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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations fact that there was no labeling may actually bolster the evidence of an intent to sell a mind-altering article without a prescription-that is, a misbranded drug. citations omitted;
United States v. Vascular Solutions, Inc., 181 F. Supp. 3d at 347 the position that evidence of objective intent is limited to statements published to the marketplace is absurd; see also United States v.
Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 n.5 9th Cir.
1985 concluding that products innocuously labeled as incense and not for drug use were in fact drugs where the overall circumstances demonstrated vendors intent that products be used as cocaine substitutes;
United States v. An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 7th Cir. 1984 intended use established in part by witness testimony that device had been used to treat patients, together with other evidence regarding a training program and financial arrangements offered by the defendant; United States v.
Undetermined Quantities of an Article of Drug Labeled as Exachol, 716 F.
Supp. 787, 791 S.D.N.Y. 1989
explaining that FDA is not bound by the vendors subjective claims of intent and that an article intended to be used as a drug will be regulated as a drug . . . even if the products labelling states that it is not a drug;
United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F.
Supp. 1159, 1165 D. Utah 1989 The objective intent referred to in the regulation may be shown not only by a products labeling claims, advertising or written statements relating to the circumstances of a products distribution, . . . but also by a products actual use. See H.R. Rep. No. 853, 94th Cong., 14 1976. . . . There also can be no dispute that the sterilizer, in its actual use, plays an integral role in the surgical treatment of patients.; Hanson v. United States, 417 F. Supp. 30, 35 D.
Minn. 1976 finding plaintiffs beliefs that many people will die if they are deprived of the tablets and vials at issue relevant to establishing intended use, affd, 540 F.2d 947 8th Cir. 1976;
United States v. Device Labeled Cameron Spitler Amblyo-Syntonizer, 261 F. Supp. 243, 245 D. Neb. 1966
While claimant contends that the machines have not been represented as a cure for any particular eye malfunction, he admits the use of them in the treatment of certain eye maladies.
Clearly, the seized machines are each a device within the meaning of 321h..

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Although one comment cited to several cases that relied only on promotional claims as evidence of intended use, only a very few, if any, cases have actually excluded non-claims evidence from consideration as evidence of intended use on the ground that the evidence was not promotional.
The presence of claims may be particularly significant in determining intended use where a product, such as honey, does not have a therapeutic benefit or physiological effect see, e.g., United States v. An Article . . . U.S.
Fancy Pure Honey, 218 F. Supp. 208, 211 E.D. Mich. 1963 claim that honey is a panacea for various diseases and ailments established the intended use as a drug, affd, 344 F.2d 288 6th Cir.
1965. But the converse is not truethe absence of claims on a product that does have a physiological effect will not automatically render the product immune from FDA jurisdiction see, e.g., United States v. Carlson, 810 F.3d 544 8th Cir. 2016 synthetic drugs, such as synthetic marijuana, labeled as incense, herbal incense, herbal potpourri, bath salts, etc., and that also bore the statement not for human consumption, found to be subject to FDAs jurisdiction as drugs.
As FDA has explained, limiting evidence of intended use to only promotional claims would allow manufacturers to circumvent FDA
regulation by masking their true intent, either by simply omitting explicit promotional claims or by making claims that are not true for example, not for human use. See 82 FR 14319 at 14321
through 14322 March 20, 2017; 82 FR
2193 at 2196 January 9, 2017; 80 FR
57756 at 57757 September 25, 2015.
As courts have recognized, selfserving labels cannot be allowed to mask the vendors true intent as indicated by the overall circumstances.
United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 n.5 9th Cir. 1985. This is an issue that comes up frequently with respect to products in domestic commerce as well as imported goods and has resulted in FDA-issued warning letters, import refusals, civil injunction actions, and criminal prosecutions. FDA
believes it is worth repeating the following previously cited examples, see 82 FR 14319 at 14321 through 14322
March 20, 2017, of the types of situations in which evidence of intended use has been derived from sources other than explicit promotional claims:
Persons distributing substances that are known to be used recreationally to achieve a mind-altering effect, such as dextromethorphan the active ingredient
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in some cough suppressants and nitrous oxide which is a prescription drug see, e.g., United States v.
Johnson, 471 F.3d 764, 765 7th Cir.
2006; United States v. Schraud, 2007
U.S. Dist. LEXIS 89231, 36 E.D. Mo.
December 4, 2007; United States v.
Travia, 180 F. Supp. 2d 115, 119 D.D.C.
2001; United States v. LA Rush, 2:13cr00249, First Superseding Information C.D. Cal. April 3, 2014.
Persons distributing synthetic drugs, such as synthetic marijuana, labeled as incense, potpourri, bath salts, and/or bearing the statement not for human consumption see, e.g., United States v. Carlson, 810 F.3d 544 8th Cir.
2016; United States v. Carlson, 12cr 00305DSDLIB, Amended Superseding Indictment D. Minn. Sept. 11, 2013
and Courts Instructions to the Jury, D.
Minn. October 8, 2013; United States v.
Bowen, 14cr00169PAB, Indictment D. Colo. May 5, 2014 and Rule 11c1A and B Plea Agreement and Statement of Facts Relevant to Sentencing D. Colo. January 29, 2015.
Persons distributing imitation drugs claimed to be incense or dietary supplements, such as imitation cocaine or imitation Ecstasy see, e.g., United States v. Storage Spaces Designated Nos. 8 & 49, 777 F.2d 1363, 1366
9th Cir. 1985; United States v.
Undetermined Quantities of . . . Street Drug Alternatives, 145 F. Supp. 2d 692
D. Md. 2001.
Persons distributing products containing the active ingredients in prescription drugs, such as VIAGRA, CIALIS, LEVITRA, or BOTOX, as less expensive alternatives to the approved products, with labeling that states that they are all natural or herbal supplements or for research only see, e.g., United States v. Dessart, 823 F.3d 395 7th Cir. 2016; United States v.
Zeyid, 1:14cr0197, First Superseding Indictment N.D. Ga. June 24, 2014 see also Ref. 2; United States v. Livdahl, 459 F. Supp. 2d 1255, 1260 S.D. Fla.
2005.
Other instances where a persons claims about the intended use of a product are belied by the persons activities or non-promotional statements or by circumstantial evidence see, e.g., United States v. An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 7th Cir. 1984; United States v. 789 Cases of Latex Surgeons Gloves, 799 F. Supp. 1275, 12941295 D.P.R.
1992.
In these situations, the evidence relied on to establish intended use has included general knowledge of actual use by customers to achieve a mindaltering effect; the known effects of a product or substance; implied claims
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