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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
from using names that sound similar to the names of controlled substances; the circumstances surrounding the sale e.g., a rock concert venue; receiving the product in bulk and repackaging into smaller plastic bags; the use of private email addresses; the absence of labeling; shipping orders, other correspondence, and memoranda relating to marketing and distribution;
statements made in training sessions;
and admissions.
Evidence other than promotional claims has also been used to establish that products offered for import into the United States without labeling or other claims that identify them as a drug or device are in fact intended for use as a drug or device and are therefore subject to refusal if it appears that they fail to meet certain requirements for importing medical products see 21 U.S.C.
381a3. For example, the defendants in United States v. Zeyid, 1:14-cr-0197, First Superseding Indictment N.D. Ga.
June 24, 2014 see Ref. 2, imported products containing active ingredients that were the same as those used in prescription drugs but that were labeled as tea, coffee, and beauty products.
Comment 2 One comment asserted that the position on intended use described by FDA in the NPRM was an alternative, novel interpretation with which FDA has flirted from time to time in the past.
Response We disagree. This is not the first time FDA has responded to arguments that its interpretation of the scope of evidence relevant to intended use is too broadthose arguments have been raised in comments in earlier stages of this and other rulemaking proceedings, petitions, and litigation involving intended use issues. Contrary to the comments assertion that the NPRM presented a novel interpretation of intended use, FDA has steadfastly maintained for decades that, in determining a products intended use, the Agency may look to any relevant source of evidence, including a variety of direct and circumstantial evidence.
FDAs position is reflected in the notices issued in this rulemaking over the past 5 years see, e.g., 85 FR 59718
at 59721 September 23, 2020; 82 FR
14319 at 14320 March 20, 2017; 82 FR
2193 at 2206 January 9, 2017; 80 FR
57756 at 57757 September 25, 2015, and has been noted in court decisions see, e.g., Spectrum Pharma. v. Burwell, 824 F.3d 1062, 1069 D.C. Cir. 2016
To be sure, FDA recognizes that there may be situations in which it will look beyond just the manufacturers statements to determine intended use.; United States v. Travia, 180 F.

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Supp. 2d 115, 119 D.D.C. 2001 The government argues that the Court should look to the objective intent of the sellers in this case, which would permit the Court to view the totality of the circumstancesnamely, the selling of balloons of laughing gas in the parking lot at a rock concertsurrounding the sale of the nitrous oxide here. See, e.g., 21 CFR 201.128.. This position has also been explained in numerous litigation briefs and other FDA
pronouncements, such as in the following excerpts from examples of such documents issued from 2000 to 2017:
In determining a products intended uses, labeling is not the exclusive evidence. See United States v. Travia, 180 F. Supp. 2d 115, 119 D.D.C. 2001.
Instead, it is well established that the intended use of a product, within the meaning of the Act, is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source. Action on Smoking and Health v. Harris, 655 F.2d 236, 239 D.C. Cir. 1980 quotation marks omitted; see also V.E. Irons, Inc.
v. United States, 244 F.2d 34, 44 1st Cir. 1957 We are free to look to all relevant sources in order to ascertain what is the intended use of a drug..
Courts have considered relevant sources to include, for example, product formulation and method of intake, actual use of the product by consumers and medical practitioners, and circumstances of sale in determining intended use. See, e.g., United States v. Ten Cartons, More or Less, of an Article . . . Ener-B Vitamin B12, 72 F.3d 285, 287 2d Cir. 1995;
United States v. Storage Spaces, 777
F.2d 1363, 1367 9th Cir. 1985; United States v. An Article of Device . . .
Toftness Radiation Detector, 731 F.2d 1253, 125758 7th Cir. 1984 Litigation brief 2011, Ref. 3.
Courts have recognized that intended use may be shown by nonspeech evidence that has included, for example, product formulation and method of intake, actual use of the product by consumers and medical practitioners, and circumstances of sale Litigation brief 2010, Ref. 4 at 89
n.5.
Courts have repeatedly held that, although promotional claims are one source of evidence of intended use, FDA
is authorized to rely on any other relevant source of evidence including . . . the products method of intake, . . . how any claims are understood by a consumer. . ., suggestive product names, . . . and meta-tags Litigation brief 2001, Ref. 5 at 2026.

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Evidence of intended use to be presented at trial includes:
1 Defendant intended the nitrous oxide he was offering for sale on his website bongmart.com to be used as a drug, despite his marking the nitrous oxide For Food Use Only; 2
Defendant knew that the nitrous oxide cartridges were commonly used as a drug for getting high; and 3
Defendants customers actually used the nitrous oxide sold by Defendant as a drug Litigation brief 2000, Ref. 6 at 6.
It has been the Agencys longstanding position that in determining a products intended use, the Agency may look to any relevant source of evidence. . . . To hold accountable firms that attempt to evade FDA drug jurisdiction by avoiding making express claims about their products or disclaiming a particular intended use, courts have relied on a variety of evidence to establish intended use, including general knowledge of actual use by customers to get high or have some other mind-altering effect;
the known effects of a product or substance; implied claims from using names that sound similar to controlled substances; the circumstances surrounding the sale e.g., a rock concert venue; receiving the product in bulk and repackaging into smaller plastic bags; the use of private email addresses;
the absence of labeling; shipping orders, other correspondence, and memoranda relating to marketing and distribution; statements made in training sessions; and admissions Regulatory letter 2017, Ref. 7 at 910.
The manufacturers intent will necessarily be determined on a case-bycase basis, looking at the totality of the facts and circumstances. . . . The trier of fact will take into account the full body of evidence. If evidence of distribution or sponsorship activity forms part of the basis of FDAs claim, the trier of fact will consider the context of that activity . . . in assessing the manufacturers objective intent Regulatory letter 2002, Ref. 8 at 6.1
In addition, issues involving the scope of evidence relevant to establishing intended use frequently arise in FDAs day-to-day operations in protecting the public health, including Warning Letters and import determinations see, e.g., FDA Warning 1 The comment erroneously asserts that FDAs reliance on evidence other than promotional claims to assert jurisdiction over cigarettes in a 1996 final rule was roundly rejected by the courts. In fact, the Supreme Courts majority opinion declined to address the issue, and the dissent endorsed FDAs analysis see FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 13132 2000; id. at 170
dissenting opinion.

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