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Section 904(a)(3) of the FD&C Act (Reporting of Harmful and Potentially Harmful Constituents (HPHCs)) states that quantities of HPHCs in deemed tobacco products (including E-Cigarettes and E-liquids) must be reported 6 or 9 months* following publication of final guidance, or 90 days prior to marketing for products entering the market after the publication of final guidance.

There are currently 29 HPHCs defined for ENDS or vapor products. Selecting the right laboratory to conduct your testing will be key in ensuring your products remain on the market after the compliance deadline.

At Broughton Nicotine Services we have developed a suite of fully validated test methods that will generate the test data you require for your HPHC submission.  Our industry and regulatory knowledge, coupled with our customer centric approach will ensure that you get the data you need on time with the minimum of fuss.

* 9 months applies to small tobacco product manufacturers classified as those with fewer than 350 employees. FDA considers a manufacturer to include employees of each entity that it controls, is controlled by, or is under common control with. 

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How We Deliver

 

During the consultation stage our team of Principal Scientists are available to offer advice specific to your products. We offer a straightforward service based on the available guidance. We are also able to offer a science and statistics backed consultancy service to ensure that your testing strategy is optimised.

Test data is generated in our state of the art facility using the latest analytical instruments from leading edge scientific equipment manufacturers. 

Once your data is generated, our team is on hand to analyse the results and work with you to ensure a seamless submission.

 

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Aerosol and e-Liquid Analysis

Our laboratories are equipped with a wide range of instruments to undertake various analytical techniques. Product analysis is undertaken for the full list of 33 HPHCs and Flavorants identified in the recent Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (PMTA) Final Guidance from FDA, and other HPHCs, as detailed below.

Technique
HPHCs and Flavorants
e-Liquid
Aerosol
LC-MS, LC-MS/MS
Carbonyls (Aldehydes, Di-ketones and Aromatic Aldehydes), TSNAs, Nicotine Impurities, Furfural
Yes
Yes
GC-MS, GC-MS/MS
Aromatic Amines, VOCs, Benzo[a]pyrene
Yes
Yes
GC-FID
Nicotine, Humectants and contaminants
Yes
Yes
IC
Ammonia, Organic Acids, Propionic Acid
Yes
Yes
ICP-MS
Heavy and Trace Metals
Yes
Yes
LC-UV/DAD
Nicotine content and purity
Yes
Yes
HS-GC-MS
Flavor additives
Yes
Yes

Resources

Brochure

Download our brochure to read how Broughton Nicotine Services can help you comply with regulations requiring HPHC testing.

 

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

 

Leaflet

Download our brochure for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.