21 CFR 201.128 - Meaning of ''intended uses''
| Cite as | 21 CFR 201.128 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
124 practice notes
-
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
...a variety of factors such as circumstances surrounding the distribution of the product or the context in which it is sold (see, e.g., 21 CFR 201.128 (drugs), 21 CFR 801.4 (devices); see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)) and sales Some examples of materials intended ......
-
Food for human consumption: Food labeling Dietary supplements; effect on structure or function of body; types of statements, definition,
...refers to the objective intent of the manufacturer, which is not limited to a manufacturer's express representations. See Sec. 201.128 (21 CFR 201.128); NNFA v. Weinberger, 557 F.2d 325, 334 (2d Cir. 1977) (``the FDA is not bound by the manufacturer's subjective claims of intent,'' but may ......
-
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
...for other uses. In addition, FDA is taking the opportunity to make changes to existing regulations at Sec. Sec. 201.128 and 801.4 (21 CFR 201.128 and 801.4), and to conform them to how the Agency currently applies these regulations to drugs and devices Summary of the Major Provisions of the......
-
United States v. Regenerative Scis., LLC, No. 12–5254.
...treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” 21 U.S.C. § 321(g)(1); see also21 C.F.R. § 201.128 (providing that a drug's intended use is shown by “the objective intent of the persons legally responsible for the labeling of [the] dru......
Request a trial to view additional results
49 cases
-
United States v. Regenerative Scis., LLC, No. 12–5254.
...treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” 21 U.S.C. § 321(g)(1); see also21 C.F.R. § 201.128 (providing that a drug's intended use is shown by “the objective intent of the persons legally responsible for the labeling of [the] dru......
-
Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
...Finally, Plaintiffs argue that FDA's own regulations require evidence of manufacturer representations to establish intended use. See 21 C.F.R. §§ 201.128, 801.4 (defining "intended use" regarding drugs and devices, respectively).15 Although the regulations defining "intended ......
-
United States v. Facteau, Criminal No. 15-cr-10076-ADB
...§ 801.4 that defines "intended use" for devices. V.E. Irons, Inc. v. United States, 244 F.2d 34, 45 (1st Cir. 1957). Compare 21 C.F.R. § 201.128, with 21 C.F.R. § 801.4. Notably, the First Circuit applied the regulation to the case and affirmed the convictions without questioning ......
-
US v. Kasz Enterprises, Inc., Civ. A. No. 93-0455 P.
...The intended use of a product is determined by the vendor's objective intent in promoting, distributing, and selling the product. See 21 C.F.R. § 201.128; Sudden Change, 409 F.2d at 739. Objective intent can be demonstrated by, among other things, "labeling" claims, advertising ma......
Request a trial to view additional results
65 firm's commentaries
-
Off-Label Use – The Times They Are A Changin’
...from “express[ing]” an “intent” or merely “know[ing]” or having “notice” that its product “is to be used” off-label. 21 C.F.R. §§201.100, 201.128; see 21 U.S.C. §352(f)(1). Preliminary Injunction Motion at 2-3. Each step, the motion charges, is unconstitutional because there is no clear int......
-
Business Litigation Report -- April 2013
...Caronia’s alleged off-label promotional activities were unlawful based on Sections 331(a) and 352(f) of the FDCA and 21 C.F.R. §§ 201.5 and 201.128. The government argued that these sections, when read together, provide that a drug is misbranded if it is introduced into interstate commerce ......
-
Caronia, The Latest
...use.” U.S. br. at 6. That’s a distinction without a difference. An ancient FDA regulation (substantively unchanged since the 1950s), 21 C.F.R. §201.128, equates one with the other. Promoting (truthfully or otherwise) off-label automatically changes the “intended use,” and the new “intended ......
-
The First Amendment and Off-Label Promotion: United States v. Caronia
...Caronia’s alleged off-label promotional activities were unlawful based on Sections 331(a) and 352(f) of the FDCA and 21 C.F.R. §§ 201.5 and 201.128. The government argued that these sections, when read together, provide that a drug is misbranded if it is introduced into interstate commerce ......
Request a trial to view additional results