About the author

Myron Levin is editor of FairWarning.

8 comments to “Tobacco Industry Batting a Thousand With Federal Judge, While FDA Strikes Out”

  1. john kelly

    ^ What Bill Godshall said. Nothing further required.

  2. Bill Godshall

    If anyone is to be blamed for Richard Leon’s three decisions (all of which I strongly supported), its Obama’s FDA (and other DHHS) appointees, their staff and their intolerant anti tobacco/nicotine extremist allies at CTFK, ACS, AHA, ALA, UCSF, AAP, Legacy, etc.

    When I convinced Senator Mike Enzi to amend the FSPTCA to require color graphic warnings on cigarettes during the HELP Committee markup session in 2007, Big Pharma funded CTFK, ACS, AHA, ALA denounced Enzi, urged Kennedy and other Democrats to reject them, and falsely claimed Enzi’s amendment (and other public health amendments offered by Enzi) were “trojan horses” and “poison pills” to protect Big Tobacco. Of course that was because Matt Myers negotiated and agreed to the FSPTCA legislative deal with Philip Morris lawyers and GSK funded Mitch Zeller in 2003/04 that only required ineffective print warnings for cigarette packs.

    But after the FSPTCA was enacted in 2009, the FDA (after being lobbied by those same groups, Stan Glantz and other extremists) approved a regulation for color graphic warnings that was clearly unconstitutional (because they included a phone number that hawked ineffective FDA approved smoking cessation drugs as the only effective way to quit smoking, because some of the disgusting photos were unrelated to the accompanied text warning, and because the warnings were clearly intended to scare viewers instead of provide useful or helpful information).

    I and others submitted comments to the FDA’s docket informing them of these very concerns, but the FDA ignored our concerns. And when FDA announced the final regulation, the FDA, CTFK, ACS, AHA, ALA congratulated themselves for the color graphic warnings that Judge Leon subsequently ruled unconstitutional (citing the very same reasons we had previously informed FDA about our concerns).

    But instead of promulgating new constitutional cigarette warnings (which could actually reduce smoking), Obama’s FDA CTP (and CDC, US SG and other DHHS agencies) have spent much of their energy lying about, demonizing and trying to ban electronic cigarettes.

    As one who collaborated with the two e-cigarette companies (SE and NJOY) in suing the FDA (and who filed an amicus brief with the DC Court of Appeals opposing FDA’s unlawful e-cigarette ban that resulted in nearly 1,000 seizures of e-cigarette shipments at US ports by Customs agents), I pleaded with Obama appointed FDA Deputy Commissioner Josh Sharfstein (who previously worked for Waxman to lobby the FSPTCA through Congress) to not ban e-cigarettes, and even sent him a petition signed by 7,000 vapers who had quit smoking by switching to e-cigs.

    In April 2009, Obama’s FDA revealed its unscientific, unethical and inhumane policy to deceive Americans about e-cigs and defend the FDA’s e-cig ban: “We don’t want the public to perceive them as a safer alternative to cigarettes.”
    http://www.webmd.com/smoking-cessation/features/ecigarettes-under-fire

    In July 2009, Obama appointee (and former Waxman staffer) FDA Deputy Cmsnr Josh Sharfstein held a press conference along with CDC OSH Director Matt McKenna and Big Pharma funded AAP’s Jonathan Winickoff (to defend the agency’s unlawful e-cig ban from lawsuits by SE and NJOY after their products were seized) where FDA’s e-cigarette lab findings were grossly misrepresented to scare the public to believe e-cigarettes are carcinogenic and toxic, where e-cigarette companies were falsely accused of target marketing to youth, and where it was alleged (without any evidence) that e-cigs are addicting children, can be gateways to cigarettes, can renormalize smoking, and don’t help smokers quit.
    http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173175.htm
    http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf

    Sound familiar? Since then, Obama’s DHHS has not only repeated those same false claims many times, but they’ve made even more fear mongering claims about them (e.g. falsely claiming e-cigs are poisoning children).

    Thankfully for the rule of law, public health, civil liberties, market competition and common sense, all 12 federal appeals court judges upheld Judge Richard Leon’s ruling striking down FDA’s e-cig ban as unlawful.
    https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54
    https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-55

    Unfortunately for public health, the FDA’s recently proposed Deeming Regulation for e-cigarettes would protect cigarettes by banning >99.9% of e-cigarettes (including all of the most effective e-cigs for smoking cessation) and by giving the entire e-cig industry to Big Tobacco companies.

