FEMA (Flavor and Extract Manufacturers Association), not to be confused with the federal disaster response agency, has released a “safety assessment and regulatory authority” statement to its membership body advising them not to sell flavorings to the e-cig industry.
FEMA is comprised of flavor manufacturers, flavor users, flavor ingredient suppliers, and others with an interest in the U.S. flavor industry.
1. 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 as defined in Section 201(f) of the Act.
Essentially, flavorings have only been tested to be safe for human food, beverages, and chewing gum. The effects of vaporization and inhalation have not been tested by the organization.
FEMA is attempting to regulate its membership from selling flavorings to the e-cig industry with the following excerpt:
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 GRASTM 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.
There is some obvious FDA pressure at work here, and most likely a bit of self-preservation. If any of these flavorings were found to cause tissue damage due to inhalation, flavor manufacturers could be held liable.
E-liquid manufacturers who have been sourcing flavorings from FEMA member companies (which include RJ Reynolds and Lorillard) will most likely have to start shopping around for a new source.
Some e-liquid companies have noted on Reddit that they have already experienced the impact of this statement from FEMA.