Opinion ID: 458862
Heading Depth: 2
Heading Rank: 2

Heading: Approval for Wet Use

Text: 16 In October 1982, Searle filed a petition to amend the aspartame food additive regulation to include the wet use of aspartame. 47 Fed.Reg. 46140. The petition referenced, inter alia, the scientific data contained in the petition for approval of dry use. 48 Fed.Reg. at 31378. In July 1984, the FDA issued a final rule permitting aspartame to be used in carbonated beverages and carbonated beverage syrup bases. Id. at 31376 (July 8, 1983) (amending 21 C.F.R. Sec. 172.804 by adding Sec. 172.804(c)(6)). 17 On August 8, 1983, the Community Nutrition Institute (CNI), Woodrow C. Monte, Ph.D. (Monte) and Turner filed objections to the rule, and requested both a stay and a public hearing. The FDA denied the request for the stay. 48 Fed.Reg. 52899 (Nov. 16, 1983). On December 9, 1983, the Arizona Dietetic Association (Arizona) and the Central Arizona District Dietetic Association (Central) filed a Joinder of Petition, indicating they too objected to the rule. (We refer, hereafter, to these five individuals or organizations as Appellants.) Also on December 9, Monte filed a supplement to his objections. On February 17, 1984, the FDA denied their objections and requests for a hearing on the ground that the objections failed to raise any genuine or substantial issue of fact. 49 Fed.Reg. 6672 (Feb. 17, 1984). On April 17, 1984, four of the objectors filed a petition for review of the FDA's denial of the hearing and interim stay. We review the actions of the FDA in Section III below.