37022 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 

1This program consisted of compliance 

monitoring, counseling, and targeted enforcement 

pursuant to the FTC’s general authority under 15 

U.S.C. 45 (‘‘Section 5’’ of the FTC Act). Section 5 

prohibits unfair or deceptive acts or practices in or 

affecting commerce. An act or practice is deceptive 

if it is likely to mislead consumers acting 

reasonably under the circumstances and is 

material—that is, likely to affect a consumer’s 

decision to purchase or use the advertised product 

or service. A claim need not mislead all—or even 

most—consumers to be deceptive under the FTC 

Act. Rather, it need only be likely to deceive some 

consumers acting reasonably. See FTC Policy 

Statement on Deception, 103 F.T.C. 174 (1984) 

(appended to Cliffdale Assocs., Inc., 103 F.T.C. 110, 

177 n.20 (1984) (‘‘A material practice that misleads 

a significant minority of reasonable consumers is 

deceptive.’’); see also FTC v. Stefanchik, 559 F.3d 

924, 929 (9th Cir. 2009) (‘‘The FTC was not required 

to show that all consumers were deceived . . . .’’). 

2Commenters argued such a rule could have a 

strong deterrent effect against unlawful MUSA 

claims without imposing new burdens on lawabiding companies. See generally Transcript of 

Made in USA: An FTC Workshop (Sept. 26, 2019) 

at 63–72, available at https://www.ftc.gov/newsevents/events-calendar/made-usa-ftc-workshop; 

FTC Staff Report, Made in USA Workshop (June 

2020) (‘‘MUSA Report’’), available at https://

www.ftc.gov/system/files/documents/reports/madeusa-ftc-workshop/p074204_-_musa_workshop_

report_-_final.pdf. 

3See Section 320933 of the Violent Crime and 

Law Enforcement Act of 1994, Public Law 103–322, 

108 Stat. 1796, 2135, codified in relevant part at 15 

U.S.C. 45a. Section 45a also states: ‘‘This section 

shall be effective upon publication in the Federal 

Register of a Notice of the provisions of this 

section.’’ The Commission published such a notice 

in 1995 (60 FR 13158 (Mar. 10, 1995). 

4Under the statute, violations of any rule 

promulgated pursuant to Section 45a ‘‘shall be 

treated by the Commission as a violation of a rule 

under section 57a of this title regarding unfair or 

deceptive acts or practices.’’ For violations of rules 

issued pursuant to 15 U.S.C. 57a, the Commission 

may commence civil actions to recover civil 

penalties. See 15 U.S.C. 45(m)(1)(A). 

5See, e.g., Vulcan Lamp Works, Inc., 32 F.T.C. 7 

(1940); Windsor Pen Corp., 64 F.T.C. 454 (1964) 

(articulating this standard as a ‘‘wholly of domestic 

origin’’ standard). 

6This principle was incorporated into the 

Commission’s 1997 Enforcement Policy Statement 

on U.S. Origin Claims (the ‘‘Policy Statement’’) 

following consumer research and public comment, 

as the ‘‘all or virtually all’’ principle. Specifically, 

the Policy Statement provides a marketer making an 

unqualified claim for its product should, at the time 

of the representation, have a reasonable basis for 

asserting ‘‘all or virtually all’’ of the product is 

made in the United States. FTC, Issuance of 

Enforcement Policy Statement on ‘‘Made in USA’’ 

and Other U.S. Origin Claims, 62 FR 63756, 63766 

information directly to the manager of the 

certification office, send it to the attention of 

the person identified in Related Information. 

Information may be emailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(j) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) Civil 

Aviation Authority of Israel (CAAI) Israeli 

AD ISR–I–24–2021–6–6R1, dated June 27, 

2021, for related information. This MCAI 

may be found in the AD docket on the 

internet at https://www.regulations.gov by 

searching for and locating Docket No. FAA– 

2021–0566. 

(2) For more information about this AD, 

contact Brian Hernandez, Aerospace 

Engineer, Systems and Equipment Section, 

FAA, Seattle ACO Branch, 2200 South 216th 

St., Des Moines, WA 98198; phone and fax: 

206–231–3535; email: Brian.Hernandez@

faa.gov. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless this AD specifies otherwise. 

(i) IAI-Aviation Group Alert Service 

Bulletin 368–24–098, Revision 1, dated June 

2021. 

(ii) [Reserved] 

(3) For service information identified in 

this AD, contact Israel Aerospace Industries, 

Ltd., Ben Gurion Airport, Israel 70100; 

telephone 972–39359826; email tmazor@

iai.co.il. 

(4) You may view this service information 

at the FAA, Airworthiness Products Section, 

Operational Safety Branch, 2200 South 216th 

St., Des Moines, WA. For information on the 

availability of this material at the FAA, call 

206–231–3195. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

email fedreg.legal@nara.gov, or go to: https:// 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued on July 8, 2021. 

Gaetano A. Sciortino, 

Deputy Director for Strategic Initiatives, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2021–15026 Filed 7–12–21; 11:15 am] 

BILLING CODE 4910–13–P 

FEDERAL TRADE COMMISSION 

16 CFR Part 323 

[3084–AB64] 

Made in USA Labeling Rule 

AGENCY: Federal Trade Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Trade 

Commission (‘‘FTC’’ or ‘‘Commission’’) 

issues a final rule related to ‘‘Made in 

USA’’ and other unqualified U.S.-origin 

claims on product labels. 

