014
993
8
Just a guess but if it true that big tobacco was behind this law then a date was chosen that would put 90% of the vape companies out of business thus driving former vapers back to cigarettes.

 

checotah

Part of the Furniture Now
Feb 7, 2012
504
3
Follow the money, Peck. It has nothing to do with logic or safety.

 

jackswilling

Lifer
Feb 15, 2015
1,777
24
It was the date the bill was introduced. Subsequently signed into law in 2009. The deeming date will be advanced to May 2016 if a House bill, which made it out of committee, becomes law.

 

jackswilling

Lifer
Feb 15, 2015
1,777
24
The E-Cig myth has been debunked many, many, many times. There was no E-Cig market as we know it when this was passed. This is simply an anti-tobacco bill. Nothing more. E-Cigs got caught in the cross-fire, an unintended consequence, which may well save us in changing the deeming date. The E-Cig businesses are helping us incidentally, and they are a force compared to the pipe clan.

 

sablebrush52

The Bard Of Barlings
Jun 15, 2013
19,621
44,832
Southern Oregon
jrs457.wixsite.com
The E-Cig myth has been debunked many, many, many times. There was no E-Cig market as we know it when this was passed. This is simply an anti-tobacco bill. Nothing more. E-Cigs got caught in the cross-fire, an unintended consequence, which may well save us in changing the deeming date. The E-Cig businesses are helping us incidentally, and they are a force compared to the pipe clan.
Actually there was an E-Cig market well before the law was passed. Back in 2006, while I was working on Dan VS., people started bringing these cigarette-like things into the studio, and puffing on them like there was no tomorrow, because there weren't any statutes on the books forbidding smoking them indoors. The vaping business appeared shortly thereafter, but E-Cigs were already popular way before the 2009 law. It might not have been the billion dollar business it now is, but it was growing.

 

jmatt

Part of the Furniture Now
Aug 25, 2014
770
74
The original law giving the FDA authority to regulate tobacco was effective February 2007. This new administrative action "deemed" cigars, e-cigs, and pipe tobacco, to be under FDA's control as well, which means they were effectively backwards regulated to the original effective date.

 

jackswilling

Lifer
Feb 15, 2015
1,777
24
"Actually there was an E-Cig market well before the law was passed."
No debating that, but the law had nothing to do with E-Cigs. That is a fact. E-Cigs were sucked-in ex post facto, as noted. I was careful to not imply there was no E-Cig market, which is why I stated:

"There was no E-Cig market as we know it when this was passed."

 
Jun 27, 2016
1,273
117
I read anecdotally that only one major tobacco company had an e-cig product on the market through that date, which is why it was chosen. They lobbied for the date and one would think that they would be the only game in town with the e-cigs until someone else pays for their own product to be approved.

 

jmatt

Part of the Furniture Now
Aug 25, 2014
770
74
The original law was unquestionably passed with no thought of e-cigs in mind. The present "deeming" is absolutely designed to kill the e-cig market. Using the 2007 date just conveniently brings virtually all (but no, not all) of the current e-cig universe under FDA control. Incidentally, the other prime driver is bogus roll-your-own tobacco mis-labeling itself as pipe tobacco.
If you want to take the time, read the full FDA comments, which recite the feedback they got, and explain their rationale point-by-point-by-point. I'm a glutton for punishment, so I've done exactly that.

 

jackswilling

Lifer
Feb 15, 2015
1,777
24
Some weak stuff here. Why don't you two put up or shut up. Better yet, here:
"The regulations establish oversight of what has been a market free-for-all of products, including vials of liquid nicotine of varying quality and unknown provenance. Finalizing the rules has taken years. They stem from a major tobacco-control law Congress passed in 2009 and were first proposed in draft form in 2014."

http://www.nytimes.com/2016/05/06/science/fda-rules-electronic-cigarettes.html?_r=0
This is common knowledge. The E-Cig regulations were first drafted in 2014 and enacted ion 2016. Here is the original bill fro 2009 which, not surprisingly does not mention E-Cigs, as it never occurred to anyone, FDA, democrats, anyone to regulate E-Cigs in 2009:
Summary: H.R.1256 — 111th Congress (2009-2010)All Bill Information (Except Text)
Listen to this page

There are 6 summaries for H.R.1256. GO

Bill summaries are authored by CRS.

