Search results for: warning

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • On November 21, 2022, FDA posted warning letters that had been issued to 11-11-11 Brands, Naturally Infused LLC, Newhere Inc dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC for illegally selling CBD-containing products. Collectively, the warning letters raised several legal objections to the sale of CBD in human and animal food and drugs, and dietary supplements, including the following:
    • The sale of a CBD-containing food or animal food renders that food or animal food adulterated because CBD has not been authorized for use by a food additive regulation, subject to a prior sanction, and does not satisfy the criteria for GRAS. On the contrary, FDA noted that the “available data raises serious concerns about potential harm from CBD added to conventional food,” including potential for livery injury, harmful interaction with certain drugs, and interference with sexual development, function, and behavior.
    • The sale of CBD in a human or animal product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body, and that has not been approved by FDA, is an unlawful introduction into interstate commerce of an unapproved new human drug or animal drug. The only CBD-containing drug approved by FDA is Epidiolex, which is approved to treat severe epilepsy.
    • It is unlawful to market any CBD-containing product as a conventional food or dietary supplement because CBD has been approved for use as a drug.
    • When a drug is used to treat a condition which is not amenable to self-diagnosis or treatment (e.g., sleep apnea), as was the case with many of the products at issue, that drug is misbranded if it does not include adequate directions for use. FDA-approved prescription drugs are exempt from this requirement, but none of the products at issue have been approved by FDA.
  • FDA was particularly concerned with some of the products at issue that appeal to children (e.g., candies, cookies, and gummies) as children may be at greater risk to adverse effects from consumption of CBD. Additionally, in the Naturally Infused LLC Warning Letter, FDA objected to the presence of Delta-8 THC, noting that its use in food renders that food adulterated because it is not authorized by a food additive regulation, the subject of a prior sanction, or GRAS. Indeed, FDA noted that the available data raises “serious concerns” about its use, including “potential for adverse effects on the central nervous and cardiopulmonary systems” and gestational neurodevelopment interference.
  • FDA has already issued a number of warning letters to companies using CBD in various products this year (see here and here) and the safety concerns raised by the Agency suggest that it will be a continuing enforcement priority. Keller and Heckman will continue to monitor and report on regulatory developments related to CBD.

Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

 

 

 

Recently, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted safe harbor warning regulations for cannabis smoke and delta-9-tetrahydrocannabinol (delta-9-THC) under California Proposition 65.[1]

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity.[2] Among other things, the law prohibits the knowing exposure of any individual to an amount of a listed chemical without first providing a “clear and reasonable warning” to such individual.[3] The law requires these warnings to be provided for Proposition 65 exposures from consumer products, the workplace, and the environment unless “the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question,” or, for a listed reproductive toxin, that the substance “will have no observable effect assuming exposure at 1,000 times the level in question.”[4] Other limited exemptions from the warning requirement also may apply under the law.

Safe Harbor Warning Regulations for Cannabis Smoke and Delta-9-THC

OEHHA initially added cannabis smoke and delta-9-THC to the Proposition 65 list for developmental toxicity in 2020, while cannabis smoke has been listed as a carcinogen since 2009. In late 2021, OEHHA initially proposed the safe harbor warning regulations for cannabis smoke and delta-9-THC. After two updated draft proposals, OEHHA adopted this final version.

The new regulations suggest specific safe harbor methods of transmission and warning language for retail products that can expose consumers to cannabis smoke or delta-9-THC via inhalation, ingestion, or dermal application, and for environmental exposures to cannabis smoke and delta-9-THC at businesses where smoking of cannabis or vaping or dabbing of delta-9-THC occurs.

As is the case with other safe harbor warnings set out in the regulations, the specific warning language is not mandatory. Thus, businesses may use another method or provide other language to satisfy the warning obligations under the law. However, those alternative warnings must satisfy the statutory “clear and reasonable” standard.

In OEHHA’s final statement of reasons for the regulations, the agency stated that “[t]he safe harbor warning content for these regulations identifies the chemical, route of exposure and provides specific information to consumers about the risks of using cannabis products including cancer and, while pregnant, the impact exposures can have on the unborn child.”[5]

The newly adopted rule took effect October 1, 2022, and includes both a one-year phase-in period and an unlimited sell-through provision for products manufactured and labeled with compliant warnings prior to October 1, 2023.

Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

[1] See Cal. Code Regs. tit. 27, §§ 25607.38-25607.47 (2022).

[2] See Cal. Health & Safety Code §§ 25249 et seq.

[3] Cal. Health & Safety Code § 25249.6

[4] Cal. Health & Safety Code § 25249.10(c).

[5] See The Safe Drinking Water and Toxics Enforcement Act of 1986 Proposition 65, Final Statement of Reasons (June 2022), https://oehha.ca.gov/media/downloads/crnr/fsorcannabisdelta9thc080822.pdf.

FDA Delta 8 Article - Continuum of Risk2

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • On May 4, 2022, FDA announced that it had issued warning letters to five companies selling products (including gummies, capsules, tinctures, lotions, vaping products, pet products, and hand sanitizers) labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC), as well as cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first time that FDA has issued warning letters for products labeled as containing delta-8 THC.
  • Delta-8 THC is an isomer of Delta-9 THC and is known to cause similar psychoactive and intoxicating effects. The warning letters follow reports of adverse events from consumers. The warning letters note the illegal marketing of delta-8 THC and CBD as unapproved treatments for medical conditions and therapeutic uses. The letters also cite to violations regarding drug misbranding, and the addition of delta-8 THC and CBD in foods.
  • The warning letters follow a consumer update from FDA in which the agency expressed its concerns regarding the potential health effects of delta-8 THC products. They also follow previous warning letters that were sent to CBD companies whose products claimed to cure, mitigate, treat or prevent various diseases.

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning lettersto ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids.  FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, is adulterated and misbranded, and may not be marketed without FDA authorization.
  • By way of background, the premarket tobacco product application (PMTA) process ensures that new tobacco products will undergo a scientific evaluation by FDA to ensure that such products are appropriate for the protection of the public health.  Certain new tobacco products (,ENDS on the market as of August 8, 2016, the effective date of FDA’s “Deeming Rule”) were required to complete and submit PMTAs by September 9, 2020 – a deadline established as a result of a federal district court order.  In compliance with that court’s order, FDA stated that companies that submitted applications by the deadline are allowed to continue selling those products for up to a year (i.e., until September 9, 2021), unless FDA rejects the PMTA filing, or uses its enforcement discretion to allow products sufficiently far along in the review process to remain on the market on a case-by-case basis. On January 19, 2021, four months after the submission deadline, FDA finalized its long-awaited “foundational rule” on PMTAs.
  • FDA also emphasizedthat it would continue to prioritize enforcement against companies that have not submitted a PMTA and that market ENDS, including e-cigarettes and products with a likelihood of youth use or initiation (g., cartridge or pod-based ENDS).
  • FDA requested that each company respond within 15 days of receiving the letter detailing how it will address FDA’s concerns, including the dates on which the company discontinued the sale and/or distribution of the tobacco products, and its plans for maintaining compliance.  FDA stated that the failure to address violations may result in a civil money penalty, seizure, and/or injunction.

To learn more about this and other FDA enforcement-related topics, be sure to register now for Keller and Heckman’s virtual E-Vapor and Tobacco Law Symposium on February 9-11, 2021.

 

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.

Warning_Icon

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.

Electronic cigarette and e-liquid (collectively “e-vapor”) manufacturers are increasingly the targets of California Proposition 65 enforcement actions brought by private plaintiffs.  Of the 168 private enforcement actions brought against e-vapor manufacturers, 150 of these have been filed since 2016.  We provide background on Proposition 65 below, followed by specifics regarding how the e-vapor industry has been targeted.

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. See Cal. Health & Safety Code §§ 25249 et seq.  Among other things, the law prohibits the knowing exposure of any individual to a significant amount of a listed chemical without first providing a “clear and reasonable warning” to such individual. Cal. Health & Safety Code § 25249.6. The law requires these warnings to be provided for consumer product, workplace, and environmental exposures unless “the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question,” or, for a listed reproductive toxin, that the substance “will have no observable effect assuming exposure at 1,000 times the level in question.” Cal. Health & Safety Code § 25249.10(c).

