793-94 (E.D.Mo. 1976), aff'd mem., No. 76-1554 (8th Cir. 1977).
This Court finds further support for classifying the
ingredients of these dietary or nutritional supplements as
food additives. First, it is a well-established canon of
statutory construction that the plain meaning of the statute
is dispositive if it is clear and unambiguous and not contrary
to legislative intent. See United States v. Ron Pair
Enterprises, Inc., 489 U.S. 235, 242, 109 S.Ct. 1026, 1031, 103
L.Ed.2d 290 (1989). This Court finds it clear that both CoQ1O
and Germanium satisfy the plain meaning of the "component"
requirement of the food additive definition because they are
one or two of several ingredients in each of the dietary
supplements produced by claimants. Moreover, "remedial
legislation such as the Food, Drug and Cosmetic Act is to be
given a liberal construction consistent with the Act's
overriding purpose to protect the public health. . . ." United
States v. Bacto-Unidisk, 394 U.S. 784, 89 S.Ct. 1410, 22
L.Ed.2d 726 (1969). See also United States v. Nova Scotia Food
Prods. Corp., 568 F.2d 240, 246 (2d Cir. 1977) (citation
Just as it is clear to this Court that the plain meaning of
the food additive definition is not ambiguous, the Court is
also convinced that it is not contrary to the intent of
Congress. The most valuable piece of legislative history is a
congressional committee or conference report on the bill.
National Ass'n of Greeting Card Pubs. v. United States Postal
Serv., 462 U.S. 810, 832 n. 28, 103 S.Ct. 2717, 2731 n. 28, 77
L.Ed.2d 195 (1983). The 1958 House and Senate Committee Reports
accompanying the bill which today is 21 U.S.C. § 321(s)
explains that "[t]he legislation covers substances which are
added to food." H.R.Rep. No. 2284, 85th Cong., 2d Sess. 3
(1958); S.Rep. No. 2422, 85th Cong.2d Sess. 5 (1958).
Claimants contend, however, that the Food Additive Amendment
was enacted to restrict only the use of chemical substances in
the processing and preservation of food and cite fragmented
excerpts from congressional hearings to support this premise.
However, "[a]lthough Congress was primarily concerned with
substances used by a food processor, neither the language nor
the history of the . . . Act limits its application to such
substances." United States v. Ewig Bros. Co., Inc.,
502 F.2d 715, 722 (7th Cir. 1974) (footnote omitted).
The legislative intent to treat nutrients as food additives
is further evidenced by the action of Congress in 1976 when,
in amending the Act, the Senate excluded a provision
prohibiting the FDA from regulating vitamins, minerals and
associated ingredients as food additives, explaining: "[T]here
are some nutrients and ingredients or natural chemicals which
are tangentially a part of vitamins or minerals which
currently may be considered food additives because of their
potential toxicity. We did not wish to prevent the FDA from
acting in these circumstances." National Nutritional Foods, 572
F.2d at 392 (quoting S.Rep. No. 94-509, 94th Cong. 1st Sess.
Finally, even if, arguendo, the language of the statute were
ambiguous on the question presented here, the Court must defer
to the FDA's construction of the statute if it is
"permissible." Rust v. Sullivan, ___ U.S. ___, 111 S.Ct. 1759,
1767-69, 114 L.Ed.2d 233 (1991); Chevron U.S.A., Inc. v.
Natural Resources Defense Council, Inc., 467 U.S. 837, 842-43,
104 S.Ct. 2778, 2781-82, 81 L.Ed.2d 694 (1984) (footnote
omitted). However, in determining whether a particular
construction is permissible, "the court need not conclude that
the agency construction was the only one it could permissibly
have adopted . . . or even the reading the court would have
reached if the question initially had risen in a judicial
proceeding." Chevron U.S.A., Inc., 467 U.S. at 843 n. 11, 104
S.Ct. at 2782 n. 11. This Court finds that the FDA's
interpretation of CoQ10 and Germanium as food additives is, at
the very least, permissible and thus takes precedence over the
interpretation offered by claimants. Accordingly, claimants'
motion for summary judgment must be denied and plaintiff's
cross-motion for summary judgment must be granted.
For the reasons set forth above, claimants' motion for
summary judgment is denied and plaintiff's cross-motion for
summary judgment is granted. The Clerk of the Court is
directed to enter judgment for the United States of America.
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