FDA Deeming Regs

FDA Deeming Regs

Some time ago, one of our customers asked me to write a blog post on the situation with the FDA Deeming regulations and the impact it will have on the pipe/pipe tobacco industry. In researching this topic over the past couple of months, I have been unable to find any current information. The latest info was published at least a year ago and it doesn't appear there has been any change in the status of the cases proceeding through the DC court system.


Everyone already knows that, if the plaintiffs fail in their cases against the FDA, there is a very high probability that we won't seen any new smoking pipes or pipe tobacco blends hit the market until these onerous regulations are reversed. This primarily is due to the excessive application fees - ranging from $117,000 to $466,000 per application! - the FDA will be charging to review and approve any new pipe and tobacco products. However, as with 99.9999% of government oversight, regulation, action, policy, laws, etc., the government is fairly clueless on the subject matter ... and these Deeming regulations for the pipe/pipe tobacco industry are no exception.


For example, when there exists a finite number of pipe tobacco leaf varietals and components used to case or flavor the leaves, what method is the FDA going to use to differentiate a "new" pipe tobacco blend from one of the thousands of existing blends that contain the same percentage of each varietal, are processed in the same way, etc.? Does the FDA plan to develop a database of every smoking pipe, pipe tobacco, and pipe accessory manufactured prior to Feb 15, 2007 with the exact physical and chemical composition of each to use as a gauge against which all "new" products are measured and compared? If so, at what cost to taxpayers??


Under the Deeming regulations, the FDA's definition of what requires a smoking pipe, pipe tobacco, or pipe accessory manufacturer to apply for permission to market a product includes, "a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient." I don't know about you, but that definition leaves my head spinning with a myriad of questions! Let's say a manufacturer decides to substitute one varietal of Virginia leaf in a blend they've manufactured since before Feb 15, 2007 with another Virginia leaf due to poor crop quality in the Virginia varietal they normally use. Does the substituted Virginia varietal constitute "a change in component" under the definition - even though the substituted leaf is still a Virginia leaf - and therefore requires the manufacturer to apply for permission to market it? If the substituted varietal increases or decreases the nicotine content of that particular batch, does that constitute "a change in form of nicotine" under the definition - even though it's still nicotine from Virginia leaf - that would require the manufacturer to apply for permission to market it? Unfortunately, the FDA has not stated how it plans to apply or enforce the definition ... and that's a problem.


The whole Deeming regs issue started under the guise of preventing children (anyone under the age of 21) from obtaining and using e-cigs and vaping devices. I say "guise" because we all know the wonderful job the federal government has done to eliminate illegal drugs from within our schools over the past 4 decades. If anything, drugs seem to be easier for kids to obtain nowadays and drug-related deaths among youths has increased significantly over the past few years according to CDC reports. And, when kids can't get their hands on illegal drugs, what do they do? They eat laundry detergent. Right. So, there's that.


Furthermore, and maybe off topic, but who is the idiot who decided the cut-off age for purchasing tobacco should be 21?? If an 18-year old is considered responsible enough to vote and serve in the US military, isn't s/he responsible enough to decide whether or not s/he wishes to smoke? And, how is it that a child of 18 can't be claimed as a dependent on a tax return unless they're a full-time student in school, but parents have no right to know the state of their child's grades or school loan balance even when the parents are financially responsible to pay the tuition/loan? Then, there are the even more bizarre cases where a girl can obtain an abortion at the age of 17 without her parent's permission or knowledge and, under Obamacare, parents can provide health insurance coverage for their children up to the age of 26. This falls into that 99.9999% "clueless" category. But, I digress ....


While I can't say I know for certain how e-cigs and vaping devices were marketed when they arrived on the scene, they obviously now carry the same warnings as all other tobacco products and retailers are prohibited from selling them to underage individuals. So, ask yourself ... how many school-aged kids do you know who are sneaking around smoking cigarettes or using a vaping device? Probably a few, right? Now, how many school-aged kids do you know who are sneaking around with a pipe and a pouch/tin of pipe tobacco? I'll bet the answer is none.


