FDA Clarifies Tobacco Jurisdiction, Definitions

Angel Abcede, Senior Editor/Tobacco, CSP

FDA Headquarters

SILVER SPRING, Md. -- In an attempt to better define whether tobacco-derived products are intended for medical use or for more traditional, nicotine satisfaction, the FDA published an extended document this week, hoping to shed more light on its regulatory authority and what rules apply to different products.

The document titled, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding Intended Uses, recapped key points about regulation and discussed the comment phase of the FDA’s review process, agreeing with or refuting concerns raised.

Here are four distinctions the Silver Spring, Md.-based U.S. Food and Drug Administration made in its recently released document …

Tobacco vs. medical products

Tobacco products

A key distinction the FDA made in the document was to claim a larger authority over both conventional tobacco products and those tobacco-derived products with medical value.

It went on to define a “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).”

The rules governing tobacco products exclude tobacco-derived products defined as a drug, device or combination product, but the FDA has other rules covering those products.

In general, all of these regulations vary and fall under the jurisdiction of different agencies within the FDA, the agency said.

Medical defined

Nicotine patch

FDA officials said the potential for consumer confusion is increasing. “This is especially true when tobacco-derived products that may otherwise appear to be … intended for recreational use make claims related to quitting smoking and treatment of nicotine addiction,” the document said.

Here’s the FDA’s definition pertaining to medical products: 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.
  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 date when the U.S. Supreme Court upheld a lower court’s decision that the FDA could not regulate tobacco as a drug.)

Intended use and broad review

People reviewing documents

To establish a product’s intended use, FDA declared no limits, saying it “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.”

Mitigated risk


Much of the revised rules underscore the importance of clarity around “mitigated risk” products, and how consumer confusion may result with products claiming to be health-focused but only achieve reduced risk. An example would be a product that contains less tar than other products.

The health risks still exist, but are less hazardous compared to other products.

In its language, the FDA said, "While medical products approved/cleared for disease mitigation or prevention act affirmatively to combat a disease or health condition, [modified-risk tobacco products] present relatively less risk of disease (e.g., by presenting reduced exposure to harmful constituents relative to another tobacco product), but do not affirmatively act to mitigate, prevent or otherwise treat disease.”