October 10, 2019
Yesterday the Washington State Board of Health (SBOH) finalized a definition of “characterizing flavor” at the behest of Governor Inslee to implement a temporary flavor ban on all flavored vapor products initiated by Executive Order (E.O. 19-03). Subsequently, the Washington State Liquor and Cannabis Board (WSLCB) released a notice requiring all cannabis retail and processor licensees to immediately cease sales of flavored vapor products.
Unfortunately, the definition of Characterizing Flavor (reproduced below and hereafter referred to as “The Definition”) created by SBOH is ambiguous. As a result, nobody has a clear understanding about what products are included, or excluded, in the flavor ban. Our interpretation of The Definition follows.
WAC 246-80-010 (3)
(3) “Characterizing flavor” means a distinguishable taste or aroma, or both, other than the taste or aroma of tobacco or marijuana or a taste or aroma derived from compounds or derivatives such as terpenes or terpenoids derived directly and solely from marijuana, as defined in RCW 69.50.101(y), or hemp plants that have been grown and tested as required by state law, imparted by a vapor product. Characterizing flavors include, but are not limited to, tastes or aromas relating to any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, menthol, mint, wintergreen, herb, or spice. A vapor product does not have a characterizing flavor solely because of the use of additives or flavorings or the provision of ingredient information. It is the presence of a distinguishable taste or aroma, or both, that constitutes a characterizing flavor. [emphasis added]
1) Marijuana flavor or aroma NOT included
Neither “marijuana flavor” nor “marijuana aroma” have an official definition in statute or regulation in Washington state or Federally. In the absence of official and objective definitions for those phrases, it seems clear that the intent of the imprecise language in The Definition was for those phrases to be interpreted broadly. For example, if a product smells like or mimics the flavor and/or aroma of the Blue Dream cannabis cultivar, then it is allowed and is not banned.
Based upon regulatory and legal precedent for food flavors, it is our belief that any objective and enforceable definition of “marijuana flavor” and “marijuana odor” would involve specific chemistry language and criteria. A logical definition of those phrases would include all flavor and aroma compounds naturally-occurring in cannabis, irrespective of the source of those compounds.
2) Characterizing Flavor does NOT include non-primary flavor notes
Unlike “marijuana flavor” or “marijuana aroma,” official definitions of “characterizing flavor” do exist. They define characterizing flavor as the primary flavor, or flavors, of a product. “Characterizing flavor” for food is defined in the U.S. Code of Federal Regulations (21 CFR 101.22). Here is an excerpt:
21 CFR 101.22 (h)(7)(i)
If the label, labeling, or advertising of a food makes any direct or indirect representations with respect to the primary recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, or other means, or if for any other reason the manufacturer or distributor of a food wishes to designate the type of flavor in the food other than through the statement of ingredients, such flavor shall be considered the characterizing flavor… [emphasis added]
The Washington State Code (WAC) explicitly incorporates the regulations found in 21 CFR 101 for food:
WAC 246-215-03610
Labeling—Food labels (2009 FDA Food Code 3-602.11).
(1) food packaged in a food establishment must be labeled as specified in law, including chapter 69.04 RCW; 21 C.F.R. 101 – Food Labeling; and 9 C.F.R. 317 – Labeling, Marking Devices, and Containers. [emphasis added]
Given the existing Washington state and Federal definitions of “characterizing flavor” for food and the authority that SBOH has over food in Washington state, it is evident that SBOH endeavored to define “characterizing flavor” for vapor products analogously to existing food law and regulation. This is further evidenced by the insertion of the sentence “A vapor product does not have a characterizing flavor solely because of the use of additives or flavorings or the provision of ingredient information.” which is reflective of existing state and Federal regulations for food. As a result, it can only be assumed that the SBOH intended to exclude secondary flavor notes from the definition of characterizing flavor.
Based on the aggregate language used in The Definition, it seems clear that any product that has a primary flavor and/or aroma of cannabis, even if it has additional, secondary flavor notes from compounds not naturally-occurring in cannabis, is also NOT covered by the ban. For example, a Super Lemon Haze vapor product would be permitted if the primary flavor was marijuana even if additional flavor notes are present.
3) Characterizing Flavor does NOT include cultivar names
The federal definition of characterizing flavor, which is included by reference in Washington state food regulations, differentiates the “characterizing flavor” and the “common and usual name” used to represent the product. This is done so that the product inside the package is not misrepresented to consumers through misleading product labels and/or labelling. Common and usual naming conventions include distinctions for cultivar and varietal names of botanical products, if there is a discernible difference. For example, “Red Delicious Apple” is an acceptable common and usual name.
This applies to cannabis products, including cannabis vapor products. Analytical testing demonstrates different compositions of flavor and aroma compounds in different cultivars of cannabis. Not only does Super Lemon Haze smells and taste different from Blue Dream, but these differences can be demonstrated by the different composition of compounds produced by these cultivars.
It would be a disservice to the consumer to prevent the communication of these cultivar names on product labels or in labeling due to allowing a hasty flavor ban to bleed into naming conventions. Amidst the urgency to protect the public health from vape-related illness, which we fully and adamantly support, short shrift should not be given to other protections offered to consumers to know what they are consuming. This is especially important given that the causes of vape-related illness remain unclear. For example, a consumer would be irreparably harmed if they were forced to digest a name change of “Red Delicious” to “Apple X” because that name has meaning to them about what the product tastes like and the constituents found therein. The same is true for cannabis cultivar names, such as Super Lemon Haze.
In light of these critical points, it is our view that all i502 licensed processors and retailers should refrain from the cessation of cannabis vapor products until WSLCB provides compliance clarity about what is and is not covered. The only exception at this time would appear to be for vapor products that the licensed processor claims are devoid of both marijuana flavor/aroma as a primary flavor AND molecules not derived from cannabis. We believe this measured approach is the only way to address the primary priority of protecting the public health.
* * * *
Sincerely,
Jeffrey C. Raber, Ph.D.
Chief Executive Officer
Brad J. Douglass, Ph.D.
V.P. Regulatory Affairs
Sytze Elzinga, M.S.
Chief Science Officer
