The FDA's Public Board of Inquiry and the Aspartame Decision
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The FDA's Public Board of Inquiry and the
Aspartame Decision
The Food and Drug Administration must resolve difficult scientific and
technological questions in promulgating and administering its regulations.'
During the 1960s the FDA encountered problems with its process for resolv-
ing scientific disputes.2 Hearings were perceived to be burdensome reveal-
ing a need for a more efficient process.' The FDA has since attempted to
improve its regulatory process by adopting summary procedures4 and by
implementing new regulations to govern its rulemaking and hearing
procedures.5 One new procedure is the public board of inquiry,' a body of
scientific experts that conducts hearings as scientific inquiries rather than
as adversarial proceedings.'
In 1980 the first public board of inquiry was convened to consider the
safety of the sugar substitute aspartame.' While the board withheld ap-
proval for aspartame,9 the FDA commissioner overturned the board's deci-
sion and gave final approval for the sugar substitute. The eight-year ap-
proval process demonstrates the difficulty of regulatory decisionmaking
and provides a context within which to examine the utility of the new board
mechanism.
I Some of the FDA's most controversial and difficult regulation involves products that
are suspected of causing cancer. For a discussion of regulatory problems of the FDA see
generally SUBCOHM. ON SCIENCE, RESEARCH, AND TECHNOLOGY, 96TH CONG, 2d SEss., THE FOOD
AND DRUG ADMINISTRATION'S PROCESS FOR APPROVING NEW DRUGS (Comm. Print 1980)
[hereinafter cited as FDA DRUG PROCESS]; COMM. ON AGRICULTURE, NUTRITION, AND FORESTRY,
95TH CONG., 1ST SESS., FOOD SAFETY WHERE ARE WE? (Comm. Print 1979) [hereinafter cited
as FOOD SAFETY]; FoodAdditives: Competitive, Regulatory, andSafety Problems: Hearings Before
the Select Comm. on Small Business, 95th Cong., 1st Sess. (1977) [hereinafter cited as Food
Additives].
2 See Hamilton, Rulemaking on a Record by the Food and Drug Administration, 50 TEX.
L. REV. 1132 (1972); Note, FDA Rule-Making Hearings: A Way Out of the Peanut Butter
Quagmire, 40 GEo. WASH. L. REV. 726 (1972). See infra note 17.
* See infra notes 16-30 and accompanying text.
'See infra note 22.
5 21 C.F.R. 5 12.32 (1983), authorizes parties to any proceeding subject to a formal hear-
ing to agree to a hearing before one of three alternatives: a public board of inquiry, an ad-
visory committee, or the commissioner. See R. MERRILL & P.B. HUTT, supra note 21, at 898-901.
6 21 C.F.R. § 13 (1981).
7 Id. § 13.30.
8 [1981 New Matters] FOOD DRUG CoSM. L. REP. (CCH) ([In the matter of] Aspartame) 38,124;
46 Fed. Reg. 38,285 (1981) (Commissioner's Final Decision) [Hereinafter cited as Final Deci-
sion]; [1980 New Matters] FOOD DRUG COSM. L. REP. (CCH) ([In the matter of] Aspartume)
38,072 (Board's Initial Decision) [Hereinafter cited as Initial Decision].
I Initial Decision, supra note 8, at 38,349.
10 Final Decision, supra note 8, at 38,734; 46 Fed. Reg. 38,285.
11 Searle petitioned the FDA in 1973 and got final approval for aspartame in 1981. Id. at
38,734-35; 46 Fed. Reg. 38,285.](ViewImageLocal?handle=hein.journals/indana58&div=29&collection=&method=preview&ext=.png&size=3)
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The FDA's Public Board of Inquiry and the Aspartame Decision
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