FDA Extends Another Deeming Rule Deadline FDA Extends Another Deeming Rule Deadline

With only ten hours left, the FDA delayed the deadline for manufacturers to submit their e-liquid ingredient listings until May 2018

The FDA’s deeming rule saga continues with their announcement yesterday that the deadline for applications regarding ingredient lists has been delayed by six months. They made this statement only ten hours before the November 8th, 2017 deadline for large-scale manufacturers (over 150 employees or $5 million in sales annually). As a result, the large e-liquid makers have until May 8th, 2018 to submit their applications. Small-scale manufacturers also had their deadline extended six months, from May 8th, 2017, till November 8th of next year.

Ever since the original deeming rules went into effect on August 8th, 2016, there have been numerous delays in different facets of the stringent regulations. In addition to this latest setback, there’s already been a postponement of the Pre-Market Tobacco Applications. These are meant to require any devices introduced to the market after the August 8th, 2016 start date to submit a new type of application before being legally sold in the US.

The constant uncertainty surrounding the deeming rules have forced many small businesses to close, not feeling they would be able to keep up with the mountains of red tape required to operate legally. These types of regulations were initially meant to be navigated by humongous tobacco companies with teams of lawyers, and therefore small businesses are just not equipped for the struggle.

Latest Delay

The latest delayed deadline concerns the ingredients found in e-liquids. This deadline had already been extended for any businesses operating in areas affected by the recent natural disasters, but now it’s been extended to everyone else as well. The FDA is asking for manufacturers to submit a list of each flavoring used, along with the nicotine level and PG vs. VG balance for every product they produce. The most significant reason for the delay is the inefficiencies of the FDA’s submission system, called eSubmitter.

After countless complaints from frustrated e-liquid manufacturers, they decided it would be best to delay the deadline; although it seems suspicious that it took them until the day before the deadline to acknowledge this issue. According to officials, the problems originate from a technical issue they are looking into solving. They’ve also stated that this new version of eSubmitter will be produced in conjunction with manufacturers to help it be easier to use by small businesses.

Some see the repeated delays as a sign that the FDA has bitten off more than it can chew by equating vaping with smoking. Trying to apply the systems they have for large tobacco companies onto the thousands of vaping manufacturers and millions of different vaping products is creating a nightmare for both the vaping businesses and FDA themselves. Others who are more critical of the FDA think the delays are only designed to force as many small companies out of the picture as possible, citing a never-ending cycle of costly preparation for the modifications to their requirements.

PMTA Delay

As mentioned above, this isn’t the first time that the FDA has delayed a significant portion of their deeming rules. In August they choose to postpone the deadline for the Pre-Market Tobacco Applications (PMTA) until August 8th, 2022. This means that any products introduced before the August 2016 cutoff could still be legally sold in the US without the new complicated application. When FDA Commissioner, Dr. Scott Gottlieb, announced the delay it was met with mixed reviews. Those against the postponement felt it gave too much time to vaping businesses, while those in favor say it finally gives companies the time they need to prepare for the overhaul in regulation adequately.

Unsurprisingly, the majority of vaping business owners were ecstatic with the decision. In fact, a new poll conducted by the analytical firm, EcigIntelligence, found that a majority of business owners are now optimistic about their prospects, after over a year of marked uncertainty. This optimism can be almost entirely attributed to the deeming rule delay, as revenue had remained the same as it was a year ago when confidence was at a low.

If you ask vape shop owners, they agree, with 77% of shop owners surveyed feeling optimistic about the industry after the PMTA delay (a 31% increase). Many owners say they were planning on cutting back or even closing altogether in the face of harsh regulations, but the tide has turned as half of the respondents indicated they would now be looking to increase their stock levels, and 42% saying they actually plan on expansion.

It’s clear that whatever the FDA decides to do is going to continue to have a tremendous impact on the vaping industry. Whether you think they are actively working against vaping businesses, or just dealing with old technology, the continued delays are having a significant impact on most manufacturers. This can be seen as a positive for the industry, as shown by the poll numbers. But it also means that the money spent to meet, now obsolete, standards has virtually gone to waste.

Do you think the FDA is actively trying to hurt the vaping industry or is it just a coincidence? Do you think that vaping should be held to the same standard of regulation as cigarettes? Do you think that the FDA will continue to push back deadlines whenever they draw near? Let us know in the comments below.

David

Katie Bercham - CocktailNerd Editor

Katie actually had a negative first experience of electronic cigarettes, picking up a cheap and horrible model from my local mall. Thanks to a chance meeting with co-editor David, she hasn’t had a tobacco cigarette in over 5 years. She brings a strong female voice to the e-cig community.