Proposition 65 Enforcement Against E-Vapor Products

The 60-day notices sent to e-vapor manufacturers have focused on four listed chemicals:  acetaldehyde (listed as a carcinogen), formaldehyde (listed as a carcinogen), nicotine (listed as a reproductive toxicant), and tobacco smoke (listed as a carcinogen).  We have identified approximately 150 60-day notices sent to e-vapor companies.  Almost all of these notices have been filed by the Center for Environmental Health (CEH).  CEH has either detected listed chemicals in the products by analytical testing (e.g., testing the e-liquid) or has alleged that the intended use of the product (e.g., the e-vapor device) will result in exposure to the listed chemical(s).

Out of the enforcement actions since 2015, there have been nearly 100 settlements that have amounted to approximately $3.9 million in combined fees and penalties.  The highest settlements amounted to $355,000, with the average settlement amount being in the range of $42,000.

E-Vapor manufacturers should be aware of their rights and responsibilities under Proposition 65, particularly in light of new warning requirements, which differ from the current Proposition 65 warnings in terms of presentation and content, that become mandatory on August 30, 2018 – around the same time the nicotine addiction warning required by the FDA’s Deeming Regulation goes into effect for e-vapor products.

If you are interested in obtaining additional guidance on this topic, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com). For more information on our Tobacco and E-Vapor Practice, visit www.khlaw.com/evapor. For more information on our Proposition 65 Practice, visit  www.khlaw.com/Proposition_65. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize and prevent additional risks associated with such products and apply to both domestic and foreign manufacturers of finished and bulk tobacco products.

A finished tobacco product is defined as a tobacco product, including any component or part, sealed in packaging, such as a pack of cigarettes, intended for consumers, while a bulk tobacco product is defined as a tobacco product that is not sealed in final packaging but is otherwise suitable for consumer use[3]. A tobacco product manufacturer is defined as any person(s), including a repacker or relabler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished or bulk tobacco product for sale or distribution in the United States[4]. Of note, under the proposed rule, small tobacco product manufacturers, defined as a manufacturer that employs fewer than 350 employees[5], would not need to comply with the TPMP requirements until four (4) years after the effective date of the final rule. FDA notes that this is consistent with Section 906(e)(1)(B)(v) of the Food, Drug and Cosmetic (FD&C) Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA), and would provide small businesses with sufficient time to implement the proposed requirements[6]. Moreover, manufacturers would only be required to comply with requirements applicable to its finished and bulk tobacco product manufacturing operations. Thus, smaller tobacco product manufacturers (such as vape shops that engage in some but not all of the activities described in the proposed rule) would be able to tailor their procedures to suit their smaller operations while still complying with the TPMP requirements[7].

With respect to vape shops in particular, the proposed rule clarifies that such establishments that only sell ENDS products and components and parts would not be considered manufacturers and would not be subject to the requirements in the proposed TPMP rule unless they also engage in the manufacture, preproduction design validation, packing, and storage of finished or bulk tobacco products within the meaning of the rule[8]. While vape shop owners will certainly appreciate the compliance extension, it is not clear how many vape shop e-liquid manufacturers will survive the next four years, given the nearly insurmountable PMTA process and FDA’s continued enforcement focus on these small U.S. businesses with de minimis market share.

In addition, while the proposed rule clearly states that TPMPs will apply to foreign manufacturers to ensure that imported tobacco products comply with the TCA and applicable tobacco product standards, it is important to note that the rule does not require foreign manufacturing establishments, including China-based manufacturers largely responsible for producing counterfeit and otherwise illegal disposable ENDS, to register their establishments with or provide a product list to FDA. Section 905(b) of the TCA made this a requirement for domestic manufacturing establishments, but left it up to FDA to extend to foreign manufacturing establishments through the rulemaking process[9]. In other words, FDA is not using the proposed TPMP rule to execute its authority provided by Congress under Section 905(h) of the TCA to promulgate a regulation to extend the registration and product listing requirement to foreign establishments. This also means that foreign manufacturers will not be subject to regular, biennial inspections required for domestic establishments, although the agency has broad authority and ability to inspect foreign manufacturers pursuant to Sections 704 and 905 of the FD&C Act, and as part of the Premarket Tobacco Product Application (PMTA) review process under 21 C.F.R. § 1114.27.  

