study notes: 2016

Friday 25 November 2016

Facts:

FDA asserted that it held the authority to regulate tobacco that fell within the category of restrictive drugs and devices. It promulgated laws related to the promotion, labelling and marketing of tobacco products. Respondents in an effort to challenge FDA’s authority filed suit. The court of appeals for the fourth circuit reversed the decision of the district court affirming Congress did not give FDA enough authority to regulate the tobacco industry.

Issue:

Did FDA have enough authority to regulate the marketing, labelling and promotion of the tobacco products?

Decision:

The court clearly affirmed that FDA was not granted ample authority by the Congress to regulate tobacco products. The authority asserted by the FDA did not sound sensible in the light of its responsibilities under the act.

Reasons:

If the act was considered in its entirety, Congress clearly intended to exclude the tobacco products from the jurisdiction of FDA. FDA’s responsibility remains to completely remove unsafe products from the market and the tobacco industry was significant to the national economy including interstate trade. So, Congress allowing FDA to regulate tobacco was not consistent with its overall regulatory scheme.