Shown Here:

Public Law No: 111-31 (06/22/2009)
(This measure has not been amended since it was passed by the Senate on June 11, 2009. The summary of that version is repeated here.)
Division A: Family Smoking Prevention and Tobacco Control Act - Family Smoking Prevention and Tobacco Control Act - Title I: Authority of the Food and Drug Administration - (Sec. 101) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration (FDA).
Defines a tobacco product as any product made or derived from tobacco that is intended for human consumption. Prohibits a tobacco product from being marketed in combination with any other article or product regulated under FFDCA. Requires the Secretary to regulate tobacco products. Excludes from FDA authority: (1) the tobacco leaf that is not in the possession of a tobacco product manufacturer; (2) the producers of the tobacco leaf, unless the producer is also a manufacturer; and (3) tobacco farms.
Directs the Secretary to establish within FDA: (1) the Center for Tobacco Products to implement this Act; and (2) an identifiable office to provide technical and other nonfinancial assistance to assist small tobacco product manufacturers in complying with this Act.
Deems a tobacco product to be adulterated if: (1) it contains any filthy, putrid, or decomposed substance or is contaminated by any added poisonous or deleterious substance that may render the product injurious to health; (2) it has been prepared, packed, or held under unsanitary conditions; (3) its package is composed of any poisonous or deleterious substance; (4) the manufacturer or importer of the product fails to pay the assessed user fee; (5) it fails to meet specified tobacco product standards; (6) it does not have required premarket review; (7) it fails to meet applicable requirements or conditions on manufacturing, packing, or storage; or (8) it fails to conform to requirements for modified risk tobacco products.
Deems a tobacco product to be misbranded if: (1) its labeling, packaging, or advertising contains any false or misleading information; (2) its label or advertising fails to contain all required information displayed prominently and conspicuously, including its established name, manufacturer, and contents and adequate directions and warnings; (3) it was manufactured, prepared, or processed in an establishment not registered with the Secretary; or (4) there is any failure to submit the required information or notices to the Secretary. Allows the Secretary to require prior approval of all label statements on tobacco products to ensure that such statements: (1) do not violate misbranding provisions; and (2) comply with other provisions of this Act.
Requires tobacco product manufacturers or importers to submit to the Secretary: (1) a listing of all ingredients, including ingredients added by the manufacturer to the tobacco, paper, or filter, by brand and quantity; (2) a description of the content, delivery, and form of nicotine in each tobacco product; (3) a listing of all constituents, including smoke constituents, identified by the Secretary as harmful or potentially harmful to health in each tobacco product; and (4) all documents developed that relate to the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents, ingredients, components, and additives.
Allows the Secretary to request additional information from a tobacco product manufacturer or importer relating to: (1) research activities or findings on the effects of tobacco products and their constituents and on whether the health risk can be reduced if the manufacturer employs known or available technology; and (2) marketing research or practices used by manufacturers or distributors.
Sets forth notifications that manufacturers must make to the Secretary regarding any change in a tobacco product.
Requires the Secretary to publicly display and annually publish a list (that is understandable and not misleading to a lay person) of harmful or potentially harmful constituents in each tobacco product by brand and quantity.
Requires owners and operators of establishments in the United States engaged in the manufacture, preparation, compounding, or processing of a tobacco product to register annually with the Secretary. Allows the Secretary to prescribe a uniform system for the identification of tobacco products, which registrants must use. Requires the Secretary to make such registration information available to the public and to inspect registered establishments every two years.
Requires foreign establishments to register and ensure that adequate and effective means are available to determine whether their tobacco products conform with FFDCA requirements.
Prohibits the disclosure of privileged or confidential trade secrets and commercial financial information that is obtained by the Secretary.
Allows the Secretary to restrict: (1) the sale or distribution of tobacco products if appropriate for the protection of the public health; and (2) the advertising and promotion of tobacco products consistent with, and to the full extent permitted by, the First Amendment. Prohibits restrictions that: (1) limit the sale or distribution of a tobacco product to written or oral authorization by a practitioner licensed to prescribe medicine; (2) prohibit the sale of a tobacco product in face-to-face transactions by a specific category of retail outlets; or (3) establish a minimum age of sale of tobacco products to any person older than 18 years of age.
Requires the Secretary to promulgate regulations to prevent the sale and distribution of tobacco products to minors through means other than a direct, face-to-face exchange between a retailer and a consumer.
