Rather, FDA’s regulations provide that intended use “refer[s] to the objective intent of the persons legally responsible for the labeling of drugs.” 21 C.F.R. § 201.128; see also Nat’l Nutritional Foods Ass’n v. Mathews, 557 F.2d 325, 334 (2d Cir. 1977). Case 1:15-cv-03588-PAE Document 51 Filed 06/23/15 Page 26 of 63 15   misleading or evidence of intended use.

The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. 21 C.F.R. § 201.128. Such intent may even be shown where the article is, with the knowledge of its producer, being offered and used for a purpose for which it is neither labeled nor advertised.

(Compl. ¶ 232) (citing 21 U.S.C. §§ 331, 352; 21 C.F.R. §§ 201.57, 201.128; and 42 U.S.C. § 1320a-7b).

28). In fact, Dr. Phuntshog did not state that he understood 4 In addition, the FDA defines “intended use” as any use that its manufacturer “knows, or has knowledge of facts that would give him notice” is occurring 21 C.F.R 201.128. Case 6:09-cv-06168-TC Document 309 Filed 08/03/12 Page 13 of 18 PLAINTIFFS’ RESPONSE IN OPPOSITION TO DEFENDANT Page 14 PLIVA, INC.’S MOTION FOR SUMMARY JUDGMENT his long-term prescription was off-label when he wrote the prescription.

Promotion of OTC Plan B to women under the age of 16 would create an unapproved new drug, as would sale of the product "for a purpose for which it is neither labeled nor advertised" by persons legally responsible for its labeling. 21 CFR 201.128. 2. FDA Can Enforce An Age Limit As a Practical Matter Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 19 of 415 Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 11 Moreover, FDA can enforce an age limitation through a variety of measures. FDA routinely requests from drug applicants commitments to implement post-market surveillance and marketing plans.