Summary of Proposed Rule

The proposed rule, which is expected to be codified at 21 C.F.R. Part 1120, establishes a framework of requirements that tobacco product manufacturers to follow, including:

  • Establishing tobacco product design and development controls to prevent or minimize certain risks;
  • Ensuring that finished and bulk tobacco products are manufactured in conformance with established specifications;
  • Minimizing the likelihood of the manufacture and distribution of nonconforming tobacco products;
  • Requiring investigation and identification of nonconforming tobacco products, including those that have been distributed, in order to institute appropriate corrective actions, such as conducting a recall as needed;
  • Taking appropriate measures to prevent contamination of tobacco products; and
  • Establishing traceability to account for all components or parts, ingredients, additives, and materials, as well as each batch of finished or bulk tobacco product, to aid in the investigation and identification of nonconforming tobacco products. 

Specifically, the proposed rule is divided into ten subparts, as follows:

1) Subpart A – General Provisions

Subpart A describes the purpose and scope of the proposed rule. As noted above, the proposed rule applies to both domestic and foreign manufacturers of finished and bulk tobacco products, requiring such manufacturers to adhere to the framework of requirements. 

2) Subpart B – Management System Requirements

Subpart B has three sections, as follows:

  • Organization and personnel, which requires establishing and maintaining an organizational structure with sufficient personnel and designated responsibilities, including management personnel with executive responsibility;
  • Tobacco product complaints, which requires establishing and maintaining procedures for handling the receipt, evaluation, and documentation of any complaints; and
  • Corrective and preventive actions (CAPA) are necessary to protect public health, which requires establishing and maintaining procedures for implementing such actions. 

3) Subpart C – Buildings, Facilities, and Equipment

Subpart C has four sections, as follows:

  • Personnel practices, which requires establishing and maintaining procedures related to personnel practices to reduce the risk of contamination with filth biological materials, chemical hazards, or other deleterious substances;
  • Buildings, facilities, and grounds, which requires ensuring that buildings and facilities are of suitable construction, design, and location to facilitate cleaning and sanitation, maintenance, and proper operation, as well as ensuring that grounds are maintained in a condition to prevent contamination;
  • Equipment, which provides requirements for the design, construction, and maintenance of equipment used in the manufacturing process, as well as requirements for testing, monitoring, and measuring such equipment; and
  • Environmental controls, which requires that systems be maintained and monitored to verify that environmental controls are adequate and functional. 

4) Subpart D – Design and Development Controls

Subpart D has two sections, as follows:

  • Design and development activities, which requires establishing and maintaining procedures to control the design and development of tobacco products, including the control of risks associated with the product, the manufacturing process, packaging, and storage, as well as procedures for design verification and validation, and requires developing a process for identifying, analyzing, and evaluating known and reasonably foreseeable risks associated with the tobacco product and its packaging and taking appropriate measures to reduce or eliminate risks; and
  • Master manufacturing record (MMR), which requires establishing and maintaining an MMR for each finished and bulk tobacco product manufactured for distribution, including tobacco product specifications, manufacturing methods and production process procedures, and all packaging, labeling, and labels approved for use with the product. 

5) Subpart E – Process Controls

Subpart E contains nine sections, as follows:

