FEMA (Flavor Extract and Manufacturer's Association) has sent a letter out to flavoring manufacturers, warning them that the flavorings they manufacture have not been approved by the FDA for use in e-cigs. This has already resulted in some flavoring manufacturers abruptly ceasing business with makers of e-juice / e-liquid.
Here are some quoted excerpts from the letter sent out by FEMA:
*****
"There is no apparent direct regulatory authority in the
United States to use flavors in e-cigarettes. In this context, it is important
to note that the “generally recognized as safe” (GRAS) provision in Section
201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA) applies only to food . . ."
*****
"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 GRASTM status for use in food because such
statements are false and misleading."
*****
"In 2014, FDA published proposed
regulations to deem e-cigarettes as tobacco products subject to the regulatory
authority of the 2009 Family Smoking Prevention and Tobacco Control Act
amendments to the Federal Food, Drug, and Cosmetic Act thereby bringing them
under regulation by the Food and Drug Administration (FDA)."
*****
"The FEMA Expert Panel evaluates the safety of flavoring
substances only under their conditions of intended use in human food, including
beverages and chewing gum. Therefore, the Expert Panel only evaluates flavor
ingredients for exposure through ingestion. The Expert Panel does not evaluate
flavor ingredients for use in tobacco products and e-cigarettes or other
products that are not human food, or products that result in exposures other
than by ingestion."
*****
"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. . . . It is improper to use OELs as indications of
safe levels of exposure to flavoring substances from the use of electronic
cigarettes."
*****
The letter is signed by John Hallagan, FEMA Senior Advisor and
General Counsel.
