• FDA's "ENDS" of Vaping (For Consumers)

    0 comments / Posted on by James Wilkens

    Ecigarettes, vaporizers, mods, tubes, mech mods, box mods, PVs, personal vaporizers, vaping products have had a lot of nicknames over the years. As of August 8th, 2016, the Federal Government in the United States has graced us with yet another, "ENDS", or somehow more affectionately sounding, Electronic Nicotine Delivery Systems.

    The FDA Deeming Regulations for tobacco products mean a lot of different things for vapers the world over. A lot of us in this industry take the public knowledge for granted. This is our daily life, this is how we keep food on our tables, roofs over our heads. We've been fighting the war on the ground, and sometimes it escapes us that our customers might not know what is currently happening to our industry. 

    For our consumers, what do the deeming regulations mean to you? As of right now, everything seems generally the same. You can visit your local vape shop, assuming you're of the legal age per the State and Federal legislation, and most of the products you know and love are well stocked, new products are still showing up here and there (or, well, new to you) and there are "new" products gaining hype and interest, while some older products have fallen by the wayside. 

    A brief super-abridged timeline:

    • August 8th: The market was frozen. No new products are permitted into the industry without filing for a PMTA (Pre-Market Tobacco Application). There will be very few if any of these. No modifications can be made to existing products (building your atomizer, changing your tank coil, anything that involves touching your hardware). We cannot offer free samples.
    • 2017: Not much should change. Most vendors are in a "grace period" preparing to either close down or submit for a PMTA. Might turn into a desperate cash-grab.
    • 2018: Unless approved by the FDA following PMTA, products unapproved will be removed from the market. Most products will disappear, manufacturers will close doors. Without products to sell, shops will close doors.

    Essentially, we have two years to comply or shut down. How this landscape will look and the reasons why is a bit of a convoluted story. From here on it's fairly involved to explain. This will be long. 

    If your local brick & mortar vape shop previously offered free samples, they're most likely now charging a fee. Per the FDA, we are no longer allowed to provide free sampling of flavors, and that we must charge an undetermined sum to permit such. They literally gave no guidelines as to how much to charge, though those of us who are members of SFATA have been advised by Venable Attorneys to show it's "enough to ensure we're not trying to circumvent the law". I believe at the time they advised a $2.00 fee, though most shops in our area are asking for $1.00.

    This is NOT because your shop has suddenly become greedy, I can guarantee we're every bit as upset about this as our patrons. Having great flavors that resonate with our customers is important to our businesses.

    We can no longer offer builds on atomizers. As our interpretation of the deeming regulations stands, we're not allowed to touch your hardware with the intention of troubleshooting, rewicking, changing your coils, changing your batteries. Any of this would constitute "tampering" or "modification".

    This is quite literally the tip of the iceberg. From here on...

    "ENDS" (Vapor) PMTA

    The reality is that as of August 8th, 2016, there is a "freeze" on the market. This freeze dictates, essentially, that no vapor product manufacturer can produce a new product, without immediately sending it to the FDA for what is called a PMTA, the "Pre-Market Tobacco Application". The application to the FDA itself is "free", offered as a "service" (yeah, I'm air quoting in my mind), but the application isn't the concern. Vapor products will need to go through a rigorous testing process, through independent scientific labs. This testing is per item (sku), and each ejuice, eliquid, different nicotine strength, size of bottle, atomizer, mod, coil, wick, anything you can think of sold with the intent of producing a nicotine-containing vapor, is subject. Estimates for this testing process, as well as lawyers to file the paperwork, usually range between $200,000 and $10,000,000, per sku. (The FDA estimates between 1,500 and 5,000 hours to evaluate each submission.)

    If an ejuice line has 0mg, 3mg, 6mg, 12mg nicotine strengths, and then offers the flavor in 15ml, 30ml, 60ml, and 120ml bottles (fairly standard), then it'd be $3,200,000 for the lower estimate, and $160,000,000 for the higher. 

    For one flavor.

    A business relation of mine who owns a moderately successful line, netted (gross minus cost of expenses) around $200k last year, and he's been operating for a couple of years. He's been growing steadily, doing a great job, taking great care of his employees, operating 100% above-board, but there is no way he could afford the PMTA process for even just once of his flavors offering the range of nicotine strengths he offers.

    Something to keep in mind is that Swedish Match, a company producing Snus, produced a 100,000 page submission for their PMTA, and the FDA's PMTA Review, just the review, came in at a whopping 67 pages. 

    The FDA gave us a timeline, with essentially what boils down to two sets of dates. One set is for "large" manufacturers, those who net over $5 million annually, and/or employ over 500 people. Since most of the vaping industry is "small business", we generally have a second, longer timeline in place. For the businesses that fuel the vaping industry:

    • August 8th, 2017: Manufacturers must register with the FDA and provide a list of products. Small-scale manufacturers must submit Tobacco Health Documents relating to “health, toxicological, behavioral, or physiologic effects” of products, constituents, ingredients, components, and additives.
    • May 18th, 2018: Manufacturers must comply with labeling and advertising requirements.
    • August 8th, 2018: PMTA is due.
    • August 8th, 2019: Manufacturers must report Harmful and Potentially Harmful Constituents (HPHC).

