Filed April 25, 2011
C (Letter from FDA to Natural Wellness, LLC, dated October 5, 2010) (statements on product and website like ―ENHANCE YOUR PERFORMANCE,‖ ―enhance frequency and duration of sensual arousal,‖ and ―increases arousal . . . enhances the sensations‖ rendered a purported dietary supplement a drug within the meaning of 21 U.S.C. § 321(g)(1)). Finally, many of the Warning Letters also make clear that a product is not a dietary supplement if it contains a substance approved as a drug, since 21 U.S.C. § 321(ff) limits dietary supplement substances to an enumerated list of dietary ingredients, which does not include pharmaceutical agents. (See, e.g., RJN Exs.
Filed June 23, 2015
Statements in a manufacturer’s labeling about Case 1:15-cv-03588-PAE Document 51 Filed 06/23/15 Page 47 of 63 36 an unapproved use of an approved drug do not trigger the FDCA’s premarket approval requirements unless they “prescribe[],” “recommend[],” or “suggest[]” the unapproved use, thereby potentially showing that the use is an intended one. See 21 U.S.C. §§ 321(p), 355(a). Similarly, a manufacturer’s statements about unapproved uses do not render the drug misbranded for lack of adequate directions for use unless they establish, by themselves or together with other evidence, that the unapproved use is an intended one.
Filed November 14, 2011
Case 1:11-cv-01187-RMC Document 12 Filed 11/14/11 Page 51 of 52 42 unambiguous regulations, and has disregarded both prior precedent and the facts of the matter at issue in this case. In view of the above, we respectfully request that this Court: (1) set aside FDA’s determination that DSW is a combination product; (2) set aside FDA’s decision that the liquid component of DSW has a drug mode of action; (3) declare that DSW meets the definition of “device” and is a device under 21 U.S.C. § 321(h); (4) declare that FDA violated the FDCA in classifying DSW as a combination product; (5) declare that FDA illegally failed to initiate rulemaking before imposing its novel standard in classifying DSW; and (6) declare that FDA otherwise violated the APA in making its decision on DSW. Dated: November 14, 2011 Respectfully submitted, PREVOR By: ____/s/ Anne K. Walsh__________________ Jeffrey N. Gibbs (D.C. Bar No. 385294) John R. Fleder (D.C. Bar No. 176123) Anne K. Walsh (D.C. Bar No. 464858) Jennifer M. Thomas (D.C. Bar No. 987518) Hyman, Phelps & McNamara, P.C. 700 13th Street, N.W., Suite 1200 Washington, D.C. 20005 Phone: (202) 737-5600 Fax: (202) 737-9329 Attorneys for Plaintiff Case 1:11-cv-01187-RMC Document 12 Filed 11/14/11 Page 52 of 52
Filed May 31, 2017
Finally, a product would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time. See 21 U.S.C. 321(p)(1) and (2). As with the grandfather clauses, this has been construed very narrowly by the courts.
Filed December 22, 2014
5 Antiperspirants are over-the-counter drugs in addition to being cosmetics. See 21 U.S.C. § 321(g)(1); 21 C.F.R. § 350.1–3.
Filed July 22, 2013
In addition, DHEA is not an approved food additive or otherwise subject to a statutory exemption from the food additive requirements of the FDCA. See 21 U.S.C. §§ 321(s), 348(a).21 Nor is FDA aware of any basis for the general recognition of safety based either on scientific procedures or common use in food prior to January 1, 1958. See id.
Filed December 10, 2010
FDA’s decisions related to GRAS/E status, i.e., whether a drug is or is not a new drug, and challenges to FDA’s determination of what constitutes a new drug as defined by 21 U.S.C. § 321(p), are vested in the agency’s discretion. And it is long- and well-established that FDA has primary jurisdiction to determine whether a drug is GRAS/E within the meaning of 21 U.S.C. § 321(p)(1). Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973).
Filed November 27, 2019
See Case 1:19-cv-00531-LG-JCG Document 36 Filed 11/27/19 Page 7 of 24 3 id. § 387a(b). FDA thus “is left only with the discretion to determine” whether the requirements “articulated by the legislature apply” to “a narrow and defined category,” Ambert, 561 F.3d at 1214, of “tobacco products” defined in 21 U.S.C. § 321(rr). This is not the first nondelegation challenge to a statute structured in this way.
Filed October 30, 2015
A “label,” in contrast, is defined as “a display of written, printed, or graphic matter upon the immediate container of any article.” 21 U.S.C. § 321(k). A “label” is thus distinct from the “article”—here, a tobacco product—itself.
Filed October 5, 2015
§ 352(f)(1), 21 C.F.R. § 201.100(c)(1); or omits material facts, 21 U.S.C. § 321(n). Therefore, departing from the FDA-approved prescribing information, failing to include a scientifically valid warning FDA believes is necessary, or including warning information of purported risks not based on reliable scientific evidence, causes the medication’s labeling to be “false or misleading” and lacking “adequate directions for use,” and renders the product misbranded – in violation of the FDCA.