Last Friday, January 10, the FDA sent out an e-mail announcing the availability of a “Safety Reporting Portal” for consumers and health care professionals to inform the FDA when they believe there is an unexpected health or safety issue with tobacco products. The announcement goes onto state that the FDA will accept reports about cigarettes, roll-your-own tobacco, smokeless tobacco, cigars, electronic cigarettes and any other products made or derived from tobacco.
After reviewing the announcement, NATO had several questions for the FDA about the scope and purpose of the expansion of the “Safety Reporting Portal” to include all tobacco products. For that reason, NATO has asked the FDA the following questions:
1. Why is the FDA allowing consumers and health care professionals to submit reports about cigars, electronic cigarettes and any other products made or derived from tobacco when the agency has not yet exercised regulatory authority over these kinds of tobacco products?
2. What legal or regulatory basis is the FDA relying on to allow the Safety Reporting Portal to receive reports on cigars, electronic cigarettes and any other products made or derived from tobacco?
3. What action or actions does the FDA have the authority to take if the agency receives a report through the Safety Reporting Portal regarding a tobacco product?
4. Does the FDA have the regulatory authority to take the following kind of actions:
A. Pursue action through the Department of Justice in federal court to remove tobacco products from the marketplace?
B. Seek a restraining order against a manufacturer or distributor to prohibit the sale and distribution of a particular tobacco product?
C. Issue a voluntary or mandatory recall notice to a manufacturer to recall a particular tobacco product?
According to the FDA’s e-mail message, the agency is “interested in reports from consumers about tobacco products that are damaged, defective, are contaminated (such as cigarettes containing mold), or [have a] smell or taste wrong. Also, FDA wants to know if tobacco product users have experienced an unexpected health or safety problem they believe has been caused by use of a particular tobacco product,” which could include:
- Reports of fire caused by a tobacco product use
- Burns or other injuries
- Accidental or unintended exposure of children
- Allergic reactions
- Poisonings and other toxicities
- An unusual reaction in a long-time user.
Other possible problems with tobacco products that the FDA is asking health professionals and consumers to report are:
- Problems with labeling, packaging or instructions for use
- Tobacco product mix-ups
- Quality problems, such as unexpected appearance, smell or taste, foreign objects in the product or other possible contamination, or a defective or malfunctioning product.
NATO has submitted its questions to the FDA about the agency’s authority to solicit reports about cigars, pipe tobacco, electronic cigarettes and hookah tobacco even though the agency’s webpage on this matter states the following:
“FDA is interested in building a comprehensive tobacco regulation program that ensures all tobacco products have an appropriate level of regulatory oversight.One part of this process includes understanding the types of adverse events being experienced by consumers of tobacco products.
FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA can accept voluntarily submitted information related to all tobacco products and how they are functioning in the marketplace under the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. To that end, FDA is also encouraging reports of problems associated with new types of tobacco products, such as electronic cigarettes and hookah.
FDA will review and evaluate reports and may take steps, as appropriate, to ensure that the public health is protected.”
The link to the FDA’s webpage on the Safety Reporting Portal announcement is below:
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