Pressure Point | How ‘Coordination’ Could Push FDA to Bargaining Table



stop look and listen it's a requirement Congress and the courts have placed on federal government agencies like the Food and Drug Administration to conduct before making final regulatory decisions such as deeming vaping products to be tobacco products the requirement is called coordination and it goes beyond soliciting public feedback in consulting local officials it's a mandate to coordinate regulatory initiatives with state local and tribal governments in order to limit the impact federal regulations could have on local communities after 40 years of US law making language codifying coordination is scattered throughout the US legal code it's detailed in federal agency policy and marshaled by presidents through executive order it was in fact Bill Clinton who went first and farthest in delineating the need for coordination and then ordering federal agencies to coordinate in a 1993 executive order of President Clinton set forth the objectives and requirements for US regulatory reform he stated the objective for federal agencies is to enhance planning and coordination with respect to both new and existing regulations with regard to state local and tribal governments President Clinton specifically ordered all federal agencies to seek the views and involvement of officials before imposing regulations which may be inappropriately burdensome federal agencies are also directed to assess the effects of federal regulations and seek to minimize the impact likely to result from a rule that may adversely effect in a material way the economy a sector of the economy productivity jobs and competition finally President Clinton specifically encouraged state local and tribal governments to assist in the identification of regulations that impose significant or unique burdens on their communities or are otherwise inconsistent with the public interest while President Clinton issued his executive order in 1993 it still remains active today as Presidents Bush Obama and Trump all chose to build on the order so what does this all mean well it means that before the food and drug administration promulgated the final rule deeming vaping products to be tobacco products it had a duty to coordinate with state local and tribal governments before implementing the rule it also means FDA's duty to coordinate continues to this day holding the Food and Drug Administration's feet to the fire regarding its duty to coordinate is the EVC a the electronic vaping coalition of america founder mark block reached out to maverick lawyer fred kelly grant who for over the last 20 years has successfully challenged a variety of federal regulations through the coordination process grant specializes in regulations issued by the Environmental Protection Agency and governed by the National Environmental Policy Act or NEPA which is the law where Congress first codified coordination back in 1976 convinced coordination could help pressure FDA into negotiations grant in the EVC a organized two public hearings with elected officials from the village of heartland to Wisconsin and from the town of Windham in New Hampshire over the course of the hearings the Coalition presented testimony from nearly two dozen witnesses including Public Health researchers industry experts and local Iggy's manufacturers we expect to show you that that through vaping people who want to get off of the cigarette habit have been able to do it and that that's the one way they've been able to get off and stay off the purpose behind the coordination hearings is to provide local officials the facts dispelling mainstream myths about the dangers of aping to demonstrate the benefits of vaping as a tool for harm reduction to review the local economic impact of the deeming regulations and a prompt regional officials to notify the Food and Drug Administration that they request coordination proceedings to begin it does give you sufficient governmental status to say to food and drug and the other agencies we expect you to coordinate with us we expect you to deal with us when it comes to issuing regulations that impact our town our citizens our taxes the corridor in which we live what Fred Kelly grant just described is the power structure behind coordination an individual group or company have no authority to request coordination with a federal agency only state local and tribal governments can do that therefore the primary goal of the hearings is to gain local government action a clear win came out of the Heartland hearing as the village subsequently sent official notice to FDA requesting the agency star coordination on top of that village of Heartland president Jeff banner still appeared at the following hearing in Windham New Hampshire as a supporting witness they explain to them what you've done in Harlan and and what's happened in the in the brief time you've been in the coordination we have a business in Hartland that employs quite a few people they make what's known as vape juice or the solution that goes in to vaping and with the regulations that have come about that I really learned about in going through our hearing and how damaging they are to these businesses are gonna cause a detrimental effect if not a complete annihilation of this company so all of a sudden we we found out by going through this court nation earring you have an economic impact on your region in your area you have a public health impact due to the nature of what vaping does and its harm reduction and you also have the impact of the federal government not coordinating with you and just throwing something down and saying this is the rule-follower so as we went through that it was it was extremely staggering to me because