HPHC or Harmful and Potentially Harmful Constituents is a submission required under the 2016 Deeming Regulation. By November 8, 2019, vape (e-liquids and hardware), hookah and cigar companies (manufacturers, importers or agents) will need to file an HPHC.

There’s been confusion about what an HPHC submission involves. In particular, since the last FDA Guidance was issued in 2012 for Roll Your Own (RYO) tobacco products. In the ENDS PMTA Guidance the FDA stated, “FDA intends to establish a revised list of harmful and potentially harmful constituents (HPHCs) that include HPHCs in ENDS products in the Federal Register, 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.” As of the date of this post, neither has been published.

The list of HPHC in e-liquids is included in the ENDS PMTA Guidance. Those are:

  • 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
  • Lead
  • Menthol
  • Nickel
  • Nicotine, including total nicotine and unprotonated nicotine 
  • NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) 
  • NNN (N-nitrosonornicotine)
  • Propylene glycol
  • Toluene
  • Other constituents, as appropriate

While the exact analytical methods aren’t specified, from the 2012 Guidance it’s clear an HPHC must a identify each tobacco product (i.e., registered products with TP numbers), the manufacturer and/or importer, and provide the HPHC data along with HPHC quantities and details about the testing method. Until new Guidance or regulations are issued it would seem as long as the analytical methodology is scientifically sound it should suffice.

New Tobacco Listing Process

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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