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CHEERS TO THE TRUSTEES OF THE VILLAGE OF HARTLAND, WISCONSIN AND THEIR ADMINISTRATIVE STAFF – THEY DID WHAT SO MANY SAID THEY COULD NOT DO.

This is my personal, unapologetic tribute to Hartland, Wisconsin’s Board of Trustees— Board President Jeffrey Pfannerstill, Karen Compton, Richard Landwehr, Michael Meyers, Rick Stevens (who makes a mean walking cane that helps me immensely), Randy Swenson and Ann Wallschlager—and Administrator David Cox, and to the Electronic Vaping Coalition of America and co-founders Mark Block and Linda Hansen.

I make this commendation with full sincerity. Probably better than any other person, I recognize just what Hartland and EVCA have accomplished. 

 I have been in the game of fighting federal regulators for a long, long time. I know first-hand that in the western U.S. nothing was working, that is until the Board of Commissioners of Owyhee County, Idaho, county ranchers, and I brought the coordination process forward.  

Back then, we were taunted by the “in crowd,” just as Hartland and EVCA were.  And we won then, just as Hartland and EVCA have won their first battle today.  If they stick to their guns, and they will, they will win the day as we did in the west three decades ago. 

The naysayers, meanwhile, can continue to sit on the sidelines and wait, sit and talk.    

Keep in mind a few of my favorite quotations about taking action instead of sitting and waiting:

“Do what today others won’t, so tomorrow, you can do what others can’t.” ~ Brian Rogers.

The successful person has the habit of doing the things failures don’t like to do.” ~ Thomas Edison.

‘Things may come to those who wait, but only the things left by those who hustle.” ~ Abraham Lincoln.

So, with this tribute I say also to Hartland and to EVCA follow the lead of H.L. Mencken, – my favrite cynic and curmudgeon – remember, to solve a problem you must go through it or over it, but you will fail if you try to go around it. 

I know all of you by now well enough to know that you won’t try to skirt the issue; you will succeed as did Farragut with his legendary strategy “Damn the torpedoes, full steam ahead.”          

July 31, 2017 from Nampa, Idaho by Fred Kelly Grant

Hartland, Wisconsin!

If you are in any way involved with the vaping industry you know the name of this village.  Just this week the Commissioner of the Food and Drug Administration made a sweeping announcement that the agency is taking an historic shift in position regarding regulation of tobacco products and electric non tobacco, non-combustible products.

I have no doubt that Hartland’s tenacious push for coordination was a primary cause of this shift.  The Village Trustees and Administrator had the courage to follow the lead given them by the Electronic Vaping Coalition of America, and push hard with a threat that unless the FDA follow its own statute requiring coordination with local governments when considering new regulations, village would sue.

Every person in America who vapes should be grateful to, supportive of and proud of the Hartland Trustees: Jeffrey Pfannerstill, Chairman, Karen Compton, Richard Landwehr, Michael Meyers, Rick Stevens (who makes a mean walking cane that helps me immensely), Randy Swenson and Ann Wallschlager  and their Village Administrator David Cox.

Credit and support is due as well to the Electronic Vaping Coalition of America and its co-founders Mark Block and Linda Hansen for introducing the coordination concept to Hartland, and giving the Trustees and Administrator the necessary support and resources to pull this off.

Hartland is a village of just about 10,000, a suburb just half an hour from Milwaukee. It is a rural community with old world charm a true all-American town. To drive through, or walk through the Village is a pleasant trip down memory lane for those of us who came from a small town but have now labored long in the trenches of the large cities. Tree lined streets, bicyclists everywhere, families strolling while eating ice cream cones.

Located along the Bark River in the beautiful surroundings of Waukesha County, Hartland offers its citizens more than 85 acres of city parks with facilities for all members of the family.  Ten parks, two golf courses and more than 600 miles of trails for walking and hiking.  There are even 12 lakes within five miles of Hartland, making it the ideal recreation-oriented town.

The River runs right through the downtown business area, adding charm and an environmentally friendly atmosphere to an all service town. The Village Board and the Administrator manage to provide full municipal services at low tax rates. In short, it is ideal for a family home.

