In May 2016, the FDA extended its authority to all tobacco products in an effort “to improve public health and protect future generations from the risks of tobacco use.” The Center for Tobacco Products (CTP), a branch of the FDA, now has regulatory authority over cigarettes, smokeless tobacco, e-cigarettes (electronic nicotine delivery systems, or ENDS), pipe and hookah tobacco, dissolvable tobacco products, cigars and “novel / future tobacco products.”
This means the FDA now requires manufacturers of e-cigarettes and e-liquids marketed after February 2007 to conduct clinical studies and submit exposure data to continue selling these products after August 2018. These companies only have two years to conduct trials and the FDA to review study data or they will no longer be able to market these products.
This two year time limit and scarcity of labs capable of validating low-level nicotine assays have led to a crippling bottleneck. Companies have samples sitting in freezers who feel their options are limited. They need a lab that can produce quick, reliable and defendable data. This is where KCAS comes in. Our team has secured additional lab space and has validated methods for nicotine, cotinine and trans-3’-hydroxycotinine in plasma to provide manufacturers and clinics a GLP-compliant laboratory with capacity to ease the logjam.
KCAS is in the process of continuing our investment in this field by establishing additional assays for urine nicotine equivalents and carbon monoxide hemoglobin (COHgb), and inflammation cell measurements by flow cytometry to support analysis of sputum samples.
View our Tobacco Testing Sales Sheet for more information.