LAUTERBACH & ASSOCIATES, LLC

Services

Conventional Tobacco Products
* Review of disclosures of all components for blends, tobacco additives, and nontobacco materials from chemical and toxicological standpoints, with recommendations for revision as indicated.
* Establishment of substantial equivalence of a new product to a predicate, and/or assistance with a pre-market tobacco product application.
* Interpretation of analytical and toxicological data on tobacco and/or tobacco smoke.
* Serve as sponsor's representative for work done by analytical and toxicological laboratories
* Establishment of procedures for incoming materials quality control/assurance.
* Establishment of good manufacturing practices, including establishment of production specifications and tolerances.
* Review of chemical/technical aspects of consumer complaints.
E-cigarettes, E-liquids, and other novel delivery systems
* Review of disclosures of all ingredients for e-liquid formulae from chemical (identify stability issues) and toxicological standpoints, with recommendations for revision of formulae as indicated.
* Establishment of substantial equivalence of a new product to a predicate, and/or assistance with a premarket tobacco product application (PMTA).
* Interpretation of analytical and toxicological data on e-liquid formulae and/or individual ingredients.
* Interpretation of analytical and toxicological data on e-cigarette aerosols.
* Serve as sponsor's representative for work done by analytical and toxicological laboratories
* Establishment of procedures for incoming materials quality control/assurance.
* Establishment of good manufacturing practices, including establishment of production specifications and tolerances.
* Review of chemical/technical aspects of consumer complaints.