To market a vape or oral pouch containing nicotine, a company must first receive written authorization from the FDA called a Marketing Granted Order (“MGO”). Tobacco products that were on the market as of 2/15/2007 are exempt from this law, but no brand of vape or oral pouch was available then. Thus, every brand of vape and oral pouch must receive an MGO to be sold anywhere in the US. All permit holders and their employees are required to comply with local, state and federal laws, rules, regulations, and requirements, including the requirement for MGOs. The following are attachments which include the recommended protocol for addressing vaping products and oral nicotine pouches that do not have an MGO, including links to a website where the few electronic cigarettes and oral nicotine pouches that have been authorized are listed; a recommended template letter to your retailers; and a letter from the FDA regarding MGOs. Like all guidance, this is not to be construed as legal advice. You should bring this matter to your municipal counsel prior to any action. The protocol cites a case that discusses some of the relevant legal issues.
If you require more information contact:
Cheryl Sbarra, Esq., Executive Director and Senior Staff Attorney, Massachusetts Association of Health Boards
sbarra@mahb.org
Christohper Banthin, Esq., Program Manager, Public Health Advocacy Institute,
chrisbanthin@phaionline.org
Lisa Stevens-Goodnight, Esq., Tobacco Control Director, Massachusetts Municipal Association,
lstevensgoodnight@mma.org
For a draft letter for retailers, guidance document for health departments, and FDA correspondence, please click below to visit the Resources tab on the MHOA Tobacco page.