Who Wrote a Fake FDA Memo from Scott Gottlieb, and Why?

Rumors have swirled lately about an advocacy group using a forged memo from FDA Commissioner Scott Gottlieb to raise funds from vaping vendors. Whether the document was used as a fundraising tool is not certain, but the document does exist, and it is not a legitimate Gottlieb memo.

Vapor Voice magazine confirmed with FDA press officer Michael Felberbaum that “this is not an FDA document and thus does not reflect comments from the Commissioner.”

Vaping360 received a copy in PDF format this week from an anonymous source. The document, which supposedly contains Gottlieb’s notes about the vaping industry and how it might be regulated, is presented here in full.

The document is titled “Guidance for Industry, Vaporization Nicotine Replacement Therapy, Working Document 14375 (DRAFT).” It is presented on what is supposed to be FDA stationery. The memo begins with the words, “SG Personal Notes,” implying that Commissioner Scott Gottlieb is the author.

The actual author of the document is unknown. Although it is presented as informal notes to himself, it is largely written in full sentences, as though meant for others. And they aren’t the well-constructed sentences seen in the commissioner’s actual work.

“Cloud-chasers and mech mods”

The notes seem to present the FDA chief musing to himself about the direction that FDA regulation of the vaping industry might take. However, the direction FDA actually took — based on Gottlieb’s announcement of July 28 — ignored the concerns outlined in the supposed memo.

The guidance document lists issues with “mech mods” and “cloud-chasers,” recycling of plastic bottles, the lack of doctors as “front men” for vaping advocacy groups in Washington, and includes a lot of thinking about whether to include vape and nicotine replacement therapy (NRT) products in the same regulatory category as vaping.

That would require removing vapor products from the Family Smoking Prevention and Tobacco Control Act (which the deeming regulations modify to include vape), or including NRT in the Act — neither of which could be done by the commissioner.

“Should vaping and combustionless tobacco be categorized together?” the author asks. The term “combustionless” is new, apparently concocted by the mystery author of the “memo.” Gottlieb would likely use the term “smokeless” to refer to snus and snuff, and wouldn’t spell snus in capital letters — “SNUS” — as though it were an acronym.

“The industry cannot make a valid argument as a clinical nicotine replacement therapy product and then have a majority of its advertising and media be for cloud chasing and be expected to be taken seriously,” the document states. But no vapor product has ever claimed to be a “clinical nicotine replacement therapy product,” and indeed vape is not categorized that way by the FDA, nor could it be without Congressional action.

“Invariably, vaping rallies have testimonials that have users tell how the product saved their life and in the same rally you will see big clouds being blown. Not very convincing,” says the “memo.” The odds that Gottlieb has witnessed a “vaping rally” are slim, but not as unlikely as him knowing and using the term “blowing clouds.”

Likewise, the use of the term “mech mods” betrays a vaping author. Mech mod or any type of vape mod and cloud blowing are vapers’ slang—like vape tanks, something only a vaper would utter—not phrases used by FDA employees or medical professionals like Dr. Gottlieb. Nor are they issues FDA has ever opined about. Conversely, a major topic of the speech Gottlieb gave on July 28 was e-liquid flavors, which is not mentioned in the fake memo.

The reference to ECTA — the Electronic Cigarette Trade Association, from Canada — is odd. It is highly unlikely that Gottlieb would be familiar with a Canadian vaping industry standards group.

But perhaps the oddest thing about the fake memo is the extraordinary attention given to the legal strategy of “coordination.”

Coordination

What is “coordination”?

The concept of coordination is solely promoted by one vaping group, the Electronic Vaping Coalition of America (EVCA). It has never been applied to food and drug law before, and no other vaping advocacy group believes it can be effective. In May, CASAA even took the unusual step of advising its members not to take part in EVCA’s crowd-funding drive to support the coordination strategy, calling the fundraising effort “misleading and deceptive.”

EVCA was formed last year, five days after the announcement of the deeming regulations on May 5. The founder and director of the group is Mark Block, former chief of staff for 2012 Republican presidential candidate Herman Cain, and a longtime fixture in Wisconsin politics. Block also owns a vaping company called Smoke Safely, which doesn’t seem to be active, at least online.

The legal concept of coordination is complicated. It originates in land use law and planning, and requires federal agencies to consult with state and local governments before imposing executive actions that could be harmful or costly to the affected state or municipality. A description of the strategy as EVCA sees it is laid out in an interview with Block, and fellow EVCA board members Linda Hanson and Fred Kelly Grant. Grant is the lawyer who has successfully sued the federal government using the coordination strategy in the past — always in land use cases.

