The Food and Drug Administration has released a draft compliance and enforcement document for vape shops falling under the deeming rule, where all shops that ‘create or modify these products are considered manufacturers under the FD&C Act and, therefore, are responsible for complying with the requirements under the law that apply to manufacturers’.
By opening a draft document to the public, the FDA offers an opportunity to educate newly-deemed retailers before such an enforcement and compliance goes into effect. The document outlines: ‘definitions, the FDA’s interpretation of and compliance policy for the label requirement in section 903(a)(2)(C) of the FD&C Act, which vape shop activities subject vape shops to certain requirements of the FD&C Act, and the limited circumstances under which FDA does not intend to enforce compliance’.
It is worth noting that the FDA intends to include ‘any establishment that performs the described activities, such as stores that sell hookah (waterpipes) or pipes’. Business owners should be aware of the impending compliance laws and their enforcement provisions. For more, read the FDA’s release linked at the top of this description.