Food Regulation. Neal D. Fortin

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target="_blank" rel="nofollow" href="#ulink_89a43cb8-72f1-5e6b-8a8d-a97733c8e237">⁷¹ FD&C Act § 201(p) [21 U.S.C. § 321(p)].

      72 ⁷² FD&C Act § 505(a) [21 U.S.C. § 355(a)].

      73 ⁷³ “An otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect. See 107 CONG. REC. 5640 (1961) (comments of Sen. Kefauver). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible.” U.S. v Rutherford, 442 U.S. 544, 556 (1979).

      74 ⁷⁴ 21 U.S.C. § 352(f)(1).

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