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This interview originally appeared here: https://www.cyclopsvapor.com/blog/qa-with-azim-chowdhury-pRight to be Smoke-Free artnerfda-group-tobacco-evapor-food-packaging-at-keller-and-heckman-llp/

Azim Chowdhury is nationally recognized as an expert on FDA issues as they relate to the tobacco and e-vapor industries. He represents tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance, and spearheaded Keller and Heckman’s FDA tobacco and e-cigarette practice group. Keller and Heckman LLP, founded in 1962, has a broad practice in regulatory law and related litigation and business transactions. Keller and Heckman’s comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices and dietary supplements before the FDA uniquely positions the firm to guide tobacco, e-cigarette and e-liquid companies through the myriad of statutory and regulatory requirements that will soon be applicable to these products.

In the anticipation of Keller and Heckman’s *2018 E-Vapor and Tobacco Law Symposium, spoke with Chowdhury about what to expect at the second annual event.

For our readers who don’t know, can you talk a little bit about how you got into vaping law/education as a specialty?

The first time I came across a vapor product was back in 2009. While shopping at the mall, I came across a kiosk selling Smoking Everywhere cigalikes. I had been practicing law for a few years at that point and was focusing on medical devices and FDA regulations. I was immediately intrigued by the so-called “electronic cigarettes,” and started researching. When and how FDA was going to regulate vapor products was very much uncertain — the Tobacco Control Act had just become law, giving FDA the authority to regulate tobacco products, but the agency had already come out against e-cigarettes (the first time) arguing that they were unauthorized drug delivery devices. I wrote one of the first law articles on what FDA might do and how it would impact the burgeoning vapor industry for the Food and Drug Law Institute’s Update magazine (which you can findhere). I continued to write articles following the Sottera lawsuit, began speaking at conferences and attending vape expos, edited a couple of books, and quickly came to be recognized as a legal expert on vapor products.

In March 2010, I joined Keller and Heckman, a firm best known for its nationally-ranked FDA practice that includes lawyers as well as scientists, and spearheaded the E-Vapor Law Practice here. Now, we represent dozens of vapor businesses in the U.S. and around the world, including trade associations, manufacturers, suppliers, distributors and retailers in matters of federal, state and global regulatory compliance, as well as litigation, business and intellectual property issues.

This year is the second E-Vapor and Tobacco Law Symposium. Can you talk about how this year’s agenda came into play and how it changed from last year’s?

Last year we launched the inaugural E-Vapor and Tobacco Law Symposium from our offices in Washington, D.C. It was an experiment to see how this industry, which is mostly used to vape expos, trade shows and advocacy events, would react to a legal training seminar. Keller and Heckman’s well-established food, packaging and environmental practices have a long history of hosting these types of seminars, so this is right up our alley. Because the Deeming Rule had just become effective, we knew it was the right time to bring this type of event to the vapor industry to help companies understand how to stay in compliance.

With the success of last year’s Symposium, we decided to take the event “on the road” to Irvine, Calif., to reach a broader audience and make it easier for businesses on the West Coast to attend. With all the changes with the new administration, a new FDA commissioner and new policies that seem to indicate a shift in the agency’s view of these products (we hope), we are covering a lot more material at this year’s event. In addition to our Keller and Heckman experts, we are particularly excited for our guest speakers, several coming from overseas, who will be presenting on topics including good manufacturing practices, state laws, EU and UK laws, and vapor device standards.

Stepping further into that, what are some of the biggest challenges that vapers and business owners need to be aware of this year?

Companies must understand that even though the deadline for premarket applications for products on the market today has been delayed until 2022, the Deeming Rule is still in effect, and there are several fast-approaching deadlines for requirements such as ingredient reporting and HPHC testing that companies need to comply with in the meantime. We are expecting FDA to ramp up enforcement and inspections of facilities, so being prepared for that is critical. We will also be addressing the elephant in the room — Premarket Tobacco Product Applications (PMTAs) — and how companies might be able to work together to save money and submit applications to FDA.

Beyond FDA, more states are passing legislation impacting this industry, including new taxes and licensing requirements. Much of this will be covered at the Symposium. We are also seeing more companies get notices from state environmental regulators regarding how they are storing and disposing of nicotine and other hazardous chemicals. We think that is going to be a big issue in 2018 and moving forward.

Finally, if you’re looking to expand your business beyond the U.S. to the EU or Asia, we are going to have a lot of great presentations on how to do that.

Have there been any wins within the law that you’ve seen for our industry?

There have been a lot of victories at the state level by advocacy organizations such as SFATA, VTA and the Smoke-Free Associations fighting for vaper’s rights. We also had a huge victory last year on behalf of the Right to be Smoke-Free Coalition in Indiana, where we got the Seventh Circuit Court of Appeals to strike down the unconstitutional parts of Indiana’s e-liquid law (seehere). The industry should also consider FDA’s extension of the PMTA deadline as a victory that resulted from everyone’s lobbying efforts, as well as the threat from the lawsuits.

One topic we will be discussing at the Symposium is the appeal of the Nicopure and Right to be Smoke-Free challenge to the Deeming Rule, and how companies can still help with that effort.

The symposium schedule is jam packed and really looks like a must-attend event. Can you talk further about the importance of this two-day event?

I do believe this is a must-attend event for businesses who truly are interested in complying with the law and staying around for the long-term. This will also be a great opportunity to network with Keller and Heckman attorneys and other experts, as well as with other businesses. So far, we have over 100 registered attendees that include some of the biggest names in the industry, but also a lot of smaller companies who are looking to do things the right way.

*Seating is limited, but it is still not too late to register! Keller and Heckman is also exploring options for next year’s Symposium, and may take it to the Midwest or back to the East Coast.

Beyond the Food and Drug Administration (FDA) and Tobacco Control Act requirements that now apply to deemed tobacco products, manufacturers and retailers of vapor products, and particularly e-liquids, also face stringent environmental and waste management regulations and compliance issues that are significantly more complex than those faced by cigarette and traditional tobacco product companies. This dichotomy arises because regulations promulgated pursuant to the federal Resource Conservation and Recovery Act (RCRA) treat nicotine in tobacco-based products differently than when found in e-cigarettes and other vaping products.

Compliance with the waste management regulations can be confusing because their scope and extent will vary by the amount of waste nicotine produced at a manufacturing facility or the amount of nicotine-containing products collected for disposal by a retailer. Further complicating the issue, even if exempted from the RCRA regulations, certain nicotine-containing products may be subject to state regulation of nicotine as a dangerous or industrial waste. Although there have been few enforcement actions brought against vapor or e-liquid manufacturers or retailers, regulators have noted the industry’s growth and potential for noncompliance. Going forward, we expect regulators to focus less on educating the industry about waste management obligations and follow a more active enforcement approach.

RCRA Overview

The federal RCRA regulations and state analogues establish a comprehensive system for managing hazardous waste from “cradle to grave,” that is from the point the waste is generated until its ultimate disposal. Broadly speaking, the regulations prescribe how to determine if and when a material is regulated as a hazardous waste, and how to manage the waste once the determination is made. Critically, RCRA only applies when the material becomes solid waste, meaning that it has been discarded by being abandoned, recycled, or treated as “inherently-waste like,” or the decision to discard has been made.[1]

Having decided to discard a material, the waste generator must next determine whether the waste is hazardous. This is done in one of two ways: (1) does the waste contain materials that EPA has listed in one of the three hazardous waste lists codified at 40 C.F.R. Part 261, subpart D; or (2) does the waste exhibit one or more of four characteristics: ignitability, corrosivity, reactivity, or toxicity?[2] With regards to e-liquids and other nicotine-bearing products, certain unused chemicals are listed hazardous wastes when discarded.[3] The hazardous waste listing applies when the following three criteria have been met. First, the chemical must be listed at 40 C.F.R. § 261.33(e) or (f). Nicotine and its salts are listed at 40 C.F.R. § 261.33(e) as an acute hazardous waste with the P075 waste code. Second, the listing applies “if and when they are discarded or intended to be discarded” prior to use.[4] Given its intended function, nicotine in e-cigarettes is not used until it has been inhaled by the end user.