On the surface, you’d never think this type of local government would make big, noisy changes in the world.

It just goes to show why you don’t judge a book by its cover.

Through Block and Hansen, EVCA pointed out to Hartland the eventual economic crisis faced by one of Hartland’s most successful business citizens Johnson Creek Enterprises, a vaping manufacturer. They explained how the FDA tobacco “deeming” regulation created a scenario which could easily put Johnson Creek out of business.

Block and Hansen spent hours introducing Cox and the Trustees to the governmental process by which local jurisdictions such as Hartland can seek relief from the economic impact of federal regulations.  The process is called “coordination” and, while it has been used successfully by local governments throughout the western and southwestern states it was virtually unknown in the mid-west and east.

Block had much earlier asked me whether coordination would work with the vaping industry and I immediately said “yes, as long as there was a local government willing to go to bat for the industry”.

Wasting no time, the Board of Trustees took a leap of faith and courageously stepped up to defend the viability of Johnson Creek. The Trustees advised the FDA Commissioner and the Health and Human Services Secretary that they intended to hold an evidentiary hearing to consider the FDA’s failure to coordinate the promulgation of the deeming regulations that threatened Johnson Creek.

The Trustees held a three-day hearing, April 27-29. The hearing was televised and was seen at any given time by thousands of people around the world.

Upon conclusion, the Trustees collected their Findings of Fact and Conclusions of Law, pointing out that the law and executive orders by five presidents including President Trump, required FDA to coordinate with local government by seeking “views of appropriate state, local and tribal officials before imposing regulatory requirements that might significantly or uniquely affect those governmental entities.”

The Trustees further found that the FDA had not based its regulations on the best science,  did not establish clear performance standards by which pre-application testing of products would be judged, did not seek input from Hartland, and did not seek to  impose the least possible economic burden on Hartland and its home based industries.

The Trustees called on the Commissioner to withdraw the strict timeline for pre-application approvals until his department could study and develop regulations based on sound science and economic theory, and to seek input from Hartland and experts in the technical categories of product analysis.

Hartland pursued its course in the face of criticism from certain vaping organizations which held forth very strongly that coordination would not work, and that it was only designed for western lands and water.  The Trustees were intrigued by the fact that members of the vaping community itself would so vocally oppose any process by which relief might be sought.

Those same critics have in the last days since the Commissioner made his announcement claimed that Hartland’s effort was not the moving effort. They claim that their petitions and grassroots efforts brought about the result. The Trustees remain silent as to this criticism, but I do not.

It is a strange and marvelous coincidence that all the talk of these critics had not brought about change at all, but that just three months after Hartland entered the fray, and just days after its threat to sue the sweeping change took place.

My friends, I put in more 50 years of hard nose trial work and work in the political-law arena (counsel to two governors and to three county governments) and I can tell you that he who believes in coincidence in politics is as naïve as is possible to be.

The critics of the coordination process as implemented by Hartland are not naïve—the reason behind their criticism is far deeper and darker that naivety. As an old friend of mine used to say in ending one of his endless letters to editors of newspapers “’Nuff said.”

On July 25, having heard nothing formal and official from the Commissioner, the Trustees sent a letter giving him the opportunity to schedule a hearing or face initiation of litigation by the end of August. The Trustees called on the Commissioner to join in talks with them about limiting online and television ads of vapor products; about seeking input from them regarding how to develop a plan of protecting youth from purchase of nicotine and how to protect youth from being drawn to combustible cigarettes; about seeking input from Hartland and expert opinion as to the burdens and costs of PMTA and while doing so, to delay the effective cutoff date by when all new products had to have the pre-applications approved, and about seeking input for developing regulations reasonable and based on sound science; and about seeking input on online sales and on flavor restrictions imposed by federal and state governments.

All the while the Trustees pressed the FDA on coordination, certain members of the industry expressed the same negativity that coordination would never accomplish anything. In the face of such criticism, which often seemed to dip into ridicule, the Trustees held firm and did not lose their tenacity based on the belief that they were right.

