18 Months Have Passed Since FDA’s Deeming Rule – Where Does the Vape Industry Stand?
Let’s face it. If you’re in the vape industry, you may be feeling like you’re being attacked from all sides. From the US Food and Drug Administration (FDA) and the uncertainties that run with its regulatory role, to local ordinances that seem to impact retailers overnight, it appears to be an industry full of landmines.
Like every government agency however, one of FDA’s underlying primary purposes is to protect the public and without the voice of those in the industry to inform them otherwise, FDA’s notion of “protection” may potentially exceed that as necessary when viewed by the vape industry and the consumers that are relying on these products continued existence and availability.
While many in the industry take the position that the FDA is not working fast enough to provide the clarification and guidance the industry needs, to be fair (or to attempt to be anyway), the FDA has been both requesting to be advised on nicotine related matters by the public, through both written and in-person participation, and appears to be attempting to be as informed as it possibly can about vaping and e-cigarette use as it gets ever closer to increased decision making over electronic nicotine devices (ENDS). One example of their information gathering is with respect to its December 2017 acquisition of public comments on good manufacturing practices for “tobacco products” and ENDS. In addition, an example of information disseminating was illustrated by its presence at this year’s Tobacco Products Expo (TPE) in Las Vegas.
It seems every week there is a new piece of information shaping FDA’s position regarding the vape industry. Just looking back since the start of 2018, examples include:
· The American Cancer Society’s position statement on e-cigs – which left many in the industry claiming the society “endorsed” e-cigs
· The release of the National Academies of Sciences, Engineering and Medicine report, which was commissioned by the FDA, to evaluate the available scientific evidence of the short- and long-term use of ENDS (such as e-cigs)
· The Jan. Tobacco Products Scientific Advisory Committee (TPSAC) meeting to discuss Philip Morris’ modified risk tobacco product (MRTP) applications – which left many generally stating that TPSAC declined to find enough scientific evidence to support a finding of harm reduction
· FDA’s Jan. public hearing on the evaluation of nicotine replacement therapies
· FDA’s Feb. request for comments to assist its Center for Tobacco Products (CTP) in identifying and addressing priorities related to the use of therapeutic nicotine for combustible tobacco product cessation
Separate from FDA actions, we have seen flavor bans and other restrictions being put in place in local counties across the country and other limitations being implemented, like New York City’s vape shop registration and license requirements, which will ultimately lead to a cap in the number of stores legally able to sell vape and tobacco products. It is important to remember that nationwide activities likewise inform the FDA about the public’s position on e-cigarettes and other types of tobacco products.
So where does the vape industry stand? As regulations remain under development, where we are continues to be one of uncertainty. We do however, know a few things.
1) There is a baseline of FDA compliance that is necessary for the industry to comply with, be it with respect to making the requisite filings, finalizing proper warning labels, posting signage, or otherwise
2) Where an establishment has registered with FDA (e.g., a manufacturer or importer), the agency has a statutory obligation to come and do a visit to the establishment every two years (which means that those of you who registered in 2016 can expect a visit this year), and
3) Where an FDA visit does occur, the first thing they will ask you for is your written FDA compliance manual so they can
a) verify your knowledge of FDA’s current laws,
b) confirm you have implemented business practices to abide by their laws, and
c) verify that you have been following your written practices (evidenced through either your own internal audit, documentary records, and/or otherwise)
Recognizing these requirements, it’s important the industry understand that compliance with what is currently known to be obligatory is required, and to the extent your company hasn’t started documenting anything, it’s time to get writing!
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