Third, the listed chemical must be discarded in the form of a “commercial chemical product or manufacturing chemical intermediate having the generic name of the listed chemical” (CCP). The term CCP refers to a chemical substance which is manufactured or formulated for commercial or manufacturing use and which consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed, all formulations in which the chemical is the sole active ingredient, and any off-specification forms of the foregoing chemicals.[5] Products with more than one active ingredient are not regulated as CCP, although they may still be regulated hazardous wastes if they exhibit one of the hazardous characteristics.

According to the U.S. Environmental Protection Agency (EPA), nicotine is the “sole active ingredient” in e-cigarettes because it is the “only chemically active component that performs the function of the product.[6] Flavorings, sweeteners, colorants and other components are considered inert ingredients. Consequently, raw material (i.e., nicotine), off-spec e-liquids, container residues, and spill residues are hazardous wastes when they are discarded or intended to be discarded from businesses. In addition, EPA has stated that because certain e-cigarettes contain cartridges that are containers of a CCP, they too must be treated as hazardous waste when disposed.[7] This also applies to tanks and pods used in open-systems and advanced vaporizers to hold the nicotine-containing e-liquid.

RCRA Requirements Depend on Quantity

Hazardous waste compliance requirements vary significantly under RCRA depending on the amount of hazardous waste a facility generates each month. Thus, the generator category of a company and commensurate requirements, including storage and accumulation, recordkeeping and reporting, and training requirements could change from month to month.[8] Keeping up with these changes and ensuring a facility complies can be particularly burdensome for small businesses, such as those that constitute a large portion of the vapor industry.

Nicotine’s status as an acute hazardous waste is likely the primary driver for determining the “generator” category for an e-liquid or vapor product manufacturer. Businesses that generate acute hazardous waste (“generators”) are categorized as very small quantity generators (VSQGs) when generating up to 2.2 pounds (1 kilogram) per month, and large quantity generators (LQGs) when generating more than 2.2 pounds per month.[9] Regulatory requirements are significantly greater for LQGs, as is clear from a guidance chart developed by EPA.[10] Thus, e-liquid manufacturers have a strong incentive to operate as VSQGs or small quantity generators (SQGs).

When a generator has multiple hazardous waste streams, the generator must quantify each waste stream separately and abide by the more stringent generator category.[11] An e-liquid manufacturer will be classified as an SQG if the manufacturer does not exceed the 2.2 pound per month threshold for acute hazardous waste but generates greater than 100 pounds of non-acute hazardous waste per month.[12] For example, a generator of up to 2.2 pounds of acute hazardous waste that crossed the 220 pound threshold for non-acute hazardous waste may need to comply with SQG requirements, as opposed to VSQG requirements.

Fortunately, a generator has some options for managing hazardous wastes: recycling, treatment, storage, or disposal. Each approach has its own implications and requirements under RCRA. Recycling (e.g., nicotine reclamation) is a management method that can have a meaningful impact on the standards applicable to hazardous waste generators. Provided that the company can demonstrate the recycling is legitimate, the reclaimed nicotine will not be considered solid waste.[13] Recycling is a particularly appealing option as it can reduce the amount of material counted as hazardous waste for purposes of determining the generator category.

E-liquids May Be an Increasing Focus for Enforcement

Compliance with RCRA requirements by vapor product and e-liquid manufacturers is an increasing area of emphasis for both the states and EPA. Thus far, states have focused on outreach to the industry regarding compliance measures.[14] Such outreach typically lasts from six months to a year to provide a chance for the industry to come into compliance before the agencies transition to enforcement. Given that the e-cigarette and vaping industries have been growing for several years, and that the past two years have seen an increase in state proposals and communications concerning this issue, industry members need to consider whether regulators will pursue a more aggressive enforcement agenda in the new year and going forward. Accordingly, e-cigarette and e-liquid manufacturers should evaluate their processes and potential impact on generator status to determine whether their facilities are complying with RCRA or state analogues.

To learn more about the environmental and hazardous waste management regulations that apply to your e-liquid or vapor business, be sure to attend our upcoming E-Vapor and Tobacco Law Symposium on February 6-7, 2018 in Irvine, California. Click here to register and for more information.

For more information on our Tobacco and E-Vapor Practice, visit www.khlaw.com/evapor. For more information on our Environmental Practice, visit www.khlaw.com/Environmental. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

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[1] 40 C.F.R. §§ 261.2(a), 261.33.
[2] 40 C.F.R. §§ 261.20-261.24.
[3] See 40 C.F.R. § 261.33.
[4] 40 C.F.R. § 261.33. See also EPA Letter to Merck Sharp & Dohme, FaxBack #11012, May 13, 1981.
[5] 40 C.F.R. § 261.33(b)
[6] Letter from Barnes Johnson, EPA, to Daniel K. DeWitt, Warner, Norcross & Judd LLP (May 8, 2015), RCRA Online #14850.
[7] Id.
[8] Recent revisions to the regulations do provide some relief to companies that consistently qualify under one category but experience an episodic event that shifts them to a more burdensome one. The rules generally limit the facility to one episodic event, however. See Hazardous Waste Generator Improvements Rule, 81 Fed. Reg. 85,732 (November 28, 2016).
[9] 40 C.F.R. § 262.13.
[10] U.S. EPA, “Hazardous Waste Generator Regulatory Summary,” available at:https://www.epa.gov/hwgenerators/hazardous-waste-generator-regulatory-summary.
[11] 40 C.F.R. § 262.13.
[12] See 40 C.F.R. § 262.13.
[13] Four factors are used to determine whether recycling is “legitimate.” 40 C.F.R. § 260.43(g). First, recycling must involve a hazardous secondary material that provides a useful contribution to the recycling process or to a product or intermediate of the recycling process. For example, the nicotine-containing materials may be the source of a valuable constituent (i.e., nicotine) recovered in the recycling process. Second, the recycling process must produce a valuable product or intermediate, which can be demonstrated by sale of the recycled product to a third party, by its use as an effective substitute for a commercial product, or by its use as ingredient in a process. Third, the generator and the recycler must manage the hazardous secondary material as a valuable commodity when it is under their control. This would entail management of nicotine-containing materials consistent with how raw nicotine is managed. Fourth, the product of the recycling process must be comparable to a legitimate product or intermediate. For example, the recycled product should meet widely recognized specifications for the raw material and not contain hazardous constituents in greater levels than a non-recycled analogue. See Letter from Barnes Johnson, EPA, to Scott DeMuth, g2revolution LLP (May 8, 2015), RCRA Online #14851.
[14] See, e.g., New Jersey Department of Environmental Protection, “Compliance Advisory Update – Compliance Assistance Available for Vape Shops and Manufacturers” (June 20, 2017), available at: http://www.nj.gov/dep/enforcement/advisories/2017-03.pdf.

Just two weeks before the September 30, 2017 registration deadline for U.S. tobacco product manufacturing establishments, on Friday, September 15, 2017, the U.S. Food and Drug Administration (FDA) published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments .See our original Client Alert summarizing the registration requirements here.

Has the Deadline Changed?

No. Registrations and product listings are still due by September 30, 2017 for U.S. manufacturing establishments. This applies to deemed tobacco products marketed as of August 8, 2016, the effective date of the Deeming Regulation.

How Do I Register?