Directs the Secretary to prescribe regulations to protect the public health and assure that tobacco products are in compliance with this Act by requiring good manufacturing practices or hazard analysis and critical control point methodology. Requires the Secretary to: (1) provide a reasonable period for manufacturers to conform to good manufacturing practices; and (2) not require any small tobacco product manufacturer to comply with such regulations for at least four years. Allows the Secretary to grant exemptions and variances from such regulations under certain circumstances.
Allows the Secretary to enter into contracts for research, testing, and demonstrations respecting tobacco products and to obtain tobacco products for such purposes.
Prohibits a cigarette or any of its components from containing as a constituent or additive any artificial or natural flavor (other than tobacco or menthol) or any herb or spice (including strawberry, grape, orange, clove, cinnamon, and vanilla) that is a characterizing flavor of the tobacco product or tobacco smoke. Prohibits a tobacco product manufacturer from using tobacco, including foreign grown tobacco, that contains a pesticide chemical residue at a level greater than any tolerance applicable to domestically grown tobacco. Allows the Secretary to adopt additional tobacco product standards as appropriate to protect the public health, which may include standards for: (1) reducing nicotine yields; (2) reducing or eliminating other constituents or harmful components; and (3) product testing. Allows the Secretary to amend or revoke a tobacco product standard.
Prohibits the Secretary from: (1) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or (2) requiring the reduction of nicotine yields of a tobacco product to zero.
Requires the Secretary to refer to the Tobacco Products Scientific Advisory Committee for report and recommendation the issues of: (1) the impact of the use of menthol in cigarettes on the public health, including such use among children, African Americans, Hispanics, and other racial and ethnic minorities; and (2) the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.
Allows the Secretary to notify the public if a tobacco product poses an unreasonable risk of substantial harm to the public health. Requires the Secretary to order a cease in distribution and a recall (after a hearing) of a tobacco product if there is a reasonable probability that it contains a defect not ordinarily contained in tobacco products that would cause serious, adverse health consequences or death.
Requires manufacturers and importers to comply with record keeping and reporting requirements established by the Secretary, such as informing the Secretary of any information that reasonably suggests that a marketed tobacco product may have caused or contributed to a serious unexpected adverse experience. Prohibits the Secretary from: (1) imposing unduly burdensome requirements; or (2) requiring that the identity of any patient or user be disclosed unless required for the medical welfare of an individual, to determine risks to the public health, or to verify information. Requires the Secretary to have due regard for the ethics of the medical profession.
Directs the Secretary to require prompt notification by manufacturers and importers of any corrective action taken or any removal from the market of a tobacco product to reduce a health risk posed by the product or to remedy a violation of this Act that may present such a risk.
Requires premarket approval of all new tobacco products (products not substantially equivalent to an existing tobacco product) commercially marketed after February 15, 2007. Defines "substantially equivalent" as having the same characteristics or having different characteristics but not raising different questions of public health.
Sets forth an application process for premarket approval of a new tobacco product, including health information that must be included. Authorizes the Secretary to: (1) allow, prohibit, or restrict distribution of such a tobacco product; and (2) temporarily suspend an application if the probability that continued distribution would cause serious, adverse health consequences or death is greater than that for tobacco products on the market.
Prohibits the sale of any modified risk tobacco product unless an order is issued by the Secretary. Defines a "modified risk tobacco product" as any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related diseases associated with commercially marketed tobacco products, specifically products where: (1) the labeling or advertising represents that the product presents a lower risk of tobacco-related disease or is less harmful than other tobacco products, contains a reduced level of or presents a reduced exposure to a substance, or is free of a substance; (2) the labeling or advertising uses descriptors such as "light," "mild," or "low"; or (3) the product manufacturer has taken action reasonably expected to result in consumers believing that the product or its smoke presents a lower risk of disease, is less harmful, presents a reduced exposure, or is free of a substance.
Sets forth requirements for filing with the Secretary an application for a modified risk tobacco product.
Directs the Secretary to issue an order that a modified risk tobacco product may be commercially marketed only if the Secretary determines that an applicant has demonstrated that such product, as it is actually used by consumers, will: (1) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (2) benefit the health of the population as a whole including users and nonusers of tobacco.
Allows the Secretary to issue an order allowing the sale of a tobacco product that may not be commercially marketed as a modified risk tobacco product for five years if certain requirements are met, including that: (1) such order would be appropriate to promote the public health; and (2) issuing such an order is expected to benefit the health of the population as a whole.
