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Category: Regulatory

For ’tis the sport to have the FDA Hoist with its own petard…

For ’tis the sport to have the FDA Hoist with its own petard…

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Sometimes advocating for smoke-free alternatives provides some interesting opportunities. Recently Clive Bates penned a rather damning post on the FDA’s deeming “FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two quotes” wherein he ends with the notion: “… that the big players behind the FDA’s intervention, such as Mitch Zeller and Matt Myers, do not have the faintest idea what they are actually doing. Carl Phillips replied to this notion with “FDA…

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How to Argue FOR Vaping

How to Argue FOR Vaping

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One of the most difficult things about this disruptive technology is how to defend it against the naysayers who are, like the Luddites of old, trying to destroy what they do not understand. It is frustrating beyond tolerance at times, to hear our lifesaving technology reduced to being perceptually more harmful than smoking itself. Those of us who have been on the front lines face endless repetition of the same pseudo-scientific lies and misrepresentations at every turn. We are besieged…

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Feelings Are a ‘Gateway Drug’ to the Abuse of Science and Public Health

Feelings Are a ‘Gateway Drug’ to the Abuse of Science and Public Health

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Published in TIME September 3, 2014 E-Cigarettes Are a “Gateway Drug” to Substance Abuse and Addiction Nicotine, in any form, can prime the brain for harder drugs This kind of thing really burns my toast. It amounts to journalistic malpractice compounding public health research malfeasance. It is the kind of thing that capitalizes on the fears of the public and their ignorance of how science works. All the participants should be drawn and quartered in a public square. Apparently I’m…

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Criticism of WHO FCTC COP#6 (for which I’ll either be sued or go straight to hell)

Criticism of WHO FCTC COP#6 (for which I’ll either be sued or go straight to hell)

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The graphic in this article is contested by the World Health Organization (WHO). It originally appeared in a blog by Clive Bates in two articles he wrote here and here, critical of the Conference of the Parties to the WHO Framework Convention on Tobacco Control, Sixth Session, Provisional Agenda 4.4.2 document. They believe they have the right to quell free speech because the graphic inappropriately subsumes the authority and integrity of the World Health Organization. Well too bad. When the…

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FDA Deeming Response #3 – 1jy-8dit-syxz

FDA Deeming Response #3 – 1jy-8dit-syxz

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June 30, 2014 To:    The Honorable Mitch Zeller, J.D. Director, Center for Tobacco Products Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 From:    Robert Bruce Nye, RN 1105 Hickory Hill Rd. Papillion, NE 68046 Re:    FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38 Dear Mr. Zeller, I am writing in regards to the Food and Drug Administration’s (“FDA”) Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by…

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FDA Deeming Response #2 – 1jy-8c7u-sdbk

FDA Deeming Response #2 – 1jy-8c7u-sdbk

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Re: The Food and Drug Administration Deems Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements. I am writing to comment as an individual consumer and healthcare professional that regularly has contact with approximately five other consumers per month who use electronic cigarettes on the Paperwork Reduction…

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FDA Deeming Response #1 – 1jy-8c5j-hwgb

FDA Deeming Response #1 – 1jy-8c5j-hwgb

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May 18, 2014 Dear Mr. Zeller: I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration’s (“FDA”) Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the “Proposed Rule”) published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment…

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