PMTA Testing

Labstat has expertise in a broad range of tobacco and tobacco products subject to potential PMTAs such as e-cigarettes (ENDS), e-liquids (ENDS), e-vapor devices (ENDS), cigarettes, cigars, oral tobacco products, gels, or tobacco-free oral nicotine products. We offer methods for all of FDA’s PMTA ENDS (Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems) and HPHC (Harmful and Potentially Harmful Constituents) testing in support of PMTA (Premarket Tobacco Product Application) or Substantial Equivalence sumbmissions.

We also offer custom method development to meet your unique needs for testing beyond the guidance documents’ listings. Our validation process is designed to meet regulatory standards to ensure that submitted data is reliable and defensible. 

Do you need assistance preparing and filing your PMTA? We can provide an end-to-end solution. Please contact us.

Premarket Tobacco Product Application for Electronic Delivery Systems Testing (PMTA ENDS)

The FDA has suggested the following compounds of interest listed in bold:

Group Instrument Analytes
Volatiles GC-MS (SIM) 1,3-butadiene, acrylonitrile, benzene, ethylbenzene, ethylene oxide, furan, isoprene, nitromethane, propylene oxide, toluene, vinyl acetate, vinyl chloride
Carbonyls GC-MS (SIM) 2,3-butanedione (diacetyl), 2,3-heptanedione, 2,3-hexanedione, 2,3-pentanedione (acetyl propionyl), 3-buten-2-one (MVK), acetaldehyde, acetoin, acetol, acetone, acrolein, butyraldehyde, crotonaldehyde, ethyl acetoacetate, formaldehyde, glycolaldehyde, glyoxal, isobutyraldehyde, methyl ethyl ketone, methylglyoxal, propionaldehyde
Metals ICP-MS aluminum, arsenic, beryllium, cadmium, chromium, cobalt, copper, iron, lead, manganese, molybdenum, nickel, selenium, silver, strontium, tin, titanium , tungsten, zinc, zirconium
Composition GC-TCD/FID diethylene glycol, ethylene glycol, glycerol, NFDAM, nicotine, propylene glycol, triacetin, water, menthol
Glycidol GC-MS (SIM) glycidol
Nitrosamines, Tobacco Specific LC-MS/MS 4-[methyl(nitroso)amino]-1-(3-pyridinyl)-1-butanone (NNK), N-nitrosoanabasine (NAB), N-nitrosoanatabine (NAT), N-nitrosonornicotine (NNN)
Flavor-Related GC-MS (SIM) 1-butanol, benzyl acetate, ethyl acetate, furfural, isoamyl acetate, isobutyl acetate, methyl acetate

For the assessment of unprotonated nicotine and nicotine salts:

Group Instrument Analytes
pH pH electrode pH
Benzoic acid HPLC-UV benzoic acid
Organic Acids HPLC-UV acetic acid, benzoic acid, formic acid, glycolic acid, lactic acid, oxalic acid
Propionic acid GC-MS (SIM) propionic acid

Aerosol particle physics:

Group Instrument Analytes/Measures
Aerosol Physics ELPI or MOUDI PM2.5 (as % of distribution); Mass median aerodynamic diameter (MMAD); Geometric standard deviation (GSD); MMAD×GSD2 and MMAD÷GSD2 (spans 95% population range); Count median diameter (nm); Particle number conc (#/cm3); Analyte concentration (contact for specific needs)
Physical Parameters - Aerosol temperature, coil temperature, color, clarity

Compounds that also may be of interest:

Group Instrument Analytes
Gold ICP-MS gold
Nicotine Degredation Products LC-MS/MS anabasine, anatabine, cotinine, myosmine, nicotine, nicotine-N-oxide, nornicotine, β-nicotyrine
Water Activity WA water activity
Water (Karl Fisher) KF water