DATES: This final rule is effective August 

13, 2021. 

FOR FURTHER INFORMATION CONTACT: Julia 

Solomon Ensor (202–326–2377) or 

Hampton Newsome (202–326–2889), 

Attorneys, Division of Enforcement, 

Bureau of Consumer Protection, Federal 

Trade Commission, Room CC–9528, 600 

Pennsylvania Avenue NW, Washington, 

DC 20580. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 16, 2020, the Commission 

published a Notice of Proposed 

Rulemaking (‘‘NPRM’’) (85 FR 43162) 

seeking comments on a new rule 

regarding unqualified U.S.-origin claims 

(‘‘MUSA claims’’) on product labels. 

The NPRM was preceded by a review of 

the Commission’s longstanding program 

to prevent deceptive MUSA claims.1

The review included a 2019 public 

workshop and public comment period, 

where stakeholders expressed nearly 

universal support for a rule addressing 

MUSA labels.2

The Commission published a new 

rule in the NPRM pursuant to its 

authority under 15 U.S.C. 45a (‘‘Section 

45a’’). Section 45a declares: ‘‘[t]o the 

extent any person introduces, delivers 

for introduction, sells, advertises, or 

offers for sale in commerce a product 

with a ’Made in the U.S.A.’ or ‘Made in 

America’ label, or the equivalent 

thereof, in order to represent that such 

product was in whole or substantial part 

of domestic origin, such label shall be 

consistent with decisions and orders of 

the Federal Trade Commission.’’ The 

statute authorizes the agency to issue 

rules to effectuate this mandate and 

prevent unfair or deceptive acts or 

practices relating to MUSA labeling.3

Specifically, under the statute, the 

Commission ‘‘may from time to time 

issue rules pursuant to section 553 of 

title 5, United States Code’’ requiring 

MUSA labeling to ‘‘be consistent with 

decisions and orders of the Federal 

Trade Commission issued pursuant to 

[Section 5 of the FTC Act].’’ The statute 

authorizes the FTC to seek civil 

penalties for violations of such rules.4

Consistent with these statutory 

provisions, the NPRM proposed a rule 

covering labels on products that make 

unqualified U.S.-origin claims. 

Consistent with the Commission’s 

MUSA Decisions and Orders since the 

1940s,5 the NPRM proposed to codify 

the established principle that 

unqualified U.S.-origin claims imply to 

consumers no more than a de minimis 

amount of the product is of foreign 

origin.6


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(Dec. 2, 1997). The Commission first used the ‘‘all 

or virtually all’’ language in Hyde Athletic 

Industries, File No. 922–3236 (consent agreement 

accepted subject to public comment Sept. 20, 1994) 

and New Balance Athletic Shoes, Inc., Docket 9268 

(complaint issued Sept. 20, 1994). In the 1997 

Federal Register Notice requesting public comment 

on Proposed Guides for the Use of U.S. Origin 

Claims, the Commission explained the ‘‘all or 

virtually all’’ standard merely rearticulated 

longstanding principles governing MUSA claims. 

FTC, Request for Public Comment on Proposed 

Guides for the use of U.S. Origin Claims, 62 FR 

25020 (May 7, 1997). The Commission has routinely 

applied this standard in its MUSA Decisions and 

Orders since 1997. See Compilation of cases at 

https://www.ftc.gov/tips-advice/business-center/ 

legal-resources?type=case&field_consumer_

protection_topics_tid=234. 

7See, e.g., Textile Fiber Products Identification 

Act (15 U.S.C. 70b); Wool Products Labeling Act (15 

U.S.C. 68); American Automobile Labeling Act (49 

U.S.C. 32304); Agricultural Marketing Act (7 U.S.C. 

1638a); Buy American Act (41 U.S.C. 10a–10c); and 

implementing rules. 

8As discussed in Section III of this Notice, the 

Commission has added a provision (section 323.6) 

in the final Rule related to petitions for exemption. 

9Comments appear on FTC Docket FTC–2020– 

0056 and are available at www.regulations.gov. For 

purposes of this Notice, all comments are referred 

to by their short docket number (e.g., ‘‘1’’), rather 

than long docket number (e.g., ‘‘FTC–2020–0056– 

0001’’). 

10See, e.g., Senators Sherrod Brown, Tammy 

Baldwin, Christopher Murphy, and Richard 

Blumenthal (‘‘Senators’’) (373); North American 

Insulation Manufacturers (631); see also Letter from 

Representative Frank Pallone, Jr., Chairman, and 

Representative Jan Schakowsky, Chair, 

Subcommittee on Consumer Protection and 

Commerce, U.S. House of Representatives (Oct. 15, 

2020). But see Retail Industry Leaders Association 

(‘‘RILA’’) (570) (arguing low levels of enforcement 

activity suggest codifying the guidance into a rule 

is unnecessary). 

11UIUC Accounting Group A13 (5); Delphine 

MUREKATETE, iMSA Program, University of 

Illinois at Urbana Champaign (21); Anonymous 

Anonymous (24); UIUC–BADM 403–A02 (25); 

Nirma Ramirez (26); Jaymee Westover (358); Joy 

Winzerling (419); United Steelworkers (526); 

Anonymous Anonymous (533); R–CALF USA (588). 