Requires the Secretary to require that advertising and labeling concerning modified risk tobacco products enable the public to understand the information and its significance in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products.
Directs the Secretary to require that the results of postmarket surveillance and studies on modified risk tobacco products be submitted annually.
Sets forth procedures for the withdrawal of an order allowing commercial distribution of a modified risk tobacco product.
Prohibits distributors from taking any action that would reasonably be expected to result in consumers believing that a tobacco product or its smoke may present a lower risk of disease or is less harmful than other tobacco products.
Sets forth provisions regarding the judicial review of regulations and denied applications for new tobacco products.
Requires the Secretary to require retail establishments for which the predominant business is the sale of tobacco products to comply with advertising restrictions applicable to retail establishments accessible to individuals under the age of 18.
Deems any violation of this Act pertaining to advertising to be an unfair or deceptive act or practice under the Federal Trade Commission (FTC) Act. Requires the Chairman of FTC to coordinate with the Secretary concerning enforcement of the FTC Act for the advertisement of cigarettes or smokeless tobacco. Requires the Secretary to consult with the Chairman in revising the label statements and requirements for tobacco products under the FTC Act.
Requires the Secretary, acting through the Commissioner of FDA, to promulgate regulations under this Act within two years that require the testing and reporting of tobacco product constituents, ingredients, and additives that the Secretary determines should be tested to protect the public health. Gives the Secretary the authority to conduct or require the testing, reporting, or disclosure of tobacco product constituents.
Delays the imposition of such testing regulations on small tobacco product manufacturers. Allows additional such delays under certain circumstances. Sets forth provisions governing testing by such manufacturers.
Declares that this Act does not: (1) prohibit federal agencies, states, political subdivisions, or Indian tribes from enacting additional or more stringent measures, except requirements relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products; (2) prohibit state, tribal, or local taxation of tobacco products; and (3) modify or affect the liability of any person under the product liability laws of any state.
Requires the Secretary to establish a Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to the Secretary, including on the effects of altering nicotine yields from tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved.
Requires the Secretary to consider: (1) designating products for smoking cessation, including nicotine replacement products, as fast track research and approval products; (2) approving the extended use of nicotine replacement products for the treatment of tobacco dependence; and (3) evidence for additional indications for such products.
Directs the Secretary to report to Congress on how best to regulate, promote, and encourage the development of innovative products and treatments to better achieve, in a manner that best protects and promotes the public health: (1) total abstinence from tobacco use; (2) reductions in consumption of tobacco; and (3) reductions in the harm associated with continued tobacco use.
Requires the Secretary to assess a quarterly user fee on manufacturers and importers of tobacco products based on the class of tobacco product and the company market share to pay for the costs of tobacco regulation activities. Requires that FDA funds (excluding user fees) used before October 1, 2009, on such activities be reimbursed.
(Sec. 102) Requires the Secretary to publish a final rule regarding cigarettes and smokeless tobacco that is identical to regulations promulgated by the Secretary on August 28, 1996, that set out restrictions under FFDCA on the sale, distribution, and use of cigarettes and smokeless tobacco that contain nicotine, except for labeling requirements. Sets forth provisions governing the distribution of free samples of cigarettes, smokeless tobacco, or other tobacco products. Limits the effect of specified advisory opinions and prohibits the Secretary and FDA from citing them as binding precedent.
(Sec. 103) Adds tobacco related violations to the list of prohibited acts under FFDCA. Prohibits the charitable distribution of tobacco products. Prohibits making any statement or representation directed to consumers in a label or labeling or through the media or advertising of a tobacco product that either conveys, or misleads or would mislead consumers into believing, that: (1) the product is approved by FDA; (2) FDA deems the product to be safe for use by consumers; (3) the product is endorsed by FDA for use by consumers; or (4) the product is safe or less harmful by virtue of its regulation or inspection by FDA or its compliance with regulatory requirements set by FDA.
Allows the Secretary to impose a no-tobacco-sale order at retail outlets for repeated violations of restrictions on the sale of tobacco products. Sets forth civil monetary penalties for violations of FFDCA related to tobacco products
Requires the Secretary to submit a report to the relevant committees on: (1) the nature, extent, and destination of U.S. tobacco product exports that do not conform to tobacco product standards established under this Act; (2) the public health implications of such exports; and (3) recommendations or assessments of policy alternatives available to reduce any negative public health impact.
