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August 14, 2016

15 years of suppression of Tobacco Harm Reduction products

Bill Godshall on August 9, 2016 at 7:06 pm
Unfortunately for science, ethics, humanity and public health, Mitch Zeller and Matt Myers known exactly what they’re doing.

In fact, they’ve been conspiring and lobbying to ban the manufacture and sale of all NEW low risk smokefree alternatives (but not deadly cigarettes) since 2001/2002 when GlaxoSmithKline, CTFK, Legacy, ACS, AHA, ALA, AAP, AMA, ACPM, APHA, ASAM, ASCO, ATS, LCAT, NALBOH, NEA, ONS, OHA, NSTEP, PfP, and 41 State Attorneys General all petitioned the FDA to ban Star’s Ariva lozenges and several other smokefree nicotine alternatives.

After leaving FDA in 2000, Mitch Zeller worked for Legacy in 2001, and then became GSK’s lobbyist (via Pinney Associates) from 2002 to 2013.

In 2003, FDA banned several of the nicotine alternatives, but stated the agency did NOT have the legal authority to regulate tobacco products (citing the 2000 SCOTUS ruling), and as such could not ban Star’s Ariva.

Matt Myers and Mitch Zeller also helped draft and lobby for the first TCA bills (after the 2000 SCOTUS ruling) in 2001 and 2003 that banned the manufacturing and sale of all new tobacco products (while exempting all deadly cigarettes) by establishing grandfather dates the year prior to the bills’ introduction.

In response, Philip Morris introduced its own TCA bills in Congress (in 2002 and again in 2003) that contained 90%-95% of the clauses and text of the already introduced TCA bills lobbied for by CTFK, ACS, AHA, ALA, AMA, etc (including banning new tobacco products by establishing a grandfather date).

Since CTFK’s legislative strategy was to partner their TCA bill with a tobacco grower quota buyout bill (to gain the votes of tobacco state Senators), RJ Reynolds responded by lobbying Congress to enact a stand alone tobacco quota buyout bill.

To preserve the votes for the TCA by tobacco state Senators, CTFK’s Myers (in collaboration with GSK’s Zeller) began to negotiate with Philip Morris on the precise wording of the TCA legislation in 2003/04 that each could support and join forces to lobby Congress to enact into law (because Myers’ priority was to quickly cut a deal with Philip Morris to prevent Reynolds’ stand alone tobacco quota buyout bill, which was gaining traction in Congress, from being enacted.

Since GSK and PM both knew smokeless tobacco products were cutting into their sales and profits, in addition to banning all new tobacco products, the different TCA bills in 2003 also included Section 911 (although with slightly different wording) that banned smokeless tobacco companies from truthfully claiming their products are less harmful than cigarettes, and both bills required the same (and even larger) false and misleading fear mongering warnings on smokeless tobacco products (i.e. “not a safe alternative to cigarettes, may cause mouth cancer, may cause gum disease and tooth loss).

After negotiation in 2003/04, PM, CTFK, Waxman and Kennedy issued press releases on the same hour in the spring of 2004 praising and introducing their negotiated and agreed-to TCA legislation.

That same day (and until 2009), I denounced (and urged public health advocates and Congress to reject) the TCA legislation because it protected PM’s Marlboro monopoly and Big Pharma’s NRT monopoly from future market competition by low risk smokeless tobacco products.

From 2004 until 2009, Philip Morris (which changed its name to Altria), GSK, CTFK, ACS, AHA, ALA, AAP, etc, hundreds of DHHS funding recipients, dozens of duped State AGs, and most left wing Democrats in Congress aggressively lobbied to enact the TCA into law.

During that same time, GSK lobbyist Mitch Zeller spoke at dozens of tobacco control conferences praising the TCA, while demonizing smokeless tobacco products, falsely claiming they were about 50% as harmful as cigarettes while NRT was 99% less harmful, and falsely accusing smokeless tobacco companies of target marketing to teens (by showing lots of slides of smokeless tobacco ads claiming they appealed to youth) even though UST signed a smokeless tobacco MSA with State AGs similar to the cigarette MSA.

At virtually all of those conferences, Mitch was touted and introduced by the conference organizers as “former FDA Deputy Commissioner” or as a “tobacco regulation expert” instead of a “GSK lobbyist”. Meanwhile, virtually all of the 20+ abstracts I submitted to many of those conferences (to expose how the TCA protected cigarettes by banning THR products) were rejected by those same conference organizers (which primarily included employees and funding recipients of DHHS and state health agencies, CTFK, ACS, AHA, ALA, Legacy, etc.)

The grandfather date (to ban new tobacco products) was originally set for 2003 in the 2004 TCA bills, while the 2005 TCA bills set it for 2/15/05, and the 2007 bills set it for 2/15/07. But in 2009, CTFK urged Waxman and Kennedy to not move to grandfather date to 2/15/09 because doing so would exempt newly introduced smokefree alternatives (Camel Snus, Orbs, Strips, Sticks).

In 2009, Sen. Frank Lautenberg (the leading recipient of Big Pharma funding in the history of US Congress) urged FDA to ban all e-cigs, and CTFK, ACS, AHA, ALA did the same one week later. Within weeks, US Customs agents began seizing shipments of e-cigarettes at US Ports, which is what prompted SE and NJOY to sue the FDA.

In 2011, GSK (under Mitch Zeller’s leadership) formally urged FDA to ban all dissolvable tobacco products (i.e. Star Ariva and Stonewall, Camel Orbs, Strips and Sticks).

When Mitch went back to FDA in 2013, the first thing he did was send a report to Congress on new low risk tobacco products and smoking cessation products that praised and proposed deregulating Big Pharma NRT, but never mentioned vapor products (even though a dozen THR advocates and vapers testified at the FDA’s hearing and even though vapers submitted >95% of the 5,000 FDA docket comments submitted to the agency pointing out how vaping helped them quit smoking after they relapsed and had psychotic experiences using FDA approved drugs).

By proposing and now finalizing the Deeming Regulation, Mitch Zeller (and Matt Myers) have now achieved their 15+ year legislative and regulatory goal of banning the manufacturing and sale of all new smokefree alternatives to cigarettes.

In order to achieve their legislative and regulatory goal, Myers, Zeller and other THR prohibitionists have knowingly and intentionally misrepresented the scientific evidence on the comparable risks and benefits of different tobacco/nicotine products (for the past 15 years).

This conspiracy (to protect cigarettes and Big Pharma drugs from future market competition by very low risk alternative products) has been unethical, inhumane, crony capitalist public health malpractice of the worst kind.

Since FDA’s Deeming Ban could cause the easily preventable deaths of millions of vapers (and tens of millions of smokers), the 15 year long conspiracy by Zeller, Myers et al (to deny smokers and vapers legal access to lifesaving vapor products) is a crime against humanity.

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