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Report

March 12

Harmful and Potentially Harmful Constituents (HPHC) Testing - Reporting in the United States

BACKGROUND

Why do manufacturers of tobacco derived products (including e-cigarettes, hookahs, nicotine pods, etc.), whose products are on the U.S. market as of August 8, 2016, need to provide to the Food and Drug Administration (FDA) the results of Harmful and Potentially Harmful Constituents (HPHC) testing?

LEGAL REQUIREMENT

In 2009 the United States Congress passed an amendment to the Federal Food, Drug, and Cosmetic Act titled the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act” or “TCA”). Section 904(e) of the Federal Food, Drug, and Cosmetic Act, as amended by the TCA[1], required the FDA to establish, no later than April 2012, a list of all constituents identified by FDA as harmful or potentially harmful (“the HPHC list”) to health in each tobacco product. At the time, the TCA only contemplated cigarettes, smokeless tobacco and roll-you-own tobacco under the definition of tobacco products. The reporting obligations for those conventional tobacco products were detailed in an FDA Draft Guidance issued in March 2012, “Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act” found here:

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf

Are Electronic Nicotine Delivery Systems Considered Tobacco Products in the U.S.?

What is a tobacco product under U.S. law? As stated in section 201(rr) of the Federal Food, Drug, and Cosmetic Act, as amended by the TCA, a tobacco product “(1) Means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product) and (2) Does not mean an article that is a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination product described in section 503(g) of the Federal Food, Drug, and Cosmetic Act.”

In May 2016 FDA brought all tobacco-derived products, that are not medicinals, under the definition of “tobacco products” through rulemaking – “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”. Thus, electronic cigarettes, vaping liquids, hookahs and all other types of tobacco-derived nicotine containing products, that do not meet the legal definition of drugs, as of August 8, 2016 became subject to the provisions of the TCA, including the HPHC reporting requirements. FDA collectively refers to electronic nicotine delivery systems and the afferent liquids as “ENDS”.

Among the various compliance deadlines outlined by FDA, testing and reporting of HPHCs for finished ENDS products is mandatory. On March 8, 2019, FDA issued an updated chart of compliance within a guidance for industry document, indicating that the HPHC reporting deadline will be rescheduled from the original November 8, 2019, date to a date that is six (6)  months from the publication date of a final guidance regarding HPHC reporting under section 904(a)(3)18, or 9 (nine) months from the publication date of a final guidance regarding HPHC reporting under section 904(a)(3), for small tobacco product manufacturers. For products entering the market after the publication date of a final guidance regarding HPHC reporting, the HPHC reporting will be due 90 days prior to marketing, in addition to, and separate from, any premarket tobacco application requirements, which stem from a separate section of the TCA .

While the full list of HPHCs issued by the FDA in April 2012 contains 93 HPHCs, FDA’s May 2016 Guidance document on “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)” (“PMTA”) contemplates at this time only the following HPHCs in ENDS:

Acetaldehyde • Acetyl Propionyl (also known as 2,3-pentanedione) • Acrolein • Acrylonitrile • 4-Aminobiphenyl • 1-Aminonaphthalene • 2-Aminonaphthalene • Ammonia • Anabasine • Benzene • Benzo[a]pyrene • 1,3-Butadiene •Cadmium • Chromium • Crotonaldehyde • Diacetyl • Diethylene glycol • Ethylene glycol • Formaldehyde • Glycerol • Isoprene • Lead • Menthol • Nickel • Nicotine, including total nicotine and unprotonated nicotine • NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) • NNN (N-nitrosonornicotine) • Propylene glycol • Toluene

These constituents are constituents that, to FDA’s current thinking, potentially could cause health hazards depending on the level, absorption, or interaction with other constituents. FDA announced its intention to establish a revised list of harmful and potentially harmful constituents (HPHCs) that include HPHCs in ENDS products, to issue guidance regarding constituent reporting (i.e., harmful or potentially harmful constituent (HPHC) reporting) under section 904(a)(3) of the FD&C Act, and later issue a testing and reporting regulation as required by section 915. To date, FDA has not issued any additional guidance or regulation on HPHC testing and reporting for ENDS, however, this is expected in the coming months.

Also, while applicants must submit certain information about HPHCs as part of their PMTA applications, the requirement to submit HPHC listings under section 904 of the FD&C Act (21 U.S.C. 387d) is separate, additional and distinct from the premarket review requirements under section 910.  

FDA is likely to issue an HPHC guidance in the near future, as vape constituents are a matter of public health scrutiny and an important hallmark of a product’s quality and properties. Once the HPHC guidance is published, six months will likely be an insufficient period of time for most manufacturers to engage testing laboratories and develop a testing plan. Furthermore, for all PMTA applicants the HPHC analysis is an essential section of the PMTA submission.

[1] Family Smoking Prevention and Tobacco Control Act, Section 904(e), 21 U.S.C. §387d(e).

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About the Author

Patricia Kovacevic is a global legal and compliance nicotine industry expert, and currently an independent consultant/principal at RegulationStrategy.com. Patricia I. Kovacevic’s experience comprises past General Counsel and Chief Compliance Officer roles at Nicopure Labs, and leading senior legal and regulatory positions at, among others, Philip Morris International and Lorillard.