And, on July 28, 2017 the FDA Commissioner proved them right!! In a sweeping, historic speech, Dr. Scott Gottlieb called on his agency to put into practice every single one of Hartland’s requests. In his speech, Gottlieb told the world that the FDA would begin to study ways to reduce nicotine in cigarettes thus reducing the deductive thought of youth connected to nicotine, to get public input and input from stakeholders in the industry as to how to protect youth from all tobacco and tobacco-deemed products, to get input on developing science based standards for judging pre-application and on the type of and content of regulations that promoted an alternative to the destruction caused by combustible cigarettes. And, he delayed the deadline for pre-applications to be approved for five years.

Johnson Creek Enterprises has new life today because it doesn’t have to rush to spend enormous amounts of money on application reviews, (a process made exponentially worse with no measurable standards to go by.)

The courage and foresight of the Trustees of Hartland paid off in spades as the Commissioner swept away some of agency’s bureaucratic, arrogant practices. Hartland‘s Trustees should stand tall and be proud to have taken the coordination process to the tough federal agency and emerge with a real, meaningful balanced seat at the table with the Food and Drug Administration.

As a result of the Commissioner’s announcements, jurisdictions in New Hampshire, New York, Virginia, and southern California expressed interest to Mark Block for coordination hearings to be held by their local governing boards.  In reply, Block simply said, “Yes, its full speed ahead.”

I extend to each and every Trustee of Hartland, and to David Cox my most sincere congratulations. I saw the dedication each of them brought throughout the three days of hearings and the hours spent prior to, and subsequent to the hearing.  I saw them persevere in the face of arrogant critics who often sank to the level of ridicule.  And to the Trustees as they move forward now into the real work of coordination, and to all the members of governing boards who may take up the coordination process, I say we faced the same taunts, the same ridicule, the same arrogance of “we’ve never done it that way before” as four tiny towns in Texas began the process that stopped the first leg of the NAFTA SUPER HIGHWAY dead in its tracks, as one small county in Colorado stopped a re-routing of a Buffet owned railroad that would destroy its industry, and as California counties stopped the federal government shutdown of roads and trails in the national forests.

I guess the lesson from all this is the truth of the age-old, over used, proverb “Nothing ventured, nothing gained.”

The faculty at the University of Chicago School of Law long ago taught me that when planning strategy, “if the law doesn’t absolutely prohibit it, do it pedal to the metal.”  The complete name of the game in politics and law is “strategy” and he who finds the workable strategy wins. Hartland won its first big battle. Now, onward Hartland, make the process work with solid solutions. And onward EVCA, continue to make your efforts the premiere efforts of the industry. Sitting and waiting and talking doesn’t cut it in politics or law. Nike had it right in one of the most successful advertising campaigns in history: “Just Do It.”

By Fred Kelly Grant

Note: This is the third and final post in a series explaining the difference between federal agencies’ “Public Comment” periods for new regulations, and “Coordination,” a legal obligation of agencies but rarely obeyed. Click links to read Part 1 and Part 2.

Good public policy should always be arrived at through the use of the scientific method. A good scientist does not bias ​himself with a predetermined outcome of an experiment and then build data around ​that bias to rationalize the outcome ​he wants.

A good scientist puts bias aside and lets ​observations and data drive the conclusions.

This is not even happening with science in America. Science has been replaced by advocacy science, which is not science at all. Where scientists used to cherish their credibility through bending over backward to ​avoid the influence of bias, the majority of scientists today either work for the federal government​ or under a government-funded grant, and are thus biased to reflect the will of whatever administration is in power.

​Failing to reflect that will in their findings means grants are not renewed, and the institutions they represent are hurt financially. There is heavy monetary reason for them to find the way to rationalize the desired decision.

Why is advocacy science bad?

Think of a King decreeing the world is flat and his scientific council bringing to the table data that justifies the King’s conclusions. No one would be any the wiser that the world is not only round but it is spherical. We only advance as a society when we allow the truth to set us free from man-made constructs like the impediments imposed by special interests.

In the vaping world, it is hard for the public to buy, when the scientific data and observations are reviewed, that vaping is detrimental to public health. Common sense would dictate that in the name of public health that policy be that the world’s best smoking cessation tool and should be nurtured and embraced by public health officials.