I had heard all the hoopla that people had heard in the past also that make people think all it's bad popcorn long and all kinds of stuff it turns out a lot of it is exactly what I call it and it's Kubla joining us today to talk coordination is andrew aguilar he's the CFO as savior vape one of the country's leading eliquid manufacturers a member of the industry advisory board at the electronic vaping coalition of America Andy thanks for coming on the show let me start with letting our viewers know you're also a practicing lawyer and has some experience with regulatory law around vaping so Andy what were your thoughts when you first heard about coordination you know in administrative procedures essentially where the FDA kind of draws their power you know they're oftentimes allowed to regulate as long as there is kind of an intent from Congress to do so but the problem is is that the big agencies have a lot of difference they're allowed to interpret their their their own rules a lot of times you know the courts often times because they defer to the agencies will kind of throw throw it back to them as long as you know there's a reasonable interpretation of the rules what I liked about coordination was you either did it or you didn't do it essentially what happens is that because it's mandated by Congress it's very difficult because it's not an Administrative Procedures issue it's just a hey in the statute it's you coordinate you know you didn't I didn't really see what the defense to that would be theater you did it or he didn't so as a procedural point and it is something that that the administrative agencies are supposed to be doing anyway they just oftentimes go and the unimaginable agencies might consider it to be a disadvantage if local officials know too much about coordination walk us through that so so essentially what you want to happen is it and that's why we do the hearings is first we essentially you know procedure on a process point of view will approach the local municipality won't per se be me it can be a coalition but it can be a local member it says you know you could go to your City Council or ever it may be you reach out we try to present the evidence to them to show them what the harm to the local community is and if that local community of the City Council or you know in New Hampshire it's the selectmen it's the village in Hartland whoever it may be it's essentially to tell them what the issue is and it's up to them to decide if they want a coordinator Andy we do know FDA is well aware of court following the hearing in heartland village officials met with FDA officials in Washington DC to discuss coordination also FDA is currently in coordination proceedings over the FSMA the Food Safety Modernization Act which according to a report from the GAO isn't going too well but you know at least the FDA is working on it you're really making an effort to coordinate the etcetera leave a coordination center they've also been setting up boards in interacting with the local communities things of that nature so that's really what the vaping industry wants you know you can we can look at some other things regulatory flexibility Act including you know a lot of presidential executive orders you'll see similar language but in particular the coordination language in the FSM a really does go go above and beyond and I would look to that language as well along with me but say look this is a pattern this is a trend this is just what the vaping industry wants everybody supports reasonable regulations but do it you know do what you're doing with food you know don't don't don't treat these this industry differently so that's not perfect Andy do you think the coordination process is a kind of failsafe for democracy yeah that's a good question and the answer is you hope so I mean when you read a coordination statute you read the way it's written in Nebo when you read the way it's written in the FSMA it sounds right it sounds exactly what Congress wants you're not passing laws in a vacuum you're passing laws because real people are affected by it and and and it's not that you know courts won't rule against administrative agencies they do but for whatever reason with with the scope and power of agencies these days coordination really from a separation of powers perspective really is the right answer it's to say look even if you're doing all these things coordination is mandated by Congress you have to do it it doesn't matter because Congress want to do it in for a court it should be very easy for them to say well did you do this or did you not do this that's it follow-up question Andy what happens if FDA doesn't coordinate with the vaping industry what happens if they don't coordinate you go back and on appeal or something else and the court says look there is no way that leapin existed back in 2009 this this law was designed for cigarettes and you can't regulate this at all you know it's a there's just so much risk for the government on this end to not to not coordinate and to not do it and you know I you know and see your point about democracy you know a lot of the public officials that are appointed to these agencies aren't democratically elected they're appointed you know I have no saying who the Commissioner is you know good or bad so I think that's another thing that just you know REM ffice eise's how much you need coordination because there is no democratic process to elect an official who's deciding you know essentially that I can't be in business well that's it for this edition of reg watch before you head off please like us on Facebook and don't forget to follow us on Twitter for Regulator watch com I bread staffer

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