FDA Clarifies Scope of Deeming Rule?

The FDA Center for Tobacco Products has released a Final Rule, “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products” which intends “to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product. . . .”

Whether the Rule achieves its goal remains to be seen. The clarifications to the deeming Rule state,

Under the final rule, a product made or derived from tobacco and intended for human consumption is regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if 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. The final rule also clarifies remaining circumstances where a product is subject to regulation as a tobacco product.

One question that remains to be answered, Is the Internet a Tobacco Product?

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