Maintaining regulatory compliance is a key factor in keeping your Electronic Nicotine Delivery System (ENDS) products on the market. A PMTA (Premarket Tobacco Application) is a regulatory requirement to allow any tobacco product or product derived from tobacco substances to be marketed in the US. The PMTA references the draft guidance for Reporting Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act. The requirement to submit HPHC listings under section 904 of the FDC Act (21 U.S.C. 387d) is separate and distinct from the premarket review requirements under section 910. The deadline for submitting quantities of HPHCs is November 8, 2019. In this blog, we share with you some of the key areas to assess when choosing your contract laboratory to support your HPHC testing requirements.
The purpose of sourcing a laboratory that holds an accreditation is to provide you with the confidence in the quality and validity of the data they deliver. A laboratory that holds an accreditation to ISO 17025 and laboratories that are also audited by government organisations such as the FDA to GMP regulations will operate quality systems that ensure accurate and reliable test data is supplied to customers.
The accreditation status of the laboratory used needs to be reported as part of your PMTA.
Limit of Detection and Quantification (LOD/LOQ)
In tobacco smoke you expect to see relatively high levels of HPHCs; whereas in electronic cigarettes, HPHCs should be at negligible or at trace levels. You should consider if your laboratory has completed a risk assessment using toxicological information to ensure their methods are capable of detecting HPHCs at the appropriate low levels. Your chosen laboratory should have the appropriate instrumentation to conduct HPHC testing, and have demonstrated that the methods are valid using a range of e-liquid products and flavours.
Communication is a key aspect for a successful relationship with your chosen laboratory. From the initial enquiry, how does the laboratory deal with and address your requests? This usually sets the tone of your working relationship. If a laboratory does not reply to your initial enquiry within a timely manner, this may also suggest they will have difficulty delivering test results to your expected service levels. A laboratory that maintains open communication and frequent status updates on progress will certainly provide you with an easy to manage supplier relationship.
What is the method of reporting and does the laboratory provide you with the data in a format that you can understand? A lot of laboratories may provide you with test results in excel spreadsheets or pdfs as an e-mail attachment; however, this can make it difficult to trend historic data. Some laboratories offer web portal access to data which makes it easy to view historical test results, trend data, and sometimes web portal functionality can provide you with progress updates of samples under analysis. Ask your chosen laboratory what methods of reporting they provide.
Does the laboratory have the capacity to deliver on your requirements? What is their process for submitting samples? Do they ask that you send the samples and can expect results in the next few weeks or even months? Or do they provide you with the ability to book time slots to ensure your turnaround requirements are met? When assessing a laboratory, you can ask them to provide examples of how they dealt with increases in workload, and do they have any monitoring systems in place to assess their performance against turnaround requirements and service levels.
A requirement of PMTA is that you provide details of the methodology used for HPHC testing. Ensure that your chosen laboratory will share the methodology with you. The FDA request the methodology to understand how testing was conducted, to ensure the method is fit for purpose, and potentially allow them to repeat the exercise. Failure to provide methodology with your HPHC submission is a risk for non-compliance.
The culture of the laboratory is also key in a successful relationship. Are they keen to work with you, do they effectively communicate and manage your expectations, and do they align themselves with your business needs? Will they allow you to audit their facilities and processes? Audits can also be a good forum to ensure expectations around communications are shared. At the end of the day, you need to feel that you can trust your laboratory and that you can rely on them to produce accurate data within your turnaround requirements.
This is the difference between selecting a laboratory as a partner versus selecting a laboratory as a service provider. A laboratory that treats the relationship as a partnership will provide you with more than just test results. A laboratory that provides you with a consultancy style partnership will help you to interpret your data, inform you of potential problem areas, assess the impact, and provide you with potential solutions to move forward. They may also help you in meetings with the FDA, and therefore, it is also beneficial to source a laboratory that has the experience of engaging with regulators.