The Food and Drug Administration (FDA) officially released the final guidelines, named Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.
A little bit about the document. It's a 53 page document that has 21 pages of comments left by the public, and their responses. This document was created by the Center of Tobacco Products (CTP) and released around 10:45 AM on January 2nd, 2020.
Get ready for a lot of reading. This blog post is going to break down every single page of this document. Let's dive in. Regarding pages, this is based on the PDF version of the guidance, meaning PDF pages--not numbered pages like the guidance has.
Disclaimer: I am not a lawyer. This breakdown is based on how I understand the material presented to me. If you have any questions, comments, or concerns, please feel free to email me or message me on Twitter. If there is any misinterpretation, please let me know so that I can update the information to be as accurate as possible. Thank you!
Page 1 & Page 2
Pages 1 and 2 give some general information about the guidance as well as a table of contents. Nothing really to see here, other than what pages correspond to what.
The first thing is a black box that says "This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page."
Realistically, this is the FDA going "hmmmmmmm.....we need to publish something so here it is." There is no binding here. This isn't law. This is just a push along.
"For ENDS products marked without FDA authorization, FDA intends to prioritize enforcement against:
-Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
-All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors' access; and
-Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors."
Let's break this little section down.
1. Any flavored, cartridge-based ENDS product. What is considered a cartridge-based product? Closed pod systems like JUUL or open pod systems like Smok Novo? JUUL already pulled their "flavored" cartridges, like fruit medley and mango. Smok Novo though, doesn't have pre-filled pods (created by Smok at least), so would they be safe?
2. All other ENDS products where the manufacturer failed to prevent minors' access? What does this even mean? The manufacturer creates a product. That's it. There are no manufacturers who deliberately created a product to market towards minors.
3. Any ENDS product that is targeted to minors...again. Nothing is marketed to minors. Nothing is out there saying HEY KIDS USE THIS!!!!! THIS IS DESIGNED FOR CHILDREN.
"Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application."
So, manufacturers need to submit their PMTA (Pre-Market Tobacco Application).
"FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance(s) describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance(s) means that something is suggested or recommended, but not required."
Basically the FDA is recommending these rules. That's it. They aren't putting anything into law or effect, just saying "hey, here is what you should be doing." These aren't enforceable responsibilities.
Finally, it begins on the BACKGROUND portion. We'll put this into page 5.
Combining the last part of page 4, we are now looking into the background.
Section A: Statutory and Regulatory History
"The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to chapter IX of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 387 through 387u) (section 901(b) of the FD&C Act)."
Let's look at the statutory definition of a tobacco product. The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
E-liquid is not a product made or derived from tobacco. E-liquid consists of vegetable glycerin, propylene glycol, natural and artificial flavoring and nicotine. Not tobacco. Devices are not a product made or derived from tobacco. Devices contain metal, glass, plastic, etc.
This is like saying that Nicorette Gum is a tobacco product, because it contains nicotine. That's not the case at all. In fact, it's considered a smoking cessation aid!
"In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of a tobacco product, except accessories of deemed tobacco products, to be subject to FDA's tobacco product authority. This included electronic nicotine delivery systems (ENDS), cigars, waterpipe (hookah) tobacco, pipe tobacco, nicotine gels, and dissolvables that were not already subject to the FD&C Act (81 FR 28974 at 28976 (May 10, 2016)).
This sounds like the FDA said "hey we can do that too, right?" and rolled with it.
Now mind you, this is a 53 page document. I'm not going to write out *every* paragraph, I'll pull some excerpts from each though.
"...which imposes certain premarket-review requirements for "new tobacco products"--i.e., those that were not commercially marketed in the United States as of February 15, 2007. Accordingly, after the rule's effective date, deemed new tobacco products were required to obtain premarket authorization under Section 910. Deemed new tobacco products that remain on the market without marketing authorization are marked unlawfully in contravention of the Tobacco Control Act."
What this means, is that all the devices and e-liquids that we know and love are *technically* breaking the law. According to CASAA, the first electronic cigarette was released in the United States in 2006. http://www.casaa.org/historical-timeline-of-electronic-cigarettes/ There was ONE year of product. Everything after that is considered unlawful.
