Acceptable Analytical Methods for Assessing the Quantity of Each

ConstituentRichard G. Higby, Ph.D.

PresidentArista Laboratories, Inc.

1. Analytical methods should not be prescribed by law

2. A defined quality system is necessary3. Machine smoking conditions must be clearly

defined4. Replicate requirements need to be explicitly

stated

Key Points

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

Analytical methods should not be prescribed by law

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

A defined quality system is necessary

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

Machine smoking conditions must be clearly defined

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

Replicate requirements need to be explicitly stated

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

Conclusion