March 8, 2015

Stanton A. Glantz, PhD

Flavor & Extract Manufacturers Assn rejects claims that use of GRAS flavors in e-cigs is safe

E-cigarette interests widely justify the use of food flavorings as safe because they are "Generally Recognized as Safe" (GRAS).  GRAS determinants apply to additives in food that are eaten  not inhaledOn March 3, 2015, the Flavor and Extract Manufacturers; Association (FEMA) updated its statement. "The Safety Assessment and Regulatory Authority to Use Flavors – Focus on E-Cigarettes;" this document bluntly rejects the claims being made for e-cigarettes.  In part it reads:

2. None of the primary safety assessment programs for flavors, including the GRAS program sponsored by the Flavor and Extract Manufacturers Association of the United States (FEMA), evaluate flavor ingredients for use in products other than human food. FEMA GRAS status for the use of a flavor ingredient in food does not provide regulatory authority to use the flavor ingredient in e-cigarettes in the U.S.

E-cigarette and flavor manufacturers and marketers should not represent or suggest that the flavor ingredients used in e-cigarettes are safe because they have FEMA GRAS status for use in food because such statements are false and misleading.

 E-cigarette manufacturers and marketers should take appropriate action to assure the safety of flavor ingredients used in e-cigarettes. FEMA GRAS status for the use of flavor ingredients in food does not mean that FEMA GRAS flavor ingredients are safe for use in e-cigarettes.

FEMA also criticised the use of occupational exposure limits for risk assessment of e-cigarettes, the approach taken in a report prepared by Igor Bursytn at Drexel that e-cigarette advocates widely quote to justify claims that inhaling e-cigarette aerosol poses little risk.

Occupational Exposure Limits and E-Cigarettes

Occupational exposure limits (OELs) have been established for a small number of flavoring substances. OELs have no relevance to exposure to flavors from the use of e-cigarettes. OELs, such as permissible exposure limits (PELs) established by the Occupational Safety and Health Administration (OSHA), recommended exposure limits (RELs) established by the National Institute for Occupational Safety and Health (NIOSH) and threshold limit values (TLVs) established by the American Conference of Government Industrial Hygienists (ACGIH), are intended to serve as regulatory limits in the case of OSHA PELs, or in the case of RELs and TLVs, as benchmarks for limiting exposure to substances in the workplace. It is improper to use OELs as indications of safe levels of exposure to flavoring substances from the use of electronic cigarettes.

You can download "The Safety Assessment and Regulatory Authority to Use Flavors – Focus on E-Cigarettes" here.
FEMA has also released an important point on the dangers of inhaling food additives that might be safe to eat, which is available here.



The paper is signed by John Hallagan, FEMA lawyer, not scientist, This is likely just a FEMA precaution against possible lawsuits.
Lawyers should be quoting scientists, and he should've quoted Glantz in his paper.


The science that Mr Hallagan/FEMA base their statement on appears, of course, to be strongly echoed here: by the AIHA, and furthermore here by ASHRAE scientist, Bud Offerman. . The writer of the previous comment needs to keep up with the science, and not potentially protect the CASSA funded Drexel paper.
Dave Bareham.

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