Sunday, December 30, 2012

Call to Action! Submit Written Comments – Sec. 918 of Tobacco Act


History:

The FDA held a public hearing on Section 918 on Monday, December 17, 2012. Many THR advocates testified. See: http://www.e-cigarette-forum.com/forum/legislation-news/361023-more-details-analysis-fdas-december-17-hearing.html

For the hearing, we issued a Call to Awareness. This is now a related (as noted below) but separate Call to Action. The FDA will use the testimony that was given at the December 17 hearing, plus the written comments submitted by January 16, 2013 as input for the report to Congress required by the Tobacco Act. 


How to Submit Written Comments:

To submit a comment electronically: On the page http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0011 (Link updated 1/3/13), click the “Comment Now” button. Comments that you type into the comment field are limited to 2,000 characters. If your comment is longer, you can upload a file that contains your comment and just type “See attachment” into the Comment field.

To submit a comment by U.S. Mail: Send to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2012-N-1148].

Electronic or written comments will be accepted until January 16, 2013.

What to Say:

1. Describe your history as a smoker: When did you start? How long did you smoke? How much did you smoke?

2. Describe your quitting attempts: How many times did you try to quit? What different products and methods did you try? What did you like and dislike about the products or methods you tried?

3. If you stopped smoking completely some time in the past and experienced problems such as feeling depressed and/or anxious, getting along with others, concentrating, remembering, etc. describe those experiences.

4. Describe the effects switching to e-cigarettes has had on how much you smoke now.

5. Describe the health effects you have experienced as a result of switching to e-cigarettes (and/or snus).

6. Tell the FDA that there should not be any time limit on using NRTs, but that it would be better to raise the amount of nicotine each piece provides than to have people use multiple types of products.

7. Tell the FDA that innovative products such as e-cigarettes should not be made less effective by setting nicotine doses too low.

8. If you use e-liquid (or snus) that has a pleasant flavor added (such as fruit, candy, beverage), tell the FDA that this has helped you and describe how.

9. Urge the FDA to not propose the "deeming" regulation because it would ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if FDA exempted e-cigarettes from the most onerous provisions in Chapter IX.

10. Ask the FDA to remove text from its web site that is inaccurate and/or misleading.

·         For example, many people believe that e-cigarettes are very likely to cause cancer or poison the user because the FDA “forgot” to mention that the amount of carcinogens detected in liquid are no higher than in pharmaceutical nicotine products such as the patch and gum, and that the only toxin detected was in an amount that has never been shown to endanger health.
·         Many people that might have switched to snus, which is much less hazardous to health than smoking, but they were convinced to continue smoking instead by the misleading statement “This product is not a safe alternative to smoking.


Background

The Family Smoking Prevention and Tobacco Control Act (Tobacco Act) was structured to regulate cigarettes, smokeless tobacco, and “roll your own” under a newly created Center for Tobacco Products (CTP) and to continue regulation of so-called “Nicotine Replacement Products” (NRPs) products and other drugs to treat “tobacco addiction” under the Center for Drug Evaluation and Research (CDER.) http://www.govtrack.us/congress/bills/111/hr1256/text

The concept of Tobacco Harm Reduction (THR) was introduced in Section 911 of the Tobacco Act, which calls for the CTP to define a process to test and approve “Modified Risk Tobacco Products” (MRTPs.)

Currently, the NRTs that are regulated by CDER have one purpose—total abstinence from nicotine. But ‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE’ asks the Secretary of Health and Human Services to consider:
(1.) Designating products for fast-track research and approval within the meaning of Sec. 506 (See § 356. Fast track products http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec356.pdf.)
(2.) Extended use of NRPs
(3.) Additional indications for NRPs, such as for craving relief or relapse prevention

Sec. 918(b) requires the Secretary to submit a report to congress “that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health--
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with continued tobacco use.”

If you substitute the word “smoking” for the words “tobacco use” in these three items, they fit the goals of the THR community. Until now, total abstinence from all tobacco use (not just from smoking) was the only regulatory goal of our government. This is still true within the World Health Organization and the European Union’s Tobacco Control Framework. Sections 911 and 918 would change our focus to include measures to mitigate the harm caused by smoking.

Currently e-cigarettes are not regulated under either the CTP or CDER, but the CTP has announced that it intends to issue a deeming regulation that would bring e-cigarettes and other tobacco products under the Agency’s regulatory authority.