12Chris Jay Hoofnagle (613) (advocating use of 

civil penalties to deter MUSA fraud). 

13UIUC Accounting Group A13 (5); Chris Posey 

(7); Family Farm Action Alliance (543). 

14See, e.g., United Steelworkers (526); Alliance 

for American Manufacturing (‘‘AAM’’) (611). 

15Honey Boynton (32); Holly Mastromatto (33); 

Doug Thompson (123); Lucilla Rinehimer (702). 

16UIUC Accounting Group A13 (5); UIUC Group 

A06 Anonymous (22); Truth in Advertising, Inc. 

(‘‘TINA.org’’) (369); Senators (373); Southern 

Shrimp Alliance (380); Council for Responsible 

Nutrition (‘‘CRN’’) (569); Personal Care Products 

Council (‘‘PCPC’’) (587); Anonymous Anonymous 

(592); Alliance for AAM (611); National Association 

of Manufacturers (‘‘NAM’’) (623); Coalition for a 

Prosperous America (625). 

17 15 U.S.C. 45a. 

18UIUC Accounting Group A13 (50); UIUC Group 

A06 (22); TINA.org (369); Senators (373); Southern 

Shrimp Alliance (380); AAM (611); Coalition for a 

Prosperous America (625). 

19TINA.org (369) (emphasis in original) (also 

arguing the Commission may draw support from the 

dictionary definition of ‘‘labels,’’ which includes 

digital labels). 

20 Id. at 2. TINA.org also suggested ‘‘courts 

regularly interpret laws expansively in the face of 

technological innovation,’’ and the ‘‘possibility that 

Congress may not have anticipated the application 

of the term label to apply online does not change 

[the] outcome.’’ 

The NPRM, consistent with the 

Commission’s prior rulings and 

consumer perception surveys, proposed 

a rule prohibiting marketers from 

including unqualified U.S.-origin claims 

on labels unless: (1) Final assembly or 

processing of the product occurs in the 

United States; (2) all significant 

processing for the product occurs in the 

United States; and (3) all or virtually all 

of the product’s ingredients or 

components are made and sourced in 

the United States. By codifying existing 

guidance, the proposed rule sought to 

impose no new obligations on market 

participants. 

To avoid confusion or perceived 

conflict with other country-of-origin 

labeling laws and regulations, the 

NPRM contained a provision specifying 

the rule does not supersede, alter, or 

affect any other federal or state statute 

or regulation relating to country-oforigin labels, except to the extent a state 

country-of-origin statute, regulation, 

order, or interpretation is inconsistent 

with the proposed rule.7

In response to the NPRM, the 

Commission received hundreds of 

comments, discussed infra Section II. 

Although some raised concerns or 

recommended changes to the 

Commission’s proposal, the majority 

supported finalizing the rule as drafted. 

Accordingly, the Commission adopts 

the proposed rule with limited 

modifications as discussed below.8 The 

rule will take effect August 13, 2021. 

II. Response to Comments 

The Commission received more than 

700 comments 9 in response to the 

NPRM from individuals, industry 

groups, consumer organizations, and 

members of Congress. Commenters 

generally supported the rule,10 stating it 

provided much-needed clarity 11 and 

would deter bad actors 12 without 

imposing new burdens on marketers.13

Most commenters agreed the rule 

should incorporate the longstanding ‘‘all 

or virtually all’’ standard.14

Additionally, the majority of 

commenters addressing the issue agreed 

the proposed rule represented a proper 

exercise of the Commission’s 

rulemaking authority under Section 45a. 

Although the Commission received 

mostly supportive comments, some 

commenters raised concerns with the 

Commission’s proposal to codify the 

‘‘all or virtually all’’ guidance through 

rulemaking, suggesting the standard 

may not reflect current consumer 

perception. Others proposed specific 

additions to the rule, including 

additional definitions, guidance on 

implied claims, and an effective date. 

Members of the beef and shrimp 

industries requested specific guidance 

for their industries. A few stakeholders 

proposed changes outside the scope of 

the FTC’s Section 45a rulemaking 

authority. For example, some 

commenters proposed making countryof-origin labeling mandatory in all 

instances. Finally, some raised 

miscellaneous concerns about particular 

businesses’ practices or claims.15 As 

discussed below, these comments do 

not provide a compelling basis to 

change the substantive requirements of 

the rule proposed in the NPRM. 

A. Rulemaking Authority Regarding 

Mail Order Advertising 

Eleven stakeholders filed comments 

addressing the FTC’s rulemaking 

authority under Section 45a, with the 

majority agreeing the proposed rule is 

consistent with that grant of authority.16

As described in Section I, Section 45a 

authorizes the Commission ‘‘[to] issue 

rules pursuant to section 553 of title 5 

[of the U.S.C.]’’ to govern the use of 

‘‘ ‘Made in the U.S.A.’ or ‘Made in 

America’ label[s], or the equivalent 

thereof’’ when a person ‘‘introduces, 

delivers for introduction, sells, 

advertises, or offers for sale [a product] 

in commerce.’’ The statute provides 

such labels must be ‘‘consistent with 

decisions and orders of the Federal 

Trade Commission issued pursuant to 

[Section 5 of the FTC Act].’’ 17

1. Comments 

Eleven commenters addressed the 

Commission’s authority under Section 

45a. The majority asserted the proposed 

rule was within the scope of Section 

45a’s grant of rulemaking authority, and 

the proposed rule appropriately covered 

labels in mail order (electronic) 