While it's not expensive to get started with pipe smoking (less than $10 can get you a starter kit with a cob pipe and an ounce of tobacco), let's be real ... it's not like kids can walk into the local 7-Eleven or Casey's and buy a smoking pipe and a tin of pipe tobacco like they can a pack of cigarettes or a tin of snuff ... or a bag of laundry detergent pods. Besides, pipe and cigar retailers have the underage sales prohibition drilled into them, and no pipe/tobacco retailer wants to risk losing his/her state license or pay the hefty fines associated with selling tobacco to anyone underage.


So, I'm throwing the BS flag on this one. The reason for including smoking pipes, pipe tobacco, and pipe accessories in the Deeming regulations isn't to prevent those under the age of 21 from obtaining the items. Instead, they are included in order to increase the federal government's control over and taxation of the piping industry ... as if federal and state licensing requirements and excise taxes aren't already difficult and high enough! Where is the government's data proving that underage pipe smoking is an actual problem in this country? And, if smoking is such a critical issue, why haven't the feds cracked down on all of the states that legalized the manufacture, sale, and use of non-pharmaceutical marijuana? For that matter, what has the fed been doing to eliminate the importation and distribution of illegal drugs within this country?


Many argue that cigarette smoking is the number one preventable cause of death in the US and the Deeming regs help to decrease cigarette smoking. That could be true. I'm not going to argue the point despite the fact the CDC's own published reports state that heart disease (primarily resulting from obesity) actually is the leading cause of death in the US. However, when was the last time the CDC or any other federal agency conducted a scientific study on the mortality rate of pipe smoking? Or the practice of pipe smoking by age group? Never, you say? Hmmmm.... then how can Congress/the FDA justify including the piping industry in the Deeming regulations?


Don't kid yourself, the Deeming regs aren't about the prevention or mitigation of underage smoking or vaping. It's about Congress realizing the tobacco industry is still a strong tax revenue stream for the government, so it's doing what it does best ... over-reaching control through excessive regulation and exorbitant taxation.


What bothers me the most is the word that's in bold, italic type and underlined in the fourth paragraph above..."permission." Can someone please tell me when Congress amended the US Constitution and gave itself the authority to require legal US citizens and business entities to ask the federal government for permission to market a product?? I must have missed the memo informing the US population that our federal government transitioned from one of defined limited powers granted by "We the People" under the Constitution into one that more closely resembles a socialist dictatorship, "Big Brother" state.


How sad it is the federal government has been allowed to over-reach its authority to "regulate commerce among the several States" to the point where US companies are now required to ask the government's permission to sell a product it produces. I seriously do not believe this is what our nation's forefathers intended when they wrote the Article 1, Section 8 of the US Constitution. But, when "We the People" relinquish our rights to make our own decisions and to be responsible for ourselves and our children and teach our children, it creates a vacuum the government eagerly fills. Honestly, it's our fault - "We the People" - that we have a government that believes it needs to increase regulation and taxation of the piping industry to prevent a non-existent group of underage pipe smokers from smoking pipe tobacco while it completely ignores the growing problem of children eating laundry detergent and still using illegal drugs to achieve a "high," and allows 17-year olds to have abortions and 18-year old to give their lives in defense of our country yet doesn't believe they're old enough to responsibly decide for themselves if they wish to smoke tobacco. Seriously, how messed up is that??


If this continues and "We the People" do not take action to stop the massive over-reach of government control (through the election of State and Congressional representatives who believe in and will fight for smaller government), it won't be long before we, as consumers, will be having to submit an application asking the government's permission just to buy a pipe or an ounce of tobacco. Maybe it's time the piping community refreshed its memory on the wise words of Thomas Jefferson ....


Happy Piping!

Sean

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