Clearly the FDA has a bias toward vaping that does not work in the best interests of the public.

This is why pursuing coordination is vital to the health and longevity of the vaping industry.

It is clearly evident that FDA leaders have prioritized special interest agendas ahead of public health. If the FDA were a legal prosecutor and public health were put on trial, ethically, the FDA would have to disclose its conflict of interest with big Pharma and recuse itself from the trial, while asking for an unbiased special prosecutor to be appointed. Unfortunately, very few federal agencies have the temerity to act ethically and responsibly

We must always remember that the “Law” is a minimum standard ​of what we are required to do. Ethics

imposes a higher standard and is based upon what we ought to do. Federal agencies only operate within the confines of the law and have no equivocations about acting unethically. Just because something is legal does not mean it is ethical. ​So often the question posed by government officials to their counsel is “CAN we do this?” without any concern about “SHOULD we do this?”  

I have been there, spending many years as counsel to federal agencies, two Governors, county governing boards, zoning boards, as well as city and town councils. So many agency leaders have ​either forgotten to ask the “SHOULD” question or know that it would interfere with the path of action they have already set upon.

Coordination is a tool that holds federal agencies accountable and helps agency leaders remember that their role is first and foremost to serve us.  

Coordination helps the public have a say through local officials to whom all of us have ready access. You see your council person in the supermarket line, or at lunch in the diner, or at the service station, or in church, or at the school carnival. He or she is responsive to you because your vote is far more important percentage wise than it is to the Congressman or Senator.  When those local officials voice your position, they push agency leaders to act in a more ethical manner or suffer the consequences of their actions.

Coordination helps society to gain value from diverse opinions and build consensus rather than allow federal agencies to act within a vacuum.

Coordination helps federal agency leaders honor the public’s expectations rather than special interest expectations.

Coordination helps promote equality and recourse for all people to be treated equitably.

Coordination supports the public’s right to know and promotes a robust public involvement in policy decision making.

This is why all Americans should not only support the use of coordination,  BUT INSIST ON IT.

If you advocate building increased confidence in the decision making of federal agencies consistent with ethical behavior that benefits the public, if you specifically advocate freedom of choice for those that would rather vape and protect their health and lives, then I hope you will join us in our efforts to promote coordination.

By Fred Kelly Grant

Note: This is the second of three posts that explain the difference between federal agencies’ “Public Comment” periods for new regulations, and “Coordination,” a legal obligation of agencies but rarely obeyed. Click links to read Part 1 and Part 3.

CONGRESS HAS PROVIDED A PROCESS WHICH CANNOT BE IGNORED OR  MANIPULATED BY AGENCIES. IT IS CALLED COORDINATION.​

The legal premise of “coordination”​ does not rest on “public comment”. It rests on a position taken by A LOCAL GOVERNMENT in support of its citizens, and it requires the federal agency to act consistently with the position taken by the LOCAL GOVERNMENT.  

The process​ puts local communities in an equal bargaining position with federal agencies. Coordination does not allow federal agencies to simply disregard ​the interests of the public as expressed through its local government. Through coordination, federal agencies can be – and have repeatedly been – forced to vacate a predetermined regulatory outcome.

I have seen this process, and been part of the process more than 50 times where this has happened. Most notable were the federal agency retreat from the NAFTA superhighway in Texas, the re-routing of a railroad  purchased by Warren Buffet, the closing of roads in all the northern forests of California, and the destruction of dams on the Klamath River in California.

In all these cases government agencies IGNORED PUBLIC COMMENT that was opposed to the “PREFERRED” action already decided on by the agencies. However, the local governments in each of those cases used COORDINATION to force federal agencies to vacate predetermined outcomes and restored power to the people. Coordination equates to greater freedom and helps to instill public confidence in our federal government.

To help understand the difference between the coordination process and public comment, let’s go back to the school carnival analogy in part one of this series.

If the school district is divided into sub-districts, and has a policy that says “the Carnival Committee must reach consistency with sub-district policies, and the public convinces leaders of a sub-district that the Carnival Committee’s plans are flawed – maybe a Mardi Gras parade would interfere with a sub district school calendar, or parking lot flow. If the public can convince the subdistrict of such a legitimate inconsistency, the Committee then has to sit down with that sub-district and other sub-districts and reach consistency and agreement. The process defeats the predetermined (Mardi Gras) decision by the Committee. In other words, the school carnival committee has to go back to the drawing board.