advertising.18 For example, TINA.org 

argued the Commission properly 

interpreted Section 45a as authorizing 

coverage of electronic labels because 

Section 45a does not limit the term 

‘‘labels’’ to physical labels, and physical 

and digital labels are ‘‘functionally 

equivalent’’ in terms of providing 

product information to 

consumers.19 TINA.org further noted 

‘‘[w]hen Congress seeks to limit ‘labels’ 

to the physical, it knows how . . . [and 

here] the statute makes no attempt to 

restrict the definition or distinguish 

physical labels from digital labels.’’ 20

Moreover, TINA.org explained, limiting 

the proposed rule to physical labels 

without addressing electronic labels 


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21 Id. at 5. 

22 Id. at 3 (emphasis in original). 

23Southern Shrimp Alliance (380); AAM (611). 

24AAM (611). Coalition for a Prosperous America 

(625) agreed Section 45a’s plain language permits 

coverage of electronic claims (arguing coverage is 

authorized where a ‘‘substantial part’’ of the 

product is of domestic origin) (citing Section 45a 

(‘‘To the extent any person introduces, delivers for 

introduction, sells, advertises, or offers for sale in 

commerce a product with a ‘Made in the U.S.A.’ or 

‘Made in America’ label, or the equivalent thereof, 

in order to represent that such product was in 

whole or substantial part of domestic origin, such 

label shall be consistent with decisions and orders 

of the Federal Trade Commission issued pursuant 

to section 45 of this title (emphasis added).’’)). 

25AAM (611). 

26CRN (569); PCPC (587); Anonymous 

Anonymous (592); NAM (623). 

27PCPC (587); CRN (569). 

28Anonymous Anonymous (56). 

29NAM (623) at 5. 

30Shirley Boyd (6). 

31Southern Shrimp Alliance (380); AAM (611). 

32See TINA.org (369). 

33See, e.g., In re Vulcan Lamp Works, Inc., 32 

F.T.C. 7 (1940). 

34CRN (569); Consumer Technology Association 

(‘‘CTA’’) (579); Global Organization for EPA and 

DHA Omega-3s (604); American Association of 

Exporters and Importers (‘‘AAEI’’) (605); NAM 

(623); Pharmavite LLC (695). 

35CRN (569). 

