FDA CONCLUDES IT HAS JURISDICTION OVER CIGARETTES
Ruling Based on Legal Principle Established in ASH Litigation
Determination Follows ASH Threat to Sue FDA a Second Time
The Food and Drug Administration (FDA) has concluded that
it has jurisdiction over cigarettes because they contain nicotine,
which the FDA has concluded meets the definition of a "drug."
The ruling is based upon a new legal principle established
in a case entitled "Action on Smoking and Health v. Harris."
In that action the U.S. Court of Appeals held for the first time
that the FDA could determine that a substance is a "drug,"
even if the manufacturer did not make any drug-type claims in
advertising or promotion.
Instead, the court held, the agency could look at other evidence
of so-called manufacturer intent, including even the reasons why
people used the substance.
More than a year ago ASH filed a legal petition with the FDA,
asking it to assert jurisdiction over cigarettes containing nicotine,
the same way it has long asserted jurisdiction over chewing gun
and patches containing nicotine.
Then, when new evidence in the form of previously secret documents
from the Brown & Williamson Tobacco Company emerged to provide
even stronger evidence of manufacturer intent, ASH filed with
the FDA a 60-day Notice of Intent to Sue. The notice was filed
on June 15th, and required the FDA to act within 60 days or face
a law suit in federal court.
Law professor John Banzhaf, Executive Director of Action on
Smoking and Health (ASH), said that the suit may be filed even
though the agency has now declared its jurisdiction over cigarettes.
He said his organization will make that decision based upon
what concrete action the FDA decides to take.
ASH's legal actions in the past have required broadcasters
to make free time available for antismoking messages; upheld the
ban on cigarette commercials; forced the Occupational Safety and
Health Administration to propose a total workplace smoking ban;
and led to many of the protections now in place for nonsmokers.
FOR IMMEDIATE RELEASE: Thursday, July 13, 1995
FOR MORE INFORMATION, CALL: John Banzhaf (202) 659-4310
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