The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.
Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.
In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.
For example, rather than conducting reviews in a silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.
“It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.
“Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”