FDA strongly encourages electronic submission of establishment registrations and product listings through the FDA Unified Registration and Listing System (FURLS) which can be accessed here. FURLS is only used to register an establishment and submit a product listing. Do not confuse this with the CTP Portal, which you can use to submit other regulatory document (e.g.,ingredient reports, health document submissions, etc.) To obtain a FURLS account and to view more instructions and webinars see here. Alternatively, you may file your Establishment Registration manually by filling out and Form FDA 3741a and mailing all of the necessary materials to CTP’s Document Control Center.

View FDA’s latest Webinar “Using the Tobacco Registration and Listing Module of FURLS – Tips and Recent Enhancements” here (published September 18, 2017).

Who Registers their Establishments and Submits Product Listing Information?

The revised guidance clarifies that owners and operators of domestic U.S. establishments engaged in manufacturing regulated tobacco products are required to register and provide a product list to FDA. This requirement does not extend to foreign establishments (e.g., e-vapor device manufacturers in China) or U.S. importers, distributors or retailers who merely distribute and sell products, but are not engaged in any manufacturing activity (e.g., manufacture, preparation, compounding, or processing, including bottling, packaging and labeling). FDA also encourages establishment owners to act as the agent for all operators and to register all establishments it owns and to submit the associated product listing, in order to reduce redundant submissions. If you have any questions about how to best structure your registration and product listing for your particular business, please let us know.

What Products Need to be Listed?

Despite the fact that the Form 3741a and the template FURLS product listing spreadsheet provided by FDA allow companies to indicate whether a particular product is for “Consumer Use” or “Further Manufacturing”, FDA’s revised guidance clarifies that the listing requirement only applies to finished tobacco products sealed in final packaging intended for consumers use. This includes components and parts sold directly to consumers in final sealed packaging. For example, an e-liquid sold in a sealed bottle for use by consumers in an open-system device would be a finished tobacco product, but an e-liquid intended to be filled into a closed system cigalike would be for further manufacturing, and should not be listed.
 
What Information Should be Submitted as Part of Establishment Registration and Product Listing?

Registration Information The following information is needed to register manufacturing establishments:
  • The name and full address of each establishment engaged in manufacturing the registrant owns or operates, as of the date of registration.
  • The name and places of business of the owner or operator. In the case of a partnership, include the name of each partner. In the case of a corporation, include the name of each corporate officer and director, and the State of incorporation.

Optional information includes an email address and a Data Universal Numbering System (D-U-N-S) number or other unique identifier (codes) for the place of business of the owner, the place of business of the operator, and the location of the establishment.

Product Listing Information

For the product list, FDA’s template product listing spreadsheet (available in FURLS) should be used, particularly if you are processing the registration online through FURLS. The spreadsheet identifies the information that must be submitted for each product, e.g., product identification number (SKU), intended use (consumer use), product category (ENDS), subcategory (e-liquid), open/closed system, flavor, and advertising, labeling and consumer information. Please note that each unique product must be identified on your product list including, for example, e-liquids under the same brand or flavor that vary in terms of package (e.g., bottle) size, nicotine strength and/or Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio.

Do I need to submit labels for all my product variations?

In addition, the product listing must include labeling information, but FDA’s revised guidance clarifies that e-liquid manufacturers in particular need not submit labels for all product variations. Specifically, the guidance states (on page 9):

However, FDA recognizes that product listing for some tobacco products may result in numerous labeling submissions that the manufacturer must prepare and submit. For example, variations in package size, nicotine strength, Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio, and flavor can result in thousands of individual product labeling submissions. 

In order to reduce the amount of uploaded labeling submissions, FDA does not, at this time, intend to enforce the requirements that owners and operators submit the labeling for each individual listed tobacco product if the registrant submits the information that represents the labeling for a selected line of products. In deciding whether a registrant’s submitted information falls within this compliance policy, FDA may consider whether the tobacco products’ labeling is essentially identical (e.g., the same formatting, fonts, colors, background text, and images) and whether the variations are limited to package size, nicotine strength, PG/VG ratio, and flavor. However, we recommend that zero nicotine formulas of a product, or product line, be grouped separately from products with nicotine. 

Rather, as described in Appendix A to the revised guidance, registrants may submit a separate “package label plan”, which is a model/generic product label with placeholder text for the specific variations, along with a “product variation index” which lists all the variations for a specific product, e.g. package size, nicotine strength, PG/VG ratio and flavor. The product variation index must list all combinations of the variations that will be using the model label. The examples from FDA’s revised guidance are copied below.

The Package Label Plans, including the Model/Generic Labels and Product Variation Indices can be uploaded in FURLS by creating a single PDF containing the label and the index. Once uploaded into FURLS you will be given the option of associating the file with all applicable products.

Example A – Sample Model Label (Package Label Plan) for nicotine containing products from the revised FDA guidance:
Example A – Product Variation Index
Example B – Sample Model Label (Package Label Plan) for 0 mg nicotine products from the revised FDA guidance:

Example B – Product Variation Index

What about advertisements and “consumer information”?

 

Finally, we note that despite previously implying that this information was optional, FDA’s revised guidance states that if product advertising exists, a representative sampling of such advertisements must be provided with the product listing. FDA interprets “a representative sampling of advertisements” to mean typical advertising material that reflects the full range of promotional statements made for the tobacco product. For example, if more than one magazine advertisement is used, but the promotional content is essentially identical, only one need be submitted.

FDA’s revised guidance further notes that, in addition, the product listing must include “a copy of all consumer information” to the extent the information is not advertising and has not already been provided as a form of product labeling. Consumer information does not include information directed at wholesalers, distributors or retailers where such information is not available to consumers (e.g., product specifications intended for manufacturing purposes, photos of components or parts not intended for individual sale, or communications between companies), but may include items like consumer brochures.

If you are interested in obtaining additional guidance on this topic contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com) or Ben Wolf (202-434-4103, wolf@khlaw.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

On Friday July 28, 2017, the U.S. Food and Drug Administration (FDA) announced its new “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” that refocuses the Agency’s implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA’s new strategy appears to be moving away from its “one-size-fits-all” approach to tobacco product regulation by recognizing that a “continuum of risk” of tobacco and nicotine-containing products exists. While FDA has indicated that its long-term plan is to, among other things, potentially lower nicotine in cigarettes to non-addictive levels, it also made major changes to its compliance policy for recently “deemed” tobacco products that immediately impacts manufacturers of e-vapor, e-liquid, cigars, hookah and pipe tobacco products.

Background: FDA Compliance Policy for Deemed Tobacco Products

The Deeming Rule became effective on August 8, 2016, extending FDA’s tobacco product authority over newly deemed products and subjecting manufacturers to the requirements in the Tobacco Control Act, including adulteration and misbranding prohibitions, establishment registration and product listing for manufacturing facilities located in the United States, ingredient reporting, testing for Harmful and Potentially Harmful Constituents (HPHCs), a ban on unauthorized modified or reduced-risk claims and, most significantly, premarket authorization for any new products first marketed or modified after the February 15, 2007 “grandfather date”.

In the Deeming Rule, FDA proposed a “compliance policy” delaying enforcement of the premarket authorization requirements for deemed products already on the market when the rule went into effect. More specifically, for non-grandfathered deemed products on the market on August 8, 2016, manufacturers initially had either two years (i.e., by August 8, 2018) to submit a Premarket Tobacco Product Application (PMTA) or 18 months (i.e., by February 8, 2018) to submit a Substantial Equivalence (SE) Report. Products intended to be introduced to the market or existing products modified in any way after August 8, 2016 are not subject to the compliance policy and would first need to obtain FDA authorization before they can be marketed (enforcement of this requirement, however, has not been a priority for FDA to date).

Moreover, even if a company could submit a timely PMTA or SE Report that FDA accepted for review, the “sunset provision” in the compliance policy only allowed that product to be marketed for an additional 12 months (i.e., until August 8, 2019 for PMTAs) while the agency reviewed the application (FDA could extend this on a case-by-case basis).  If FDA was unable to complete its review by then, the product would have to be removed from the market, and could only be re-introduced if the Agency ever granted marketing authorization.

Due to the copious amounts of data and associated expenses needed for a PMTA, which potentially includes clinical and epidemiological studies to demonstrate that a product is “appropriate for the protection of the public health”, this resulted in a particularly dire situation for the vapor industry – which faced effectively being banned – because there are no known grandfathered e-vapor or e-liquid products and, therefore, no way to make use of the less arduous SE pathway. Indeed, through September 2016, FDA had refused to accept 362 PMTAs submitted, presumably, without the data needed to even begin the substantive review process. (To date, only Swedish Match’s PMTAs for its snus smokeless tobacco products have survived the review process, and those applications included a substantial amount of clinical and long-term epidemiological data from Sweden.)

Earlier this year, in light of multiple lawsuits filed by the industry, the PMTA deadline (as well as all other forthcoming TCA compliance deadlines for deemed products) was delayed by three months to November 8, 2018 “to allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final [Deeming Rule].”

The new leadership, led by FDA Commissioner Dr. Scott Gottlieb, has now announced FDA’s revised compliance policy for deemed products. Under the new timelines, the February 15, 2007 grandfather date remains in place, but the deadlines for “applications” (i.e., SE Reports or PMTAs) for deemed products on the market have been delayed. Specifically, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, are due by August 8, 2021, and applications for non-combustibles, such as e-vapor and e-liquid products, are due by August 8, 2022. In his remarks, Dr. Gottlieb also indicated that FDA would be revising the sunset policy so that existing products under review remain on the market.

How Will This Impact Your Vape Business?

While the PMTA delay provides much needed breathing room on the most complicated and expensive requirement – and saves the vapor industry from a de facto ban – it is important for vape businesses to understand that none of the other fast approaching TCA deadlines have been impacted by FDA’s new policy.

Specifically, the Agency noted in its press release that its new policy will not (1) apply to provisions of the Deeming Rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors, or (2) affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors. The table below summarizes the major compliance deadlines for e-vapor product manufacturers:
Requirement
Deadline for Large-Scale Manufacturers
Deadline for Small-Scale Manufacturers
Free sample ban, age restriction, photo-ID check, use of modified/reduced risk claims and descriptors, adulteration and misbranding prohibitions
August 8, 2016
Introduction of new, deemed products without FDA premarket authorization (products on the market before this date are subject to the new compliance policy deadlines)
August 8, 2016
Registration of U.S. manufacturing establishments and submission of List of Products manufactured in such establishments [does not apply to foreign establishments]
September 30, 2017
Submission of Health Document Notification
February 8, 2017
November 8, 2017
Submission of Ingredient Listing Reports
November 8, 2017
May 8, 2018
Submission of Harmful and Potentially Harmful Constituents (HPHCs) reports
November 8, 2019
Nicotine Addiction Warning on Labels and Advertisements
August 10, 2018
 (distribution of products without the required warning must cease by September 10, 2018)
 
PMTA or SE Report for deemed combustible products (e.g. cigars or hookah) on market on August 8, 2016
August 8, 2021
PMTA or SE Report for deemed non-combustible products (e.g., vapor products) on August 8, 2016
August 8, 2022

To learn more about the U.S. manufacturing establishment registration & product listing, health document submission, and ingredient listing requirements, see here, here and here. If you have any questions about how to complete these submissions, please let us know.

What’s Next?

Beyond the immediate PMTA delay, FDA broadly announced that it is working to develop foundational rules and guidance, including rules and guidance to clarify the requirements for the SE Reporting process, PMTAs, and Modified Risk Tobacco Product (MRTPs) applications and the standards of review. Specifically, FDA:

  1. Plans to issue product standards for vapor products to protect against known public health risks;
  2. Will issue new “foundational rules” and guidance to modify the product review process and clarify the requirements for the SE Reporting process, PMTAs, and Modified Risk Tobacco Product (MRTPs) applications;
  3. Will study the effects of flavors (including menthol), both on young people and adult smokers looking for a less harmful alternative;
  4. Will begin a public dialogue through an Advanced Notice of Proposed Rulemaking (ANPRM) on the impact of reducing nicotine in cigarettes to non-addictive levels (FDA stressed that, at this time, it is only contemplating a reduction in nicotine in cigarettes and not for other tobacco (i.e., vapor) products); and
  5. Will issue an ANPRM soliciting comments and data relating to the use and public health impacts of premium cigars.
If you are interested in obtaining additional guidance regarding tobacco and e-vapor compliance contact Azim Chowdhury (+1 202.434.4230, chowdhury@khlaw.com). For more information on Keller and Heckman LLP’s Tobacco and E-Vapor practice in general, visit www.khlaw.com/evapor. Follow Azim Chowdhury on Twitter.
Although we are still waiting for an official announcement, FDA’s Stakeholder Relations Office recently indicated that the Agency will be delaying enforcement of all future Deeming Regulation compliance deadlines set for May 10, 2017 or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports. We understand that this does not apply to provisions of the Deeming Regulation where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.

The Stakeholder Relations Office further indicated that “this extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court”.

Click here to learn more about Keller and Heckman LLP’s lawsuit on behalf of the e-vapor industry currently pending before the U.S. District Court for the District of Columbia.

We will let you know as soon as FDA officially announces the new deadlines or issues new guidance.

Updated Compliance Deadlines Under Deeming Rule [Pending FDA Official Announcement]

Requirement
Deadline for Large-Scale Companies 
Deadline for Small-Scale Companies 
Registration of U.S. manufacturing establishments
 September 30, 2017
 September 30, 2017
Submission of List of Products manufactured in U.S. establishments
 September 30, 2017
 September 30, 2017
Health Document Submission
February 8, 2017
[Note: this deadline has passed]
 November 8, 2017
 Submission of Ingredients Listing Reports
November 8, 2017
 May 8, 2018
Premarket Tobacco Product Application (PMTA) for products on market on August 8, 2016
November 8, 2018
 November 8, 2018
Submission of Harmful and Potentially Harmful Constituents (HPHCs) Reports
November 8, 2019
 November 8, 2019

For more information on our tobacco and e-vapor practice, please contact Azim Chowdhury (+1 202.434.4230; chowdhury@khlaw.com) and visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor partner Azim Chowdhury on Twitter. 

The U.S. Food and Drug Administration’s (FDA’s) “Deeming Regulation” became effective on August 8, 2016, extending the Agency’s regulatory authority over tobacco products beyond traditional cigarettes, smokeless tobacco and roll-your-own tobacco products to include “other” tobacco product categories such as cigars, pipe tobacco, hookah/shisha, electronic vapor and e-liquid products, and components and parts of such products. Now, manufacturers of newly deemed products are subject to the Tobacco Control Act (TCA) requirements, including registering U.S. manufacturing establishments, reporting ingredients and health documents to FDA, and obtaining premarket authorization.

Products made or derived from tobacco usually fall within the meaning of “tobacco products” under the TCA, and are regulated as such by FDA’s Center for Tobacco Products (CTP) unless claims made for the product trigger a different regulatory classification. In FDA’s final rule, “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses,'” published on January 9, 2017, FDA is seeking to clarify when a product made or derived from tobacco would be excluded from the definition of a tobacco product, and instead subject to FDA’s drug, medical device, and combination product (i.e., medical product) authority.  

Determining Intended Use

Determining a product’s intended use is critical to establishing whether a product made or derived from tobacco will be regulated as a medical product. A drug is defined in Section 321(g) of the Food, Drug and Cosmetic Act (FDCA), in pertinent part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” (the “disease” or “therapeutic benefit” prong) or “articles (other than food) intended to affect the structure or function of the body of man or other animals” (the “structure/function” prong).

FDA’s new rule “reiterates” that a product made or derived from tobacco will be subject to FDA’s medical product authority, and not its tobacco authority, (a) if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms; or (b) if it is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.  21 C.F.R. § 1100.5.

Medical products cannot be marketed without FDA approval, which requires demonstrating, typically through significant non-clinical and clinical evaluations, that a product is “safe and effective” for its intended use. The process of getting a medical product approved for a particular indication is complicated, takes many years, and costs millions of dollars. New medical products are also approved for a particular indication, virtually always require a prescription (with adequate data and FDA approval, over-the-counter status is possible), and may not be used recreationally, as e-vapor products generally are. Additionally, the Supreme Court has said that because FDA considers tobacco to be inherently unsafe, “if tobacco products were ‘devices’ under the [FDCA], the FDA would be required to remove them from the market,” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 135 (2000). Although scientific research, both in the United States and abroad, supports that e-vapor products are substantially less hazardous than combustible tobacco products (see, for example, Public Health England’s report finding that e-vapor products are 95% less harmful than traditional cigarettes, which was followed by the Royal College of Physicians’ ground breaking report lauding the public health benefits of e-vapor products), manufacturers should understand how FDA determines a product’s “intended use” and avoid making claims, statements, or taking other actions that might trigger FDA’s medical product authority.

In the preamble to the new rule, FDA sought to clarify when it would consider a manufacturer to have intended to market a tobacco product in a way that satisfied either the structure/function or disease prongs of the drug definition.  According to the FDA and associated court rulings, a manufacturer’s intended use can be determined through “any relevant source.” Common sources could be product labeling, promotional claims, or advertising. FDA has taken the position that when it is seeking to determine whether a product is intended for use as a medical product, it may consider direct and circumstantial evidence, as well as circumstances surrounding distribution of the product.  82 Fed. Reg. 2196. Any representation by a manufacturer in a public forum can provide evidence of intent, including communications and reports to other administrative agencies or a manufacturer’s websites. For example, FDA has previously determined the intended use of a product based on statements made in the manufacturer’s SEC filings or patent filings with the USPTO. Importantly, FDA may also look at how the product is actually being used by consumers as evidence of the manufacturer’s intent.

Disease Claims (Claims of Therapeutic Benefit)

FDA further emphasized that manufacturer claims related to “smoking cessation in the context of curing or treating nicotine addiction and its symptoms” would bring a product within the disease prong of the drug or device definition. This would include claims, for example, that an e-vapor device can help a smoker quit or treat their nicotine addiction. Indeed, FDA is clear that it considers smoking cessation claims to “create a strong suggestion of intended therapeutic benefit” which would be difficult to overcome. Beyond smoking cessation or quit claims, any claims that a product may be used to diagnosis, cure, mitigate, treat or prevent of disease (particularly tobacco-related disease) would cause a product made or derived from tobacco to be a medical product.

Structure/Function Claims

Disease claims are not the only type of claims that might trigger FDA’s medical product authority. Claims that a tobacco product affect the “structure or function” of the body in any way related to the effects of nicotine may as well. FDA’s new rule states that the only nicotine structure/function claims permissible are those that were customarily used by tobacco companies to market cigarettes and smokeless tobacco prior March 21, 2000 – the date of the U.S. Supreme Court decision in FDA v. Brown & Williamson. In other words, claims that were commonly and legally made in the marketing of cigarettes or smokeless tobacco prior to March 21, 2000 will not cause products made or derived from tobacco to be marketed as medical products.

Permissible structure/function claims could relate to satisfaction, pleasure, enjoyment, or refreshment. Additionally, claims that a particular tobacco product will provide the same effects as another tobacco product may be acceptable. FDA offers several examples of such claims, such as “get your nicotine fix” or “provides smokers the same delight, physical and emotional feelings.” 82 Fed. Reg. 2200.

On the other hand, statements that a product can “relieve tension” or “promote weight loss” would be considered structure/function claims that are related to the pharmacological effects of nicotine but that were not commonly and lawfully used prior to March 21, 2000. Absent evidence to the contrary, FDA would likely consider products subject to those claims to be medical products. Even if you had evidence of such claims having been made prior to March 21, 2000, FDA’s position would be that such claims were not lawful.


Other Claims

The new rule also reminds manufacturers that claims that a tobacco product may present reduced risk or harm (compared to other tobacco products) can only be made with FDA’s explicit authorization through the Modified Risk Tobacco Product (MRTP) application process set forth in Section 911 of the FDCA, as amended by the Tobacco Control Act. In addition, false or misleading claims, including unsubstantiated claims, regarding any product regulated by FDA would cause the product to be misbranded and subject manufacturers to enforcement action. 82 Fed. Reg. 2202.

Quick Tips for Compliance

  • Make truthful and substantiated claims, but avoid focusing on any health impact or potential reduced risk compared to other products.
  • Avoid making claims that could be perceived as “smoking cessation” or “quit” claims, or nicotine addiction claims.
  • Claims regarding “enjoyment” or “satisfaction” are permitted. 
  • Claims about e-vapor device functions, features, and e-liquid flavors are permitted.

 

UPDATE:  On December 5, 2016, FDA finalized its Guidance for Industry, “Health Document Submission Requirements for Tobacco Products” which is available here.  As noted above, manufacturers and importers of newly deemed tobacco products (such as e-vapor products) that were on the market on the August 8, 2016 effective date of the Deeming Regulation are required to submit health documents developed during June 23, 2009 and December 31, 2009 to FDA by February 8, 2017.  FDA has indicated that documents developed after December 31, 2009 may be required to be submitted in the future, so they should be retained.

On September 9, 2016, the Food and Drug Administration (FDA) issued revisions to its guidance regarding the Health Document Submission Requirements for Tobacco Products, as required by section 904(a)(4) of the Food, Drug, and Cosmetic Act (21 U.S.C. 387d(a)(4)), for comment purposes. The revised guidance provides further information to manufacturers and importers of tobacco products including those products newly regulated following the August 8, 2016 effective date of FDA’s “Deeming Regulation,” including cigars, pipe tobacco, shisha and e-vapor products that contain tobacco-derived nicotine. (See also: E-Vapor Industry Challenges Deeming Regulation.)

Notably, FDA now only intends to enforce the health document submission requirements with respect to “finished tobacco products,” which are defined as a “tobacco product, including all components and parts, sealed in final packaging intended for consumer use” (and do not include “products that are sold or distributed solely for further manufacturing”). FDA reserves the right to change its compliance policy in the future and, as such, health documents related to components and parts must be preserved for potential future submission.

Manufacturers and importers of newly deemed tobacco products (such as e-vapor products) that were on the market on the August 8, 2016 effective date of the Deeming Regulation are required to submit health documents developed between June 23, 2009 and December 31, 2009 to FDA by February 8, 2017. Small-scale manufacturers (“meaning a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less”) have until August 8, 2017 to comply. Newly deemed products intended to be introduced to the U.S. market after August 8, 2016, in addition to obtaining FDA premarket authorization, must submit the relevant health documents to FDA at least 90 days prior to the delivery for introduction into interstate commerce of the tobacco product.

Although the guidance document states that FDA intends to enforce these submission requirements with respect to health documents developed between June 23, 2009 and December 31, 2009, manufacturers and importers should preserve health documents developed after December 31, 2009 for potential future submission to FDA.

The guidance explains that documents that fall within the health document submission requirements broadly include those documents “related to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.” For newly regulated tobacco products such as e-vapor products, “current or future tobacco products” refers to “products commercially distributed on or after August 8, 2016, or products in any state of research or development at any time after” that date.

FDA intends to enforce the health document submission requirement only with respect to documents in the “possession, custody, and control” of the manufacturer or importer. Manufacturers or importers who do not have any health documents to report must still let FDA know this by the aforementioned submission deadlines. Moreover, FDA will not enforce this requirement with respect to certain duplicative documents, substantively identical documents, or publically available information.

The guidance also outlines manufacturer/importer information that should be included in the health document submission, as well as the preferred organization, labeling, and formatting of the submitted documents. Electronic submission of documents via FDA’s electronic submission tool (eSubmitter) is highly encouraged.

Parties interested in obtaining additional guidance regarding submission of health documents to the FDA should contact Azim Chowdhury (+1 202.434.4230, chowdhury@khlaw.com). For more information on our tobacco and e-vapor regulatory practice in general, visit khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

UPDATE: On December 9, 2016, FDA issued a revised guidance for industry, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments,” extending the December 31, 2016 deadline for registration and product listing for U.S. manufacturers by six months by June 30, 2017. According to FDA, the guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA. The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.

Please note that this does not change the fact that no new deemed tobacco products can be introduced into the U.S. market after August 8, 2016 without first obtaining FDA Premarket Tobacco Product marketing authorization (products marketed on August 8, 2016 can take advantage of the 2 year grace period before the PMTA deadline on August 8, 2018, pursuant to FDA’s compliance policy)

________________________________________________________
Section 905(b) of the Tobacco Control Act requires every person who owns or operates any “establishment” in the United States that manufactures, prepares, compounds, or processes a “tobacco product” to register with FDA by December 31 of each year. Now that the Deeming Regulation is effective, e-vapor products, including their components and parts (e.g., e-liquids that contain tobacco-derived nicotine), are considered regulated tobacco products. If you own or operate a facility in the United States that manufactures, prepares, compounds, or processes an e-vapor product, which includes repackaging or otherwise changing the container, wrapper, or labeling of such product package, then you must register with FDA by the end of the year. (See also: E-Vapor Industry Challenges Deeming Regulation.)

At the time of registration, registrants must also submit to FDA a detailed list of all products that are being manufactured, prepared, compounded, or processed for commercial distribution, along with copies of consumer information, all product labeling, and a representative sampling of advertisements. Registrants must also file a biannual report of certain changes to their product lists.

How Do I Register?

FDA strongly encourages electronic submission of establishment registrations and product listings through the FDA Unified Registration and Listing System (FURLS) which can be accessed here. FURLS is only used to register an establishment and submit a product listing. Do not confuse this with the CTP Portal, which you can use to submit other regulatory documents (e.g., ingredient reports, health document submissions, etc.). To obtain a FURLS account and to view more instructions and webinars see here.

Alternatively, you may file your Establishment Registration manually by filling out and Form FDA 3741 and mailing all of the necessary materials to CTP’s Document Control Center, or by packaging the files electronically using FDA’s eSubmitter software and submitting that package through the CTP Portal.

Establishment Registration
 
Domestic manufacturers of finished tobacco products must register their facilities.
 
Deemed tobacco products, including e-liquids, that are intended or reasonably expected to be used with nicotine or tobacco, are now regulated by FDA, and are thus subject to the Establishment Registration and Product Listing requirements of the Tobacco Control Act.
 
Section 905(b) (21 U.S.C. 387e(b)) of the Act requires that domestic businesses engaged in the preparation, manufacture, compounding, repackaging, relabeling or processing of finished tobacco products register their establishment(s) on or before December 31 of each year.
In FDA’s Registration and Product Listing guidance document, released in July, 2016, FDA states it only intends to enforce the registration and listing requirements with respect to domestic manufacturers of “finished tobacco products.” A finished tobacco product is defined as a “tobacco product, including all components and parts, sealed in final packaging intended for consumer use” (and do not include “products that are sold or distributed solely for further manufacturing”).
 
Only Domestic Establishments 
Per Section 900(20) (21 U.S.C. 287(20)) of the TCA, a tobacco product manufacturer means “any person, including any repacker or relabeler, (A) who manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States.” FDA’s guidance document states, however, that an importer who does not own or operate “domestic establishments engaged in manufacturing tobacco products” is not subject to the registration and listing requirements. Accordingly, only domestic U.S. establishments engaged in the manufacture, compounding, repackaging, relabeling or processing of finished tobacco products are required to register their facilities and provide product information. This means e-liquid and e-vapor device manufacturers, including vape shops that mix, bottle, assemble or label their own products, located in the United States must register their manufacturing establishments with FDA by the end of the year.  As noted, this requirement does not currently apply to foreign manufacturing establishments.
Therefore, if you are both a domestic manufacturer and produce finished tobacco products, you must register your U.S. manufacturing facility as directed by FDA by December 31, 2016. Registration instructions are provided below. The information required by FDA includes:
  • The name and address of establishments engaged in manufacturing and owned by the registrant as of the date of registration;
  • The name and place of business of the owner or operator; and
  • If filing electronically, FDA also recommends providing an email address and DUNS number.
Tobacco products that are produced in an establishment that is not registered under Section 905 will be deemed misbranded per Section 903(a)(6) (21 U.S.C. 387c(a)(6)), which can lead to enforcement actions against the manufacturer such as fines, seizures, or injunctions.
Product Listing
When you register your domestic facility, you must also list the tobacco products you manufacture and provide information regarding those products. 
 
In conjunction with registration, Section 905(i)(1) requires manufacturers to submit a complete list of tobacco products being manufactured for distribution. A manufacturer’s tobacco product list must be accompanied by certain product information. At this time, the principal requirement is that the product list must include all labeling for each product, as well as “a representative sampling of advertisements” for each product. FDA’s guidance document states that FDA interprets “representative sampling” to mean “typical advertising material that reflects the full range of promotional statements made for the tobacco product.” If manufacturer’s have additional consumer information that is not submitted as either advertising or labeling, manufactures should submit this consumer information as well. This means that when you register your manufacturing facilities, the list of products produced at such facility must be accompanied by copies of labels and advertising materials (e.g., any ads for your products in VAPE Magazine, for example) for each product.
FDA’s Registration and Listing guidance states that “each product included in a product listing [should] be clearly identified and distinguished.”  If two products are different, for example if they contain different components or parts, the products should be listed separately. FDA requires that the listed products be identified by category, unique name, and identification number such as a SKU or UPC, as needed. For examples of the information required for a product listing, see pages 8 and 9 of FDA’s Form 3741.
Finally, under Section 905(i)(3), changes that occur to a manufacturer’s most recent product list must be submitted biannually, during June and December. As FDA’s guidance explains, these changes include: tobacco products introduced for commercial distribution; tobacco products for which manufacturing was discontinued; tobacco products that for which manufacturing was previously discontinued but which has since resumed; and “any material change” to information previously submitted in a product list.
Examples
FDA’s website for manufacturers provides the following examples of completed registration and listing forms for various types of tobacco products:
Parties interested in obtaining additional guidance regarding submission of registration and listing information to the FDA should contact Azim Chowdhury (+1 202.434.4230,chowdhury@khlaw.com). For more information on our tobacco and e-vapor regulatory practice in general, visit www.khlaw.com/evapor . Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

Azim Chowdhury was interviewed in VB2B’s Winter Edition. Azim discussed current events in the e-vapor industry and what companies need to do in the face of rapid regulatory change.

  1. What are the different services Keller Heckman offers the business owners?

We are a regulatory law firm specializing in the U.S. Food and Drug Administration (FDA), European Union (EU), and global requirements for e-vapor products. Our expertise is in promoting, protecting, and defending products made by the spectrum of industries regulated by government agencies which, in the United States, now includes e-vapor products since FDA’s Deeming Regulation became effective on August 8, 2016. For over 50 years, Keller and Heckman has provided global legal counseling in the areas of regulatory law, litigation, and business transactions. With offices in Washington, D.C., Brussels, Paris, San Francisco, and Shanghai, the firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Further details regarding our services and personnel can be found at www.khlaw.com. With respect to e-vapor products specifically, our comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices, dietary supplements, and packaging before FDA and regulatory agencies around the world uniquely positions us to guide e-vapor companies through the Deeming Regulation and other requirements for various products. We currently represent e-liquid and device manufacturers and trade associations in matters of federal, state, and global regulatory compliance. We defend lawsuits, including class actions, against e-liquid companies. We are also currently representing the Right to be Smoke-Free Coalition and a number of industry trade associations in Federal district court in Washington, D.C., challenging aspects of the Deeming Regulation and the Tobacco Control Act. You can learn more about our e-vapor specific practice on our website at www.khlaw.com/evapor.

  1. Without exposing any confidential information or creating a conflict of interest, what types of companies in this industry do you represent? 

We represent a broad spectrum of e-vapor industry stakeholders, including ingredient suppliers, manufacturers (both e-liquid and devices), distributors and retailers, and trade associations of such companies located in the United States and around the world.

  1. What is the R2B foundation? How can businesses help support its cause?

In July 2015, a group of e-liquid companies came together to form the Right to be Smoke-Free Coalition—a non-profit, industry-led trade association of e-vapor businesses dedicated to promoting the interests of the industry, as well as for the right of vapers to be smoke-free. The specific goal of the Coalition is to legally challenge in court unconstitutional state and federal laws related to the vape industry. The first case that we took on for the Coalition was the unconstitutional e-liquid ban in Indiana. We are still fighting that battle in the 7th Circuit Court of Appeals. We are also challenging the approach FDA took in the Deeming Regulation in regulating vapor products.

Specifically, our position is that FDA’s treatment of vapor products, which is more onerous than cigarette products, violates the Administrative Procedure Act (APA), among other laws. Our main concern is that forcing all vapor products on the market today to go through the Premarket Tobacco Application (PMTA) process within 2 years (where each application is expected to cost hundreds of thousands if not millions of dollars), will result in a virtual ban of all products within 3 years. In short, this regulation will kill the industry. That is why we must come together now to fight this regulation and force FDA to take a more reasonable approach.

The FDA litigation is expected to cost between $1-2 million over the next couple of years (including appeals).  The Coalition is actively recruiting responsible vapor companies to join and contribute to the cause. The more reputable companies that join the Coalition, the less the financial burden will be for all members to fight these laws in court. In terms of contribution amounts, companies have donated between $5,000 and $50,000. But, any amount will help! You can join and contribute here: www.r2bsmokefree.org.

  1. What was going through your mind when you started R2B?

The original e-liquid companies that came together—Vapor Shark, Cosmic Fog Vapors, Mt Baker Vapor and NicQuid—recognized that there was a huge need for an industry-led coalition to challenge laws in court, particularly when the lobbying efforts to prevent such laws were unsuccessful. Indiana was the first example of this, but there are many other states with laws that may challenge, including California and Pennsylvania.

  1. What is your background of expertise? How many years have you been experienced in the field?

I have been practicing law for 10 years and am a Partner in Keller and Heckman’s food and drug law group, where I have been focusing on the e-vapor industry since 2009. Beyond my tobacco and e-vapor work, I advise domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, I assist companies in establishing clearances for food and drug additives and food-contact substances. I am also a frequent contributor to the Tobacco Reporter and the Food and Drug Law Institute’s (FDLI’s) Update magazine. I have edited and co-authored FDLI’s upcoming manual: Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. I have also previously served on the Editorial Advisory Board of the Food and Drug Law Journal.

  1. What types of law can your firm practice for potentially interested readers?

We practice in a wide variety of areas of potential interest to your readers including: Advertising & Promotion, Business Counseling and Transactional, Chemical Control (REACH, TSCA), Environmental, Litigation, Product Safety, Telecommunications, Workplace Safety and Health, among other areas. Our full practice list can be found here: http://www.khlaw.com/areas.aspx.

  1. How many partners does Keller Heckman currently have, how many on staff? 

We currently have 41 Partners, 24 of which practice in our food and drug law group. In addition to our legal staff, we have about 20 in-house scientists who work closely with the firm’s attorneys on matters of technical complexity (including e-liquid toxicity assessments, for example).

  1. What are some of the obstacles manufacturers and retailers have to overcome to manufacture finished American vapor products for retail sale in the USA, while now under federal regulation?

Since the Deeming Regulation became effective on August 8, 2016, e-liquid and e-vapor products are now regulated by FDA as tobacco products. That means they are subject to a host of regulatory requirements including establishment registration, product listing, ingredient reporting, health document submissions, warning requirements and, most critically, premarket review via the Premarket Tobacco Product Application (PMTA).  Products on the market on the August 8 effective date can take advantage of a two-year grace period before the PMTA deadline on August 8, 2018. But, new products cannot enter the market today (post-8/8/16) without first getting PMTA authorization.

  1. What are some of the requirements, and the timelines, for manufacturers who had their products on the market before August 8, 2016?

FDA’s full Deeming compliance calendar is available here: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM501016.pdf. For products that were on the market on August 8, 2016, here are the important deadlines:

  • Register facilities and submit product listings by December 31, 2016 for all U.S. establishments (this does not yet apply to foreign establishments, including Chinese manufacturers, but FDA has indicated it will propose a new rule to extend this requirement to foreign establishments).
  • Submit ingredient lists (i.e., product formulations) by February 8, 2017 (or by August 8, 2017) for small-scale manufacturers.
  • Submit health and safety studies (developed between June and December 2009) by February 8, 2017 (or by August 8, 2017 for small-scale manufacturers).
  • Submit PMTAs by August 8, 2018.
  • Have compliant labeling by May 10, 2018 (e.g., name and place of business, quantity of the contents, and “Sale only allowed in the United States” disclaimer), and the nicotine addiction warning by August 8, 2018.
  1. What are some of the scientific requirements of PMTA applications and how would you recommend manufacturers to go about obtaining such information about their products?

The Tobacco Control Act requires a PMTA to include the following:

  • full reports of all investigations of health risks;
  • a full statement of the components, ingredients, additives and properties, and principles of operation of the tobacco product;
  • a full description of methods of manufacturing and processing;
  • an explanation of how the product complies with any applicable tobacco product standards;
  • samples of the product and its components; and
  • specimens of proposed labeling.

FDA has issued a guidance document to assist manufacturers with preparing and submitting a PMTA, which is available here: http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf. The guidance details the information that should be submitted in order to meet the statutory criteria set forth above, and it further recommends the submission of particular additional materials (such as a cover letter and executive summary) that will assist FDA in the review of the submission. Of particular note, FDA has interpreted the provision regarding the “full reports of investigations of health risks” required under the Act to require submission of not only investigations that support the PMTA, but also any investigations that do not support, or are adverse to, the application. FDA further recommends that a PMTA provides information on both nonclinical and clinical investigations, including, but not limited to, any studies assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure, and consumer use profiles. In addition, FDA recommends that manufacturers provide information on (i) investigations concerning products with novel components, ingredients, additives or design features that are similar or related to those of the new tobacco product, and (ii) investigations concerning products that share novel components, ingredients, additives, or design features with the new tobacco product so that FDA may adequately assess the health risks of the product. The PMTA Guidance contains other detailed recommendations to assist manufacturers in making the required statutory showings, including general principles for scientific studies, product chemistry, nonclinical studies, and studies in adult human subjects.

  1. What would you say was the biggest hurdle you had to overcome throughout your venture as one of the partners of Keller Heckman?

The highlight of my career is actually not related to my food and drug or e-vapor practice, but to my pro bono work. A few years ago, I had the opportunity to assist a young boy and his family obtain asylum in the United States. It was a heartbreaking story—my clients had fled their home country of El Salvador because of the physical violence and threats of death they faced at the hands of the notorious, internationally-known criminal enterprise, the Mara Salvatrucha (MS-13). The gang had singled out my clients and an additional family member for refusing to join them, and actually murdered one of the brothers. Although asylum is rarely granted to the victims of gang-based violence abroad, the Executive Office of Immigration Review agreed that my clients’ case was distinguishable from other cases involving victims of gang violence. They are now productive U.S. residents and hope to become citizens.

  1. What’s the firm’s number one goal for the future?

Our goal is to continue to provide creative legal, scientific, and business solutions for our clients. We are here to help you grow your business, using both law and science.

  1. If you yourself could share one piece of advice with retailers what would it be?

Work with reputable suppliers who plan on doing their best to comply with the law itself (check IDs, no free samples, etc.) and help fund the litigation and lobbying efforts to change the law.

  1. If you had all of the vapor product manufacturers in America in one room, what would you say to them?

The industry must come together with one voice if it is going to survive. We are all on the same team.

     15. What are some new regulations or upcoming changes we can expect to see on the market in the  near future?

The Deeming Regulation is a “foundational” rule that gives FDA authority over deemed products, including e-vapor. There will be more regulations in the future covering, for example, advertising restrictions, Good Manufacturing Practices, online sales, and possible restrictions or prohibitions on the use of flavors. Those regulations would have to go through separate Notice and Comment Rulemaking processes and so are likely years away.

On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by  Rep. Tom Cole (R – OK) and Rep. Sanford Bishop (D – GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 “grandfather date” for currently unregulated tobacco product categories, including nicotine-containing electronic vaping devices and the “e-liquid” used in them. The U.S. Food and Drug Administration (FDA) is expected to “deem” such e-vapor products subject to its authority under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), pending finalization of the so-called “Deeming Regulation” (FDA-2014-N-0189). The inclusion of the Cole-Bishop Amendment in the appropriations bill has been hailed as a victory for the e-vapor industry, but there remains a long road ahead before this budget amendment can effectively change the statutory grandfather date for deemed products.

In 2009, the Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to give FDA authority to regulate the manufacture, distribution, and marketing of tobacco products. Although the new law defined “tobacco product” broadly to include, in pertinent part, anything made or derived from tobacco intended for human consumption, including any components, parts, and accessories of such products, it only gave FDA the immediate authority over certain types of tobacco products, e.g., cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own-tobacco. These four product types are the only product types currently regulated by the FDA under the Tobacco Control Act. In addition, the new law also gave FDA the ability to use its rulemaking procedures to promulgate a regulation that would “deem” other, currently unregulated, tobacco products under its tobacco authority. In April 2014, FDA published a Notice of Proposed Rulemaking for the Deeming Regulation which proposed to extend its regulatory authority to other tobacco products that were not initially captured by the Tobacco Control Act, including cigars, shisha/hookah, pipe tobacco, and e-cigarettes/e-liquid that contain nicotine derived from tobacco.

The Deeming Regulation, as proposed, would treat all deemed products in essentially the same manner as the currently regulated products under a one-size-fits-all regime, subjecting the newly covered products to the same requirements including, among other things, facility registration, product and ingredient disclosures, Harmful and Potentially Harmful Constituent (HPHC) testing and reporting and, critically, the premarket authorization requirements for “new” products. Under the Tobacco Control Act, any regulated tobacco product not marketed on or modified after the February 15, 2007 grandfather date is a “new” product that requires FDA marketing authorization – via either a Premarket Tobacco Application (PMTA) or Substantial Equivalence (SE) Report – before it can enter the market. For more on the Tobacco Control Act requirements that will apply to deemed products including e-vapor products, see “FDA Regulation of E-Cigarettes – Are You Prepared?”

In October 2015, having completed its review of the over 135,000 public comments received, FDA submitted its draft version of the final Deeming Regulation to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs. This is the final step in the rulemaking process. Subsequently, from November 2015 through January 2016, OMB met with industry stakeholders and members of the public health community to hear their concerns about the pending rule. The final rule is expected to be published this year, during the Obama administration according to Mitch Zeller, Director of FDA’s Center for Tobacco Products.

Given that there were virtually no e-vapor products on the market as of February 15, 2007, effectively all e-vapor products would be considered new tobacco products requiring premarket authorization. Further, because the SE process requires a manufacturer to compare their product to a “predicate” product (i.e., a grandfathered product, or a product authorized previously for sale through the SE process), if the grandfather date is not amended, the only pathway to market for e-vapor products would be through the PMTA process. For more on potential alternative grandfather dates for deemed products, see “The Grandfather Date – What are FDA’s Alternatives?”

The Cole-Bishop amendment to the 2017 Agricultural Appropriations bill would change the grandfather date specifically for deemed products from February 15, 2007 to the effective date of the Deeming Regulation (i.e., most likely sometime in 2016). If this amendment becomes law, any nicotine-containing e-vapor products on the market as of the effective date of the final rule would be grandfathered and, although such products would still have to comply with the rest of the Tobacco Control Act, could avoid the lengthy and expensive PMTA process. Grandfathered products could also serve as predicate products for future SE Reports for new products intended to be marketed after the new grandfather date.

In addition to changing the grandfather date for deemed products, the amendment also includes language that will:

-Require FDA to begin rulemaking to establish a product standard for e-vapor product batteries within 1 year of the effective date of the Deeming Regulation, and publish a final product standard for e-vapor product batteries within 2 years of the effective date of the Deeming Regulation.
-Cause an e-vapor product to be considered misbranded under the FDCA if it is advertised in a newspaper, magazine, periodical, or any other publication other than an adult publication (i.e., a publication with 15% or less of its readership from readers younger than 18 years of age, and read by fewer than 2 million persons under 18 years of age).
-Require retailers to sell e-vapor products in direct face-to-face exchanges without the use of any electronic or mechanical devices, such as a vending machine. This provision contains an exemption for mail-order sales (i.e., internet), and allows the use of vending machines or self-service displays if the machine or display is located in a facility where the retailer can ensure no persons under the age of 18 would be permitted to enter (i.e., adult-only facilities).
-Require publication, within 1 year of the effective date of the Deeming Regulation, a regulation that would require e-vapor products to be labeled with the phrases “Keep Out of Reach of Children,” and “Underage Sale Prohibited,” as well as feature an accurate statement of the nicotine content of the product.
-Requires retailers (e.g., vape shops) to register their establishment with FDA unless such retailer has already registered under any state or federal law.

What Next?
While it is certainly good news for the e-vapor industry, the Cole-Bishop amendment still has a long way to go before it becomes law. Both the House and the Senate will eventually have to vote on and pass the Agricultural Appropriations bill (with the amendment), which must ultimately be signed by the President. In addition, it is not yet clear when the bill will advance through Congress and make its way to the President, as recent budget bills have been passed in the final days of the previous fiscal year. It is very possible, if not probable, that the Deeming Regulation will be published before the Agricultural Appropriations bill becomes law, likely leading to additional showdowns between anti-tobacco and vaping advocates over the public health and economic impact of FDA’s rule, and the need to change the grandfather date for deemed products.

If you have any questions about the forthcoming Deeming Regulation and the premarket authorization requirements for new products, please contact us. For more information about our Tobacco and E-Vapor practice, click here.