Are FDA Investigational New Drug (IND) applications needed for tobacco products like Electronic Nicotine Delivery Systems (ENDS)?
Generally, the default for an investigational product "made or derived from tobacco" is to submit an ITP to the FDA Center for Tobacco Products (CTP) instead of an IND. Examples are provided beginning with slide 35 of the
FDA Tobacco or Medical Product Training
These are the only two circumstances in which a product made or derived from tobacco will be subject to regulation as a drug, device, or a combination product:
- Use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms.
- The product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
If the IRB is ever unsure if a tobacco derived product needs an IND or not, they may ask the PI to seek guidance from the
cross-center FDA Nicotine Steering Committee
that is responsible for determining whether a study should be evaluated by CTP or one of the medical product centers at FDA.
