EVALI: What Manufacturers Have Long Been Saying, Finally Heard

Staff Report

The year 2019 has presented some challenges to the e-cigarette industry with reports of illness allegedly related to vaping coming out of the US, starting back in April. After months of investigations by relevant government agencies, their findings are in line with what industry manufacturers said all along – quality and safety are key: always buy products from reputable sources rather than questionable ones.

The US Centers for Disease Control and Prevention (CDC) reports that, as of November 20, 2019,  there were 2,290 cases of e-cigarette or vaping, product use associated lung injury (EVALI)  reported to CDC from 49 states (all except Alaska), the District of Columbia, and two US territories (Puerto Rico and US Virgin Islands). Forty-seven deaths have been confirmed in 25 states and the District of Columbia.

THC and vitamin E acetate

EVALI symptoms include severe shortness of breath, fatigue, and chest pain. Most patients reported a history of using THC-containing e-cigarette or vaping products. CDC tested bronchoalveolar lavage (BAL) fluid samples (fluid samples collected from the lungs) from 29 patients with EVALI submitted to CDC from 10 states, and identified vitamin E acetate, which is used as an additive, most notably as a thickening agent in THC-containing e-cigarette or vaping products, as a “chemical of concern” with EVALI as it was found in all of the samples.

THC was found in 82% of the samples, and nicotine was identified in 62% of the samples. CDC said no other chemicals that might be found in e-cigarette or vaping products, such as plant oils, petroleum distillates like mineral oil, MCT oil, and terpenes  (which are compounds found in or added to THC products) were found in the test samples.

Obvious recommendations

Following these findings, CDC recommended that people should not use THC-containing e-cigarette or vaping products, particularly from informal sources such as friends, family, or in-person or online dealers.

The agency also recommended that people should not add any substance to e-cigarette or vaping products that are not intended by the manufacturer, including products purchased through retail establishments.

The US Food and Drug Administration (FDA) previously issued a similar recommendation, back in September, saying consumers should “avoid buying vaping products of any kind on the street and to refrain from using THC oil or modifying/adding any substances to products purchased in stores”.

Industry’s stance

The FDA and CDC recommendations are in line with what leading manufacturers of e-cigarette or vaping products have already been doing.   

Dr. David O’Reilly, British American Tobacco’s (BAT) director of scientific research, said, “As one of the world’s largest vapor companies, providing high-quality products to more than nine million consumers, we take our consumer safety responsibilities very seriously. We apply industry-leading standards of quality and safety testing to the way we develop and manufacture our products all around the world.”

“Every single ingredient and component in these products has been scrutinized by our toxicologists for their suitability for vaping. Consistent with this, oils containing THC and vitamin E acetate are not, and have never been, added to our vaping products.”

“From FDA’s statements we have seen, these tragic events appear to be a new phenomenon linked to liquids that were not sourced from reputable manufacturers and which contained ingredients, including THC and vitamin E acetate, which we do not use.”

Dr Joe Thompson, group science and regulatory affairs director at Fontem Ventures, subsidiary off Imperial Brands Plc. and owner of blu, reiterates the same points.  “All of our blu vaping products, their ingredients, and the vapor produced undergo thorough scientific assessment prior to manufacture and sale. Our e-liquid ingredient selection is guided by toxicological principles and all our e-liquid ingredients undergo a rigorous assessment process. None of blu’s vaping products contain THC, vitamin E acetate, mineral oils, or animal fats.”

He went on to add that “blu has been an established business in the US for over 10 years and our message to concerned vapers is that they should purchase vaping products from reputable brands and retailers and ensure that products are properly sealed, packaged, and labeled.”

Regulations are vital

Contrary to what critics may want to believe, manufacturers of e-cigarettes or vaping products have been calling for regulations that would help establish clear guidelines and standards for the industry, which would result in high-quality, safer alternatives for adult smokers.

Fontem Ventures has called upon the World Health Organization (WHO) to recognize the growing evidence that vaping can make a significant contribution to tobacco harm reduction, as well as to encourage the world’s most populace countries, including China and India, to take a progressive approach to vaping regulation.

“We are encouraged by China’s recent decision to create a product standards-based regulatory framework for vaping, which would potentially enable hundreds of millions of smokers to access an alternative to combustible tobacco,” said Dr. Nveed Chaudhary, scientific & regulatory affairs senior manager at Imperial Brands, Fontem Ventures’ parent company.

BAT’s Dr. O’Reilly also pointed out the importance of effective regulation and enforcement to ensure product safety. “We fully support FDA’s view that vapers should always source their devices and liquids from reputable manufacturers, should avoid modifying or adding substances to the products they purchase, and should only ever use the devices as the manufacturer intended.”

“We are monitoring the situation in the US and will work closely with all relevant public health authorities around the world such as FDA, [CDC], and Public Health England.”

Breaking ban

In September, the current US administration announced a ban on flavored e-cigarettes and nicotine pods in the US, in response to reports of EVAL illness and deaths that were suspected to be linked to vaping, as well as to an increase in teen use. Two months later, however, at a meeting with top executives from the health community as well as the tobacco and vaping industries, the White House warned that a flavor ban would spawn counterfeit vaping products, pointing out how a “prohibition” would only increase the use of black-market products. 

It would seem that government and the industry are actually on the same page right now.