Thursday, December 20, 2012

E-cigarette research survey, new case study announced

Dr. Konstantinos Farsalinos

Dr. Konstantinos Farsalinos, research fellow at the Onassis Cardiac Surgery Center and his colleague, Dr. Giorgio Romagna, have prepared an extensive questionnaire for electronic cigarette users. The goal is to make the biggest ever survey on electronic cigarette users - more than 10,000 people - that will be published in a medical-epidemiological journal. The survey will cover major aspects on electronic cigarette use, address many of the common arguments made by those against e-cigs and could positively influence public health authorities.

The questionnaire will be released using Survey Monkey and be available in English, Greek, Italian and possibly French. The cost of the survey and data manipulation is expected to be approximately 15,000-20,000 euros (approx. $20,000 - $27,000), depending on the number of participants. CASAA will publish a link to the survey when it becomes available.

Additionally, Dr. Farsalinos recently announced that a case report he submitted for publication - of a patient with a rare clinical condition that was relieved by smoking cessation with the use of e-cigarettes - has been accepted for publication. Dr. Farsalinos wrote that the main conclusion of this case study is that, "despite the daily use of e-cig, you still obtain the health benefits of smoking cessation."

Those following electronic cigarette research may recall that Dr. Farsalinos and his team recently published the first clinical study of the acute effects of electronic cigarettes on cardiac function. They decided to compare their results with the acute effects of regular cigarettes on cardiac function since electronic cigarettes are marketed to smokers only, as an alternative habit. Researchers found that e-cigarettes appeared to cause no acute adverse effects on cardiac function during the study.

Tuesday, December 18, 2012

CASAA testifies at FDA hearing

Silver Spring, MD, December 17, 2012 --

Yesterday, the FDA held a public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA). CASAA President Elaine Keller spoke on behalf of the organization.  Also presenting before the FDA panel* as private citizens or as representatives of other organizations were CASAA's Legal Policy Director Gregory Conley, CASAA's Scientific Director Carl V Phillips, and CASAA advisor Bill Godshall.

Dr. Carl Phillips, CASAA Science Director
 speaking at FDA hearing
The hearing was held for the FDA's consideration of new regulations regarding already approved smoking cessation products such as gums, patches and lozenges (NRTs) and the possible "fast tracking" of innovative new products that are intended to promote 1) total abstinence from tobacco use, 2) reductions in consumption of tobacco, and 3) reductions in the harm associated with continued tobacco use.

While electronic cigarettes and low-risk, smoke-free tobacco products were not being considered at this hearing, CASAA supports the consideration of NRT for long-term use as a form of tobacco harm reduction (THR) for smokers who cannot or will not quit, rather than requiring the products to be used solely as tools for complete nicotine abstinence. It is CASAA's opinion that this could open the door for products such as electronic cigarettes and low-risk, smoke-free tobacco products to also be considered as THR products. Therefore, CASAA's presence at the hearing was to speak on behalf of tobacco harm reduction policies.

The topic of electronic cigarettes did arise several times and some known opponents of electronic cigarettes admitted that testimony given by electronic cigarette consumers was compelling and warranted future study. Surprisingly, most of the anti-tobacco speakers at the hearing seemed to agree with THR advocates that smoking cessation is a far more urgent goal than total nicotine abstinence.

"Risk needs to be assessed not in comparison to abstinence but in comparison to a percentage scale of harm impact," CASAA's Dr. Phillips told members of the FDA panel. "Smoke-free alternatives are far healthier. A lifetime of [smoke-free nicotine/tobacco] use is less harmful than a couple months of relapse smoking."

Written public comments will be accepted until January 16, 2013. If you would like to submit comments supporting tobacco harm reduction policies, you may find information on how to submit and what to say here: CASAA Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

Recordings of yesterday's hearing may be watched using these links:

https://collaboration.fda.gov/p98191651/
https://collaboration.fda.gov/p95861884/
https://collaboration.fda.gov/p36279658/
https://collaboration.fda.gov/p20988129/


CASAA Media Contact
Elaine Keller, President
202-241-9117
ekeller@casaa.org





*FDA Panel: Grail Sipes, JD  Senior Regulatory Counsel, Office of Regulatory Policy Center for Drug Evaluation and Research; Sandra Kweder, M.D., Deputy Director of FDA Office of New Drugs, Center for Drug Evaluation and Research; Christine Win, Acting Deputy Director of FDA Office of New Drugs, Center for Drug Evaluation and Research; Bob A. Rappaport, M.D., Director Division of Analgesics, Anesthetics, and Rheumatology Products, FDA’s Center for Drug Evaluation and Research; Dr. Celia Winchell, Team Leader with the Division of Anesthesia, Analgesia and Rheumatology;  Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Center for Drug Evaluation and Research; Corinne Huston, MSPH, M.D., Senior Medical Advisor in the Office of the Director, Center for Tobacco Products; and Eric Lindblom, J.D., Director, Office of Policy, FDA Center for Tobacco Products.




