Mr. Bruce Levinson, Senior Vice President—Regulatory Intervention, of CRE will testify at the upcoming FDA meeting on the composition of tobacco leaf. Interested stakeholders should submit relevant information here. []

Nov. 16 Update: CRE Tells FDA about the Tip-of-the-Iceberg: Two-Billion Illegally-Made Cigarettes

In its presentation to FDA 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:

  1. 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.
  2. FDA needs to adhere to OMB’s Updated Principles for Risk Assessment and Final Information Quality Bulletin for Peer Review .

Nov. 14 Update: Illegally-Made Cigarettes: A Rapidly Growing Product Category

CRE testimony on November 16 will explain why the FDA needs to assess the public health risks associated with illegally-made cigarettes.

Nov. 7 Update: Counterfeit Chinese Cigarettes are Flooding Detroit

The public health implications of counterfeit cigarettes, which are extremely high in lead and cadmium, will be discussed in CRE’s testimony.

Nov. 4 Update: Hell’s Angels, NASCAR, and OMB’s Peer Review Bulletin

Murderous motorcycle gangs, the origins of NASCAR, and OMB’s guidance to federal agencies on peer review procedures are only a few of the topics that CRE will discuss on November 16th at the FDA’s risk assessment workshop.

Nov. 2 Update: CRE on Tobacco Leaf Hazard Characterization

CRE’s testimony at the FDA risk assessment workshop will focus on the first question FDA has put to the presenters and panelists, “What toxicological or epidemiological data and methods are available to characterize the hazards associated with constituents that are present in or produced by different types of tobacco products?”

CRE’s testimony will include discussion of how OMB’s Updated Principles for Risk Analysis and OMB’s Final Information Quality Bulletin for Peer Review will govern the FDA’s regulatory risk assessment process.