On September 6, 2019, the U.S. Food & Drug Administration (FDA) issued a consumer/health professional MedWatch safety alert titled, Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses.
Today, CannaMD takes a closer look at what the FDA warning says and what medical cannabis patients need to know about marijuana vaping products.
UPDATE: On November 8, 2019 the CDC issued an updated, specifically identifying vitamin E acetate as a potential cause of illness. For full details, please see our updated post: Do Medical Marijuana Vaping Products Contain Vitamin E Acetate?.
UPDATE: On September 27, 2019, the CDC issued an investigation update. Details are included at the end of this post and noted where appropriate throughout the article, below.
Why Did the FDA Issue A Warning About Vaping?
Prior to the FDA’s MedWatch warning, but also on September 6, the Centers for Disease Control and Prevention (CDC) issued an investigation notice stating:
[The] CDC, FDA, state and local health departments, and other clinical and public health partners are investigating a multi-state outbreak of severe pulmonary disease associated with e-cigarette product (devices, liquids, refill pods, and/or cartridges) use.
This investigation is ongoing and has not identified a cause, but all reported cases have a history of using e-cigarette products.
Note: E-cigarettes are devices that deliver an aerosol to the user by heating a liquid that usually contains nicotine, flavorings, and other chemicals. E-cigarettes can also be used to deliver marijuana or other substances.
According to the CDC, at the time of its notice, over 450 possible cases of lung illness associated with the use of e-cigarette products have been reported. Five deaths have been confirmed in California, Illinois, Indiana, Minnesota, and Oregon.
As the CDC explains:
No evidence of infectious diseases has been identified; therefore lung illnesses are likely associated with a chemical exposure. Initial published reports from the investigation point to clinical similarities among cases.
These findings align with the CDC’s earlier (August 30) health advisory, which warned:
Youth, young adults, pregnant women, as well as adults who do not currently use tobacco products should not use e-cigarettes. E-cigarettes containing nicotine have the potential to help some individual adult smokers reduce their use of and transition away from cigarettes.
However, e-cigarettes are not currently approved by the FDA as a quit smoking aid, and the available science is inconclusive on whether e-cigarettes are effective for quitting smoking.
Following the CDC’s investigation notice, the FDA issued its MedWatch safety alert. A CDC update was later issued on September 27, 2019.
What Does the FDA Vaping Warning Say?
While investigative efforts are still underway, the FDA notes:
[M]any of the samples tested by the states or by the FDA as part of this ongoing investigation have been identified as vaping products containing tetrahydrocannabinol (or THC, a psychoactive component of the marijuana plant) and further, most of those samples with THC tested also contained significant amounts of Vitamin E acetate.
Vitamin E acetate is a substance present in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.
While Vitamin E acetate has attracted a lot of attention, the FDA is quick to point out that researchers are analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including:
- Nicotine
- THC
- Other cannabinoids
- Cutting agents/Diluents
- Additives
- Pesticides
- Opioids
- Poisons
- Toxins
The FDA notes:
No one substance has been identified in all of the samples tested.
Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about causality.
As more information becomes available, the FDA will update its consumer alert page.
UPDATE: As of September 27, the specific chemical exposure(s) causing lung injuries remains unknown. The CDC has updated language to “recommend that you consider refraining from e-cigarette or vaping products, particularly those contain THC” while the investigation is ongoing.
What Does the FDA Recommend?
According to its official MedWatch report:
While the FDA does not have enough data presently to conclude that Vitamin E acetate is the cause of the lung injury in these cases, the agency believes it is prudent to avoid inhaling this substance.
The FDA continues:
Because consumers cannot be sure whether any THC vaping products may contain Vitamin E acetate, consumers are urged to avoid buying vaping products from the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.
Additionally, no youth should be using any vaping product, regardless of the substance.
Health care providers and consumers are encouraged to document adverse events or any problems related to vaping products by submitting a report via the FDA’s Safety Reporting Portal.
UPDATE: On September 27, the CDC added the following statement:
While this investigation is ongoing, CDC recommends that you consider refraining from using e-cigarette, or vaping, products, particularly those containing THC.
The CDC also added digital resources for patients and physicians.
What Vaping Symptoms Should Patients Look For?
Concerned individuals should monitor symptoms such as cough, shortness of breath, and chest pain, and promptly seek medical attention as necessary.
In addition to submitting an online report via the FDA’s Safety Reporting Portal, individuals who experience adverse reactions are also encouraged to contact their local health care provider and/or call their local poison control center at 1 (800) 222-1222.
The FDA adds that health care providers should also contact their local poison control center and/or utilize the Safety Reporting Portal.
What Does the FDA Vaping Warning Say About Medical Marijuana?
While the FDA warning doesn’t explicitly mention medical marijuana, it does state:
Because consumers cannot be sure whether any THC vaping products may contain Vitamin E acetate, consumers are urged to avoid buying vaping products from the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.
[Emphasis added.]
This statement places significant weight on the role of Vitamin E acetate; however, it’s also important to note that, by the FDA’s own admission, the agency “does not have enough data presently to conclude that vitamin E acetate is the cause of lung injury in these cases.”
As mentioned earlier, the FDA is also investigating the role of a broad range of chemicals, including nicotine, THC and other cannabinoids along with cutting agents/diluents and other additives, pesticides, opioids, poisons and toxins.
That being said, Vitamin E acetate is the only agent singled out and heavily discussed in the FDA’s warning.
What Medical Marijuana Products Contain Vitamin E Acetate?
A number of Florida medical marijuana treatment centers (MMTCs), or dispensaries, have issued statements in response to the FDA’s warning.
While patients are encouraged to consult their state-licensed dispensary directly to confirm chemical profiles of any purchased products, available statements are highlighted below.