would ‘‘leave American consumers 

unprotected.’’ 21 Accordingly, TINA.org 

concluded, ‘‘[a]s a matter of statutory 

interpretation, the Commission can 

regulate digital MUSA labels. As a 

matter of consumer protection, the 

Commission ought to regulate digital 

MUSA labels.’’ 22

The Southern Shrimp Alliance 

(‘‘SSA’’) and AAM agreed, arguing 

Congress made an affirmative decision 

to defer to the FTC when it removed a 

definition of ‘‘labels’’ that appeared in 

initial drafts of the legislation.23

Moreover, AAM argued the text of 

Section 45a specifically authorizes 

coverage of electronic labels because of 

the words ‘‘the equivalent thereof’’ in 

the phrase authorizing coverage of 

products introduced into commerce 

‘‘with a ‘Made in the U.S.A.’ or ‘Made 

in America’ label, or the equivalent 

thereof.’’ 24 AAM argued the phrase 

refers to the ‘‘equivalent’’ of introducing 

a product into commerce with a label, 

i.e., making a claim on a website.25

In contrast, four commenters asserted 

the proposed rule exceeds the scope of 

the Commission’s rulemaking authority 

under Section 45a.26 CRN and PCPC 

argued Section 45a’s consistent use of 

the term ‘‘label’’ demonstrates 

Congress’s intent to authorize a rule 

limited to labels on products, not one 

that would cover advertising 

generally.27 An anonymous commenter 

argued Section 45a does not provide 

authority to regulate claims in mail 

order advertising materials as proposed 

in Section 323.3, so the proposed rule 

‘‘should be revised to only cover labels 

on products.’’ 28 Should the FTC finalize 

a rule that purports to cover more than 

labels on products, NAM warned, the 

result could be ‘‘lengthy litigation 

[, which would leave] manufacturers 

and consumers alike . . . without clear 

guidance at a time when manufacturers 

need as much regulatory certainty as 

possible.’’ 29 Given these concerns over 

the scope of the Commission’s 

rulemaking authority, Shirley Boyd 

stated the Commission should proceed 

pursuant to the Magnuson Moss 

Warranty-Federal Trade Commission 

Improvements Act to issue a broader 

rule covering MUSA advertising 

generally.30

2. Analysis 

After reviewing the comments, the 

Commission has concluded proposed 

Section 323.3 falls within the scope of 

its authority under Section 45a. As 

described above, Section 45a authorizes 

the Commission to issue rules to govern 

labeling of products as ‘‘Made in the 

U.S.A.’’ or ‘‘Made in America,’’ or the 

equivalent thereof. Section 45a 

specifies: ‘‘[t]o the extent any person 

introduces, delivers for introduction, 

sells, advertises, or offers for sale in 

commerce a product with a ‘Made in the 

U.S.A.’ or ’Made in America’ label, or 

the equivalent thereof, in order to 

represent that such product was in 

whole or substantial part of domestic 

origin, such label shall be consistent 

with decisions and orders of the Federal 

Trade Commission.’’ The Commission is 

empowered to ensure such labels are 

consistent with decisions and orders of 

the Federal Trade Commission defining 

unfair or deceptive acts or practices 

under Section 5. The Commission 

agrees with SSA and AAM that 

Congress’s removal of a definition of 

‘‘label’’ from Section 45a before its 

passage strongly suggests Congress 

deliberately chose to defer to the FTC’s 

interpretation of the term in the context 

of MUSA claims.31 Moreover, the 

Commission agrees with TINA.org that 

digital and physical labels are 

functionally equivalent, especially with 

the growth of e-commerce, and a failure 

to cover labels in print or electronic 

mail order catalogs or promotional 

materials would leave consumers 

without much-needed protection.32

The final rule does not cover MUSA 

claims in all advertising. Instead, as 

Section 323.3 explains, the rule covers 

labels appearing in all contexts, 

whether, for example, they appear on 

product packaging or online. With this 

clarification, the Commission adopts 

Section 323.3 as proposed. 

B. ‘‘All or Virtually All’’ Standard 

As described in Section I above, the 

NPRM proposed to codify the 

Commission’s longstanding 

interpretation of Section 5’s 

requirements governing substantiation 

of unqualified MUSA claims. This 

interpretation was first articulated in 

Commission cases dating back to the 

1940s 33 and was formalized in the 1997 

Policy Statement. Specifically, the 

NPRM proposed to prohibit unqualified 

MUSA claims on labels unless: (1) Final 

assembly or processing of the product 

occurs in the United States, (2) all 

significant processing that goes into the 

product occurs in the United States, and 

(3) all or virtually all ingredients or 

components of the product are made 

and sourced in the United States. 

Although many commenters, 

particularly those with interest in food 

products, supported the decision to 

incorporate the ‘‘all or virtually all’’ 

guidance, others raised concerns. In 

particular, commenters questioned 

whether the ‘‘all or virtually all’’ 

standard represents current consumer 

understanding of MUSA claims. Some 

proposed alternative standards for 

consideration. 

After analyzing these comments, as 

discussed below in Section II.B.3., the 

Commission has determined it has a 

reasonable basis to adopt the 

longstanding ‘‘all or virtually all’’ 

standard, and the rule provides 

appropriate and clear guidance to 

marketers. 

1. Consumer Perception Testing 

Six commenters argued the FTC 

should conduct new consumer 

perception testing before codifying the 

‘‘all or virtually all’’ guidance into a 

rule.34 They noted the Commission has 

not conducted comprehensive testing 

since the 1990s. CRN explained 

‘‘codifying a standard for unqualified 

U.S.-origin claims that is based on 

consumer perception data that has not 

been reanalyzed by the Commission in 

over 20 years’’ is potentially 

problematic because ‘‘[g]iven significant 

changes to the global economy, 

consumer perceptions of U.S.-origin 

claims are very likely to have changed 

over time and consumer perception in 

1997, and even 2013, could be very 

different from how consumers perceive 

U.S.-origin claims today.’’ 35 CTA agreed 

and asserted that proposing to codify 

the ‘‘all or virtually standard’’ without 

conducting new consumer perception 


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36CTA (579). 

37NAM (623). 

38See, e.g., CTA (579) (arguing the ‘‘all or 

virtually all’’ guidance deters innovation because 

many electronic product components are only made 

internationally); Personal Care Products Council 

(587) (guidance deters manufacturers from using 

maximum levels of U.S. parts and materials); AAEI 

(605) (guidance negatively impacts U.S. companies 

that will not risk making the claim). 

39National Fisheries Institute (‘‘NFI’’) (628); RILA 

(570); TRAVIS HEDSTROM (600); Acuity Brands 

(609); NAM (623); American Coatings Association 

(‘‘ACA’’) (666) (stating marketers need guidance on 

percentage values or other guidance on how to deal 

with trace components of foreign/unknown origin). 

40NFI (628). 

41See Cal. Bus. & Prof. Code § 17533.7 (as revised 

in 2015). 

42RILA (570). 

43TRAVIS HEDSTROM (660). 

44 GOED (604); Pharmavite LLC (695). 

45The California law makes such an allowance, 

although it is not unlimited. Specifically, California 

permits up to 10% (instead of 5%) of costs to be 

attributable to imported content if that content 

cannot be made or obtained in the USA for reasons 

other than cost. Cal. Bus. & Prof. Code § 17533.7. 

46BWC (622). Indeed, BWC argued, given 

consumer expectations and current supply chains, 

rather than analyzing the percentage of costs 

attributable to U.S. versus foreign costs, it might be 

more appropriate to analyze the proportion of an 

entity’s overall manufacturing workforce in the U.S. 

Id. 

47NAM (623). See also Glenda Smith (612) 

(requesting more detail on how to handle raw 

materials not capable of being sourced in the USA). 

48CBP defines ‘‘substantial transformation’’ as a 

manufacturing process that results in a new and 

different product with a new name, character, and 

use different from that which existed before. This 

standard does not take into account the origin of 

materials or parts. See 19 CFR part 134; Energizer 

Battery, Inc. v. United States, 190 F. Supp. 3d 1308 

(Ct. Int’l Tr. 2016) (holding a substantial 

transformation occurs when a product emerges from 

a manufacturing process with a new name, 

character, and use, and the ‘‘simple assembly’’ of 

a limited number of components does not constitute 

a substantial transformation). 

