On Thursday the U.S. Food and Drug Administration (FDA) finalized a long-anticipated rule regulating e-cigarettes and tobacco vaporization devices, including vape pens.
The 499-page document left many in the cannabis industry scrambling to understand the new rule’s potential impact on vape devices intended for consumption of marijuana and its extracts, instead of for nicotine.
The key question is whether products in the rapidly growing cannabis vape industry can be defined as “tobacco products.”
The new rule gives FDA the power to regulate any devices “intended or reasonably expected…to be used with or for the human consumption of a tobacco product.” Such products and their components will have to undergo a lengthy and costly testing, review and approval process.
The FDA estimates the reviews will take an average of 1,713 hours to complete, which vape industry advocates say could cost companies $1 million for each device or component that an application must be filed for.
The definition of devices and components subject to the new rule could lead to an ironic shift in how marijuana consumption tools are talked about in advertising and points of purchase.
Many cannabis consumers have had the experience of visiting a head shop and being scolded to describe bongs clearly intended for marijuana consumption as “tobacco water pipes” in order to avoid violating drug paraphernalia laws. But thanks to the new FDA rules and rapidly changing public attitudes and laws surrounding cannabis, consumption device manufacturers and retailers may begin to advertise such products as “for marijuana use only.”
The federal drug statutes contain an exemption for “any person authorized by local, state or federal law to manufacture, possess or distribute” paraphernalia, but explicitly advertising vape products as for cannabis consumption could be risky for companies without a clear state or local license to manufacture marijuana devices or who operate in or distribute products to states without legalization.
Some in the industry have taken a more cautious approach all along.
Pantelis Ataliotis, president of Dr. Dabber, which makes vape pens popular with cannabis enthusiasts, said that his company has always positioned its devices as aromatherapy products, which can be used to vaporize essential oils like chamomile and lavendar.
“We have always avoided mentioning the words ‘tobacco’ or ‘smoking’ on our website and in our advertising as our products truly to do not work with the nicotine e-liquids, therefore this particular set of regulations should not apply,” he said in a e-mailed statement to Marijuana.com. “Whether or not this distinction will be recognized within FDA guidelines is yet to be seen (albeit unlikely), but the legal classification of products like ours has always been a grey area [and]this is just another instance of the difficulties faced in our industry.”
Companies whose devices fall under the new regulations will have two years to submit applications for approval. The products can then remain on the market for another year while FDA decides.
The rule, first proposed in draft form in 2014, has caused much controversy, particularly over the exemption it grants to devices on the market prior to February 15,2007.
Small vape businesses and others have described it as a giveaway to “Big Tobacco” companies which can much more easily afford the new review process.
In the new document, published in the Federal Register, FDA provides what it says is a nonexhaustive list of vape components and parts that will be subject to the regulations. It includes atomizers, batteries, cartomizers (atomizer plus replaceable fluid-filled cartridge), digital display/lights to adjust settings and programmable software.
Also potentially of note to bong manufacturers is a list of components and parts for waterpipe tobacco devices, including hose cooling attachments, water filtration base additives, bowls, valves, hoses and heads.
More information about the new rule’s impact on e-cigarettes and other devices is available on the FDA’s website.
Photo Courtesy of John Abbate.