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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.

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XII. References The following references are on display at the Dockets Management Staff see ADDRESSES and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https
www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act, 17 FR 6818, 6820 1952.
2. U.S. Department of Justice, U.S. Attorneys Office, Northern District of Georgia, Five Defendants Charged With Illegally Importing Male Enhancement Products, May 29, 2014 available at https
www.justice.gov/usao-ndga/pr/fivedefendants-charged-illegally-importingmale-enhancement-products.
3. Defendants Memorandum in Support of Motion to Dismiss or for Summary Judgment and in Opposition to Motion for Preliminary Injunction at 8, Par Pharmaceutical Inc. v. United States, 1:11cv01820 D.D.C. December 23, 2011.
4. Defendants Memorandum of Points and Authorities in Support of Motion to Dismiss or for Summary Judgment at 89 n.5, Allergan Inc. v. United States, 1:09cv01879JDB, D.D.C. January 11, 2010.
5. Plaintiffs Motion for Summary Judgment at 2026, United States v. Undetermined Quantities of Articles of Drug, Street Drug Alternatives, Identified in Attachment A, et al., Civil No. AW00
1687 D. Md. January 12, 2001.
6. Government Trial Memorandum at 6, United States v. Teiman, Criminal No:
7:00CR00054 W.D. Va. September 29, 2000.
7. Letter from Steven B. Barber, District Director, Cincinnati District, FDA to Marc C. Sanchez, Esq., Mood and Mind, LLC, at 910 April 6, 2017.
8. Letter from Margaret M. Dotzel, Assoc.
Commissioner for Policy, FDA to Daniel J. Popeo and Richard A. Samp, Wash.
Legal Found., at 6, Docket No. 01P0250
January 28, 2002.
9. Letter from Ann Simoneau, J.D., Director, Office of Compliance and Enforcement, Center for Tobacco Products and Donald D. Ashley, J.D., Director, Office of Compliance, Center for Drug Evaluation and Research, FDA to HelloCig Electronic Technology Co., Ltd October 11, 2018.
10. Letter from Ramon A. Hernandez, Director, San Juan District Office and
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Program Division Director, Office of Human and Animal Food Operations, Division IV East, FDA, to Ricardo MayoAlvarez, Duy Drugs, Inc. August 28, 2018.
11. Letter from Daniel Solis, Director, Import Operations Branch, Los Angeles District to Carol A. Pratt, K&L Gates LLP
December 3, 2012.
12. Letter from Alonza E. Cruse, District Director, Los Angeles District, FDA to Richard Carieri, Lifetech Resources Labs Inc. April 18, 2011.
13. Letter from Ronald M. Pace, District Director, New York District, FDA to Peter Erlikh, INZ Distributors, Inc. August 23, 2010.
14. U.S. Department of Justice, December 2, 2016: Woman Arrested for Injecting Adulterated Liquid Silicone, accessed December 23, 2020, https
www.justice.gov/usao-pr/pr/womanarrested-injecting-adultered-liquidsilicone.
15. U.S. Department of Justice, 2018, March 2, 2018: Woman Sentenced for Injecting Adulterated Liquid Silicone, accessed December 23, 2020, https
www.justice.gov/usao-pr/pr/womansentenced-injecting-adulterated-liquidsilicone.
16. Robertson, C.T. When Truth Cannot be Presumed: The Regulation of Drug Promotion Under An Expanding First Amendment, 94 B.U.L. REV. 545, 549
50 2014.
17. Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products January 2017 available at https www.regulations.gov/
document?D=FDA-2016-N-1149-0040.

21 CFR Part 201
Drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR parts 201 and 801 are amended as follows:
PART 201LABELING
1. The authority citation for part 201
is revised to read as follows:

Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc1, 360ee, 360gg360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

2. Revise 201.128 to read as follows:

201.128

Meaning of intended uses.

The words intended uses or words of similar import in 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally
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responsible for the labeling of an article or their representatives. The intent may be shown by such persons expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firms knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
PART 801LABELING
3. The authority citation for part 801
continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.

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4. Revise 801.4 to read as follows:

801.4

Meaning of intended uses.

The words intended uses or words of similar import in 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article or their representatives. The intent may be shown by such persons expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely
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