49 International Precious Metals Institute, Inc. 

(‘‘IPMI’’) (520); AAEI (605); American Apparel and 

Footwear Association (‘‘AAFA’’) (675). 

50AAEI (605). See also BWC (622) (raising 

concerns about increased regulatory burden). 

51AAFA (675) (also suggesting the FTC 

‘‘eliminate’’ qualified claims for any products that 

do not meet the ‘‘substantial transformation’’ 

threshold). 

52China (699). 

testing ‘‘put the cart before the horse.’’ 36

NAM also encouraged the FTC to 

undertake a comprehensive review 

similar to the Commission’s process in 

the 1990s before promulgating any 

rule.37

2. Alternative Standards 

In addition to requesting the FTC 

conduct new perception testing, 

numerous commenters proposed 

alternatives to the ‘‘all or virtually all’’ 

standard. These proposals, which were 

based on policy arguments and were not 

accompanied by supporting consumer 

perception evidence, fell into two 

groups. On one hand, more than twenty 

commenters, mostly individual 

consumers, suggested unqualified 

MUSA claims should be limited to 

products 100% made in the United 

States. On the other hand, other 

commenters, mostly manufacturers, 

argued ‘‘all or virtually all’’ is too strict, 

and by incorporating it into a rule, the 

FTC could chill unqualified claims, 

discourage innovation, and harm 

industries where parts or ingredients are 

not available in the United States.38 To 

address these concerns, this second 

group of commenters suggested 

alternatives: (1) Introducing a 

percentage-of-costs standard; (2) 

adopting a standard that makes 

allowances for imported parts or 

materials not available in the United 

States; (3) aligning with U.S. Customs 

and Border Protection’s (‘‘CBP’’) 

substantial transformation standard; or 

(4) adding a safe harbor for ‘‘good faith’’ 

efforts to comply. 

i. Percentage-Based Standards 

Several commenters argued the 

Commission should provide marketers 

greater certainty by promulgating a 

‘‘bright line’’ rule outlining a specific 

percentage of manufacturing costs that 

must be attributable to U.S. costs to 

substantiate an unqualified claim.39 For 

example, NFI suggested the FTC could 

align the rule with California state 

law,40 which permits manufacturers to 

make unqualified MUSA claims for 

products with up to 5% of the final 

wholesale value of the product 

attributable to articles, units, or parts of 

the merchandise obtained from outside 

the USA.41

RILA agreed a rule providing a brightline percentage would help marketers 

comply, and suggested the FTC consider 

‘‘analogous federal regulations that 

incentivize U.S. manufacturing,’’ and 

incorporate a 70% threshold for 

unqualified claims.42 Alternatively, one 

commenter suggested a rule that would 

permit an unqualified claim for a 

product assembled in the United States 

where more than 50% of its value is 

based on components of U.S.-origin.43

Two representatives of the dietary 

supplement industry, the Global 

Organization for EPA and DHA Omega3s (‘‘GOED’’) and Pharmavite LLC, made 

an alternative percentage-based 

proposal with different standards for 

active and inactive ingredients. 

Specifically, they argued consumers 

likely interpret an unqualified MUSA 

claim to mean 100% of a dietary 

supplement’s active ingredients are 

made and sourced in the United States. 

They claimed, however, consumers care 

less about the origin of inactive 

ingredients. Accordingly, they 

contended the rule should incorporate a 

10% tolerance for foreign-made or 

sourced inactive ingredients.44

ii. Unavailability Exemption 

Other commenters argued the rule 

should allow marketers to make 

unqualified MUSA claims for products 

that include imported content only if 

the imported components are not 

available in the United States.45 Some 

argued there should be a blanket 

exemption for such content. For 

example, Bradford White Corporation 

(‘‘BWC’’) suggested the rule broadly 

allow marketers to exclude foreign parts 

from the analysis if those parts cannot 

be ‘‘reasonably sourced’’ from a 

domestic manufacturer.46 Others agreed 

the rule should permit unqualified 

claims for products that contain foreign 

content that cannot be sourced in the 

United States, but argued this 

exemption should be capped at a certain 

percentage of manufacturing costs. In 

NAM’s view, a rule permitting 

marketers to incorporate an appropriate 

percentage of imported components or 

labor, not otherwise unavailable 

domestically, ‘‘would give 

manufacturers clear and predictable 

rules and play a significant role in 

helping to encourage manufacturers to 

increase domestic investments in order 

to meet an attainable standard.’’ 47

iii. Substantial Transformation Analysis 

Several commenters suggested the 

FTC adopt a ‘‘substantial 

transformation’’ standard for 

unqualified claims.48 Three commenters 

from U.S. trade associations 49

explained harmonizing the FTC’s rule 

with the CBP standard for determining 

foreign country of origin pursuant to the 

Tariff Act, 19 U.S.C. 1304, would 

provide clarity and alleviate the burden 

on U.S. companies that ‘‘must navigate 

a number of different country of origin 

requirements.’’ 50 AAFA explained 

adopting the ‘‘substantial 

transformation’’ standard would result 

in a ‘‘clear, simple, and easy-tounderstand rule.’’ 51 The People’s 

Republic of China (‘‘China’’) also 

argued, to avoid uncertainties and bias, 

the FTC should incorporate CBP’s 

‘‘change in Tariff Classification’’ 

analysis, as suggested in Article 9 of the 

World Trade Organization’s (‘‘WTO’’) 

Agreement on Rules of Origin.52

iv. Good Faith Efforts To Comply 

PCPC and RILA recommended the 

Commission provide safe harbors for 

two types of good-faith efforts to 

comply. PCPC, a trade association 


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53PCPC (587). Although not specifically 

advocating for a good-faith claim safe harbor, the 

Family Farm Action Alliance similarly argued the 

FTC should continue its practice of counseling 

inadvertent offenders into compliance (543). 

