FDA Final Rule: Is it a Drug/Device or a Tobacco Product?

FDA published its final rule clarifying what it considers to be the distinction between tobacco products, and products derived from tobacco that constitute a drug or device. This distinction is important because FDA has separate requirements and standards to which entities must adhere depending on whether they manufacture or sell tobacco products or they manufacture and sell drugs or devices.

That said, FDA has explained that a key distinction is the "intended use" of the product, however, FDA further explained that:

[t]o establish a product’s intended use, FDA is not bound by the manufacturer or distributor’s subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Thus, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold.


studies have shown that many consumers are using e-cigarettes to attempt to quit smoking [ ] despite the fact that no e-cigarette has been approved for use as a smoking cessation aid. We believe that the rule will help to mitigate this confusion and help ensure that consumers do not mistakenly use tobacco products, which are inherently dangerous, for medical uses.

Thus, if circumstances indicate that the product is intended for cessation or mitigation of addiction, it may be categorized as a drug or device.

Read the final rule here

For more information please contact Thomas Norby or Lindsey Streicher.

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