"...FDA intended to defer enforcement for failure to have premarket authorization during two compliance periods related to premarket review: one for submission and FDA receipt of application and one for obtaining premarket authorization. The first compliance period depended on the type of application. The compliance date was 12 months from the effective date of the rule for substantial equivalence exemption requests, 18 months for substantial equivalence reports, and 24 months for premarket tobacco applications. In addition, the preamble explained that under the second compliance period: Unless FDA has issued an order denying or refusing to accept the submission, product for which timely premarket submissions have been submitted will be subject to a continued compliance period for 12 months after the initial compliance period described previously. For such products, FDA does not intend to initiate enforcement for failure to have premarket authorization during this continued compliance period.
The preamble further explained that this compliance policy did not apply to any new tobacco products that was not on the market on August 8th, 2016. Significantly, this policy did not confer lawful marketing status on new tobacco products being marketed without the necessary premarket authorization."
The vaping industry was supposed to have two compliance periods, neither which had any guidance. August 8th, 2016 was also when the FDA stated no free samples, no builds...with no idea on what they were doing.
"In July 2017, FDA announced a new comprehensive plan for tobacco and nicotine regulation that would serve as a multi-year roadmap in an effort to significantly reduce tobacco-related disease and death." "One aspect of the plan involved striking a balance between regulation and encouraging development of innovative tobacco products that may be less harmful than cigarettes."
Here is the "comprehensive road map": https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regulatory-plan-shift-trajectory-tobacco-related-disease-death
This allowed for PMTA to be submitted by August 8th, 2022 for ENDS products.
"In March 2018, the August 2017 Compliance Policy was challenged in the U.S. District Court for the District of Maryland, and on May 15, 2019, the court issued an order that vacated the guidance. On July 12, 2019, the court issued a further order directing FDA to require that premarket authorization for all new--i.e., not "grandfathered"--deemed tobacco products to be submitted to the Agency within 10 months, by May 12, 2020, and providing for a one-year period during which products with timely filled applications might remain on the market pending FDA review."
Basically, the District of Maryland said "to hell with that guidance, here is what you are doing now."
The next section is titled "FDA Response to Evidence of Increasing Youth Use of ENDS Products." Now mind you, I have a blog post on FDA Compliance Reports. Here is that post: https://www.yes-i-vape.com/post/fda-compliance-check-statistics
Let's see what the FDA has to say about this.
"In April 2018, FDA conducted a nationwide undercover enforcement effort that resulted in FDA issuing 56 warning letters to online retailers and 6 civil money penalty complaints to retail establishments related to the illegal sales of certain ENDS products to minors. In addition, FDA sent an official request for information to manufacturers of certain ENDS products commonly used by minors requiring them to submit documents to facilitate the Agency's understanding of the reported high rates of youth use and the particular youth appeal of these products. FDA also took measure to address the sale of ENDS products to minors online by contacting eBay to raise concerns over several listings on its website. This resulted in listings for these ENDS products being removed from eBay."
Considering there have been 11,948 reports overall and 3,346 of those reports are from January 1st, 2018 to December 31st, 2018, I do not find this information impressive.
In May of 2018, "FDA issued 17 warning letters to manufacturers, distributors, and retailers for selling e-liquids with labeling and/or advertising that resemble kid-friendly food products, such as juice boxes, candy, or cookies."
I'm not sure the reason these warning letters were distributed. There is nothing stating marketing.
"On September 12, 2018, FDA announced a series of enforcement and other regulatory actions related to the labeling and advertising of ENDS products, including that it had conducted nationwide, undercover investigations of brick-and-mortar and online stores over the summer of 2018 and issued more than 1,300 warning letters and civil money penalty complaints to retailers who illegally sold ENDS products to minors. FDA also issued 12 warning letters to online retailers that were selling misleading labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies."
Oh, so candy and cookies are now "kid-friendly food products." I guess adults, who purchase cookies and candies for children, are not allowed to indulge in these delicacies, because they are "kid-friendly food products." How dare adults have access to these flavors!
"Examples of potential safeguards included:
-Establishing or enhancing programs, such as mystery shopper programs, to monitor retailer compliance with age-verification and sales restrictions;
-Establishing and enforcing contractual penalties for contracted retailers that sell tobacco products to youth;
-Using age-verification technology to better restrict access to the manufacturer's website, such as through independent, third-party age- and identity-verification services that compare customer information against third-party data sources; and
-Limiting the quantity of ENDS products that a customer may purchase within a given period of time."
Huh, so WHAT THE INDUSTRY WANTS. Third party age-verification systems like what most places have for alcohol...limiting bulk sales to end straw-man selling....I mean, we as an industry want these protocols.
