In its presentation to an FDA risk assessment workshop today, CRE informed that massive quantities of cigarettes are being illegally-manufactured in Canada with US-grown tobacco and then re-exported to the US and beyond. A recent international law enforcement operation found that two million kilos of tobacco were trafficked into Canada from North Carolina where it was grown, enough tobacco for two-billion cigarettes. The two-billion cigarettes represents only the tip of the illegal cigarette manufacturing iceberg as dozens of illicit factories are still operating in Ontario and Quebec.
CRE also informed the agency about two recent peer reviewed studies about illegally-made cigarettes. One study demonstrates that illicit tobacco has a unique molecular signature which allows it to be conclusively identified in the laboratory while the other study, by a NIST researcher, demonstrates that counterfeit cigarettes pose higher risks to public health than legally-made products.
CRE’s two conclusions:
- Illegally-made cigarettes are a distinct and growing tobacco product category which present an elevated health risk, FDA needs to study and characterize the risk of illegally-made cigarettes.
- FDA needs to adhere to OMB’s Updated Principles for Risk Assessment and Final Information Quality Bulletin for Peer Review.