Sets forth provisions providing for notice of violations to retailers.
(Sec. 104) Directs the Secretary to convene an expert panel to study the public health implications of raising the minimum age to purchase tobacco products.
(Sec. 105) Requires the Secretary to develop an action plan to enforce restrictions on the promotion and advertising of menthol and other cigarettes to youth.
(Sec. 106) Directs the Secretary to report to specified congressional committees on FDA's progress in implementing this Act.
Directs the Comptroller General to study and report to such committees on: (1) the adequacy of the authority and resources provided to the Secretary to carry out the goals and purposes of this Act; and (2) any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco products.
Title II: Tobacco Product Warnings; Constituent and Smoke Constituent Disclosure - (Sec. 201) Amends the Federal Cigarette Labeling and Advertising Act to prohibit any person from manufacturing, packaging, selling, offering to sell, distributing, or importing for sale or distribution within the United States any cigarettes the packages of which fail to bear specified warning labels. Specifies the location, size, type size, and color of such labeling.
Prohibits tobacco product manufacturers, importers, distributors, or retailers to advertise cigarettes within the United States without specified labeling. Specifies the location, size, type size, color, and border of warning labels for different types of advertisements.
Directs the Secretary to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany cigarette label statements.
(Sec. 202) Allows the Secretary to alter label requirements to promote greater public understanding of the risks associated with the use of tobacco products.
(Sec. 203) Allows states or localities to impose specific bans or restrictions on the time, place, and manner, but not the content, of the advertising or promotion of any cigarettes.
(Sec. 204) Amends the Comprehensive Smokeless Tobacco Health Education Act of 1986 to apply the same restrictions on labeling and advertising to smokeless tobacco products.
(Sec. 206) Requires the Secretary to determine whether manufacturers should be required to include on the label and advertisements the tar and nicotine yields of the product. Allows the Secretary to require disclosure of the level of constituents in a tobacco product if such disclosures would benefit the public health or increase consumer awareness of the health consequences of the use of tobacco products.
Title III: Prevention of Illicit Trade in Tobacco Products - (Sec. 301) Sets forth labeling, inspection, and record keeping requirements to prevent the illicit trade, smuggling, or counterfeiting of tobacco products.
Requires a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury promptly of any knowledge that reasonably supports the conclusion that a tobacco product manufactured or distributed has left its control and may be or has been: (1) imported, exported, distributed, or sold without paying duties or taxes; or (2) diverted for possible illicit marketing.
(Sec. 302) Requires the Comptroller General to conduct a study to collect data on cross-border trades and advertising in tobacco products and the health effects resulting from such trades and to make recommendations on monitoring such trades and preventing or eliminating such advertising.
Division B: Federal Retirement Reform Act - Federal Retirement Reform Act of 2009 - Title I: Provisions Relating to Federal Employees Retirement - (Sec. 101) Thrift Savings Plan Enhancement Act of 2009 - Requires the Executive Director of the Federal Retirement Thrift Investment Board to provide for: (1) automatic enrollment in the Thrift Savings Plan (TSP) at a specified default percentage (between 2% and 5%) of basic pay of anyone appointed, transferred, or reappointed to a position in which that individual is eligible to contribute to TSP; and (2) the inclusion in TSP of a qualified Roth contribution program.
(Sec. 104) Authorizes the Board to include a mutual fund window under TSP, if such window would be in the best interest of participants.
(Sec. 105) Sets forth reporting requirements related to the operation of TSP.
(Sec. 106) Requires any participant who elects to invest in any investment fund or option other than the G Fund to sign an acknowledgment that the participant is not protected by the government against any loss on such investments and that a return on such investment is not guaranteed by the government.
Provides that a fiduciary shall not be liable and no civil action may be brought against a fiduciary for: (1) providing for the automatic enrollment of a participant; (2) enrolling a participant in a default investment fund; or (3) allowing a participant to invest through the mutual fund window or establishing restrictions applicable to a participant's ability to invest through such a window.
(Sec. 107) Gives the Executive Director authority to issue subpoenas to obtain materials.
(Sec. 108) Revises provisions regarding the legal proceedings to which TSP funds are subject.
(Sec. 109) Sets forth terms under which a surviving spouse may maintain the portion of a TSP account to which he or she is entitled.
(Sec. 110) Directs the Secretary of Defense to report to Congress on the cost, and the effect on recruitment and retention, of providing a matching payment for TSP contributions by members of the Armed Forces.
Title II: Special Survivor Indemnity Allowance for Surviving Spouses of Armed Forces Members - (Sec. 201) Increases the monthly special survivor indemnity allowance paid to surviving spouses of members of the uniformed services who have had their survivor benefit plan annuity reduced due to dependency and indemnity compensation payments.

