Upcoming FDA guidelines to control e-cigarette use
Nextgen Pharma: Our Cannabis vaping products are safe
SAN JUAN — Given the recent alerts issued by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) on the use of e-cigarettes and their possible link to lung disease, one of the main pharmaceutical companies involved in the cultivation and manufacture of medical cannabis in Puerto Rico, Nextgen Pharma, reiterated that its products—including cannabis oil, which is inhaled via a vaporizer—are safe and free of hazardous chemicals.
In its most recent report, the CDC said that among patients that have reported a history of using e-cigarette products containing cannabinoids such as tetrahydrocannabinol (THC), the main active ingredient of cannabis, some have reported the use of e-cigarette products containing only nicotine, and others have reported using both.
“No consistent e-cigarette product, substance, or additive has been identified in all cases, nor has any one product or substance been conclusively linked to pulmonary disease in patients,” the CDC said.
“The extraction process we use is known as ‘CO2 extraction,’ through which—under a pressurized and controlled environment—positive substances are extracted from the plant. As part of this process, cannabinoids are extracted in the form of oil and their content is purified, eliminating any impurity and dangerous agent. They are also free of vitamin E acetate, a chemical used in the illegal cannabis market and that has been identified by the FDA as the potential link responsible for the lung diseases reported in other jurisdictions,” said Julián Londoño, founding partner of the local company.
Londoño also pointed out that the cartridges that are used for the packaging and use of these products are original, high-quality and free of hazardous chemicals. Also, oil extractions come from cannabis plants grown under the “best growing conditions, organically, without the use of chemicals or pesticides,” in accordance with the local regulatory framework.
“Nextgen Pharma is committed to the development of safe and quality products that promote the health and well-being of our patients. Our product development processes are guided by the highest standards of quality and reliability promoted by the pharmaceutical industry and the medical cannabis industry, and are regulated by the Puerto Rico Department of Health,” he added.
The Nextgen Pharma executive took the opportunity to urge medical cannabis patients to only consume products made legally in Puerto Rico.
On Sept. 12, 2018, the FDA published a release outlining the latest efforts to control the multibillion-dollar vaping industry’s marketing and sale of e-cigarettes to minors, adding that sanctions could include a possible ban on flavored liquids that are used in vaporizers, known as e-liquids. That ban came closer to happening Wednesday.
Health and Human Services Secretary Alex Azar announced that the FDA will request e-cigarette flavors, except tobacco, to be eliminated.
The reason is that the use of e-cigarettes and the practice of vaping among minors have reached epidemic levels. However, attention has recently been focused on Juul-branded vapes, which have been on the market for less than three years and are raising concern over their safety and potential to lead minors to use regular cigarettes or other illegal drugs.
Although no single device, ingredient or additive has been identified, many cases involve marijuana vaping, according to the Associated Press, which added that the restrictions would only apply to nicotine vaping products.
Juul said it would “fully comply with the final FDA policy when effective,” the AP reports.
Legislature to investigate
Faced with the dramatic increase in the number of people diagnosed with severe respiratory diseases from using vaping devices stateside, Puerto Rico Rep. Maricarmen Mas Rodríguez introduced a resolution to investigate the use of e-cigarettes in Puerto Rico.
“In the United States, about 450 possible cases of severe respiratory diseases related to vaping have already been identified, not to mention the six deaths attributed directly to this practice. That is why it is worthwhile to investigate what is happening with this in Puerto Rico to develop an early intervention plan and to regulate this modality even more,” Mas said in a statement.
She noted that health authorities in New York are focusing on vitamin E acetate, which has been used recently as a thickener in vaping cartridges.
“We have doubts, for example, about chemical substances in vaping devices such as formaldehyde, which some studies have indicated can cause cancer. There are also other chemicals, such as propylene glycol and vegetable glycerin, which we still do not know its real long-term effect. There are many questions and that is why we want to do this investigation, the people have to know what they are exposed to with these devices,” the lawmaker said.
The CDC warns that aerosols produced by e-cigarettes “can contain harmful or potentially harmful substances, including heavy metals such as lead, volatile organic compounds, ultrafine particles, cancer-causing chemicals, or other agents such as chemicals used for cleaning the device.”
—CyberNews contributed to this report.