  • Purchasing controls, which requires establishing and maintaining procedures for ensuring that purchased or otherwise received products and services related to the manufacture of finished or bulk tobacco products are from qualified suppliers and conform to established specifications;
  • Acceptance activities, which requires establishing and maintaining procedures for incoming, in-process, and/or final acceptance activities, including acceptance criteria, to ensure that products meet established specifications;
  • Production processes and controls, which requires establishing and maintaining procedures for production processes, including process specifications and process controls, process validation, and manual methods and manufacturing material;
  • Laboratory controls, which requires demonstrating laboratory competency to perform laboratory activities associated with the manufacture of finished and bulk tobacco products and establishing and maintaining appropriate laboratory control procedures;
  • Production records, which requires establishing and maintaining procedures for ensuring that a production record is prepared for each batch of finished or bulk tobacco product to demonstrate conformity with the requirements established under the MMR;
  • Sampling, which requires establishing and maintaining an adequate sampling plan that uses representative samples based on a valid scientific rationale;
  • Nonconforming tobacco products, which requires establishing and maintaining procedures for the control and disposition of nonconforming tobacco products, including specific requirements for identification and segregation, investigation, and disposition and follow-up
  • Returned tobacco products, which requires establishing and maintaining procedures for the control and disposition of returned tobacco products, including specific requirements for identification, segregation, evaluation, and disposition; and
  • Reprocessing and rework, which provides specific requirements for the evaluation of the tobacco product to determine that it is appropriate for reprocessing or rework, authorization of the reprocessing or rework, and production processes, including process controls, to ensure that reprocessed and reworked tobacco product conforms to MMR specifications. 

6) Subpart F – Packaging and Labeling Controls

Subpart F contains four sections, as follows:

  • Packaging and labeling controls, which requires establishing and maintaining procedures for ensuring that the correct packaging and labeling are used to prevent mix-ups, ensuring that all packaging and labeling are approved for use by the manufacturer and comply with all requirements of the MMR as well as other applicable requirements promulgated by FDA, ensuring that packaging and labeling control procedures to ensure that labels are indelibly printed on or permanently affixed to finished and bulk tobacco product packages, and ensuring that the packaging, labeling, storage, and shipping cases do not contaminate or otherwise render the tobacco product adulterated or misbranded;
  • Repackaging and relabeling, which requires establishing and maintaining procedures for repackaging and relabeling operations;
  • Manufacturing code, which requires applying a manufacturing code that contains the manufacturing date and batch number to the packaging or label of all finished and bulk tobacco products; and
  • Warning plans, which requires establishing and maintaining procedures for implementing the requirements of such plans. 

7) Subpart G – Handling, Storage, and Distribution

Subpart G contains two sections, as follows:

  • Handling and storage, which requires establishing and maintaining procedures to ensure that tobacco products are handled and stored under appropriate conditions to prevent nonconforming products as well as mix-ups, deterioration, contamination, adulteration, and misbranding of tobacco products; and
  • Distribution, which requires establishing and maintaining procedures to ensure that tobacco products are distributed to the initial consignee under appropriate conditions and that only those finished and bulk tobacco products approved for release are distributed. 

8) Subpart H – Recordkeeping and Document Controls

Subpart H requires that all documents and records be maintained at the manufacturing establishment or another location that is readily accessible to responsible individuals of the manufacturer and to FDA and that they be written in English, or an English translation be made available upon request. Additionally, documents and records associated with a batch of finished or bulk tobacco product must be retained for a period of at least four years from the date of distribution of the batch or until the product reaches its expiration date, if one exists, whichever is later, while documents and records that are not associated with a batch of finished or bulk tobacco product must be retained for a period of at least four years from the date they were last in effect. 

9) Subpart I – Small Tobacco Product Manufacturers

Subpart I provides that small tobacco product manufacturers, defined as tobacco product manufacturers that employ fewer than 350 employees, are not required to comply with the proposed rule until four years after the effective date of the Final Rule. 

10) Subpart J – Exemptions and Variances

Finally, Subpart J contains five sections that set forth procedures and requirements for petitioning for a permanent or temporary exemption or variance from any of the proposed requirements. 

Next Steps

The proposed rule is open to public comments for 180 days, until 11:59 PM (Eastern) on September 6, 2023. As part of the rulemaking process, FDA will review all comments received, conduct a comment analysis, and decide whether to (i) proceed with the proposed rule; (ii) issue a modified proposed rule based on the comments received; or (iii) withdraw the proposed rule. Depending on how many comments are received, we anticipate it will take FDA at least two years to finalize the TPMP rule.

FDA will host a public hearing on April 12, 2023, to gather comments from stakeholders, including industry, the scientific community, advocacy groups, and the public. FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18, 2023, to seek recommendations from FDA’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations.

