ASA Urges FDA to Implement Good Manufacturing Principles for Vaporization Products

Posted by on September 18, 2019

Washington, DC — In a letter to the heads of the U.S. Food & Drug Administration (FDA), the Centers for Disease Control and Prevention, and the U.S. Department of Health and Human Services, Americans for Safe Access calls for the safe regulation of vaporization products and cartridges. As part of its recommendations, ASA urges the FDA to use its regulatory authority to, at minimum, issue guidance that encourages consumers to only buy vaporization products in legal, licensed stores and not on the illicit market.

“The ongoing health crisis attributed to vaping highlights the need for regulations on issues such as third-party testing and accurate labeling,” said Heather Despres, Director of Americans for Safe Access’ Patient Focused Certification program. “For many medical cannabis patients, vaporization is a popular delivery method. Patients have a right to know what is in their medicine, and the FDA should recognize that the only way to prevent further health complications from vaping products is to allow a lawful, regulated marketplace for them to exist.”

ASA recommends that the FDA: 1) develop a recall and adverse event reporting procedure for cannabis and other vape cartridges consistent with other consumer protection laws; 2) promulgate good manufacturing practices for vape cartridges similar to those adopted by the American Herbal Products Association for plant-based material; 3) enforce OSHA guidance and other workplace safety regulations, including sanitization, for vape cartridge manufacturers; and 4) mandate that vape products undergo third-party laboratory testing and certification. 

To date, there have been 380 confirmed cases of lung illness and six confirmed deaths attributed to vaping products. However, there has been no consistent e-cigarette or vaping product, substance, or additive that has been identified in all cases, nor has any one product or substance been conclusively linked to lung disease in consumers.