Wednesday, December 5, 2012

Tobacco ban in parks approved

Newton Citizen
Crystal Tatum
12/5/2012

COVINGTON -- Commissioners on Tuesday unanimously approved a ban on use of all tobacco products in county parks, effective April 1.

#Recreation Commission Director Tommy Hailey said the purpose of the ban is to discourage youths from using tobacco and teach them the disadvantages of using.

#Attorneys with the state Department of Health have reviewed the ordinance and given their approval, Hailey said, meaning the county qualifies to apply for grants to fund signs and brochures to notify and educate the public on the ban.
...

During citizens' comments at the end of the meeting, which followed commissioners' vote, Julie Anderson, a member of CASAA, The Consumer Advocates for Smoke-free Alternatives Association, said it doesn't make sense to include smokeless tobacco and smoke-free products in the ordinance. Electronic cigarettes have not been shown to be a danger as far as secondhand smoke, she said. Anderson said she smoked two packs a day for 35 years and, "If it weren't for these I'd still be smoking, so it's important to get people to quit, but taking away an alternative for them that's not harmful for bystanders is sometimes, I think, shortsighted."

Read full story >

New Study Suggests that Electronic Cigarettes May Encourage Maintenance of Tobacco Use

The Rest of the Story: Tobacco News Analysis and Commentary
by Dr. Michael Siegel, Boston University

Dr. Michael Siegel
A new study, published online ahead of print in the journal Tobacco Control, concludes that electronic cigarettes may encourage the maintenance of tobacco use.

(See: Cheah NP, et al. Electronic nicotine delivery systems: Regulatory and safety challenges: Singapore perspective. Tobacco Control 2012; doi: 10.1136/tobaccocontrol-2012-050483.)

The study examined 20 brands of electronic cigarettes, and analyzed the contents of their cartridges for nicotine, propylene glycol, glycerin, polycyclic aromatic hydrocarbons, and tobacco-specific nitrosamines.

The results were reported in the study abstract as follows: "Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled."

The paper concludes as follows:

"While the current attention on traditional tobacco products is important, it is also necessary to focus on novelty products like ENDS, which may encourage maintenance of tobacco usage behaviour and slow down the impact of national smoking control programmes. Tobacco control policy makers and professionals are seriously urged to find ways to address the gap in the scientific understanding and the legal framework of such products, as this gap may impede efforts at curbing tobacco use."

The Rest of the Story

If you read the introduction, methods, and results of this study, and then proceed to the discussion, you will be shocked and you might think you are reading the discussion to a different study. This is because the discussion has very little relevance to the actual findings in the paper....READ MORE >>

CASAA Weekly Video Update


Pueblo, CO City Council requires e-cigarette vendors to obtain license

Government funded anti tobacco extremists falsely claim products are target marketed to youth.

Article: http://www.chieftain.com/health/council-targets-nicotine/article_c
5aec7b2-39e9-11e2-8710-0019bb2963f4.html

Please note that the groups lobbying for this law are funded by the Colorado Department of Public Health and Environment, which last year demonized and called for a ban on the sale of dissolvable smokefree tobacco products to adults (which they also falsely accused of being target marketed to children).

Most local tobacco retailer licensing laws/regulations require all tobacco products to be kept behind the counter, and some tobacco retail licensing laws prohibit use of the products in retail locations (not good news for an e-cig vendor).

And while I've advocated annual tobacco retailer license fees of $100-250 per licensee (to cover costs of enforcement), during the past several years some state/local tobacco retail licensing laws have imposed punitively high annual license fees because the politicians need government revenue and because they dislike tobacco products, companies and/or users (e.g. New York increased its annual tobacco retailer fee to several thousand dollars several years ago based upon overall store revenue, and then reduced it after many retailers justifiably protested).

Also, some recently enacted tobacco retailer licensing laws ban flavored tobacco products (Providence RI), have banned pharmacies from selling tobacco (e.g. Boston and many towns in MA), have limited the number of licenses (preventing new retailers from obtaining a license), prohbited licensees from being within several thousand feet from a school or playground, etc.

The article didn't indicate if Pueblo's health department wants to license e-cigarette vendors under an existing tobacco retailer licensing system or if they were planning a new licensing system just for e-cig vendors (which is much more problematic)

~ Bill Godshall, CASAA Advisor

Tuesday, December 4, 2012

Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

The Food and Drug Administration (FDA) has announced a 1-day public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA.)

