FDA released proposed regulation that would allow sponsors to determine if their product is a drug/device, or if it is not a drug/device.
Last week, the Agency announced a proposed rule “to provide clarity regarding the types of intended uses of products made or derived from tobacco that may fall within the drug/device definitions and therefore cause those products to be regulated as medical products under the FD&C Act.”
By definition, the term ‘tobacco product’ includes “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” The definition does not include drugs, devices, or combination products; thus, they are subject to regulation as such rather than as a tobacco product, even when the product in question is made or derived from tobacco.
Due to the ambiguity around when a product made from tobacco is subject to regulation as a drug, device, or combination product and when it is subject to regulation as a ‘tobacco product,’ FDA is suggesting that the interpretation of drug and device definitions (regarding tobacco) is in need of clarity, and, as such, is proposing to amend the definition of “intended use” with regards to drugs and devices. If finalized, the rule will “increase clarity regarding the types of claims and other evidence that make a product made or derived from tobacco subject to regulation as a drug, device or combination product, helping consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses.”
The proposed rule will:
- Provide clarity regarding the types of intended uses of products made or derived from tobacco that may fall within the drug/device definitions and therefore cause those products to be regulated as medical products under the FD&C Act.
- Reduce consumer confusion regarding which products are intended for medical use (i.e., as a drug, device, or combination product) and which may be marketed for recreational or other purposes.
- Amend the existing intended use regulations for drugs and devices to clarify the interplay among these regulations and this proposed rule.
Under this proposed rule, there are two circumstances in which a “product made or derived from tobacco would be excluded from the definition of “tobacco product” and be subject to regulation as a drug, device, or combination product,” including:
- 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
- If the product is intended to affect the structure or any function of the body, in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
Regarding the Agency’s definition of “intended use,” the document states that “intended use may be determined from any relevant source and is not based solely on claims made in a product’s labeling or advertising materials.” For more details, view the full document here.
In general, the proposed rule primarily addresses the circumstances in which a tobacco product would be considered to have an intended use that triggers regulation as a drug or device. The changes to this would provide clarity on various aspects of the Agency’s approach to assessing the intended use of a drug or device. FDA is asking industry professionals to review the proposed changes and to submit comments within 60 days of the announcement that was made on the Federal Register (comment period closes on November 24, 2015).
Do you have a tobacco product that is either developed or still in the process of being developed? Not sure if your product is considered a drug/device or not? We can help classify your product and ensure that you are compliant with the FDA regulations. We have a history of working with various tobacco and e-cigarette products, and using our unique approach that combines scientific knowledge with regulatory expertise, we have been able to successfully help our clients get through FDA. To learn more about our tobacco and e-cigarette services or for more information on how we can help you, email us here.