Dockets now available to submit comments urging FDA to protect the health of smokers and vapers, not cigarettes
The Citizens Petition by the American Association of Public Health Physicians (AAPHP) urging the FDA to reclassify and regulate electronic cigarettes (nicotine vaporizers) as tobacco products (instead of trying to ban the products by classifying them as drugs or devices) is at
http://www.regulations.gov/search/Re...DA-2010-P-0095
To submit a comment urging supportive action by the FDA, go to
http://www.regulations.gov/search/Re...00006480aa84a7
Suggested talking points:
- since e-cigarettes (nicotine vaporizers) are derived from tobacco, the FDA can legally reclassify and regulate them as "tobacco products",
- by choosing to classify e-cigarettes as "drugs" or "devices", the FDA was/is attempting to ban the products,
- hundreds of thousands of smokers already have significantly reduced their health risks by switching to e-cigarettes,
- by reclassifying e-cigarettes as tobacco products, the FDA would ban their sale to minors, can establish other reasonable and responsible product regulations, would help to reduce (instead of maintain) cigarette consumption, and would save taxpayers money that FDA continues to waste,
- in SE vs FDA, federal Judge Richard Leon has ruled that the FDA can regulate e-cigarettes as "tobacco products", but not as "drugs" or "devices",
- sales and use of e-cigarettes have continued to sharply increase despite the FDA's ongoing attempt to ban the products,
- banning e-cigarettes would primarily protect cigarette markets at the expense of consumer and public health,
- if applicable, describe your personal experience using e-cigarettes.
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The Citizens Petition by the American Association of Public Health Physicians (AAPHP) urging the FDA to clarify/correct inaccurate and misleading claims about electronic cigarettes (nicotine vaporizers) made at the FDA's July 22, 2009 press conference, and to truthfully inform the public of existing evidence about the products is now available at
http://www.regulations.gov/search/Re...DA-2010-P-0093
To submit a comment urging supportive action by the FDA, go to
http://www.regulations.gov/search/Re...00006480aa7cac
Suggested talking points:
- the FDA
http://www.fda.gov/NewsEvents/Public.../ucm172906.htm grossly mispresented its own laboratory test findings on two brands of e-cigarettes
http://www.fda.gov/downloads/Drugs/S.../UCM173250.pdf
- in contrast to claims made at the FDA's press conference, there is no evidence that e-cigarettes have ever harmed any user or nonuser, and there is no evidence that e-cigarettes are marketed to youth,
- the FDA failed to acknowledge any evidence (sent to the agency) that e-cigarettes are far less hazardous alternatives to tobacco cigarettes, and that thousands of e-cigarette users informed the agency they had quit smoking by switching to the products,
- cigarette smokers have a human right to truthful information about, and legal access to, less hazardous alternatives,
- FDA officials have an ethical duty to protect consumer health and to provide truthful health risk information,
- if applicable, describe your personal experience using e-cigarettes.
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More than TWO YEARS have passed since NY State Health Commissioner Richard Daines submitted a Citizens Petition to the FDA at
http://www.regulations.gov/search/Re...DA-2008-P-0116 to (1) allow FDA approved Over The Counter NRT products (i.e. nicotine gums, patches and lozenges) to be sold in all stores that sell cigarettes; (2) allow NRT products to be sold in less expensive daily dose units; and (3) change labels on NRT products to inform consumers of the health benefits of NRT compared to cigarettes, to eliminate unsubstantiated health warnings, and to encourage use of NRT if tobacco use continues.
To submit a comment urging supportive action by the FDA, go to
http://www.regulations.gov/search/Re...000064803ae224
Please note that another petition very similar to Richard Daines' petition was recently submitted by SRNT and ATTUD, which is now awaiting docketing by the FDA.
Suggested talking points:
- many more smokers would try using NRT products if they are sold in $5-$10 packages instead of just in $35+ packages,
- more smokers would try using NRT products if they are sold at more retail stores alongside cigarettes,
- current warning labels on NRT products mislead many consumers to believe they pose far greater health/safety risks than is the case,
- NRT products are far less hazardous than cigarettes, and are often used as temporary and/or long term substitutes for cigarettes,
- smokers can reduce their health risks by concurrently using NRT products and cigarettes, with risk reduction proportionate to cigarette reduction,
- many/most NRT products are consumed by people who have used the products longer than the twelve weeks currently approved by the FDA, and
- although clinical trials find that just 7% of NRT users remain smokefree after six months, many NRT users consider them acceptable alternatives to cigarettes.
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
ALERT FROM BILL GODSHALL RE: FDA PETITION
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Originally Posted by Kate