THE COORDINATION PROCESS IS A FUNDAMENTAL TOOL TO ASSURE THAT THE SYSTEM OF FEDERALISM IS FOLLOWED.

​Federalism, which our national Founders chose as the basis for our constitutional government, rests on a balance of powers between the national government (the President and the Congress), the states (the Governors and the state legislatures), and local government (the towns, cities and counties). Coordination is the process by which the public – indeed, you, the citizen – can have your direct say through your local government.

Late last week, the village of Hartland, Wisconsin and its favorite son, took the next bold step into the coordination process.  The Trustees, led by president Jeff Pfannerstill, and village administrator David Cox, signed and delivered a formal recommendation to advance coordination between the local and federal governments over the U.S. Food and Drug Administration’s e-liquid regulations under the Tobacco Control Act. The Hartland representatives met with federal officials in the District of Columbia a little over a month ago, and now have taken a pro-active step to put the coordination talks into gear. Hearing Officer Fred Kelly Grant made recommendations to the Board on the last Monday of June, and the Board acted on the recommendation, pushing the ball into the FDA’s court.

First, Hartland reminded the FDA that the Deeming Regulations were issued in violation of several statutory mandates including the requirement that the agency coordinate with the Village as to the content of the regulations. Hartland again requested that the FDA rescind the unlawful regulations, but then addressed three specific elements that could be worked on through coordination while the rescission is taking place.

  • The Village suggested working on a protocol for deterrence of youth from beginning a smoking habit. The Trustees said that through coordination, the parties could discuss and jointly develop a deterrence protocol not through prohibitive federal regulations, but through real life testimonials from actual vapers who describe the differences in their lives between when they smoked combustible cigarettes and after vaping products helped them quit The Village Board advised FDA that they heard several very telling examples during their three-day, televised, hearing which could form the base for educational deterrence.  They expressed doubt that restrictive regulations could bring about deterrence since the law now prohibits sale and use by youth and has not worked.

 

  • The Trustees suggested that through coordination the parties encourage Johnson Creek Enterprises to develop a protocol by which each step necessary in applying for and gaining approval would be defined and cost analyzed. This would give the FDA an actual cost for analysis instead of mere speculation upon which it now relies.  Since no cost analysis was performed prior to the issuance of the regulations as it should have been, the FDA can now use that failure as a stepping stone toward a meaningful and actual analysis.

 

  • Third, the Village suggested that a tax revenue loss study be performed, with identification of repercussions from the loss of tax revenue. If the vaping industry goes out of business, or loses significant business every level of government—local, county, state and federal will lose significant tax revenues and no study of that loss has been made.  The Village suggested a cost analysis profile to include a three-dimensional view of the revenue losses. The profile would study every angle of every tax paid to every government level by every element of the business: manufacturer, retail seller, transportation, user, and all incidentals.  This tax study is vital because it raises the issue of loss of tax revenue by local governments as well as the state and federal government for the first time.

After Grant’s presentation, the Trustees discussed the recommendations and with some adjustments approved them and sent them on to the next forward step toward meaningful coordination.  During the meeting, Grant advised the Trustees that efforts were underway to help a California town from the southern part of the state to join Hartland in the field seeking coordination.  Mark Block, founder and CEO of the Electronic Vaping Coalition of America (EVCA) advised the Board that the Coalition was working in support of them and would assist in pushing coordination through southern California.  EVCA is the organization that first introduced Hartland to the concept and process of coordination which Grant has worked with successfully for nearly thirty years. Block also gave the Board an update on the bill to repeal and replace the Deeming Regulations introduced in the United States House of Representatives by Congressman Duncan Hunter of California.  Legislative relief through that bill is being pursued by EVCA while also supporting the coordination process.

David Cox has advised Grant that a local jurisdiction in another state has contacted him for information regarding the coordination process, so Hartland is being looked to as a standard bearer to move the coordination process forward.