TRIBUTE TO HARTLAND, WISCONSIN AND EVCA – PROVE CRITICS WRONG ON COORDINATION, DESERVE HIGHEST PRAISE

 
 

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.”

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