 

jackswilling

Lifer
Feb 15, 2015
1,777
24
BTW, this ^^^ partially answers Peck's original question. The answer is that it is in this dumb-ass bill.
"Requires premarket approval of all new tobacco products (products not substantially equivalent to an existing tobacco product) commercially marketed after February 15, 2007. Defines "substantially equivalent" as having the same characteristics or having different characteristics but not raising different questions of public health."

 

jackswilling

Lifer
Feb 15, 2015
1,777
24
The Vape lobby has provided the answer to Peck's question and more on the E-Cig Myth:
What is the Grandfather Date of the Tobacco Control Act & How Will it Impact the Vapor Industry?
August 4, 2015/in SFATA Blog /by robertsfata

By Bill Godshall, Executive Director, Smokefree Pennsylvania

Although the FDA has promoted its proposed deeming rule as a reasonable regulation to protect children, the agency’s proposal would ban the sale of most nicotine vapor products on the market because the Tobacco Control Act established February 15, 2007 as the “grandfather date,” which is the date for any tobacco product regulated by Chapter IX (including newly deemed products) to be sold on the U.S. market, and avoids having companies submit (and FDA approve) a PreMarket Tobacco Application (PMTA). Virtually no vapor products were on the market at that time, so the time-consuming and expensive PMTA is the only legal pathway for all other vapor products”.[/u] This is why moving the “grandfather date” is so important. Complicating the issue, the FDA has also claimed, “We do not believe that we have the authority to alter or amend this grandfather date.”
In the originally introduced Tobacco Control Act legislation in 2004 (negotiated and agreed to by Phillip Morris, the Center for Tobacco Free Kids’ Matt Myers and then Glaxo Smith Klein lobbyist Mitch Zeller), the grandfather date was set at June 30, 2003. When the legislation was reintroduced in 2005, the grandfather date was then changed to February 15, 2005, and later to February 15, 2007 when it was reintroduced in 2007, which remained when the legislation was reintroduced, again, in 2009; probably in an attempt to ban several recently introduced smokeless tobacco products by Reynolds.
Just one e-cigarette product has been found that was on the market prior to the Tobacco Control Act’s 2007 grandfather date — a first generation e-cigar manufactured by NJOY.
But the manufacturers of an estimated 100,000+ different nicotine vapor products now on the market (including all nicotine containing e-liquids) would be required to submit a PMTA for each SKU (stock keeping unit). The FDA would have to approve the PMTA in order for the product to remain legal to market 24 months after issuance of its final rule. The FDA’s deeming regulation basically redefines all nicotine vapor products introduced since 2007 as new tobacco products, thus requiring FDA approval of a PMTA to keep these so-called “new” tobacco products legal to market to adults.
In 2011, the FDA issued its “Draft Guidance for Applications for Premarket Review of New Tobacco Products” that listed some of the many different requirements for submitting a PMTA.
To date, the FDA issued a Refused to File (RTF) for the four PMTAs that were submitted (for cigarettes, RYO and/or smokeless tobacco products) to the agency, and in 2014, it issued a brief summary of RTF determinations.
