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FDA ‘Deeming’ of e-cigs – designed to destroy?

09, May, 2016

By Tom Pruen

The FDA recently released their finalised regulations for e-cigs. Actually, that in itself is a bit of mis-description. What the FDA has released is a regulation to cover tobacco products they don’t already regulate. This includes some kinds of cigars, and other tobacco products, but does dedicate a lot of space to e-cigs.

Essentially, the FDA have ‘deemed’ e-cigs to be tobacco products, and applied the existing regulatory methods to them. 

When this method was applied to cigarettes, it had little effect on mass market products, as those that existed prior to 2007 were ‘grandfathered’ into the regulation. New products have two main ways of applying – SE (Substantial Equivalence) or PMTA (PreMarket Tobacco Applications).

With e-cigs, very few products would have been on the market in 2007, and any that were would have had a radically different design to those on the market today.  The FDA have stated that:

 “A product must have the same characteristics--all of the same characteristics--as the predicate product, to be found substantially equivalent”

 

This would seem to leave PMTA as the only realistic approach for e-cigs and other vaping products.

There is another layer of complication here too.

For e-liquids:

“For example, where a manufacturer seeks authorization of a new e-liquid to be used with ENDS, the manufacturer may need to provide evidence and analysis of the product's likely impact when used in the range of delivery systems available.”

This would imply that a liquid would need to be tested will ALL of the available hardware it might be used in, although they do go on to say:

“FDA expects that the range of delivery system specifications authorized by FDA will provide a sufficiently specific spectrum of possibilities”

Which does at least limit it to testing on only FDA approved hardware, although how this is to be achieved before FDA approves any hardware is problematic.

Hardware has its own problems:

“a manufacturer seeking authorization of a stand-alone apparatus component--such as a heating coil or cartridge--may need to provide evidence and analysis of the product's likely impact when used together with the range of other components and liquids available”

This has the rather problematic implication that hardware will have to be tested will all the available liquids (and presumably power supplies in the case of atomisers, and atomisers in the case of power supplies). How this Mobius regulatory requirement is to be resolved is also open to much debate.

There is however a very strong indication that most of the current hardware (which shares common connectors, and allows consumers to mix and match components from different suppliers) will not be able to meet the FDA’s requirements:

“FDA expects that it may be difficult for manufacturers to make the showing necessary to meet the statutory standard, given the great extent of possible variations in combinations of hardware components”

Note that this doesn’t even suggest that the products may be dangerous – just that they are unlikely to be able provide sufficient evidence to satisfy the regulation.

“FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems”

The details of the PMTA requirements are too complicated to cover in depth, but even for the type of products that might receive approval:

“a PMTA may require one or more types of studies including chemical analysis, nonclinical studies, and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.”

FDA also expects that for companies that are new to FDA regulation, and have complex products to require

“as many as 5,000 hours for early applications that involve complex products and for which the company has no experience conducting studies or preparing analysis of public health impacts, or for which reliance on master files is not possible”

just to process their data, and submit it to FDA, which gives some idea of the scale of data that is likely to be required.

The FDA estimates:

“the number of PMTAs that FDA expects to receive annually will be 750 (642 ENDS Liquids and 108 ENDS Delivery Systems).

Bearing in mind that most of the products on the market are open systems allowing consumers to easily mix and match products, this may actually be an over-estimation of the number they will receive.

Even this number is rather alarming when viewed in the context that:

“FDA estimates the average number of vape shops that meet the definition of a manufacturer are 4,250.  FDA also estimates that there will be 186 other manufacturers and 14 importers of ENDS products.”

In other words, despite the current market position having nearly 4,500 companies that would require PMTAs, each for several (and possibly multiple hundreds) of products, the FDA is expecting less than 1000. One (not entirely unreasonable estimate) puts the number of affected products in the region of 100,000.

The FDA are expecting this regulation to reduce the number of available products by 2 orders of magnitude. They have very firmly stated that this isn’t a ban, but if the number of products available post-regulation will be less than 1% of those available now – what else do you call it?

 

It could be argued that this is just poor understanding on the part of the FDA, but this very clearly is not the case.

In the pre-regulatory impact assessment, issued in 2014 these sections provide a pretty clear indication of the impact the FDA expected, before even writing the regulations:

 

“If electronic cigarettes are deemed to be subject to chapter IX of the FD&C Act, the cost of premarket applications would increase the cost of entering and remaining in the market. (It is uncertain whether there are any valid predicates for the electronic cigarette products currently on the market. If no such predicates exist or if they are hard to identify, then all or most electronic cigarettes would require premarket applications in order to remain on the market.)  In addition, warning labeling would serve as a negative signal to consumers and possibly discourage use.  The combined effects of these two requirements would reduce consumption below levels that would be observed without regulation.  It is important to note that this comparative reduction is a separate consideration from any general secular trend toward greater use of electronic cigarettes.”

“Therefore, we expect that considerable product consolidation and exit would occur, as well as the entry, exit, and consolidation that would be expected to occur in an emerging market and that would occur under baseline conditions.  (For example, consolidation might occur under the baseline as large manufacturers of traditional tobacco products enter this market and perhaps absorb smaller manufacturers and products.)”

“Most electronic cigarette manufacturers are also small, though the number of small domestic manufacturers is uncertain. Premarket tobacco applications, discussed above in section II.B, are expected to be the most burdensome requirement for electronic cigarettes. We expect to see adjustment through additional product consolidation and exit from the U.S. market, compared with what we would expect without regulation.”

In 2014, the FDA expected their deeming of vaping products to essentially destroy the US vaping industry, but this didn’t appear to influence the creation of regulation at all.

Not surprisingly, this approach will favour those companies with greatest experience of the SE and  PMTA approaches – the tobacco companies.

It appears that the FDA viewed the vaping industry as too large and complicated to regulate – so they are re-shaping it to fit their own needs.  The future US market seems likely to focus on simple, closed system products. These are the products most favoured by big tobacco (but not consumers), and also those that appear to have the least benefit for complete switching from cigarettes. This appears to be a plutocratic regulation, far from the meritocracy that a free market would imply (in fact it's more 'fee market' than 'free market').

Rather than adapting regulation to fit the products being sold, FDA are forcing the market to sell products to fit the regulation, and in the process favouring the tobacco companies.

The FDA’s approach is a big win – but not for the vaping industry, vapers, or public health.

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