With the rise of e-liquids/e-cigarettes, new testing standards and analyses are being developed to ensure that the end product is safe for its customers to use. For US customers this comes in the form of the FDA’s upcoming Premarket Tobacco Application (PMTA).
Why turn to Avomeen? Our laboratory is FDA-Registered & Inspected, DEA-Licensed (Schedule I-V), GMP-Compliant and GLP-Compliant. We are an accredited testing laboratory that can help you navigate the changing regulations facing the E-Liquid Industry and keep your product on the market.
WHAT ARE E-LIQUID/E-JUICE PRODUCTS:
Ejuice 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.
E-cigarettes have been growing in popularity due to smoking restrictions that regulate places that allow use for traditional cigarettes put in place within certain states, as well as the ability to choose between products that contain very high nicotine levels to no nicotine at all.
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AVOMEEN’S LABORATORY CAN PERFORM A VARIETY OF PRODUCT TESTING AND DEVELOPMENT SERVICES ON THESE PRODUCTS. OTHER ELIQUID TEST SERVICES INCLUDE:
- Stability Study/Shelf Life Assessment – Determine the shelf life of a product
- Quality Control – Raw Material & Finished Product Testing
- Carcinogenic Flavoring Analysis (Including Banned Flavors -Diacetyl, Propinyl Acetyl, and Acetoin)
- Carbonyls & Diketones (2,3-pentanedione & butane-2,3-dione)
- Carbonyls (Formaldehyde, Acrolein & Acetaldehyde)
- Consistency of Dose/ Nicotine Content Levels (USP Assay)
- Nicotine dosing study to determine the amount of nicotine expressed per puff in the e-cigarette/e-liquid combination.
- The study will be performed using actual use conditions, as an average of 10 puffs over the length of the entire cartridge using the manufacturer’s instructions
- Metals – Volatile Organic Compounds (VOC’s) & Other Impurities Testing
- Particle Size in Vapour
- Emissions Testing
- Determine if any new chemical entities are created through the heating and vaporization process. The e-liquid will be vaporized at the highest setting of the unit expected to be used and the vapor analyzed for analytes of toxicological significance including Acetaldehyde, Acrolein, Formaldehyde, Diethylene Glycol, Ethylene Glycol, Diacetyl, and Pentane 2,3 Dione
- Ensure that metals are not being extracted from the device, the vapor will also be tested for Al, Cr, Fe, Ni, Sn
- Safety Data Sheet (SDS) / Toxicology Testing – Verify the Safety of your Product
- VG/PG ratio
- Deformulation analysis of flavor package – Identification of flavoring agents or additives used within a product’s formulation – Determine an e-liquids recipe through chemical reverse engineering
- Deformulate the product – Determine the major and minor ingredients with quantitation. The analysis will include 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
- Flavoring Agent Identification
- Medicinal Product Development
- Product Replication/Reformulation
- Develop New Custom Formulation
WHAT WILL YOU RECEIVE?
A full report will be provided 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 for a free consultation 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.
COMPLY WITH FDA (PMTA) REGULATIONS PER THE GUIDANCE OF MAY 2016 PREMARKET TOBACCO PRODUCT APPLICATIONS FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS
- The FDA has required an application for every flavor in the form of a premarket tobacco product application (PMTA) which must include both non-clinical as well as clinical information as to the safety of the product
- The FDA does not at this time intend to enforce these requirements for components …and products that are sold or distributed solely for further manufacturing into a finished ENDS product (the guidance, p. 8)
- E-liquids that are sold direct to consumers are subject to enforcement. Avomeen offers a range of services to aid in compiling the information needed for the PMTA including – Product Analysis and Manufacturing FDA requires 10 replicates on three batches of product for each analysis
- Methods can be transferred in or developed and validated for accuracy, precision, linearity, range, LOD/LOQ, and robustness.
- Official methods will not require validation
- The pH must be measure and reported
- Further a study must be performed to determine if any new chemical entities are created through the heating and vaporization process.
- A full report will be provided with all source data, accreditation information, test validation information, and a complete description of the aerosol generating methodology (the guidance, p.24). The FDA also requires in-vitro toxicology as well as clinical results in order to assess safety.
- The agency encourages the use an of a tobacco product master file (TPMF), which is a confidential filing with the agency on a product that may be used in manufacturing, such as a flavor package, whose safety and chemistry data can be incorporated into a PMTA by reference (with permission)
- Our analysis may include 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, as needed
- LEARN MORE ABOUT PMTA – CLICK HERE
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