The FDA’s proposed deeming regulation states: “We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.“ Amazingly, the FDA’s deeming regulation estimated it would cost an average applicant just 5,000 staff hours (i.e., 2.5 full time employees working for one year) and just $333,554 to submit a PMTA.
In sharp contrast, a recent Wall Street Journal article cited the regulatory consulting company Sci-Lucent LLC estimating it would cost $2-$10 million to submit a PMTA, while my 2014 comment to FDA estimated it would cost $3-$20 million to submit a PMTA that FDA would actually evaluate.
Please note that Philip Morris International has already spent $2 billion in research and development for its new low-risk tobacco and nicotine products.
One estimate in FDA’s proposed deeming regulation probably closest to reality is the agency’s estimate that 25 PMTAs would be submitted annually for different e-cigarette products. Those PMTAs would likely to be submitted for cig-alike products by Altria, Reynolds, Imperial, BAT, PMI, JTI and perhaps NJOY. But even if FDA approved all PMTAs submitted for e-cigarettes prior to the FDA’s e-cigarette ban 24 months following final rule issuance, the agency has estimated the deeming regulation would ban >98.5% of the agency’s grossly underestimated 1,675 different e-cigarette products on the U.S. market. So the FDA has essentially acknowledged that the deeming regulation would ban nearly all e-cigarette products now on the market, and creates a new e-cigarette cartel controlled by several large manufacturers.
Even worse for vapor product industry is that FDA’s proposed deeming regulation would effectively ban the sale of all bottles of nicotine containing e-liquid because FDA would require manufacturers to submit studies and lab tests of each e-liquid product when used with each of the hundreds (or thousands) of different premium vaporizers, or open tank systems on the market.
Thankfully, US Representative Tom Cole (R-OK) has introduced a bill (HR 2058) which would change the Tobacco Control Act’s February 15, 2007 grandfather date for e-cigarettes (and other newly deemed tobacco products) to the date of the FDA’s final rule issuance The bill currently has 24 cosponsors.
Concurrently, the US House Appropriations Committee recently approved a bill that would prohibit the FDA from spending federal funds to enforce the deeming regulation’s 2007 grandfather date (Section 747, page 86), but still would allow the agency regulatory oversight if the grandfather date is changed.
Although these legislative options would keep all e-cigarettes currently on the market legal to make and sell in the future, both still require FDA approval of PMTA’s for all new e-cigarette products following issuance of the Deeming regulation’s final rule.
All nicotine vapor companies (including all vape shops) are urged to contact their members of Congress, explain how the FDA’s proposed deeming regulation would impact their ability to manufacture and market vapor products, and urge them to support measures to not only move the grandfather date and continue to sell these product to adults, but not stifle an industry that is creating jobs and has the potential to reduce the public harm caused by smoking.
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http://sfata.org/what-is-the-grandfather-date-of-the-tobacco-control-act-and-how-will-it-impact-the-vapor-industry/

 

jmatt

Part of the Furniture Now
Aug 25, 2014
770
74
Who you barking at Jackswilling? I was agreeing with you, no?

 
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