PAGE 8 & 9
"Current e-cigarette use had increased considerably among U.S. middle and high school students during 2017-2018, reversing a decline in e-cigarette use that had been observed in recent years and increasing overall tobacco product use in 2018. Specifically, among high school students, current e-cigarette use had increased by 78 percent in the past year, while among middle school students, current e-cigarette use had increased by 48 percent." "In 2019, two of the largest surveys of tobacco use among youth found that e-cigarette use has hit the highest levels ever recorded. As detailed in Section IV below, data from both the National Youth Tobacco Survey (NYTS) and the Monitoring the Future (MTF) Study have documented a continued increase in youth use of ENDS products and further underscored the magnitude of the problem."
I find it hard to believe that these statistics are true. Mainly, the NYTS and MTF studies. I know when I was in high school (graduated in 2014), I was asked ONCE if I used tobacco products. Despite being a two pack a day smoker, I said that I didn't use any tobacco products. What would they know? How would they know? They wouldn't. I find this information difficult to believe.
Then we get to go into EVALI. Let's look at what the FDA says first before I just start rambling.
"Furthermore, as of December 17, 2019, there have been approximately 2,506 reported cases of hospitalizations for lung injuries associated with use of vaping products ("hospitalized EVALI patients"), including 54 confirmed deaths. Working closely with other federal and state agencies, FDA has not been able to determine the cause of this outbreak. It appears that most of the patients impacted by these illnesses reported using THC-containing products, with evidence suggesting that additive agents, specifically Vitamin E Acetate, may play a causative role. In many of these cases, individuals reported using multiple products, including some with nicotine. Many different substances and product sources are still under investigation."
Okay. I. Can. Not. Even. Handle. This.
This is DIRECTLY from the FDA website: "As of Dec. 23, 2019, 758 of the 1,040 samples connected to patients (73%) have undergone some level of testing and additional testing is likely to be conducted on many of these products. 494 of these samples have been found to contain THC, 50% of the THC products have been found to contain vitamin E acetate as a diluent. The concentration of vitamin E acetate determined in a subset of these samples has ranged from 23% to 88%. 23% of the THC products have been found to contain another diluent such as medium chain triglycerides."
Yet somehow, they STILL want to blame flavored nicotine e-liquid. This is pure carelessness on the FDA and the CDC, as well as other government agencies such as the HHS.
Let's look at Section 3. Section 3 covers Definitions. This will cover the END OF PAGE 10, and BEGINNING OF PAGE 11.
Let's see how they define all of this.
1. Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.
2. Electronic nicotine delivery systems (or ENDS) include devices, components, and/or parts that deliver aerosolized e-liquid when inhaled. For example, FDA considers vapes or vape pens, personal vaporizers, e-cigarettes, cigalikes, e-pens, e-hookahs, e-cigars, and e-pipes to be ENDS.
3. E-liquids are a type of ENDS product and generally refer to liquid nicotine and nicotine-containing e-liquids (i.e, liquid nicotine combined with colorings, flavorings, and/or other ingredients). Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or part and, therefore, subject to FDA's tobacco control authorities.
4. Label means a display of written, printed or graphic manner upon the immediate container of any article. Section 201(k) of the FD&C Act.
5. Labeling means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. Section 201(m) of the FD&C Act.
6. New tobacco product means (1) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (2) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. Section 910(a) of the FD&C Act.
7. Tobacco product means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term "tobacco product" does not mean an article that under the FD&C Act is a drug (section 201(g)(1) (21 U.S.C 321(g)(1))), a device (section 201(h)), or a combination product (section 503(g) (21 U.S.C 353 (g))). Section 201 (rr) of the FD&C Act.
PAGE 11 (Bottom of page)
Here is where we *finally* start a new section! Section 4: Enforcement priorities regarding certain ENDS products on the market without premarket authorization
This Section has several subsections: Overview, Data, other Considerations and enforcement priorities. I'm going to skip over the "overview" section, because it just summarizes the other sections. Let's dive in.
PAGE 12-17: Data shows substantial increase in youth use of ENDS products, particularly certain flavored, cartridge-based ENDS products.
"The recent surge in youth use of ENDS products has caused us to reevaluate our July 2017 assessment and to modify our enforcement priorities for ENDS products."