EVCA encouraged the Village of Hartland, WI to hold hearings regarding vaping and the effects the deeming rule would have on the community, and ultimately to meet with the FDA to explain the village’s objections, and its plan to challenge the agency legally. Hartland is home to Johnson Creek Vapor Company, a pioneering e-liquid manufacturer that produced many flavors in common beginner e-cigarette devices.

The FDA apparently didn’t respond after meeting with representatives of the village. A letter from the village was delivered July 27 to Commissioner Gottlieb giving him a deadline of Aug. 25 to engage with the village or face a lawsuit.

A day later, Gottlieb made his monumental announcement, delaying enforcement of the premarket tobacco application (PMTA) provision of the deeming rule, and EVCA posted a press release titled, “ONE DAY AFTER NOTICE BY HARTLAND, WISCONSIN, FDA DELAYS TOBACCO 'DEEMING' REGULATION.”

Is Scott Gottlieb worried about coordination?

The fake Gottlieb memo contains a half-page of concerns about the coordination “threat.”

“Would a coordination win by the vaping industry be good for the FDA in the long term? Or would it destroy the FDA? Is it time to start thinking differently about regulation?” writes the memo’s author.

But the real Gottlieb would know that even if the Village of Hartland won a lawsuit — and the appeals to follow — it wouldn’t “destroy the FDA,” just as coordination challenges didn’t destroy the U.S. Fish and Wildlife Service or the Bureau of Land Management.

The heavy emphasis in the forged memo on this obscure legal strategy has led to widespread speculation that EVCA — the only vaping advocacy organization that has promoted coordination as a viable strategy — may be behind the memo. EVCA might be able to raise funds from vendors, the thinking goes, by implying that the FDA commissioner has doubts about winning a legal battle against a challenger using the coordination strategy. Possession of a leaked FDA memo might also impress potential vaping industry donors.

But for now that is only speculation. Whoever is responsible could face consequences far more severe than disapproval from the vaping industry. Forgery carries criminal penalties that can include prison time.

EVCA Director Mark Block denied being connected to the document [see comments below].

Responses from advocacy leaders

We reached out to leaders of all the national advocacy groups for comment on the fake memo.

Mark Block, Director, Electronic Vaping Coalition of America (EVCA)

“The question you posed, is my take on the Gottlieb memo.

“First, the libelous accusations by others in the Vaping Community that I or anyone affiliated with EVCA had anything to do with drafting the document is preposterous.

“Is the memo an official statement from the FDA - no.

“We still have no reason to believe it’s fake.

“EVCA continues to execute its strategy of ‘Repeal & Replace,’ the FDA Deeming Regulations, and trust the supporters of our strategies see the Vape Drama for what it is - Drama.”

Dimitris Agrafiotis, Chairman, SEVIA USA

“I don't mind using the same tactics against the opposition that they use against us, but using those tactics within our industry for funding is completely unethical.”

Alex Clark, Chief Executive Officer, Consumer Advocates for Smoke-free Alternatives Association (CASAA)

"One of the few genuine unintended consequences of aggressive anti-THR campaigning and anti-vaping regulation is that activists have directly contributed to creating a group of people who are now desperate to save their lives and are ripe for being taken advantage of.”

Gregory Conley, President, American Vaping Association (AVA)

"For those in the vape industry whose livelihoods depend on the continued existence of vaping, it is completely understandable this memo and those who pitched it would be so attractive. Unfortunately, as this incident shows, when something sounds too good to be true, usually that is when the red flags begin to emerge."

Stefan Didak, President, Not Blowing Smoke

“It's reckless for anyone to engage in the sharing, or worse, usage for any gain, of forgeries because it blows back on the entire industry, every trade- and advocacy organization. It would be too easy for opponents of the industry to create headlines reading Vapor Industry Involved in Felony and paint us all with the brush created by unscrupulous individuals who created this fake ‘memo’.”

Pamela Gorman, Executive Director, Smoke-Free Alternatives Trade Association (SFATA)

“I thought its validity was suspect immediately. It certainly didn’t appear to be anything ready for prime time such that anyone with an education would have put it on official agency letterhead and then circulated it under their name proudly. If it is real, it is only a working document that was leaked (which means “stolen”). I don’t react to fake documents and don’t share real ones that are stolen. So, I had no use for it."

The fake memo is reproduced in full below.