The negative health effects of tobacco smoke are well known. In an effort to better inform the public, the FDA is requiring the tobacco industry to inventory certain human health hazards in tobacco and tobacco smoke. Due to our extensive testing capabilities, GEL and Cape Fear Analytical, LLC were contracted by a laboratory to provide the specialty analyses for radioactive isotopes and dioxins.
FDA Approved Laboratory
While there are more than 7,000 chemicals in tobacco and tobacco smoke, the FDA established a list of 93 potentially harmful constituents that tobacco companies will be required to report to the FDA for every regulated tobacco product sold in the U.S. While the FDA does provide a target list of constituents it does not provide any guidance on methodology, detection limits, or possible concentrations for these constituents.
The challenge for GEL and our affiliate, Cape Fear Analytical, LLC (CFA), was to perform these analyses on a number of non-standard matrices, which included tobacco products and cigarette smoke collected on various media. GEL and CFA had to ensure that the results were provided with extensive quality assurance and quality control documentation to validate our testing procedures.
GEL Labs Services Provided
GEL and CFA provided more that just analytical results for this project for radioactive isotopes and dioxins. We also worked with our client to provide expertise regarding sample collection scenarios, sample analysis, and data interpretation.
Final results were reported using the best available quality control and detection limits. Upon conclusion of the study, the data was sent to the FDA for further evaluation.
The results of the FDA's inventory of organic, inorganic and radioactive human health hazards will be used to establish a list of compounds for further testing. Amendments to the FDA notice may require additional method development, consultation, and evaluation by the FDA laboratory and GEL / CFA.