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 |