FDA Regulation Update 2016

FDA Regulations E Cigs 2016

The FDA Regulations Broken Down

Since the U.S. Food and Drug Administration made the fateful decision to pretend that electronic cigarettes are tobacco products, and thereby give the agency the power to regulate these products as if they actually were tobacco (hint: they’re not), many vaping enthusiasts and industry experts have tried to sort out what these changes mean for the industry. To do that properly, you need to understand these regulations and how they will impact every vaping company and enthusiast. This break-down of the impact of the recently approved FDA regulations governing electronic cigarette products and use should help you make sense of it all.


Here are the Rules:

FDA Rules for E CigarettesThe new FDA rules are going to mean some major changes in how the industry operates. Here are some of the most pertinent:

  • E-cig products can no longer be sold to minors (note: many states had these laws already or were in the process of enacting them – but apparently laws only matter if they come from the federal government)
  • All products that entered the market after February 15, 2007 (which is most vaping technology, mind you) will need to undergo an FDA approval process. Companies have two years to apply for that approval.
  • New restrictions on devices require manufacturers to make a standards showing for all devices.
  • Ingredient lists for e-juices will have to be submitted to the agency.
  • Manufacturing facilities will need to be registered. Complete product listings will need to be submitted to the FDA
  • Health warnings need to be placed on all products.
  • The FDA will have to approve any product claims that suggest a reduction of risk.

As you might expect, the entire list of rules contains both good and bad features. Many of the best features, like the prohibition against sales to minors, have already seen growing support at the state level. Furthermore, industry professionals have encouraged many of those state laws, so they are unlikely to oppose a similar restriction at the federal level. Other changes will be less welcome, however. In fact, some of these changes could have a severe impact on the industry’s ability to provide its products to customers, and will almost certainly force vapers to change their lifestyles as well.


Prepare for Higher Prices

FDA Regs Causes High PricesIt often seems as though government has never been really adept at understanding just how its actions impact the private marketplace. Fuel efficiency standards, some regulatory restrictions on energy companies, and similar central-planning activities often cause consumer prices to rise in unacceptable ways. Sadly, that type of impact is almost certainly going to be seen in the e-cig industry as well. One only needs to examine the rules related to product approval to see how this impact could occur.

The FDA itself is guessing that its Premarket Tobacco Application (PMTA) will cost e-cigarette companies about 1,500 hours for each product seeking approval – an estimate that includes the time involved in securing approval for all of the different nicotine strengths and flavors associated with that product. Hundreds of thousands of dollars in costs will attach to each effort at seeking approval, which means that even the smallest companies with limited product options face millions of dollars in new regulatory costs.

Those costs will inevitably be passed along to the customers, no matter how much those companies might wish to avoid raising prices. Like other industries facing similar government intrusion in the past, the electronic cigarette industry will no doubt try other cost-saving measures before resorting to price increases. In all likelihood, however, those prices will rise – and that means less incentive for tobacco smokers to switch to these safer alternatives.


Custom Mods Are Facing a Huge Challenge

Mods will changeWith the need to get approval for every product, the makers of custom mod components will be facing their own challenges to keep costs down. If they are forced to absorb the costs associated with seeking safety approval for each individual component, they will be faced with the choice of substantially increasing the price of those parts to cope with the approval process costs or ending production and focusing on complete, closed-system products without the customization options. Either option would be a burden for vapers who love their mods.


The FDA will Promote Studies of Vaping

In the UK, vaping products are not only recognized by the government as being a safer option than tobacco, but are promoted as such. Indeed, that country’s Royal College of Physicians has specifically referred to electronic cigarettes as harm-reduction products, and encouraged the nation to promote their use for that purpose. That approach is, of course, completely at odds with the FDA’s pretense that a non-tobacco product can somehow be considered tobacco.

With its new regulatory power, however, the FDA is now better-positioned to study the effects of electronic cigarette usage. If those studies are untainted by undue influence from the tobacco industry or other interests, it is likely that they will conclude what non-governmental studies have discovered: that electronic cigarettes are much safer than tobacco. If so, then those studies could lead to a rethinking of these rules and a soberer approach to how the government interacts with this industry.


Less Choice is on the Horizon

Make no mistake: these burdensome regulations will make it almost impossible for the industry to obtain approval for the many thousands of products already on the market. The PMTA process is inherently unsuited for meeting this demand, as the FDA estimates that no more than 750 of the applications will be formally received and processed by the agency each year. There are currently many thousands of vaping devices, e-liquids, and other vaping tools in the marketplace, and most of them will need this approval. Since that approval window only encompasses a two-year period, however, no more than 1500 PMTAs will be considered for approval.

Ultimately, that means that thousands of existing products are likely to go by the wayside over the next two years, leaving consumers with fewer options than they have today. The idea that choice is about to be limited by process rather than by actual market forces is certainly nothing to celebrate.


Vapers May Go Underground

As has been true with so many other products and ideas in history, any regulations or laws that limit consumer choice are likely to result in the development of what can only be considered a “black market” for the goods. Vapers are no different than alcohol lovers during Prohibition. Many who wake to discover that their favorite brand or flavor is suddenly no longer allowed to be made and sold in the United States will almost certainly seek those products from outside of the country – just as bootleggers brought alcohol into the U.S. during the Prohibition Era. History would be repeating itself, in a sense, as law-abiding citizens would be made to run afoul of the law just for seeking products that are essentially the same as others the FDA has formally approved.

It is always possible, of course, that the FDA will awaken to the sad reality of these changes when it sees the negative impact caused by its regulatory decisions. It is also possible that its own studies may yet convince it of the error of its ways. Given the tendency of most governments to double-down on poor decisions, however, possibilities seem remote in the near term. Change is coming, and the industry had best be prepared to adapt.

Back to Page 1 - The FDA Review Process

Page 3 - The Impact of the FDA Regulations

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