To submit a successful premarket tobacco product application (PMTA), the FDA currently requires all manufacturers of new or newly deemed finished tobacco products that were on the market as of August 8, 2016, to present an analysis of any HPHCs. Given recent industry and FDA updates, we can help you plan and navigate the uncertainty regarding the exact deadlines and specific analytes that require testing.
With specialized instruments and a diverse set of technical expertise, we continue to refine and optimize our HPHC reporting and guidance to ensure our clients meet their regulatory goals. Our qualified team is set up to test and report quickly and efficiently, having created a modular, custom approach that can be tailored to your needs.
The FDA published a list of 93 HPHCs in tobacco products and tobacco smoke as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in March 2012. The list focuses on chemicals that are linked to the five most serious health effects of tobacco use; cancer, cardiovascular disease, respiratory effects, reproductive problems, and addiction. The FDA issued additional guidance in 2012 that identified a subset of 20 HPHCs that manufacturers and importers need to test for and report to the FDA. In new tobacco/nicotine products, Avomeen is aware of up to 17 key analytes to test for. We can help customers cut through the red tape to conduct simple, low-cost testing for all relevant HPHCs.
About E-Cigarette, E-Liquid, and E-Juice Product Ingredients
The nicotine levels present in e-cigarette, e-liquid, and e-juice products can vary widely, from very high levels to no nicotine at all. E-juice commonly contains nicotine, glycerin, water, propylene glycol/glycerol, ethylene glycol/diethylene glycol, and flavoring additives. Flavorings often aim to match a variety of food and fruit products including apple, cherry, pina colada, grape, chocolate, menthol, blueberry, butterscotch, strawberry, and more.
Become an Expert In E-Juice & E-Cigarette HPHCs Learn More
FDA-Approved HPHC Testing for E-Cigarettes, Cigars, and All Other Tobacco Products
Avomeen offers FDA-approved HPHC testing and development services for e-cigarettes, cigars, and other e-liquid and ENDS-related products. We undertake:
- Stability studies and shelf life assessments
- Quality control and raw material and finished product testing
- Carcinogenic flavoring analysis (including banned flavors such as diacetyl, propinyl acetyl, and acetoin)
- Carbonyls and diketones (2,3-pentanedione and butane-2,3-dione)
- Carbonyls (formaldehyde, acrolein and acetaldehyde)
- Consistency of dose and nicotine content levels (USP Assay)
- Nicotine dosing studies to determine the amount of nicotine expressed per puff in the e-cigarette/e-liquid combination
- This study is performed using real life use conditions, for example, an average of 10 puffs over the length of the entire cartridge following the manufacturer’s instructions.
- Metals testing, including volatile organic compounds (VOCs) and other impurities testing
- Particle size in vapor testing
- Emissions testing
- Determination of new chemical entities created through the heating and vaporization process
- The e-liquid is vaporized at the highest consumer setting so the vapor can be analyzed for toxic analytes including acetaldehyde, acrolein, formaldehyde, diethylene glycol, ethylene glycol, diacetyl, and pentane-2,3-dione.
- Vapor testing for Al, Cr, Fe, Ni, Sn to ensure metals are not being extracted from the device
- Safety data sheet (SDS) toxicology testing to verify product safety
- Vegetable glycerin (VG) and propylene glycol (PG) ratio analyses
- Flavoring agent identification
- Deformulation analysis of flavor packages, agents, or additives to reverse engineer the e-liquid formulation
- Product deformulation to quantify the major and minor ingredients
- This analysis includes testing on one or more of the following state-of-the-art instruments: FT-IR, LC/MS, SEM/EDXA, NMR, HPLC, ICP, PIXE and GC/MS, as well as a wide range of other analytical techniques and other instrumentation.
- Medicinal product development
- Product replication/reformulation
- Development of new custom formulations
HPHC Testing and Submission: What You Receive
Avomeen’s clients receive a full report with all source data, accreditation information, and a complete description of the aerosol generating methodology. If you manufacture or distribute these products, or are an entrepreneur looking to start your own product line, give us a call to speak with one of our Ph.D. chemists.
Our full-service chemical testing laboratory can perform the e-liquid testing that you need to stay in compliance with industry and legal regulations. Throughout the process, our regulatory experts can provide the guidance and support you need to efficiently prepare an FDA submission that meets and exceeds current regulatory requirements for reporting HPHCs.
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