In considering whether to initiate or continue an investigation, civil complaint, or criminal prosecution involving promotion of an unapproved use of an FDA-approved drug or device, the Department will prioritize matters involving promotion that is false, misleading, or encourages unapproved new uses likely to cause consumer harm. In any such matter, Department attorneys also should consult relevant Department resources and note that some courts have held that truthful, non-misleading commercial speech does not itself violate the FDCA.

[updated January 2021]