Synopsis

The tobacco industry successfully challenged an FDA guidance document that changed the way that the agency administers the premarket review process.

Background

The Tobacco Control Act requires tobacco companies to receive authorization from the FDA before marketing new products (“premarket review”). One marketing “pathway” allows a company to market a new product so long as the applicant shows that the new product is essentially the same as already-marketed “predicate” product. These new products are known as “Provisional SE” products. On March 4, 2015, the FDA issued a guidance document making changes to the Provisional SE process, allowing manufacturers to identify Provisional SE products to serve as “predicate” products, potentially creating dozens of new permutations and potentially allowing many new products onto the market. For more information on this action and the implications for public health, see FDA Policy Puts Industry Interests Before Public Health. After some wrangling with major tobacco companies over the legality of the guidance, on September 8, 2015, the FDA reissued its guidance document without changing any of the underlying policies. One of those policies outlined when changes made to a product’s labeling required the company to obtain premarketing approval the product could be sold.

District Court Proceedings

On September 30, 2015, the industry filed a lawsuit challenging the FDA’s guidance document, claiming that the proposed approach to labeling changes infringed on the tobacco companies’ First Amendment Rights and that the guidance misinterpreted the Tobacco Control Act. In addition to refuting the merits of the industry’s claim, the FDA has also argued that the tobacco industry’s claims were not yet ripe for review because the industry has yet to suffer any harm based on its allegations.

On August 16, 2016, a district court judge found that the portion of the FDA’s guidance related to labeling changes exceeded its statutory authority by misinterpreting the Tobacco Control Act. The judge ordered the FDA to revise its guidance accordingly. The FDA’s revised guidance on this issue now indicates that “manufacturers need not receive premarket authorization for existing products that are subject to a label change only.”

Litigation Status

The FDA did not appeal this decision, making the district court’s decision final.