VAPE OIL ADDITIVES – CUTTING AGENTS, THICKENERS, THINNERS, PRESERVATIVES, FLAVORS, COLORANTS – AND CART COMPONENTS ARE NOT REQUIRED TO BE TESTED OR LISTED(WITH THE RECENT EXCEPTION OF MASSACHUSSETTS)
Compiled by Jason Keehn
Welcome to an open research doc with clustered links, quotes & mild commentary. Not quite a live blog, but will try to keep updating every couple days. Updated 9/28.
The Science – What Is Known So Far
Current Case Reports
Past Relevant Research
Breakdown Products of Common Terpenes and Additives
Vitamin E Acetate Formaldehyde
Mass Media Stories (Descending Order of Usefulness)
Addendum: Forward Options for Regulators
As of 9/27, 13 deaths; closing in on 1000 cases to date, “more expected”; 38 states affected, including dozens in CA, but, so far, seems mostly concentrated in states with no medical or adult use program. Most patients report having purchased illicit product.
Trump Wants to Ban Flavored E-cigs
House Hearing with CDC on 9/24, Senator Durbin threatens to hold a separate hearing shortly; FDA asks for 3 weeks to design guidance (or by May 2020 – conflicting info);
Vape oil additives – cutting agents, thickeners, thinners, preservatives, flavors, colorants – are neither tested for nor banned in any legal state, currently; states don’t set recommendations on dilution ratios; and there is relatively little long term health research on aerosolized terpenes or other additives.
Latest State Actions:
MI bans flavored e-cigs
NY subpoenas 3 vape brands, moves to ban e-cigs as well
CA DPH issues harsh warning, and Newsom authorizes $20M education campaign and warning notices to be posted on retail storefronts
Mass mandates all ingredients to be listed on labels
WA asks retailers to review all product, threatens recalls; sets 21 year age limit for vaping purchases
Hawaii goes after… CBD and… gummies?!
OR issues guidance, retailers to post warning letter and report any novel / suspicious ingredients
First marker identified by Univ of Utah – “lipid-laden macrophages”.
Most cases seem to involve both THC and nicotine use; most in NY involve Vitamin E Tocopheral Acetate (synthetic chemical), and it appears implicated in cases in other states as well – but medical authorities are not ruling out other additives, synthetic cannabinoids or interactions.
Various sources suggest inverted ratios of THC/DBD to additives may be standard in street carts – from 70 THC extract /30 diluents, to 30/70, for example.Even terpenes at high concentrations could be a problem.
California licensed operators ConstanceTherapeuticsand WercShop both issue statements — Constance has a patent on plant-based ALPHA-Tocopherol, and deems it safe for human use in their formulations. WercShop was using a trace amount of Alpha-Tocopheral from a plant source as a stabilizer in its patented, proprietary “Nexus 2.0” formulation, but has now stopped. TrueTerpenes states it does not currently use Tocopheral Acetate, denying anonymous claims and testing results on Reddit. Various licensed prominent brands declare they use only 100% cannabis and terpenes. Honeycut, a LA-based supplier of Vitamin E, has taken its website down.
Some scattered research exists on aerosolized Tocopheryl, one study indicates the Alpha version may be beneficial and the acetate version dangerous.
Best place to start if you’re not already following all this closely — David R. Downs’ coverage (@davidrdowns):
CADPH 9/24 Major statement:“We are seeing something that we have not seen before… There are numerous unknown factors at this time, and due to the uncertainty of the exact cause, it is our recommendation that consumers refrain from vaping until the investigation has concluded… do not discard any used vaping cartridges you might have, as CDPH is interested in testing the remaining substance in used cartridges. Those cartridges are being collected by local health departments and sent to CDPH labs for analysis.”
NY State DOH: Update on Investigation into Vaping-Associated Pulmonary Illnesses / Department Warns Against Use of Black Market Vaping Products / Lab Test Results Show High Levels of Vitamin E Acetate, Now Focus of Investigation 9/5
Sen. Durbin Calls on FDA Acting Head to Act on VAPI or Resign –Senate Hearing in One Week, Durbin-authored Cannabis Research and Down-scheduling Bill to be Fast-Tracked in Congress? 9/6 –“Most e-cigarette brands sold in the U.S. are legal, but none of them have been subject to FDA review, leaving a regulatory gray area as more and more products flood the market. The agency gained the authority to regulate tobacco products in 2009, but it wasn’t extended to vaping products until 2016. When the Trump administration took over in 2017, the FDA decided to delay enforcing the laws until 2022, much to the frustration of public health groups… If the FDA had acted initially, Durbin argued, “many of these e-cigarette devices and flavors would not be on the market, countless numbers of children would not now be addicted to nicotine, regulations would be in place to help prevent against the adulteration of e-cigarette devices, and we would have far better information about the short- and long-term health consequences of vaping.”
“Floraplex CEO Alec Riffle told Leafly he estimates “50 MILLION” US carts may contain something labeled “Vitamin E oil” – One thickener maker previously boasted that his product was “a far healthier alternative” to other diluents. This week the product disappeared from the company website. Jones notes that the thickener is not subject to any state or federal regulations. There is nothing “to keep you from putting this in every head shop, gas station, dispensary in the country,” he says. “It tastes great, and to be honest with you, it tastes better than any e-juice on the market. … We’ve made juices out of this that are amazing. This product right here is going to revolutionize the e-juice industry.”
CNBC Documentary – “CNBC’s Carl Quintanilla investigates the rapidly growing and controversial e-cigarette industry, a market expected to hit $9 billion by the end of 2019. CNBC gets unprecedented access inside Juul Labs, a company whose innovative product design and marketing have made it the industry leader as well as a lightning rod for criticism that vaping companies are luring teenagers into nicotine addiction. While some believe e-cigarette sales should be restricted to protect kids, others claim stricter regulation could cost the lives of many adult cigarette smokers struggling to kick their deadly habit. In “Vaporized,” CNBC explores the raging debate: are e-cigarettes a curse or a cure?
Former FDA Head Gottlieb Defends his Tenure at FDA From Durbin’s Attack w WaPo OpEd – Scott Gottlieb: E-cigarettes are not off the hook “The established e-cig brands and the vape stores that mix legal e-liquids have been regulated by the Food and Drug Administration since summer 2017 (when I was the agency’s commissioner) for their ingredients, marketing and labeling, among other features. Since putting this framework in place, the agency has conducted more than 1,000 inspections of these businesses. … Manufacturers need to separate legitimate e-cigs from illegal adulterants by publishing detailed information on their ingredients, by taking meaningful steps to limit youths’ access to their products and its appeal to them, and by fully embracing an FDA application process that they’ve largely fought.”
Twitter thread from pharmacist -Eliana Golberstein Rubashkyn “I can see that nobody in the media and not many Drs understand the chemistry of surfaces and membranes, and this is key to understand why Vit E is so toxic when inhaled. This happens due to a physico-chemical process known as surface physio sorption by lipophilic bonding. // Having in mind the #tensioactive properties of substances is key to harm reduction in #vaping e-liquid formulations with cannabinoids, we need to respect the chemistry of our lungs and be rational in a product’s formulation. #VitaminE and #MCT are terrible ideas for a safe #Vape. // MCTs and #VitaminE are terrible thickening aids for cannabinoid #vaping formulations. Their tensioactive properties cause #occlusion in the lungs membranes (Here the Vit E and its lipophilic structure compare it to an MCT)…. Occlusion of cells by lipophilic bonding therefore induces Lipoid pneumonia like conditions. That triggers apoptosis by a sudden elevation of free radicals in the mitochondria which is involved in cellular respiration.”
Vaping’s Plausible Deniability Is Going Up in Smoke / Ongoing FDA investigations and a spate of hospitalizations show that “safer than cigarettes” does not mean safe.” Advocates for the nicotine-vaping industry have been quick to point to black-market cannabis products as the real source of health problems, which they claim are being used misleadingly by anti-tobacco advocates to fuel their own crusades. But that argument belies the fundamental lack of information available when evaluating nicotine vaping’s impacts on health and its potential interactions with other drugs. Many of the people who are known to have fallen sick this summer use nicotine vapes in addition to cannabis, and it’s possible that lung irritation caused by frequent use of nicotine e-cigarettes could hasten or worsen the impacts of chemicals found in black-market cannabis products.”
Looming E-Cig Ban in NY State – Cuomo on the attack… “The companies being served with subpoenas and their product names are: Honey Cut Diluting Agent by Honey Cut Labs LLC in Santa Monica, California; Uber Thick by Floraplex Terpenesin Ypsilanti, Michigan, and Pure Diluent by Mass Terpenes in Amherst, Massachusetts, state officials said. … Business selling vaping products in New York will also now be required to post a warning sign declaring the health risks of vaping, Cuomo said Monday, calling it a “risky adventure and risky activity.””
Move rapidly to mandate additives testing (but standards and methods need to be developed)
Require a detailed list of all ingredients and additives (as in Massachussetts)
Set limits for some additives/dilutants and even added terpenes, individually or in aggregate
Require testing and health data from companies before introducing new cutting agents not on an “approved list”
And, possibly, outright bans.
FDA/NIH/NIDA will fund research on long-term health effects of aerosolized vape oil ingredients, terpenes, and vape trace metals, as well as testing analytics methods – university researchers, prepare your grant applications now!
Will this crisis push FDA to now coordinate and oversee the state-level manufacturing and testing standards for legal cannabis – but can it do so without new federal legislation?
(Stay tuned for our more detailed article forthcoming in the premiere issue of theJournal of Endo-Cannabinoid Medicine)