The FDA makes its move : Pipes and Tobaccos Magazine

The FDA makes its move

by William C. Nelson

On May 5, 2016, the Food and Drug Administration (FDA) announced that it had finalized a rule in which it “deemed”  its  own  regulatory  authority to extend to all tobacco products, encompassing pipe tobacco, cigars, hookah tobacco and e-cigarettes, among other  industry-related  items,  including pipes and their constituent parts. News of the regulatory move landed on the pipe smoking world like a thunder-clap, and consumers as well as tobacco manufacturers and pipemakers have been grappling with the legal implications ever since. So have we at Pipes and tobaccos magazine. Readers can down-load the deeming rule at the following URL: www.goo.gl/xB3oIC.

The   new    regulations—authorized by the Family Smoking Prevention and Tobacco Control Act of 2009—will, if allowed to bear full, poisonous fruit, have the effect of prohibiting the sale of most small-batch “boutique” pipe tobaccos and cigars introduced to market since Feb. 15, 2007. That covers a lot of products in an era celebrated, by pipe smokers and cigar lovers alike, as a golden age of innovation.

For  the  moment,  it  appears  that any product that can be proved by its maker to have been already on the market on Feb. 15, 2007, will be grand- fathered in—assuming the product’s specifications have not been altered since that date. Even this assurance about older-name products might not  last  forever;  the  FDA  is  free  to reformulate and reinterpret its own regulations retroactively. It does seem clear that products introduced since Feb. 15, 2007, will have to be submitted to a labyrinthine FDA approval process. According to the District of Columbia periodical The Hill, “The FDA claims the applications will take 5,000 hours and cost $330,000 each, but some estimates put the cost at as much as $1 million for each product.” Any products brought to market between the  2007  grandfathering  date  and Aug. 8 of this year will have two years’ grace period to gain approval. Products still  unapproved  after  Aug.  8,  2018, will have to be removed from the market or else be subject to seizure, until and unless they ever do gain approval. New products introduced after Aug. 8 of this year have no grace period; they must clear the approval process before they can ever be sold. Old, classic labels being reintroduced are treated under the rules as new products.

Some parts of the rule are already being felt in brick-and-mortar stores. There is a new federal proscription on the sale of tobacco products to persons under 18 years of age. While few of us would argue against that restriction, many would prefer that this matter  be  decided  at  the  state  level,  as it previously had been. (Higher age limits already adopted in some states still  apply.)  Of  greater  concern  are the new constraints that tobacconists face  in  serving  adult  pipe-smoking customers. For one, tobacconists are no longer permitted to give free samples. So, there will be no more exploratory dipping of your pipe into those big jars at your local brick-and-mortar shop. And there are likely to be fewer of those jars present anyway because tobacconists are no longer legally allowed to blend  tobaccos  in-house.  What  they can do is sell you the constituent parts of a mixture separately, disclose to you the recipe (if they will), and let you do the mixing at home. Mark Ryan, owner of Daughters & Ryan Tobacco, says it is  even  possible  the  regulations  can be interpreted to require that online sellers—merchants  engaged  in  any sale  “not  face  to  face”—obtain  proof of age eligibility from buyers. People who  wish  to  buy  online  might  have to upload some form of identification proving that they are of legal age, an image of the document to be kept on file by the seller in case of future audit. Ryan says he is already making changes to his computer servers to accommodate such a contingency.

Of great long-term concern is that this bureaucratic power-grab has the obvious potential to put all but the largest manufacturing firms out of business. The regulations’ effect, if not their stated intent, will be to deliver nearly all of the tobacco-related industry into the hands of Big Tobacco—large firms able to retain the legal counsel and pay the fees required to keep their products on store shelves.

Big  Pharma  stands  to  benefit  as well.  There  is  credible  evidence  that e-cigarettes have helped many thousands of smokers kick the cigarette habit. But because nearly all vapor devices came to market since the grand- fathering date, nearly all will be subject to the high bar of the FDA’s approval process; few vaping manufacturers will be able to clear that bar. This spells a likely death knell for the vapor industry, whose customers now appear destined to be forced into the embrace of pharmaceutical products for their cigarette cessation efforts—a boon for the makers of pills and patches. It does not escape our attention that Mitch Zeller, director of the FDA’s Center for Tobacco Products and the man most responsible for advancing this rule, was recruited to his job from Pinney Associates, a pharmaceutical consulting firm in the employ of GlaxoSmithKline, maker of the smoking-cessation products Nicorette, NicoDerm CQ and Zyban.