54PCPC (587) at 3. 

55RILA (570). 

56Commission staff considered this study 

previously as part of a request for a staff advisory 

opinion on unqualified MUSA claims for recycled 

gold jewelry products. See Response to Request for 

FTC Staff Advisory Opinion (Sept. 9, 2014), https:// 

www.ftc.gov/system/files/documents/closing_

letters/made-usa/140909madeisusajvc.pdf 

(declining to provide an opinion stating MUSA 

claims for recycled jewelry do not deceive 

consumers based on perception evidence provided 

by Richline Group). 

57See also Hanna, Transcript of Made in USA: An 

FTC Workshop (Sept. 26, 2019) (hereinafter, 

‘‘MUSA Tr.’’) at 14 (study showed ‘‘25% or 30% of 

[American consumers] really did feel that 

everything, including the natural resource, 

including the gold, had to be part of the final 

product in order to say it was made in the USA’’). 

58 62 FR 25020, 25036. 

59Hanna, MUSA Tr. at 15. 

60See, e.g., FTC Staff Closing Letter to Niall 

Luxury Goods, LLC (Nov. 20, 2015), available at 

https://www.ftc.gov/system/files/documents/ 

closing_letters/nid/151120niall_letter.pdf. 

61See Policy Statement, 62 FR 63756, 63768. 

representing manufacturers, 

distributors, and suppliers of personal 

care products, suggested incorporating a 

safe harbor for ‘‘good actors who are 

trying to overcome the difficulties in 

sourcing domestic components and 

materials.’’ 53 PCPC explained, ‘‘[a] safe 

harbor provision for unqualified claims 

would not dilute the purpose of the 

FTC’s goal with this proposed rule—to 

deter bad actors from making false 

claims. Rather, such a provision would 

provide businesses who in good faith 

make every reasonable effort to make as 

much of their product as possible in the 

U.S. the flexibility to comply with any 

new regulations.’’ 54

Alternatively, RILA suggested that to 

avoid deterring retailers and 

marketplaces from offering products 

with MUSA labels the final rule should 

‘‘include an express statement . . . that 

allows retailers and marketplaces that 

have exercised reasonable due diligence 

to rely on documented supplier and 

vendor certifications to substantiate 

MUSA labeling claims.’’ 55

3. Analysis 

The Commission has concluded it is 

not necessary to undertake additional 

consumer perception testing before 

adopting the proposed Rule. 

Accordingly, the Commission adopts 

the ‘‘all or virtually all standard’’ to 

govern unqualified claims as proposed 

in the NPRM. Although some 

commenters speculated consumer 

perception may have shifted over time, 

or argued the Commission should adopt 

a new standard for unqualified claims, 

there is no evidence on the record 

disputing the Commission’s past 

findings that at least a significant 

minority of consumers expect a MUSAadvertised product to be ‘‘all or virtually 

all’’ made in the United States. Nor is 

there evidence suggesting new 

perception testing would find 

otherwise. 

Indeed, the limited survey evidence 

submitted in conjunction with the 2019 

workshop on MUSA claims suggested 

consumer perception has remained 

stable since the 1990s. Specifically, one 

panelist, Mark Hanna of Richline Group, 

Inc. submitted a survey, conducted in 

2013, which found almost 3 in 5 

Americans (57%) agree ‘‘Made in 

America’’ means all parts of a product, 

including any natural resources it 

contains, originated in the United 

States.56 Additionally, the survey found 

33 percent of consumers thought 100 

percent of a product must originate in 

a country for that product to be labeled 

as ‘‘Made’’ in that country.57 These 

findings are consistent with the FTC’s 

1995 survey, which found roughly 30 

percent of consumers would be 

deceived by an unqualified MUSA 

claim for a product where 70 percent of 

the cost was incurred in the United 

States.58 As Hanna explained during the 

workshop, ‘‘at least 25% of the 

consumers were skeptical that if there’s 

something introduced to that finished 

product other than something that 

originated in the US now, they didn’t 

think it should be made in the USA.’’ 59

Accordingly, the Commission has a 

reasonable basis to conclude the ‘‘all or 

virtually all’’ standard accurately 

represents current consumer perception 

regarding unqualified MUSA claims. 

Should future consumer research clearly 

establish the ‘‘all or virtually all’’ 

standard is inapplicable to a specific 

class of products, entities may petition 

the Commission for an exemption from 

the Rule’s requirements, as discussed in 

Section III of this document. 

