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.
Further reading:
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