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.
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.
Download our brochure to read how Broughton Nicotine Services can help you comply with regulations requiring HPHC testing.
Download our free white paper to get further information on the FDA’s Guidance for Industry on PMTA for Electronic Nicotine Delivery Systems (ENDS).