Background:
CASAA endorses the use of low-risk, smoke-free alternatives; in an effort to reduce harm and risks associated with smoking. Currently, no products are approved by the FDA for use as "harm reduction." The FDA currently classifies nicotine products in just two ways: (1) as an approved treatment for nicotine addiction called "nicotine replacement therapy (NRT,)" which is better described as "nicotine reduction therapy;" intended to end nicotine and/or tobacco use (ie., pharmaceutical nicotine gums, patches and lozenges) and (2) as a "tobacco or tobacco product," which encompasses all tobacco and nicotine products not intended to treat nicotine addiction, including but not limited to cigarettes, cigars, snus, snuff, chewing ("spit") tobacco, tobacco lozenges, strips, sticks and electronic cigarettes.

With the passage of  the FSPTCA, Congress required the FDA to submit a report examining "how best to regulate, promote, and encourage the development of  'innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments)' to better achieve the following three goals: (1) total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use."

What this means for CASAA members:
This particular hearing is related only to NRT products and is NOT seeking comments on the regulation of electronic cigarettes or smoke-free tobacco. However, the FDA is interested in receiving any new or additional information that might be relevant to the extended use of NRTs for tobacco dependence:

    "What evidence is available to support the approval of NRTs for extended use to maintain abstinence in individuals who have quit?" and  "What evidence is available to support the approval of NRTs for extended use to achieve cessation (quitting)?"

To put it very simply, the FDA is considering allowing the promotion and use of products such as nicotine gums, patches and lozenges not only as NRT to achieve complete nicotine abstinence, but also as "harm reduction" products for those who cannot or will not remain nicotine and/or tobacco abstinent. By doing so, the FDA will finally be approving nicotine products for a third category for which CASAA has campaigned: smoking-related "harm reduction" products. This would open the door for harm-reduction products such as electronic cigarettes and low-risk tobacco products for consideration. It is CASAA's understanding that the FDA still insists upon an "end date" for use, rather than using products as a permanent replacement for smoking. It is our intention to ask the FDA to consider removing such restrictions, since there is no scientific evidence that such restrictions are either beneficial or necessary.

What you can do:
CASAA directors will be in attendance at this hearing and will speak on key points on behalf of its membership. If members would like to add their own written comments, we have included "talking points" below for you to follow. It is very important that we focus on the harm reduction aspect of this hearing and not on e-cigarette or smoke-free issues. Our time for those points will come later. 

Regardless of attendance at the public hearing, interested persons may submit written comments in one of two ways. Printed comments can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2012-N-1148].

To submit a comment electronically, on the page http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0001, click the “Comment Now” button. Electronic or written comments will be accepted after the public hearing until January 2, 2013. NOTE: The FDA has extended the deadline for written comments until January 16, 2013.

If members plan to attend in person, CASAA requests that you first email your proposed presentation to board@casaa.org, so we may assist in the talking points and avoid duplication of our efforts. Once the FDA notifies registered presenters of their scheduled times, the FDA will require an electronic copy of your presentation be submitted by December 10, 2012.

The public hearing will be held on December 17, 2012, 8 a.m. to 5 p.m. Individuals who wish to present at the public hearing must register by December 6, 2012 and provide complete contact information, including name, title, affiliation, address, email, and phone number  Section III of this link has more information on registering to comment at the hearing: http://www.gpo.gov/fdsys/pkg/FR-2012-11-28/html/2012-28835.htm The hearing will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993.

What you can say:
1) Write about what you know:
  • Did you ever try the nicotine patch, gum, lozenges, or inhalers?
  • How did they work for you? Were you able to completely quit smoking, just to reduce how much you smoke, or did they not help at all?
  • What do you see as some of the shortcomings of the products and how do you think the NRT products could be improved?
  • What other ways did you try to control your smoking in the past?
  • If you have quit smoking, what product made this possible? (Perhaps e-cigarettes?) What does this product (or the combination of products that you use) provide that NRTs did not?
2) Tell the FDA:
  • Providing smokers with low-risk alternative sources of nicotine works much better than requiring nicotine abstinence.
  • Recommend removing barriers to using the products such as time limits on how long to use them, warnings about using more than one product at a time, and warnings against smoking while using an NRT.
  • Point out that reducing the number of cigarettes smoked each day can be a stepping stone to quitting altogether.
  • Point out that achieving freedom from inhaling smoke is much more important for health than concerns about addiction to nicotine.
  • Recommend that the FDA educate the public about the relative safety of nicotine that comes from sources other than smoking.
  • Recommend that the FDA consider promoting other innovative products that have helped smokers reduce their consumption of cigarettes and eventually stop smoking altogether.