"Overall, data showed that ENDS product use more than doubled among middle school and high school students from 2017 to 2019. Data from MTF showed that from 2017 to 2018, current (past 30-day) e-cigarette use significantly increased from 6.6% to 10.4% among 8th graders (a 58% increase), 13.1% to 21.7% among 10th graders (66% increase) and 16.6% to 26.7% among 12th graders (61% increase).
"Among high school students, 4.11 million reported having used an e-cigarette in the past month in 2019 with 1.24 million middle school students reporting the same. For the first time ever, the total number of middle and high school student reporting current use of e-cigarettes surpassed 5 million in 2019."
Yet, the 13 million or more adults who vape are pushed to the side.
"Research has long shown that flavors increase youth appeal of tobacco products, including ENDS."
Yet, companies such as Swisher Sweet, Drew Estate, Fantasia, Black & Mild, Criss Cross, and other tobacco manufacturers continued to have flavored products. In fact, when I was going to quit smoking the first time, I switched from Marlboro Menthol 100s to Criss Cross Cherry flavored "cigars." They still came in a pack of 20, they were $2 a pack....I just switched to those entirely. Not because they were flavored, but because they were cheap.
"The NYTS survey instrument groups mint- and menthol-flavored products together, so it is not possible to differentiate youth use of mint and menthol flavors separately based on the NYTS data."
So, they want to ban mint, but have no evidence that mint is the issue. Okay....
"Most youth who were current e-cigarette users reported a cartridge-based e-cigarette as their usual brand. In fact, the leading brand is a cartridge-based product that commands approximately 70% of the market."
WHAT. I assume they mean JUUL, although it isn't specific at all. I disagree that JUUL commands approximately 70% of the market. Actually, I know that JUUL doesn't command 70% of the market. Vuse does on a national standard. Check out the statistics:
JUUL: 2,262 (18.94%)
Blu: 2,560 (21.43%)
Vuse: 5,363 (44.90%)
MarkTen: 328 (2.74%)
Logic: 40 (0.33%)
NJOY: 90 (0.75%)
Other: 1,299 (10.87%)
See, Vuse is 44.9% and JUUL is a mere 18.94%.
"With cartridge-based products, there are no settings to change and very little assembly is required."
Incorrect, please look up the SMOK RPM40.
"In the notice of proposed rulemaking for the Deeming Rule, FDA noted that the overall public health impact of ENDS products would depend crucially upon "who uses the products and how they are used. If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then there is a potential for the net public health impact at the population to be positive. If, on the other hand, there is significant initiation by youth, minimal quitting, or significant dual use of combust[ed] and non-combust[ed] products, then the public health impact could be negative."
So, basically the FDA is saying a big "screw you" to the 13,000,000 or more adults who successfully quit using tobacco products because kids are illegally purchasing and using products intended for adults.
Subsection C: Additional Relevant Considerations
I'm really interested to read this. The FDA obviously hasn't considered the 13,000,000 adults who vape. Let's see.
"Overall, out of the over 15,000 public comments submitted FDA received to the Draft Guidance, many were related to form letter campaigns, while approximately 294 public comments provided unique and substantive information, FDA received thousands of general comments expressing support or opposition to the guidance and separate provisions within the guidance."
"FDA also remains concerned about health and safety issues connect to ENDS products--e.g., cases of lung injuries associated with use of vaping products as well as battery explosions with ENDS products--particularly given that these products have been marketed without premarket evaluation."
Well, 15,000 public comments is quite impressive. Whether it be in support or opposition, at least the comments were there.
FDA is concerned about health and safety issues. Lung injuries are from Vitamin E Acetate. Battery explosions are due improper battery safety. There you go. That wasn't difficult at all.
Subsection D: Enforcement Priorities for ENDS Products
Here is their prioritization to enforce ENDS products. Hmm...
"FDA will prioritize enforcement of flavored, cartridge-based ENDS products (other than tobacco- and menthol-flavored products), which are produced primarily by large manufacturers. This policy should have minimal impact on small manufacturers (e.g., vape shops) that primarily sell non-cartridge-based ENDS products, unless they market to youth or fail to take adequate measure to prevent youth access. Specifically, FDA intends to prioritize enforcement regarding the lack of marketing authorization against:
1. Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
2. All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors' access; and
3. Any ENDS product that is targets to minors or whose marketing is likely to promote use of ENDS by minors.
FDA intends to prioritize enforcement beginning 30 days after issuance of this Final Guidance."
First thing is first. Enforcement begins FEBRUARY 1, 2020.