According to a statement published September 9 on AltMed’s Facebook page by Dr. Chris Witowski, Chief Scientific Officer at AltMed Florida:
We do not use other cutting agents such as coconut (MCT) oil, PG, VG, PEG, or the recently publicized Vitamin E acetate in any MÜV Vape Pens as these additives have been shown to be potentially harmful and even deadly.
Instead we use cannabis-derived terpenes in all of our vape pens to reduce the viscosity of cannabis extracts for vaping.
According to a public statement published on September 9:
Curaleaf and UKU vapable products do not contain Vitamin E acetate or any other Vitamin E derivative.
Curaleaf notes that “to date, Curaleaf has not received any reports from patients or customers regarding any adverse effects from vaping products manufactured by Curaleaf or UKU.”
A GrowHealthy representative issued the following statement on September 11:
We want to assure our patients and customers that we do not use Vitamin E acetate in the production of any of our inhalation products.
In addition, all of our products are tested by third-party, independent laboratories and comply with all applicable state laws.
GrowHealthy encourages concerned patients to email them at [email protected].
A Liberty Health Sciences representative confirmed on September 10:
We do not cut our vaporizer products with anything, including Vitamin E acetate.
Liberty Health Sciences also states that their products are very pure and that “Pax Era is one of the cleanest delivery systems on the market.”
According to a public statement published to Trulieve’s Facebook page on September 9:
We want to assure our patients and customers that we do not use vitamin E acetate in any inhalation product.
Trulieve encourages concerned patients to email them at [email protected].
A Vidacann representative confirmed on September 10:
None of our products contain Vitamin E acetate.
Our products only contain natural cannabinoids and terpenes.
CannaMD will continue to update this resource section as additional information becomes available.
For more MMTC-specific information, including contact details, please see: Florida Medical Marijuana Dispensaries.
What Are Experts Saying?
In a New England Journal of Medicine article published September 6, doctors in Illinois and Wisconsin reviewed 53 cases of vaping-related illnesses between April and August in those states and found that 84% of the patients reported having used THC products in e-cigarette devices.
According to the study:
The most common THC product that was reported was marketed under the ‘Dank Vape’ label.
Twenty-four of 41 patients interviewed said they used Dank Vapes, which – as Insider explains – are emerging as a “shadowy, black-market way to sell relatively cheap marijuana-based vapes in places where they may not be legal.”
On a September 6 CDC press call, Mitch Zeller, the director of the FDA’s Center for Tobacco Products, warned:
If you’re thinking of purchasing one of these products off the street, out of the back of a car, out of a trunk, in an alley, or if you’re going to go home and make modifications to the product yourself using something that you purchased from some third party or got from a friend, think twice.
What’s the Bottom Line for Medical Marijuana Patients?
To date, there have been over 450 possible cases of lung illness and five deaths associated with the use of e-cigarettes. (UPDATE: As of September 27, the number has risen to 805.) The FDA and CDC are currently investigating a number of factors that could contribute to adverse reactions, including: nicotine, THC and other cannabinoids along with cutting agents/diluents and other additives, pesticides, opioids, poisons and toxins.
Many of the samples tested as part of this ongoing investigation have been identified as vaping products containing THC and, further, most of those samples with THC also contained significant amounts of Vitamin E acetate.
While the FDA does not have enough data presently to conclude that Vitamin E acetate is the cause of the lung injury in these cases, the agency believes it is prudent to avoid inhaling this substance.
A number of Florida medical marijuana dispensaries have come forward to clarify that their products do not contain Vitamin E acetate.
In line with the FDA’s warning, CannaMD warns patients to avoid inhaling Vitamin E acetate and confirm with their dispensary that purchased products do not contain this agent.
While Vitamin E acetate is highlighted by the FDA’s initial warning as its main source of concern, CannaMD would also like to draw attention to the agency’s disclaimer that the FDA “does not have enough data presently to conclude that Vitamin E acetate is the cause of lung injury” in reported cases.
Patients are encouraged to review all available information, avoid inhaling Vitamin E acetate, and consult their doctors with any additional questions.
CDC Update: September 27, 2019
On September 27, 2019, the CDC updated their website to include the following language:
While this investigation is ongoing, CDC recommends that you consider refraining from using e-cigarette or vaping products, particularly those containing THC.
The update also notes that as of September 24, 2019 at 5pm, 805 lung injury cases associated with the use of e-cigarette or vaping products have been reported. All reported patients have a history of e-cigarette product use or vaping.
The CDC has received data on substances used in e-cigarettes or vaping products in the 30 days prior to symptom onset among 514 patients:
- About 77% reported using THC-containing products; 36% reported exclusive use of THC-containing products.
- About 57% reported using nicotine-containing products; 16% reported exclusive use of nicotine-containing products.
The specific chemical exposure(s) causing lung injuries associated with e-cigarette product use, or vaping, remains unknown at this time. No single product or substance has been linked to all lung injury cases.
According to the CDC:
More information is needed to know whether one or more e-cigarette or vaping products, substances, or brand is responsible for the outbreak.
For more details, please visit: CDC.gov.
Need to Switch to Medical Marijuana Vaping Products?
The FDA’s alert specifically warns against buying vaping products “from the street.” In fact, a Forbes article from September 3 suggests that dangers related to non-medical marijuana vaping products could even lead to federal cannabis legalization (which would allow regulatory boards to make sure harmful agents are not included).
According to Forbes:
Just like the days when alcohol was outlawed in the United States, back when thousands of people died every year as a result of tainted liquor produced in the underground, black market criminal organizations are counterfeiting popular cannabis brands.
These knock offs are being sold all over the country — even in states where weed is legal – and it could get worse before it gets better.