[1] 88 Fed. Reg. 15174 (March 10, 2023), available at: https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice. 

[2] See United States Food and Drug Administration, “FDA Proposes New Requirements for Tobacco Product Manufacturing Practices” (March 8, 2023), available at: https://www.fda.gov/news-events/press-announcements/fda-proposes-new-requirements-tobacco-product-manufacturing-practices. 

[3] 88 Fed. Reg. 15174, 15253 (March 10, 2023). 

[4] Id. at 15174, 15254. 

[5] The proposed rule indicates that, for purposes of this definition, the number of employees of a manufacturer includes those employees and personnel of each entity that controls, is controlled by, or is under common control with such manufacturer. Id. 

[6] Id. at 15174, 15237. 

[7] Id. at 15174, 15186. 

[8] Id.

[9] See United States Food and Drug Administration, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments: Guidance for Industry” (December 2017), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registration-and-product-listing-owners-and-operators-domestic-tobacco-product-establishments. 

On February 22, 2023, the U.S. Food and Drug Administration (FDA) announced the filing of civil money penalty (CMP) complaints against four domestic e-liquid manufacturers, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system electronic nicotine delivery systems (ENDS) devices.[1] The four named companies are:

In response to the complaints, the companies must now either pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing by an Administrative Law Judge.[2] The companies risk a default order imposing the full penalty amount—statutorily set at $19,192 for a single violation relating to tobacco products—if no action is taken within 30 days of receiving the complaint.[3]

FDA’s press release also stated that this is “the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the [Federal Food, Drug, and Cosmetic Act (FFDCA)] premarket review requirements for new tobacco products.”[4] It should be noted that this is not the first groundbreaking action FDA has taken against small vape shops within the last year. As reported on this blog on October 25, 2022, FDA filed permanent injunctions against six small vape shops for alleged premarket review violations.[5] FDA had noted at the time that “these cases represent the first time FDA has initiated injunction proceedings to enforce the [Federal Food, Drug, and Cosmetic Act (FFDCA)] premarket review requirements for new tobacco products.”[6]

In the CMP complaints, FDA alleges that it previously warned each of the companies between late 2021 and early 2022 that they were in violation of the premarket review requirements set forth in the FFDCA and that follow-up inspections confirmed that the companies were continuing to manufacture and sell unauthorized e-liquid products.[7] Both BAM Group and Great American Vapes had previously submitted Premarket Tobacco Product Applications (PMTAs). However, FDA issued marketing denial orders to both companies, presumably for their non-tobacco flavored e-liquids in September 2021.[8] The Vapor Corner Inc. and 13 Vapor Co. LLC allegedly did not submit PMTAs. FDA has previously indicated that it is prioritizing enforcement against companies that have either not submitted PMTAs, whose PMTAs have been refused acceptance or filing by FDA, or whose PMTAs are subject to marketing denial orders.[9]  

FDA’s Center for Tobacco Products (CTP) Office of Compliance and Enforcement (OCE) has broad responsibility to (1) develop and provide compliance training and education; (2) monitor regulated industry’s compliance via surveillance, inspections, and investigations; and (3) initiate advisory and enforcement actions. With regards to the scope of permitted enforcement actions, CTP has the power to issue warnings, civil money penalties, no-tobacco-sale orders, seizures, and injunctions and to initiate criminal prosecution. Between January 2021 through February 17, 2023, FDA has issued more than 550 warning letters to firms, mostly small U.S. businesses, for manufacturing, selling, and/or distributing new tobacco products without FDA marketing authorization.

[1] See FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers.

[2] See 21 C.F.R. Part 17 (setting forth the practices and procedures for hearings concerning the administrative imposition of civil money penalties by FDA).

[3] This maximum amount for this civil monetary penalty was most recently adjusted for inflation in March 2022. See 87 Fed. Reg. 15,103 (March 17, 2022). The maximum total CMP for all violations adjudicated in a single proceeding is $1,279,448. 

[4] See FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers.