    That’s why Altria, Reynolds, Lorillard and the National Association of Convenience stores not only endorsed FDA’s proposed deeming regulation, but why their CEO just urged FDA to imposed the deeming regulation even more swiftly.
    http://www.bloomberg.com/news/2014-10-02/tobacco-ceos-urge-fda-to-adopt-e-cig-rules-quickly.html

    Nothing like FDA proposing (and CTFK, ACS, AHA, ALA, AAP, Legacy, ASTHO, NACCHO etc lobbying for) a crony capitalism regulation to enrich Big Tobacco and threaten the lives of all vapers, smokers and secondhand smokers under the deceitful guise of “protecting children and public health”.

    BTW Smokefree Pennsylvania’s 110 page comment urging FDA to kill its proposed cigarette industry protecting Deeming Regulation, citing nearly every published study on e-cigs and exposing dozens of DHHS lies about e-cigs is at: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-80846

    Finally, on the issue of FDA TPSAC’s deeply flawed and biased report denouncing menthol cigarettes, I and many others repeatedly pointed out that virtually all (if not all) of the original TPSAC appointees had extensive and irreconcilable conflicts of interest.
    But of course, the FDA falsely claimed (at every TPSAC meeting) that none of the TPSAC members had conflicts of interest. In fact, it appears that having a conflict of interest is still a prerequisite for being appointed to TPSAC.

    Many members of TPSAC member have received Big Pharma funding to demonize and lobby to ban or excessively restrict tobacco products, some were paid as expert witnesses at trials against tobacco companies, some lobbied to ban smokeless tobacco and/or other tobacco products, and nearly all have publicly advocated and urged Congress to enact the TPSAC.

    Not one tobacco harm reduction advocate has been appointed to TPSAC (nor hired by Obama’s DHHS), and none of the TPSAC members have opposed anything FDA has proposed. In sum, TPSAC is nothing more than a FDA cheerleading and rubber stamp committee.

    In response to TPSAC’s proposed menthol report that was little more than cherry picked junk science, I and many others submitted comments to the docket citing lots of scientific evidence finding that menthol cigarettes are just as addictive, deadly and hard to quit as nonmenthol cigarettes. I and other public health advocates also pointed out that TPSAC report failed to consider the enormous black market a menthol ban would create (which is required by the FSPTCA). We also pointed out that the loss of menthol cigarette tax revenue and MSA payments would sharply reduce funding for SCHIP and for many tobacco education, smoking cessation and other public health programs.
    But none of those facts changed TPSAC’s predetermined conclusion that menthol cigarettes should be banned.

    So nobody should have been surprised when Richard Leon negated the TPSAC’s menthol report because 3 members of TPSAC had conflicts of interest.

    Those responsible for Judge Leon’s three rulings against the FDA were Obama appointees and their staff at FDA and other DHHS agencies, CTFK, ACS, AHA, ALA, AAP, Legacy, Stan Glantz, TPSAC, etc.

    But of course, its more convenient to blame Judge Leon.

    Bill Godshall
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
    email hidden; JavaScript is required

  3. Audrey Silk

    Going to the anti-smokers for their opinion on manipulation — even if they concede evidence is lacking — is like going to the fox to ask if the hens could have eaten other animals.

  4. Daniel

    As I have already mentioned on MotherJones where this story has also been posted, the calculations are not correct. What Myron is calculating is the probability of getting any one specific judge all three times, but we don’t care which judge we get as long as it’s the same one each time. Therefore your first choice is only restricted to the point that it ensures that you have selected one of the 11 judges that are still on the list for the final case.

    This means that the actual probability of getting the same judge all three times is roughly 11/13 * (1/13)^2 = 1/200, not 1,859

  5. Mar Burrow

    Yes, it’s almost as coincidental as when the gov’t gets all of its tobacco litigation in front of the Honorable Gladys Kessler…

  6. louis v. lombardo

    Bravo!

    Thanks to Myron Levin and FairWarning for this excellent reporting.

    Indeed!

    What are the odds?

    This judge was appointed by George W, Bush.

    Another bit of evidence that government policy (whether Legislative, Executive, or Judicial) is heavily politically influenced.

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