Acceptable Analytical Methods for Assessing the Quantity of Each Constituent Richard G. Higby, Ph.D. President Arista Laboratories, Inc.
Key Points • Analytical methods should not be prescribed by law • A defined quality system is necessary • Machine smoking conditions must be clearly defined • Replicate requirements need to be explicitly stated
Analytical methods should not be prescribed by law • ISO methods are valuable • Validated through collaborative studies • Process of development is lengthy • Only six methods exist today for mainstream smoke • Development continues through WHO’s TobLabNet, CORESTA • Published literature methods are not “optimized” • Administrative or technical errors exist • Detail is often insufficient • Correction conflicts with statutes • Sound principles of validation should prevail • Consistent with FDA’s approach in other areas • Accreditation and audits reinforce practices
A defined quality system is necessary • ISO 17025 laboratory standard • Scheduled and periodic assessments • Laboratories exist today accredited to ISO 17025 for tobacco specific work • Accrediting bodies are increasingly rigorous • Good Laboratory Practices • Consistent with FDA’s practice in other areas • Limited tobacco specific capacity exists today • Compliant equipment will be slow to develop for the tobacco smoke specialty equipment (smoking machines) • Economies of scale do not exist for instrument development
Machine smoking conditions must be clearly defined • Machine smoking is not representative of human smoking behavior • Allows product to product comparisons • Published methods such as ISO or the Canadian intense method are well understood • The ISO method does not deliver the same results as the FTC method which should be abandoned
Replicate requirements need to be explicitly stated • Tobacco is a natural product • Subject to seasonal variation • Variability requires a larger sample to be statistically significant • Emissions are more variable than constituents • Health Canada TRR prescribes 7 replicates for emissions (smoke) • Health Canada TRR prescribes 3 replicates for constituents (tobacco) • FTC and Massachusetts prescribed an average of 100 cigarettes (20 replicates) for TNC which is excessive
Conclusion • Time is short • Establishing capacity may be a challenge if notice is short • Implementing a quality system requires time to qualify personnel and equipment • We encourage the early publication of the list of constituents and the testing requirements