[5] See FDA Files Permanent Injunctions Against Six Small Vape Shops for Alleged Premarket Review Violations, available at: https://www.thecontinuumofrisk.com/2022/10/fda-files-permanent-injunctions-against-six-small-vape-shops-for-alleged-premarket-review-violations/.

[6] See FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers?utm_medium=email&utm_source=govdelivery.

[7] See Complaint at 4-5, Center for Tobacco Products v. 13 Vapor Co., LLC (2023) (FDA Docket No. FDA-2023-U-0484); Complaint at 4-5, Center for Tobacco Products v. BAM Group, LLC (2023) (FDA Docket No. FDA-2023-U-0481); Complaint at 4-5, Center for Tobacco Products v. Great American Vapes LLC (2023) (FDA Docket No. FDA-2023-U-0483); Complaint at 4-5, Center for Tobacco Products v. Vapor Corner, Inc. (2023) (FDA Docket No. FDA-2023-U-0486).

[8] FDA keeps an updated listing of all companies that have received Marketing Denial Orders on its website. See Marketing Denial Orders, Food & Drug Admin. https://www.fda.gov/media/165602/download (last visited February 23, 2022).

[9] See https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products (“As the FDA has stated in the past, unauthorized electronic nicotine delivery system (ENDS) products for which no application is pending, including for example, those with an MDO, are among our highest enforcement priorities.”)

To be placed on the European Union market, tobacco and related products must comply with specific requirements and procedures, harmonized at the European level by Directive 2014/40/EU concerning the manufacture, presentation, and sale of tobacco and related products (hereinafter the “Tobacco Products Directive” or the “Directive”). This article provides a general overview of the requirements and procedures necessary to comply with the Tobacco Products Directive. This is the first of a series of articles that we will publish on marketing tobacco and related products in the EU. Future articles will address specific insights on (i) ingredients requirements and flavor bans, (ii) notification and reporting obligations under the Directive, (iii) labeling and packaging of tobacco products, and (iv) implementation of the Directive by the European Member States.

I. Scope of the Directive: Heated Tobacco Products Now Included

The Directive applies to electronic cigarettes, herbal products for smoking, and tobacco products. Under the Directive, “tobacco products” include pipe tobacco, roll-your-own tobacco, smokeless tobacco, cigarettes, cigars, cigarillos, waterpipe tobacco, and novel tobacco products. ‘Novel tobacco products’ is a new and open category introduced by the Directive, which encompasses all tobacco products not falling under the one previously mentioned and that are placed on the market after May 19, 2014. Following the Commission Delegated Directive (EU) 2022/2100, which became effective on November 23, 2022, novel tobacco products include ‘Heated Tobacco Products,’ which are defined as a product  “that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by user(s), and that, depending on its characteristics, is a smokeless tobacco product or a tobacco product for smoking.”

II. Notification and Reporting Obligations

Under the Tobacco Products Directive, prior to placing a product on the market, manufacturers and importers of tobacco products and e-cigarettes must submit to the Member State authorities specific information containing details on (i) ingredients, accompanied by relevant toxicological data, (ii) emissions resulting from the use of the products, (iii) studies and market research on smokers, ingredients and emissions, and (iv) on a yearly basis, information on the sales volumes of the products. Enhanced reporting obligations apply to cigarettes and roll-your-own tobacco products only if they contain additives on a priority list[1]. For electronic cigarettes, additional information includes components of the product, a description of the production process, and the nicotine doses and the nicotine uptake (i.e., the body absorption). The above information must be submitted through an electronic entry gate, common for all Member States of the European Union (also known as “the EU Common Entry Gate”).

III. Product Requirements

Emission levels and ingredients

The Tobacco Products Directive sets forth requirements on maximum emission levels, measurement methods, and standards (the latter for cigarettes only) and prohibits the use of ingredients that (i) are listed in the Directive,[2] (ii) have carcinogenic, mutagenic, or reprotoxic (CMR) properties, or (iii) pose a risk to human health (for tobacco products and electronic cigarettes). The use of flavorings is banned in cigarettes and roll-your-own tobacco. Importantly, the flavor ban will apply (as of October 23, 2023) to heated tobacco products as well, pursuant to recent Directive (EU) 2022/2100. Further to the above, the Directive also provides specific product requirements for electronic cigarettes, such as maximum nicotine levels (20 mg/mL), volume requirements for refill containers and cartridges, and mechanical requirements for electronic cigarettes and refill containers.