I love the fact that FDA believes that this will have "minimal impact" on vape shops. Vape shops do carry cartridge-based ENDS products. Not all of them, of course, but some do.
"Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application). "
FDA still intends to enforce PMTA. A process that will cost hundreds of thousands of dollars. A process that no small vape shop can afford.
Subsection E: Avoiding a "Black Market"
"FDA has regulatory tools and enforcement authorities to address ENDS and other tobacco products that are marketed without authorization, that are counterfeit, and/or that are otherwise involved in illicit trade. FDA has previously issued letters to companies suspected of marketing counterfeit or otherwise unauthorized products. Additional potential actions against adulterated or misbranded illicit tobacco could include: (1) issuing a Warning Letter; (2) issuing an import alert and refusing admission of tobacco products imported or offered for import into the United States; and (3) initiating seizure or injunction court actions. Persons engaging in illicit trade in tobacco products may also be criminally prosecuted under the law."
Here is how I see it. There has been a large black market for illicit THC cartridges with very little repercussions.
SECTION 5: Premarket review for other deemed new tobacco products
This section covers cigars, hookah, pipe tobacco, and other traditional tobacco products.
"Accordingly, at this time, FDA has decided to prioritize use of its limited enforcement resources to address the sudden and dramatic increase in youth use of ENDS products, as well as to focus on health and safety concerns connect to ENDS products such as vaping-associated lung injuries. While acknowledging that all new tobacco products on the market without the required authorization are marketed unlawfully and are potentially subject to enforcement action, at any time, in FDA's discretion, FDA's primary focus will be to address the sudden and dramatic increase in youth use of ENDS products, and the products covered by this section of the guidance will therefore be a lower priority."
Basically, if you are a traditional tobacco group, you're safe.
APPENDIX A- Significant comments received in response to March 2019 draft guidance and FDA responses
This appendix discusses public comments given during the commenting period. There are seriously 19 pages of comments. Here are some highlights to the comments!
1. "FDA is supposed to be an advisory agency, not a regulatory agency, and its actions are an overreach." FDA responded, "The Tobacco Control Act provides FDA with regulatory authority over tobacco products."
2. "FDA's proposed actions are arbitrary and capricious because it has failed to proved adequate reasoning/scientific reasoning/used incomplete or incorrect data." FDA responded, "The enforcement priorities explained in the Final Guidance are based upon and supported by, among other things, multiple high-quality scientific data sources (e.g., NYTS, PATH, MTF).
3. "Draft guidance will kill innovation and force industry out of work." FDA responded, "FDA disagrees that the Final Guidance will cause these results. The Final Guidance explains FDA's enforcement priorities for certain deemed new products that are being marketed without required premarketed tobacco product authorization. The Final Guidance would only affect those products that are illegally on the market; none of the products affected by the guidance were ever in compliance with the premarket authorization requirements of the law. In any event, FDA believes that the use of premarket pathways will incentivize development of innovative tobacco products that meet the applicable statutory standards."
4. "There is no evidence/limited evidence to connect liquid nicotine use with harmful health effects in youth." FDA responded, "As discussed in the Final Guidance the studies of the effects of nicotine exposure in the naive adolescent brain find that the adolescent brain is uniquely vulnerable to nicotine compared to the adult brain. Repeated exposure to nicotine during adolescence induces long-lasting structural and function changes in brain regions involved in addiction, attention, learning, and memory."
The FDA does not care about adult smokers and ex-smokers. The FDA does not care that 13,000,000+ individuals have used e-cigarettes and vapor products to quit tobacco products. The FDA does not care about other scientific facts, such as the British Heart Foundation or the Royal College of Physicians. The FDA does not care that a black market is very feasible, and they do not have enough enforcement agents to take care of such. The FDA does not care that 480,000 people die annually from cigarettes, but allow them to stay on the market.
The PMTA's are due on May 12th, 2020. This leaves 130 days to fill out applications, spend hundreds of thousands of dollars, and shut down businesses.
Mind you, these are guidance not law.
Vape shops, if you aren't already, enforce 21 and older in your store. As an industry, we cannot continue to play games. We know we have until February 1st, 2020 for undercover agents to begin "mystery shopping."
I.D. every single person that comes in the store. Order signage from https://store.wecard.org/ and have signage EVERYWHERE.
Be vigilant. Be compliant. Discuss with attorneys. Discuss with employees.
I know this is an exhausting read, but I hope this breaks down everything for you.
Happy New Year, everyone!