HPHC testing for ENDS products is crucial to the development of your products. HPHC stands for “harmful and potentially harmful constituents”, and FDA requires tobacco manufacturers, including those who manufacture e-cigarettes and other ENDS products, to report the level of HPHCs in their products and any smoke or vapour the products produce.
Why do you need to test for HPHCs?
The FDA needs to ensure that any products on the market are safe to consumers and not a danger to public health. It’s well known that combustible cigarettes are damaging to health and produce harmful chemicals, however with ENDS products still being fairly new, ENDS manufacturers are also required to report any HPHCs found in or produced by their products.
Ultimately, this regulation ensures that your products are safe for your customers to use and are in the interest of public health.
What are you looking for in HPHC testing results for ENDS products?
You need to know whether your products contain any harmful, or potentially harmful, chemicals, and if it could potentially produce them when used.
To get the best results, it’s important to work with the laboratory who will be conducting the tests for you to develop an effective testing and reporting strategy based on the HPHCs you expect to find (if any) and how you plan to deal with any unexpected results.
The FDA have published a list of established HPHCs to test for.
How to report your HPHC results
The results of HPHC testing should be submitted to the FDA using their eSubmitter tool via the CTP Portal which is available to ENDS manufacturers and importers.
Your submission should include:
- Your company name, contact information, address, email address and telephone number
- Your company D-U-N-S number/FEI number
- Names of the products tested, what type of product they are (for example e-liquid) and a unique product identification number such as their Universal Product Code
- The quantities of HPHCs in each product and any produced by its smoke/vapour
- HPHC testing details including dates/date range of tests, number of tests completed and the analytical methods used to extract, separate, and detect the HPHCs
While HPHC testing may not be ideal, it is much cheaper than many of the other regulatory requirements of ENDS products, and forms part of your PMTA , should you choose to submit one. It is also beneficial for you as a manufacturer to ensure that your products are safe to use, which is an essential part of complying with the regulations in the countries you choose to sell in so you can get your products on the market.
Our laboratory is fully equipped to offer HPHC testing for your products. To learn more and get a quote, contact info@inter-scientific.com.
The post HPHC Testing for ENDS products: what you need to know appeared first on Inter Scientific.
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