It is becoming an old story in the American economy—small operators finding themselves frozen out while big- money players go on largely unaffected. In that vein, the FDA deeming appears to serve as an extension of an economic trend that is turning contentious in political campaigns: the concentration of wealth and economic viability into fewer hands year by year. Holman W. Jenkins Jr., writing in the Aug. 13–14 weekend edition of The Wall Street Journal about the effects of the rule on the  e-cigarette  industry,  stated,  “Lovers of freedom and enemies of regulatory overkill do not exaggerate when they  say  FDA  rules  are  designed  to kill numerous small manufacturers. … In  time,  what  remains  of  the  market will be consolidated in the hands of Big Tobacco companies.”

Thus far,  one  of  the  most  striking and  frustrating  aspects  of  the  deeming is that even today no one knows for certain what the full scope of the new regulations will entail, or how far the FDA  will  be  allowed  by  Congress  to go in circumscribing tobacco-related commerce. It seems clear from the wording in the regulations that the FDA has scant knowledge of the pipemaking trade or how to regulate it. One member of the industry, speaking on the condition of anonymity, said even now there is no telling which blends are affected by the deeming and which are grandfathered: “The FDA might tell us that the same product is really a different product in different years because the leaf comes from different crops. If they rule it so, what can we do about it?”

It also remains unclear at this time whether the FDA intends to go after artisan pipemakers, forcing lone crafts- men working in home workshops to undergo the same, onerous product approval process as everyone else. But in our reading of the regulations, we can find no exceptions made for pipemakers. Some observers have pointed out the sheer ridiculousness of any demand that solo pipemakers submit their creations to an expensive government approval process—an obviously impossible requirement when every product is unique and none can represent the others. The very unworkability of the idea encourages some to believe that individuals working alone in small work- shops might be able to “fly under the radar” and avoid drawing government attention. Unfortunately, this overlooks the government’s most reflexive possible response: outright prohibition of the artisan pipemaker’s work—effective extinction of the craft. The FDA is not interested in safeguarding the livelihoods of pipemakers, or in maintaining the tax revenue stream paid by small tobacco companies.

We don’t wish to leave readers with the feeling that our situation is completely hopeless. Remember: This is a regulatory move, and that means it is susceptible to legislative correction. Cigar enthusiasts are already getting some licks in. For example, pending legislation in the U.S. House of Representatives (FDA funding appropriations  for  fiscal year  2017:  H.R.  5054, Sec. 749) contains the following provision: “Prohibits the FDA from using funds provided by this bill to enforce the proposed ‘deeming rule’ for tobacco products if the rule would apply to traditional large and premium cigars.” Whether or not that provision survives a journey through the House and Senate and ultimately becomes law, at least we know that someone in the House is try- ing to support cigars. Can pipe smokers, too, find a congressional friend?

Another possible avenue for circumventing the FDA’s power move is found in the raft of lawsuits that have already been filed by industrial interests and lobbying groups to stop the deeming, or at least to blunt its impact. Plaintiffs of some of these suits include the International Premium Cigar and Pipe Retailers Association (IPCPR), the Cigar Association of America and Cigar Rights of America (CRA). On Aug. 15, the Tobacconists’ Association of America announced that it had donated $50,000 to the IPCPR and CRA to help fund the legal  effort.  Another  industry  player that has filed suit is John Middleton Co. LLC, whose “Black & Mild” trademark appears to run afoul of the regulations’ prohibition   on   the   “mild”   descriptor.  Nicopure  Labs,  a  Florida-based e-liquid maker, filed suit within the first week after the FDA’s deeming became public; other vapor industry players have  since  piled  on  as  well.  Indeed, so  many  lawsuits  are  being  filed that the courts have begun combining and consolidating them.

So even though the headlines of the day seem threatening, this thing is by no means over. And as events play out, we can suggest at least two courses of action that readers of this magazine should consider:

Get  in  touch  with  your  senators and  House  members  right  away.  You can find their contact information at www.house.gov/representatives and www.senate.gov/senators/contact. We encourage every reader to both write letters and place phone calls to your representatives’  offices.  Yes,  do  both, and be persistent. They work for us; stay on them until they respond constructively. This is important.

In preparing for the possibility that the worst might come to pass, consumers should make an effort now to stock up on favorite products that could be endangered. Ask your favorite retailer where your best-loved products stand in light of the new regulations. Officially, you have two years, but effectively, products could begin disappearing from shelves sooner than that if it becomes clear that manufacturers will soon have to  spool  down  operations.  One  way to look at it is, as Smokingpipes.com owner Sykes Wilford reminds us, “Any reason is a good reason to stock up on your favorites.”

 

 

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Category: Fall 2016, Feature Article, Other Stories

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