Labeling and packaging

The Directive also regulates certain aspects of the labeling, packaging, and presentation of tobacco products, electronic cigarettes, and herbal products for smoking. For each of these product categories, the mandatory health warnings required to be placed on the product packaging are provided in the Directive.

Traceability requirements

For tobacco products only, the Directive sets out a traceability system in order to address the issue of illicit trade[3]. Under the traceability system, (i) all unit packets of tobacco products must be marked with a unique identifier and a tamper-proof security feature enabling authorities and consumers to verify their authenticity, and (ii) economic operators in the supply chain must maintain records of the traceability of the products and transmit the related information to an independent provider of a repository, approved by the EU Commission, that stores therein the data transmitted. The competent authorities of the Member States and the Commission have access to the data stored in the repositories to ensure compliance with the tobacco products legislation.

Cross-border distance sales of tobacco products

Specific requirements (i.e., registration and verification obligations) apply to cross-border distance sales of tobacco products and electronic cigarettes. Cross-border distance sales may also be prohibited by Member States[4]. 

IV. Implementation of the Directive by the EU Member States

In general, EU Directives only set forth the objectives that all EU countries must achieve. However, it is up to the individual Member States to devise their own laws on how to achieve the objectives within the Directive. It follows that (i) Directives need to be implemented in each EU Member State to be enforceable and that (ii) the Directives may be, in practice, implemented differently in each Member State[5]. In this regard, we note that pursuant to the Tobacco Products Directive:

  • Member States may maintain or introduce further requirements in relation to the standardization of the packaging of tobacco products when justified on the grounds of public health;
  • Member States may also prohibit a certain category of tobacco or related products, provided again, the provisions are justified by the need to protect public health

V. Revision of the Tobacco Products Directive

The European Commission is currently reviewing the Tobacco Products Directive, aiming to address issues such as further enforcement of the current regime for cross-border distance sales, emerging novel tobacco products, regulatory challenges posed by heated tobacco products and electronic cigarettes, new herbal products entering the market, and options to increase tobacco manufacturers’ liability[6].  According to the European Commission’s Implementation Roadmap[7] of Europe’s Beating Cancer Plan, the Commission is expected to adopt a proposal for the revision of the Tobacco Products Directive in 2024.

VI. Conclusion

In summary, the Tobacco Products Directive establishes numerous and detailed provisions that manufacturers must take into consideration when placing electronic cigarettes and tobacco products on the European Union market. Given the numerous requirements, differences in Member State implementation of the Directive, upcoming flavor bans, and anticipated revisions to the Directive, companies must take a careful approach and monitor developments closely to ensure compliance and avoid enforcement.  

We will be covering EU regulation of tobacco products in detail at Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

[1] Decision (EU) 2016/787 laying down a priority list of additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations. This is a list containing the most commonly used additives, for which there are indications that they:  a) contribute to/increase the toxicity or addictiveness of the products, or b) result in a characterizing flavor, or c) facilitate inhalation or nicotine uptake, or d) leads to the formation/increase of CMR substances/their quantities.

[2] The list is provided by Article 7.6 of the Tobacco Products Directive.

[3] See Par. 5 (Traceability and security features) of the Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products of May 20, 2021 (the “2021 Commission Report”).

[4] According to the 2021 Commission Report, more than half of the Member States banned cross-border distance sales of tobacco and/or related products to consumers in their countries (Par. 6 Cross-border distance sales).

[5] We note that aspects not harmonized by the Directive may be regulated autonomously by the Member States. For example, the Directive (recital 47) mentions that it does not harmonize all aspects of electronic cigarettes or refill containers and that the responsibility for adopting rules on flavors remains with the Member States.

[6] See the 2021 Commission Report.

[7] Europe’s Beating Cancer Plan: Implementation Roadmap was published in November 2021 and is available here: https://health.ec.europa.eu/latest-updates/europes-beating-cancer-plan-implementation-roadmap-2021-11-17_en.