FDA proposes new requirements for makers of tobacco products aimed at minimizing contamination, protecting public health

American Heart Association photo illustration

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration is proposing new rules that are aimed at minimizing contamination of tobacco products, including electronic cigarettes, and that would create manufacturing specifications to ensure product consistency. 

“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” Brian King, director of the FDA’s Center for Tobacco Products, said in a news release. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

The proposed regulations aim to see that tobacco products are made according to established specifications and would require manufacturers to take appropriate measures to prevent contamination of the product. 

One regulation says companies that create products that don't meet those specifications will be investigated and be required to institute appropriate corrective actions, such as a recall. 

Another establishes the ability to trace all components or parts, ingredients, additives and materials, including by batch of the finished product, to aid in such investigations. 

"These requirements would help minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products," FDA said in its release. "The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids; such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins."

"The FDA says there have been inconsistencies between what’s in e-cigarettes and what’s on the label," CNN reports. Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told CNN he was disappointed by the timing of the proposed rule.

“The vaping industry has tried in vain for more than a decade to work with FDA on sensible manufacturing standards, only to be ignored while the agency recklessly vilified nicotine vaping,” Conley told CNN in an email. “It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market. The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal, but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”

The FDA will hold a public hearing April 12 about the proposed rule.