Thursday, September 19, 2019

ASA Urges FDA to Implement Good Manufacturing Principles for Vaporization Products

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.

September 18, 2019 |  Reenal Doshi
About Reenal Doshi: 
Reenal Doshi, Director of Outreach and Communications
phone: (202) 857-4272 x. 4

Reenal Doshi has more than 13 years of experience in health policy and communications at the global, federal, state, and nonprofit levels. She holds a Bachelor of Science degree in Community and Public Health and a Master of Public Health degree. She worked in the government relations department of a health advocacy organization to increase awareness of global health issues in Congress by tracking federal legislation, performing outreach, and meeting with Members of Congress and their staff. She has also worked in Congress in legislative, press, and caseworker positions.

As a health fellow for the World Health Organization in Geneva, Switzerland, Reenal carried out research and created communications materials for the United Nations. Reenal also served as a delegate for the health sector at the United Nations Summit on Sustainable Development in South Africa, where she helped write a position paper that was read at the UN General Assembly.

Most recently, she worked in the office of policy and compliance for the State of Maryland’s Department of Health and Mental Hygiene.