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

Who would gain from creating a fake Gottlieb memo about vaping regulations?

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Man-holding-a-mask-behind-his-back

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 Felderbaum 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.

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

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”

mech mod

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.

Likewise, the use of the term “mech mods” betrays a vaping author.

“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 mods and cloud blowing are vapers’ slang, 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

Puzzle

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. The video above shows Fred Kelly Grant at the Hartland hearings explaining the coordination process.

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

microphone

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.

Guidance for Industry
Standards for Safety and Securing of Vaporization
Nicotine Replacement Therapy Products
U.S. Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner (OC)
Center for Tobacco Products (CTP)
Office of Regulatory Affairs (ORA)

SG Personal Notes:

The supposed main benefit of the Cole-Bishop bill and its predecessor the Cole-Bishop amendment to the FDA appropriations bill is that it changes the predicate date from February 2007 to the date 21 months after enactment of this new bill or 21 months after the effective date of deeming regulation.

The passage of this bill would be tantamount to acquiescing to PMTA’s for the industry moving forward which would naturally mean a consolidation of the industry over the next decade as smaller manufacturers are unable to bring new products to market. Once PMTA’s are in place, it is very unlikely Congress would ever be repealed.

Cole Bishop represents a path towards greater consolidation within the industry. Consolidation that will lead to less innovation and choice within the industry that will not benefit public health.

If we believe that vaping is a health benefit the Cole Bishop is a net negative because it will reduce choice and competition in the Marketplace.

Does big tobacco have their hands in Cole Bishop because they do not object to its passage? Big tobacco does object to the Duncan Hunter Legislation.

Self Regulation

There is no single United States organization that supports retail, manufacturing, and consumers interests simultaneously. No single entity to point the finger at when something goes wrong. Congress wants a single finger to point at if the industry self regulates.

My problem is:

All organizations that represent the vaping industry are immature, underfunded, and are incapable of working together to coordinate safety for the public.
Congressional leaders want three main areas addressed.

Manufacturing: Batteries, Liquid, Wicks, Coils, Vaporizer
Retail: Training of Employees, Audit of Health Claims, Audit of Advertising
Consumers: Weights and Measures, safety warning, proper instruction

Under self regulations industry would provide:
Need: Certification, Accreditation, Licensing, Standards, Audit, and
substantive financial Penalties for non-compliance. FDA would suggest
to Congress criminal penalties in addition to financial penalties.

Example path to follow: ECTA (Canada)

Should vaping and combustionless tobacco be categorized together?
Would allowing both provide a killing blow to cigarettes?
Would SNUS allow States to keep their tax base on tobacco products?
Should the Patch, Lozenge, and Spray be categorized with combustionless products?
Would traditional Nicotine Replacement Therapy survive in the marketplace if competing on an equal footing with vaporization?

Many in Congress on the left and right want to kill vaping due to cloud-chasers and mech mods. 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.

Can the vaping industry be moved to embrace the NRT aspect?
Will business leaders in the Vaping industry shun the alternate culture
being created by cloud chasing?

Anti Vaping Coalition Demands:

  1. Vaping liquid cannot be sold to the public through online sources.
  2. Vaporizers that meet an American Standard can be sold to the public through online resources.
  3. Devices over 65 watts are hobbyist devices and are subject to state Sin taxes
  4. Devices under 65 watts are beneficial devices used to facilitate Nicotine Replacement Therapy
  5. Wherever liquid or vaporizers are sold no children are allowed unless escorted by a parent or guardian. No convenience store sales of e-liquid. Could be sold in convenience stores if it goes through the PMTA process and is packaged and advertised to certain standards.
  6. No liquid sold above 24mg of nicotine.
  7. Elimination of Mech Mods
  8. Anti short circuit batteries and devices
  9. Would be allowed to make smoking cessation claims
  10. Would be allowed to make weight loss claims
  11. Tamper Resistant bottles with warning of addictive substance, batch numbering for recall purposes
  12. Testing for BHT and lead

Current vaping industry is not doing enough to promote safety.

  1. No PSAs for children not to start vaping
  2. Little to no PSAs on battery safety
  3. No PSA campaigns on Mech Mods
  4. No PSA campaigns on how to safely store liquid out of reach of children.
  5. No PSAs explaining that the product is an NRT device
  6. No PSAs explaining proper vaping etiquette in public.

What PSAs are out there come from a company and not from an industry Organization.

The aspects of recycling plastic bottles is never addressed.

Only valid PSA’s were produced by Not Blowing Smoke and they were not safety oriented.

The industry does not realize that education of congressional members by vapers is detrimental to their cause. Many members of Congress have confided that if heroin was not illegal that there would be a heroin lobby buffered by a grassroots team of heroin addicts touting its medicinal
benefits. Vapers are looked upon as addicts by Congress. The vaping industry needs to have Doctors and health professionals be their front men in Washington D.C.. Addicts have no credibility because they are addicts. 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.

Coordination

  • Legal says they will not win but does not really want to take the chance of losing because of the expected thousands of lawsuits the FDA would face. Sticking point they are unsure about is the environmental aspects of secondhand smoke and its reduction by vaping. There is a point of contention they could win on this issue.
  • It would look bad for the FDA if we increased deaths from secondhand smoke by prohibitively regulating vaping out of business. Secondhand vape has consistently been shown to cause no harm.
  • Why would the FDA face more lawsuits than the EPA or BLM?
  • Legal: because the FDA deals with more products and each can become a legal right to sue on the basis of “Right to Try”
  • A win by the industry would almost assurdedly mean a tremendous change in how the FDA does business.
  • Is this good or bad?
  • Many view the FDA to be tyrannical and full of activists for big Pharma.
  • 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?

Jim McDonald
Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy