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Benjamin Wolf practices in the area of food and drug law. Mr. Wolf provides state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers. His practice also includes providing advice to food, dietary supplement, medical device, consumer product, and pharmaceutical clients regarding compliance with domestic and foreign regulations.

Prior to joining Keller and Heckman, Mr. Wolf worked for the Food and Drug Administration (FDA) as a regulatory counsel in the Center for Tobacco Products (CTP) and Office of Regulatory Affairs (ORA). In his role as a regulatory counsel, Mr. Wolf worked closely with CTP, ORA, the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) to develop and implement policies including tobacco compliance and enforcement, tobacco premarket review, medical device compliance and enforcement, device premarket, and device and combination products good manufacturing practice. This work touched upon areas including tobacco substantial equivalence (SE), premarket tobacco product applications (PMTAs), modified risk tobacco product applications (MRTPAs), investigational tobacco product applications (ITPAs), data integrity, medical device quality metrics, utilization of benefit and risk factors in determining appropriate FDA engagement for devices being marketed, laboratory developed tests (LDTs), and good manufacturing practice (GMPs) for medical devices and combination products.

Also while at the FDA, Mr. Wolf served as a reviewer of certain tobacco premarket applications and submissions; responded to Congressional, Government Accountability Office (GAO) and Office of Inspector General (OIG) inquiries; and trained in bioresearch monitoring for field investigators.

Mr. Wolf’s practice is benefited by his extensive background as a research and development engineer at a medical device company in Boston, Massachusetts. In that role, he gained experience in GMP compliance, preparing regulatory submissions and addressing FDA questions. He has executed numerous bench and animal studies to support regulatory filings.

Prior to law school Mr. Wolf completed graduate-level coursework in Aerospace and Mechanical Engineering at Boston University. While at George Washington University Law School, Mr. Wolf worked as a student attorney assisting clients with proceedings in the Vaccine Injury Compensation Program (VICP). His Student Note, written while serving as a member of the Federal Circuit Bar Journal (FCBJ) and regarding the VICP, was selected for publication as the best Student Note written for the FCBJ during the 2011-2012 academic year. Mr. Wolf was the recipient of the Henry R. Berger Award, awarded to one graduate annually for excellence in tort law.

On Tuesday October 2, at 2PM EST, Azim Chowdhury and Ben Wolf will present a webinar, “Ingredients Listing: Walk Through” sponsored by the Smoke-Free Alternatives Trade Association (SFATA). Ingredient listing reports for small-scale tobacco product manufacturers are due by November 8, 2018. This program is recommended for manufacturers of deemed tobacco products, including e-liquids, their management, and staff who are responsible for regulatory compliance. Participants will learn how to prepare and submit ingredient listing reports to FDA. The floor will also open for questions regarding FDA compliance. For more information and to register, click here.

 

In a widely anticipated move, FDA has significantly increased the frequency of inspections of vapor manufacturing and retail facilities over the past few weeks, with some inspections spanning two days. We have received reports from vapor businesses across the country that they are receiving unannounced visits from FDA investigators conducting biannual inspections pursuant to Sections 704 and 905 of the Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. Under the Act, FDA is required to inspect every tobacco manufacturing facility at least once every two years. FDA uses a broad definition of manufacturing – repacking and relabeling are considered manufacturing acts and retailers that mix e-liquids for consumer sale are considered manufacturers.

During the course of their inspection, FDA investigators have requested product samples, labeling and invoices for raw materials, and labeling and invoices for finished goods. We understand that inspections have included both production (cleanroom) and non-production areas and have made use of photography and recordings. FDA appears also to be doing a lot of “fact finding” – learning as much as they can about the industry and how these products are manufactured and distributed, potentially for use in the development of future guidance documents and rulemakings.

We have also received reports of inspectors visiting vapor businesses from other agencies, including the Federal Aviation Administration (FAA), federal and state Environmental Protection Agencies (EPA), as well as state inspectors (e.g., California Department of Tax and Fee Administration).

As FDA continues to visit facilities across the country, it is critical that manufacturers, including retailer-manufacturers, understand the types of information that they are required to provide to the Agency upon request, as well as the type of that information that can or should be withheld. Similarly, Companies should understand the scope of authority that an FDA Investigator has in asking for specific product details. Vapor product manufacturers should fully prepare for their impending inspection now, so that they can demonstrate a high-degree of confidence when FDA arrives. Critically, and as third-party consultants begin to enter the Good Manufacturing Practice (GMP) space, manufacturers and retailer-manufacturers should ensure that the guidance they receive from outside counsel is accurate and based on experience in sound science and law and is protected from disclosure to FDA by attorney-client privilege.

Audit and Inspection Program Completes Coast-to-Coast Site Visits in First Half of 2018

Keller and Heckman’s Audit and Inspection Program (AIP) provides companies that are involved in any aspect of the tobacco or vapor product supply chain with assurance that their facilities are operating in accordance with FDA requirements. AIP Program attorneys have completed audits from Florida to California since the Program first began in early 2018, and feedback has been overwhelmingly positive:

Having your team run a thorough inspection was extremely helpful in preparing us for a “real” FDA inspection. The knowledge and insight you guys were able to provide my “Team Awesome” will certainly help us navigate through the regulations and future inspections. During this interesting time for the industry, and as a responsible manufacturer, we must do everything possible to ensure we are going above and beyond what potential GMP’s may be down the road to keep consumers and the industry’s reputation safe.

As “cool” as some people think it is to be a manufacturer in the vape industry, it’s not to be taken lightly. We try to do everything possible to provide our consumers and retailers with top quality products that are manufactured in a clean and safe environment. Having your team come in to review our facility and manufacturing practices gives us confidence that we are doing exactly what we have set out to accomplish!

The AIP Program includes both audit and training components from attorneys experienced in tobacco and vapor law, inspections, and good manufacturing practices, and addresses a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Audits by the AIP Program staff are covered by attorney-client privilege and attorney work-product privilege.

Pre-registration for the AIP is available immediately by filling out the form available here:

Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form

The completed pre-registration form can be E-mailed to chowdhury@khlaw.com, faxed to (202) 434-4646, or mailed to:

Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001

Space is limited, and scheduling is generally available on a first-come, first-serve basis.

Today, August 10, 2018, is the compliance date for the health warnings contained in the FDA’s Deeming Rule and codified in 21 C.F.R. Part 1143.  In particular, as of today, roll-your-own (RYO) tobacco, cigarette tobacco, or covered tobacco products (except cigars and pipe tobacco) such as e-liquids that contain tobacco-derived nicotine manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States must bear the required warning statement (i.e., “WARNING: This product contains nicotine.  Nicotine is an addictive chemical.”) on the package label, per 21 C.F.R. § 1143.3(a)(1).  This warning statement requirement also applies to advertising (including websites and social media) for RYO tobacco, cigarette tobacco, and covered tobacco products (except cigars and pipe tobacco).

The warning statement must also comply with certain requirements, with respect to font, text, size, placement, and formatting of the warning statement on the package labels.  Indeed, the regulation requires that the required warning statement “appear directly on the package” and “be clearly visible underneath any cellophane or other clear wrapping as follows”:

  • Be located in a conspicuous and prominent place on the two “principal display panels” of the package;
  • Comprise at least 30 percent of each of the principal display panels;
  • Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
  • Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
  • Be capitalized and punctuated as indicated in 21 CFR § 1143.3(a)(1); and
  • Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.[1]

For covered tobacco products (other than cigars), cigarette tobacco products, and RYO tobacco products that are too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statement, the required warning statement must appear on one of the following: carton, outer container, wrapper, or tag firmly and permanently affixed to the tobacco product package.

Compliance Policy and Safe Harbor for Retailers

FDA created a compliance policy for the 21 C.F.R. § 1143.3 nicotine addiction warning in its Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, which provides (on page 5):

 

The Deeming Rule also contains a retailer safe harbor, which provides that a retailer of cigarette tobacco, RYO tobacco, or covered tobacco products (other than cigars) will not be in violation of 21 C.F.R. § 1143.3 for packaging that: (i) contains a health warning; (ii) is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) is not altered by the retailer in a material way.[2]

If you have questions about the compliance policy or the retailer safe harbor, please let us know.

Alternative Required Warning Statement for Zero Nicotine Products

For products that do not contain nicotine, but that are made or derived from tobacco, a tobacco product manufacturer is permitted to display an alternative statement (i.e., “This product is made from tobacco”) on all packages and advertisements in accordance with the requirements of 21 C.F.R. § 1143.3.  An example of such a product would be a zero-nicotine e-liquid that contains tobacco-derived flavors or extracts.  To be permitted to make such a statement, manufacturers are required to submit a confirmation statement to FDA certifying to be true that the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion.[3] If you would like to submit such a self-certification to FDA, let us know.

A zero-nicotine e-liquid that does not contain any other tobacco-derived ingredients is not a covered tobacco product subject to either the nicotine addiction warning or alternative statement.

Effect of Injunction in Cigar Association of America v. FDA

Importantly, due to a recent decision by the United States District Court for the District of Columbia, the warnings set forth in 21 C.F.R. §§ 1143.3 and 1143.5 are not applicable to cigars and pipe tobacco until 60 days after final disposition of the plaintiffs’ appeal of the courts’ order on the health warning requirements.[4]   FDA has stated that the Agency intends to comply with the court’s order in Cigar Association of America.[5]  Further, FDA explained that the Agency does not intend to enforce the labeling requirements under sections 903(a)(2) (i.e., requirement that label contain the name and place of business of the tobacco product manufacturer, packer, or distributor; an accurate statement of the quantity of contents in terms of weight, measure, or numerical count; and an accurate statement of the percentage of domestically grown vs. foreign grown tobacco) and 920(a)(1) (i.e., requirement to bear “Sale only allowed in the United States” statement) for cigars and pipe tobacco while the injunction is in effect so that firms are able to make required label changes at one time.[6]

Notably, the court’s order does not enjoin FDA from enforcing the health warning requirements for other product categories, including electronic nicotine delivery systems (ENDS) products, hookah tobacco, and cigarette tobacco and RYO tobacco.

Other Labeling Requirements

The Deeming Rule also imposed additional labeling requirements on newly deemed products. For example, tobacco products deemed under the Deeming Rule to be subject to FDA’s authority, if in package form, are required to bear a label containing:

  • the name and place of business of the tobacco product manufacturer, packer, or distributor;
  • an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and
  • the statement “Sale only allowed in the United States” on labels, packaging, and shipping containers pursuant to Section 920(a) of the Federal Food, Drug, and Cosmetic Act (FDCA).

In addition, pursuant to Section 903(a)(2)(C) of the FDCA, a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of foreign and domestic grown tobacco used in the product.  However, in a draft guidance document entitled, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops,” FDA stated that, at this time, it does not intend to enforce this requirement for products made or derived from tobacco, such as tobacco-derived liquid nicotine and e-liquid made or derived from tobacco.[7]  FDA explained that it provided this compliance policy “because it recognizes the current difficulty, in many circumstances, qualifying the percentage of foreign and domestic grown tobacco used in these products.”[8]

If you have any questions about warning requirements for product labels and advertisements or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury, Partner (202) 434.4230, (chowdhury@khlaw.com).  For more information on our Tobacco and E-Vapor Practice in general, visit www.khlaw.com/evapor. You can also follow Azim Chowdhury on Twitter for updates.

[1] 21 C.F.R. § 1143.3(a)(2).

[2] 21 C.F.R. § 1143.3(a)(3).

[3] 21 C.F.R. § 1143.3(c).

[4] See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. July 5, 2018).

[5] See FDA, “Covered” Tobacco products and Roll-Your-Own Cigarette Tobacco Labeling and Warning Statement Requirements, https://www.fda.gov/TobaccoProducts/Labeling/Labeling/ucm524470.htm?utm_source=CTPTwitter&utm_medium=social&utm_campaign=ctp-warninglabel.

[6] See Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28974, 29006 (noting that the compliance date for the 903(a)(2) and 920(a)91) requirements is intended to match the date for health warnings).

[7] FDA, Draft Guidance for Industry: Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops (Jan. 2017), https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM536997.pdf .

[8] Id., at 5-6.

 

 

Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along with copies of all labeling (see our full summary of the registration requirement here).  This registration must be renewed annually before midnight on December 31 (Eastern time) every year, and product lists must be updated bi-annually: by midnight June 30 and December 31 every year.

This means that operators of manufacturing establishments of newly deemed products (e.g., vapor, cigars, hookah, etc.) on the market as of August 8, 2016 that have made changes to their product offerings must update their product lists with FDA by tomorrow, June 30, 2018, or as soon as possible to avoid FDA enforcement (considering the likelihood that FURLS may crash, the sooner you start this process, the better). Specific examples of changes that need to be updated (in FURLS, if you used that system to register online) include (1) discontinuing products on your product list that you are no longer actively manufacturing, (2) adding new products that are now being manufactured (e.g., co-packers now manufacturing pre-August 8, 2016 products that were not on the co-packers’ initial product list), (3) adding a new manufacturing location for products already listed by another establishment, or (4) labeling changes (including rebranding) of existing products.

Note that if you are planning to update your labels to comply with FDA’s nicotine addiction warning and other labeling requirements (that go into effect on August 10, 2018) after June 30, you have until December 31, 2018 to update your product listing with the revised labels.

If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, 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 May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products such as juice boxes, candies, and cookies.  Warning letters were issued to manufacturers, distributors, and retailers of eight products.

All of the warning letters included allegations of misbranding under Sections 903(a)(1) and 903(a)(7) of the Food, Drug, and Cosmetic Act (FDCA) – both of which relate to labeling or advertising that is misleading or untrue in any particular – and Section 5 of the FTC Act for unfair or deceptive advertising.  Both the FDA and FTC alleged violations are based on the risk of confusion, especially by children, between the e-liquid products and foods that are marketed toward, or appealing to, children.

In some of the warning letters issued to distributors and retailers, FDA added allegations that the e-liquids were sold to minors in violation of Section 903(a)(7)(B) of the FDCA.  In one instance, FDA alleged that the company violated Section 201(rr)(4) of the FDCA – which bars the marketing of a tobacco product “in combination with any other article or product regulated” by FDA – because a combination pack of candy and e-liquid were offered together.  The warning letters also highlighted the potential harm that could result if nicotine-containing e-liquids are ingested by children, although the number of poison center calls regarding e-liquids has fallen dramatically since the Children’s Nicotine Poisoning Prevention Act went into effect in 2016.  That law requires “liquid nicotine containers” use child-resistant packaging just like prescription drugs, some over-the-counter (OTC) drugs, and other potentially hazardous products found in the home, pursuant to the Poison Packaging Prevention Act.

The issuance of the 13 warning letters comes about a week after FDA Commissioner Gottlieb announced that FDA (1) recently issued warning letters to 40 retailers for underage sales of JUUL products, (2) was in the midst of a “new blitz of retail establishments targeting youth sale violations”, (3) is seeking to end sale of JUUL products to minors, and (4) would examine the youth appeal of JUUL products.  FDA also requested JUUL Labs submit information regarding, among other things, its marketing, research studies, and how certain product features might appeal to different age groups.  While some have argued that the panic over JUUL, which appears to be based on anecdotal evidence and media reports, could actually adversely impact the public health, there is no doubt that FDA is committed to cracking down on underage sales and reducing youth appeal of tobacco products, including vapor products.

In light of the warning letters issued on April 24 and May 1 and the Agency’s interest in tobacco product flavors, it appears that FDA may be setting its sights on the elimination of flavored e-liquids, which have also been shown to help adult smokers transition to less harmful vaping alternatives, as part of its effort to curb the use of vapor products by youth. Of note, a recent study evaluating how young people use vapor products in the United Kingdom, where the products are actively promoted by the government as less harmful than cigarettes and as a way to quit smoking, found that most product experimentation does not turn into regular use, and that regular use of vapor products in young people who have never smoked remains very low.

Industry and other stakeholders interested in maintaining the availability in the U.S. of flavored e-liquids have until June 19, 2018 to submit comments to FDA’s Advanced Notice of Proposed Rulemaking.

The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1]  On April 13, 2018, just 25 days before the reporting deadline for large manufacturers of deemed tobacco products, FDA published a revised Guidance for Industry: Listing of Ingredients in Tobacco Products.  FDA now intends to enforce the ingredient listing requirement only with respect to those tobacco product components or parts that are made or derived from tobacco, or contain ingredients that are burned, aerosolized or ingested (i.e., consumed) during use.  Although the revised guidance is late – and comes after many companies have spent considerable time and funds to comply with the reporting requirement – it is welcome news for the industry.

The ingredient listing deadlines for the applicable components and parts of deemed finished tobacco products[2], however, have not changed – large manufacturers of such products still have only until May 8, 2018, while small-scale manufacturers[3] have until November 8, 2018.

Manufacturers of vapor devices and finished deemed tobacco product components and parts should keep in mind that FDA’s decision to exempt such products from ingredient listing does not change the fact that these products are still subject to FDA’s premarket authorization requirements.  It remains the case, for example, that any new vapor device intended for introduction into the U.S. market after August 8, 2016 requires Premarket Tobacco Product Application (PMTA) authorization (which requires ingredient information, along with a significant amount of additional data) before it can be marketed, and any devices on the market on August 8, 2016 have until August 8, 2022 before PMTAs are due, and can remain on the market after that date only if PMTAs for the products are accepted by FDA for review.

Components and Parts Subject to Ingredient Listing 

The revised guidance provides examples of “consumable” components and parts that still require ingredient listing including, but not limited to:

  • Cigar filler;
  • Cigar binder;
  • Cigar wrapper;
  • Pipe tobacco;
  • Waterpipe tobacco;
  • E-liquids;
  • Cigarette tobacco;
  • Cigarette paper;
  • Smokeless tobacco;
  • Roll-your-own (RYO) tobacco;
  • RYO rolling paper;
  • RYO tube; and
  • Cigarette filter that contains any ingredient that burns, aerosolizes, or is ingested during use (e.g., cigarette filter with menthol because the menthol will aerosolize during cigarette smoking).

Ingredients of tobacco product components and parts that are not made or derived from tobacco or consumed during use, e.g., pipes, hookah apparatus, vapor devices, etc., need not be submitted to FDA.  Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement at this time include, but are not limited to:

  • Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors;
  • System software;
  • Digital display, lights, and buttons to adjust settings;
  • Connection adapters;
  • Cartomizers;
  • Coils;
  • Wicks;
  • Tanks;
  • Mouthpieces;
  • Pipes;
  • Waterpipes;
  • Hoses;
  • Bowls;
  • Charcoal; and
  • Cigarette filter that does not contain any ingredient that is burned, aerosolized, or ingested during tobacco use.

Based on this, e-liquid manufacturers need only provide ingredient information on the liquid component of their products, not other non-consumable components such as bottles, drippers and packaging.  FDA expects to receive ingredient information for these non-consumable components and parts during its pre-market review of finished tobacco products (e.g., Premarket Tobacco Applications and Substantial Equivalence Reports).

Single Submissions for Multiple Products

With respect to consumable components and parts, the revised guidance also now makes clear that there are a number of situations where ingredients for multiple products may be listed together under a single submission, provided all of the different brands/subbrands and product sizes for the associated products in the submission are identified.  Examples of situations allowing a single ingredient listing for multiple products are provided in the guidance as follows:

  • Identical per weight composition of ingredients for tobacco products sold under multiple brands/subbrands:
    • Pipe tobacco with identical per weight composition of ingredients sold under 30 brands/subbrands;
    • E-liquids with identical per weight composition of ingredients sold under 200 brands/subbrands; and
    • Waterpipe (shisha) tobacco with identical per weight composition of ingredients sold under 15 brands/subbrands.
  • Identical per weight composition of ingredients for tobacco products sold in multiple product sizes:
    • E-liquid with identical per weight composition of ingredients sold in volumes of 30mL, 60mL, 90mL or sold in a range of product sizes (e.g., 20mL-100mL);
    • Pipe tobacco with identical per weight composition of ingredients sold in product sizes of 5g, 10g, 50g;
    • Waterpipe (shisha) tobacco with identical per weight composition of ingredients sold in product sizes of 100g, 200g, 500g; and
    • Pouched snus with identical per weight composition of ingredients sold in a can of 12 snus sachets or a can of 15 snus sachets.

For open-system e-liquids more specifically, the revised guidance indicates that manufacturers can satisfy the ingredient listing requirement by providing one listing that corresponds to multiple products if the manufacturer sells e-liquids that (1) are identical in chemical composition to one another or (2) are identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ.8 For example:

  • E-liquids with identical nicotine concentrations (e.g., 0.5 mg/ml nicotine) but varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and all other ingredients having identical per weight composition.
  • E-liquids with identical PG/VG ratio (e.g., 50/50) but different nicotine concentrations (e.g., 0.5, 1.0 1.5 mg/ml) and all other ingredients having identical per weight composition.
  • E-liquids with varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and different nicotine concentrations (e.g., 0.5, 1, 2 mg/mL) with all other ingredients having identical per weight composition.

However, changes to relative ratios of ingredients or to the quality or type of an ingredient will require separate submissions.  For e-liquids, the revised guidance provides several examples of when separate submissions to correspond to each brand/subbrand of a product are required:

  • E-liquids that have identical PG/VG chemical structure, but the nicotine chemical structure is different (e.g., moving from free nicotine to nicotine salt), even with identical per weight composition of all other ingredients.
  • E-liquids that have identical PG/VG chemical structure and identical nicotine chemical structure but where the per weight composition of all other ingredients is different in any way (e.g., increased amount of cherry flavor #1 added when all other ingredient ratios stay the same).
  • E-liquids where the grade of the PG/VG is different in any way (e.g., percent purity changes).

For more detailed background on the ingredient listing information needed and submission process, see here.

*          *          *          *

If you need assistance with ingredient listing or for more information regarding other regulatory obligations facing tobacco product manufacturers, distributors, importers, or retailers, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230.

 

_________________________________________________________

[1]           See e.g., comment to the FDA Ingredient Listing Guidance document submitted by Shenzhen E-Vapor Industry Association (SEVIA) in May 2017, available at https://www.regulations.gov/document?D=FDA-2009-D-0524-0034.

[2]              The term “finished tobacco product” means a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. Components and parts that are sold separately from other tobacco products are finished tobacco products if they are sold in final packaging intended for consumer use.

[3]           The term small-scale tobacco product manufacturer means 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. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.

Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product….”  Unlike the Registration and Product Listing requirement, which only applies to domestic U.S. manufacturing establishments, ingredient listing is required for all finished deemed tobacco products marketed in the United States, regardless of where the product was produced.[1]

Upcoming Deadlines

When the Deeming Rule became effective on August 8, 2016, FDA’s initial compliance policy required large deemed tobacco product manufacturers (i.e., manufacturers earning over $5M in annual revenues or who have over 150 full-time employees) to submit ingredient lists to FDA for all of their finished products by February 8, 2017; small-scale manufacturers had until August 8, 2017.  Over the course of 2017 these deadlines were extended several times for various reasons; now, large-scale manufacturers have until May 8, 2018 and small-scale manufacturers have until November 8, 2018.[2]  While it is always possible FDA could further push the deadlines back, we think it is unlikely to do so for ingredient listing.

Information Required

The ingredient listing process can be complicated and time consuming, particularly for manufacturers of e-liquids and vapor devices, for whom FDA has provided little specific guidance, and that may have hundreds of SKUs or more.  Broadly speaking, ingredient listing reports require the following:

  • Contact information for the manufacturer/submitter and U.S. agent;
  • A product list (similar to the product list U.S. manufacturers had to prepare for establishment registration);
  • For each product, a list of “components”;
  • For each component, a list of “ingredients” (e.g., single chemical substances and complex purchased ingredients); and
  • Specific information regarding each ingredient (e.g., quantity, ingredient number, SKU number, supplier information for complex purchased ingredients, etc.).

For more detailed background on the information needed to prepare ingredient listing reports, see our previous postings.

Submission Process

Although companies can submit ingredient listing reports manually to the CTP Document Control Center using the paper Form 3742, FDA encourages electronic submission through the CTP Portal.  This should not be confused with the separate FDA Unified Registration and Listing System (FURLS), which is only for U.S. Establishment Registration and Product Listing.  Obtaining CTP Portal access typically takes a few weeks, so you should apply for an account as soon as possible if you do not yet have one.

Only files that are packaged using FDA’s eSubmitter software can be submitted through the CTP Portal (download eSubmitter here). The eSubmitter tool does not transmit data over the Internet, but resides locally on your computer along with any output files, allowing you to work on a submission offline, save, and continue later.  Once a submission is complete, eSubmitter “packages” (i.e., compiles) the submission into a format that can be securely submitted through the CTP Portal.

Preparing Reports in eSubmitter

The eSubmitter tool contains templates for various FDA required submissions, including health documents and ingredient listing reports, among other things.

Of note, on March 5, 2018, FDA Center for Tobacco Products published a new set of instructions which provides a step-by-step guide on using eSubmitter to list ingredients in tobacco products.  At the same time, eSubmitter was updated to include two new options for preparing ingredient listing reports, which are discussed in the new instructions.

The first new option (“Option (c)”) allows for the use of a single spreadsheet to input ingredient information for all of a company’s products, rather than using multiple spreadsheets (Option (b)). The Option (c) spreadsheets come in both e-liquid specific (download here) and any tobacco templates (download here).

The second new option to attach your own spreadsheet (“Option (d)”) permits manufacturers to create and submit their own ingredient listing files in any format they wish.  While FDA requests that a spreadsheet be generated, eSubmitter will support the submission of a number of file types: .pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .sgml, .mol, .xls, .xlsx, .csv or .txt.

New eSubmitter Spreadsheets

The new Option (c) spreadsheets require all the same information as before, but has several unique differences compared to the original, multiple-spreadsheet method.  For example, now combinations of flavors and other additives can be saved as “master recipes” that can be added to any e-liquid formulations that contain it, along with levels of nicotine, PG and VG, making it easier to list ingredients for e-liquids that differ only in concentration of nicotine or other ingredients.  In addition, the Option (c) spreadsheets simplifiy the process of inputting component information, making it easier to, for example, “link” different bottle sizes to a formulation without re-inputting all the ingredient information. The new spreadsheet is also less cumbersome to complete and, so far, appears not to have as many bugs that often made importing the original tobacco ingredient spreadsheets into eSubmitter an onerous process (see our May 2017 webinar here which demonstrates how to use the original, multiple-spreadsheet method in eSubmitter).

E-liquid manufacturers should also keep in mind that the Option (c) e-liquid spreadsheet can only be used for the e-liquid component of a product; information regarding the other components of the finished product (e.g., bottle, cap/dripper, label, packaging, etc.) will need to be entered separately (either manually in eSubmitter or with a separate spreadsheet).

Manufacturers of vapor devices and hardware components, many of whom have argued that the current “ingredient” listing requirement and process does not make sense for such products[3], will also need to report ingredients to FDA either manually in eSubmitter, using the original multiple spreadsheet method, the Option (c) spreadsheet for products other than e-liquids, or by developing and submitting their own files as attachments using Option (d).

*          *          *          *

While the new eSubmitter spreadsheet options could make submitting ingredients to FDA easier for some manufacturers, the process still presents a significant time commitment.  Companies should not hesitate to start the process sooner rather than later.

If you need assistance with ingredient listing or for more information regarding other regulatory obligations facing deemed tobacco product manufacturers, distributors, importers, or retailers, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230.

 

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[1]              A finished tobacco product is defined in the Deeming Rule and FDA guidance as “a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. See FDA, Guidance for Industry (Revised)*: Listing of Tobacco Products, pg. 5 (Nov. 2017).

[2]           See FDA, Guidance for Industry (Revised)*: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Nov. 2017).

[3]           See e.g., comment to the FDA Ingredient Listing Guidance document submitted by Shenzhen E-Vapor Industry Association (SEVIA) in May 2017, available at https://www.regulations.gov/document?D=FDA-2009-D-0524-0034.

February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.

The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as amended by the Tobacco Control Act, which provides that FDA shall inspect each factory, warehouse, establishment, or vehicle in which tobacco products, including deemed tobacco products, are manufactured, processed, packed, or stored.  Pursuant to Sections 704 and 905 of the Act, FDA is directed to inspect every establishment at least once every two years.

Audit and Inspection Program

Keller and Heckman’s experienced team of attorneys and scientists will provide a comprehensive, on-site training and facility auditing program designed to help your company adequately prepare for an FDA inspection.  As part of the AIP, companies can expect:

  • An introductory presentation and memorandum detailing FDA’s inspection authority, what to expect during an inspection, and how to adequately prepare for – and respond to – an FDA inspection;
  • A full facility audit, consisting of a complete mock-inspection; and
  • A written post-inspection report detailing the overall readiness of the facility for an FDA inspection, including a list of specific recommendations and opportunities for improvement*

Keller and Heckman’s AIP program is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements.  The AIP will consider a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Supplemental Environmental and OSHA Compliance Components

In addition to FDA compliance, the AIP offers companies the option to include supplemental compliance training and auditing focusing on environmental and occupational health and safety regulations and requirements – efficiently leveraging the FDA mock inspection and full facility audit.

  • Environmental: The AIP program will offer companies the opportunity to add an additional training and compliance component focusing on federal and state environmental and waste management regulations. Specifically, nicotine-bearing products may be subject to regulation under the Federal Resource Conservation and Recovery Act (RCRA) when disposed.  State regulations governing dangerous or industrial wastes also could apply.  This component will provide an overview of how nicotine in tobacco-based products are regulated differently than when found in e-cigarettes and other vaping products, and will provide valuable information regarding companies’ obligations in responding to these additional requirements.  For more information on environmental requirements, see here.
  • Occupational Health and Safety: Participants in the AIP program will also have the opportunity to add an additional training and compliance component focusing on federal and state Occupational Safety and Health laws. OSHA recordkeeping requirements apply to all employers, except very small businesses.  Most other OSHA standards apply to all employers, regardless of size.  This component will provide companies with a review of existing policies and practices, and will recommend specific actions designed to bring companies into compliance with regulations in areas relevant to the industry, including: personal protective equipment, emergency plans, fire protection, and hazard communication (g., labeling and safety data sheets).

Pre-Registration

Pre-registration for the AIP is available immediately by filling out the form available here:

Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form

The completed pre-registration form can be E-mailed to chowdhury@khlaw.com, faxed to (202) 434-4646, or mailed to:

Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001

Upon receipt of your pre-registration form, Keller and Heckman will provide your company with a formal written proposal and cost-estimate to conduct on-site training and mock inspection at your facility.  Scheduling is generally available on a first-come, first-serve basis.

*The written post-inspection report is covered by any existing attorney-client relationship between Keller and Heckman and the Company, and is generally not subject to discovery.  The recommendations set forth in the post-inspection report are for informational purposes only, and do not constitute any warranties or guarantees regarding the outcome of an actual FDA, EPA or OSHA inspection.  Keller and Heckman’s attorneys remain available and look forward to the opportunity to assist with any post-inspection activities or questions following completion of the written report.

Just five days before the September 30, 2017 registration deadline for U.S. manufacturing establishments, on Tuesday, September 26, 2017, the Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, tweeted that due to “website connectivity problems” with the FDA Unified Registration and Listing System (FURLS), FDA would be “implementing a short term extension to allow firms to register”. On September 28, 2017, FDA officially announced via e-mail  that it was revising its guidance once again to extend the Registration and Product Listing deadline for U.S. manufacturing establishments to October 12, 2017. This applies to U.S. manufacturers of deemed products on the market as of August 8, 2016, but of course does not apply to foreign manufacturing establishments or U.S. importers, distributors or retailers not engaged in manufacturing, packaging or labeling activities.

FDA also indicated that if you continue to have technical issues with FURLS you should send an email to CTPRegistrationandListing@fda.hhs.gov with “IT Questions” in the subject line. In the body of the email provide:

  • Name of the Owner or Operator of the establishment;
  • Name and Address of the establishment;
  • Contact phone number; and
  • The best time for FDA to call the contact.
If IT issues prevent you from completing your registration and product listing by October 12, 2017 let FDA know as soon as possible so that they can work with you to address any technical problems.

FDA also recently issued a separate alert noting that establishments affected by Hurricanes Harvey or Irma may also be eligible for a separate extension, determined on a case-by-case basis. If you would like to be considered for such an extension, send an email with the information bulleted above to CTPRegistrationandListing@fda.hhs.gov and the subject line “Natural Disaster”. We also recommend providing a brief description of how the recent natural disasters have impacted your ability to register on time.

On September 15, 2017 FDA published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. Keller and Heckman’s analysis of this revised Guidance, including a summary of how to register and who must register can be found in our previous Client Alert.

If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, 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.

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 reportshealth 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/evaporFollow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.