    (For the whole breakdown, FDARegs.info has an amazing timeline breakdown and BRIEF descriptions of what happens when and who it applies to, as well as a ton of other information and ways you can help.)

    Now the PMTA process is to determine, and establish, that the product we're introducing to the market has a benefit to public health. The FDA has stated that vaping is safer than combustible cigarettes, and under the guidance of Congress are suggesting this PMTA process as a reasonable means to "facilitate efforts to develop and market products with potentially less risk than conventional tobacco products".

    The PMTA as it stands now, gives manufacturers that were on the market after February 15th, 2007, previous to August 8th, 2016 a grace period to get their affairs in order, conduct their testing, get their thousands of pages of testing together and submit for a PMTA. After this grace period, no sales, period. Any new products created after August 8th, 2016 must submit for their PMTA prior to selling any product. 

    The February 15th, 2007 "grandfather date", allows any product on the market to submit for a different "pathway", an approval process much cheaper and easily attainable. The problem with this date is 99% of vapor products didn't exist before this date.

    A few months ago Sen. Ron Johnson and Chair of the United States Senate Committee on Homeland Security and Governmental Affairs (the chief oversight committee of the United States Senate) sent letter to the FDA. In this letter, he questioned the overreach of the FDA and their deeming regulations, demanding they answer his inquiries into this overreach. With no response, he submitted his inquiry again, and then again, and finally the FDA responded. Rather than answering his specific questions, they came back with a vague defense. Included in their retort was the following:

    “Based on logo counts from trade association websites and information from FDA listening sessions, we estimated that there are 168 to 204 formal manufacturers of ENDS products; we used this range for the quantitative analysis. We acknowledge that the total, including informal manufacturers, may be far greater. Using the same logo counts from trade association websites and information from FDA listening sessions, we also estimated that there are 14 importers of ENDS products.”

    The ejuice/eliquid distributor http://www.ejuices.co shows they distribute 1225 individual brands (usually stand-alone manufacturers) within the United States. One. Distributor. In addition to that, we at Status have an excel spreadsheet with contact information for over 6,000 vape shops, so the expected financial burden this places not just on our industry, but the American public in form of extreme taxation to foot the FDA's review bill, assuming each company were somehow able to miraculously afford the PMTA process would be astronomical. 

    The reason for their aversion to answering Sen. Johnson's questions probably has little to do with this overreach, any monetary inclination or agenda independently, but rather that the 400 page deeming regulations wasn't a specific legal document outlining exact procedures and repercussions, but rather a 400 page document vaguely outlining their expectations of an industry they don't understand and can literally not comprehend. We don't fit neatly into some current structure that they can rewrite the legislation for, and there is far too much variety in hardware, variations between formulations, that any specific regulation could apply to. 

    Simply put, they don't know what they're doing, apart from decimating 99% of our industry (their words per their impact report issued to OIRA). Special interests, agendas, progress and all else aside, they would rather destroy a multiple billion dollar industry than deal with reasonably regulating the legislative nightmare it's become.

    The FDA has been trying to shut us down for literal years prior to the regulations. Smoking Everywhere and Njoy derailed their embargo on imported vapor products in 2009. The result of the lawsuit presented by these two companies was that the Court of Appeals indicated to the FDA they could regulate the marketing of vapor products as a tobacco product, and not a medical cessation device. The worst part here is while Congress wanted the FDA to reasonably regulate this industry, a vast majority of combustible products will remain on the market due to having been available prior to the grandfather date. While this looks like it's simply favoring the tobacco industry, the incentives are a fair amount more complex than simple industry favoritism. 

    Now we're in an election year, with the two most polarizing political candidates we've ever seen, and State-side youth smoking prevention is an easy and popular subject. For example, here in California we're fighting against Prop 56, which would slap a 67% tax on vaping products (before the BOE gets their cut) but this proposition also rewrites tax fund allocation, so much so that our schools aren't guaranteed the funding they've already been receiving, in addition to no guarantee they'd get their allotted 43% cut of the new taxes per our State's constitution. 

    What can we do?

    Maybe the most important thing would be supporting legislation that could help save the industry. Both HR 2058 and the Cole-Bishop amendment would change the predicate date for vapor products. 

    HR 2058 would change the predicate date, or the grandfather date, for vaping products from February 2007 to the date that the deeming regulations went into effect, August 8th, 2016). While this would limit future products from entering into the market, existing products would remain available. This is the generally preferred legislation, but it's also less likely to pass than the Cole-Bishop bill. For a breakdown, more information and support these bills, please visit the CASAA Cole-Bishop/HR 2058 Take Action Page.

    Other resources for information or ways to help:

    FDARegs.info

    FDA Regs gives a breakdown of the FDA Regulations, timeline, and links where you can go to verify information, get more details, as well as ways you can help.

    Consumer Advocates for Smoke Free Alternatives Association

    This is the quintessential resource for consumers to find out who their representatives are, how to contact them, as well as providing local legislation that will affect your vaping rights.

    Read more