While commenters proposed 

alternative standards that might 

promote certain policy goals, the 

Commission declines to adopt these 

alternative proposals for the reasons 

discussed below. Section 45a authorizes 

the Commission to issue rules to ensure 

products labeled as ‘‘Made in the 

U.S.A.,’’ or the equivalent thereof, 

comport with the requirements of 

Section 5 of the FTC Act that prohibit 

unfairness or deception. The ‘‘all or 

virtually all’’ standard is designed to 

prevent consumer deception and, 

therefore, the Commission declines to: 

(1) Adopt a bright-line, percentagebased standard; (2) include a broad 

carve-out for inputs not available in the 

United States; (3) incorporate CBP’s 

‘‘substantial transformation’’ standard; 

or (4) provide a safe harbor for goodfaith efforts to comply. 

First, percentage-based, bright-line 

rules could allow deceptive unqualified 

claims in circumstances where the low 

cost of the foreign input does not 

correlate to the importance of that input 

to consumers. For example, the 

Commission’s enforcement experience 

has established unqualified U.S.-origin 

claims for watches that incorporate 

imported movements may mislead 

consumers because, although the cost of 

an imported movement is often low 

relative to the overall cost to 

manufacture a watch, consumers may 

place a premium on the origin and 

quality of a watch movement and 

consider the failure to disclose the 

foreign origin of this component to be 

material to their purchasing decision. 

Under those circumstances, the foreign 

movement likely is not a de minimis 

consideration for consumers, and an 

unqualified U.S.-origin claim for a 

watch containing an imported 

movement would likely deceive 

consumers.60 The Policy Statement has 

instructed marketers since the 1990s 

that the cost of foreign versus U.S. parts 

and labor is only one factor to consider 

in determining how material a part may 

be to consumers.61 Accordingly, the 

Commission declines to adopt a 

percentage-based standard because the 

‘‘all or virtually all’’ standard is better 

tailored to prevent unqualified U.S.- 

origin claims that will mislead 

consumers in making purchasing 

decisions. By maintaining this 

precedent, the rule accounts for the 

likelihood consumers interpret MUSA 

claims somewhat differently for 

different product categories. 

Second, the record similarly does not 

support excluding foreign content 

unavailable in the United States from 

the ‘‘all or virtually all’’ analysis. 

Specifically, as described above, 

consumer perception testing has 

consistently shown consumers expect 

products labeled as MUSA to contain no 

more than a de minimis amount of 

foreign content. There is no evidence 

this takeaway varies in scenarios where 

some parts or inputs are not available in 

the United States. Indeed, the Policy 

Statement explains unqualified claims 

for such products could be deceptive, 

for example, ‘‘if the [nonindigenous] 

imported material constitutes the whole 

or essence of the finished product (e.g., 

the rubber in a rubber ball or the coffee 


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62 Id. at 63769 n.117. 

63The Policy Statement explains in some cases 

‘‘where [a raw] material is not found or grown in 

the United States [and that raw material does not 

constitute the whole or essence of the finished 

product], consumers are likely to understand that 

a ‘Made in USA’ claim on a product that 

incorporates such materials (e.g., vanilla ice cream 

that uses vanilla beans, which, the Commission 

understands, are not grown in the United States) 

means that all or virtually all of the product, except 

for those materials not available here, originated in 

the United States.’’ Id. The Policy Statement 

provides that this guidance applies only to raw 

materials, not manufactured inputs. 

64See, e.g., FTC v. World Travel Vacation 

Brokers, Inc., 861 F.2d 1020, 1029 (7th Cir. 1988). 

65See FTC, ‘‘Complying with the Made in USA 

Standard,’’ at 7–8 (Dec. 1998), available at https:// 

www.ftc.gov/system/files/documents/plainlanguage/bus03-complying-made-usa-standard.pdf 

(also providing an example of a certification a 

marketer could request from a supplier that 

generally would constitute an acceptable basis for 

determining the appropriate country-of-origin 

designation for a product). 

66RILA (570). 

67E.g., AAEI (605) (advocating adoption of the 

‘‘substantial transformation’’ standard). 

68See, e.g., Shirley Boyd (6); Pacific Coast 

Producers (27); RILA (570); Vietnam (577); AAEI 

(605); NFI (628); ACA (666); AAFA (675). 

69AAEI (605). 

70 Deontae Lafayette (20); Jaymee Westover (358). 

71Shirley Boyd (6); Pacific Coast Producers (27); 

RILA (570). 

72Pacific Coast Producers (27). 

73LSA (404). 

74SSA (380) (further explaining menus should 

fall under this definition because they are used in 

the direct sale or offer for sale of a product, are 

disseminated in print or can be delivered by 

electronic means, and are solely disseminated to 

solicit the purchase of a product). 

75Frost Brown Todd LLC (522). 

beans in ground coffee).’’ 62 However, 

the flexibility inherent in the ‘‘all or 

virtually all’’ analysis accounts for the 

possibility a marketer could substantiate 

an unqualified claim for a product 

containing nonindigenous raw materials 

if the manufacturer has evidence 

demonstrating the specific claim in 

context does not deceive consumers.63

Third, the record also does not 

support adopting government standards 

developed for other purposes (e.g., the 

CBP substantial transformation standard 

developed for the imposition of tariffs) 

as part of the rule. Based on its 

enforcement experience, the 

Commission is concerned the standards 

adopted by CBP for purposes of 

calculating tariffs are not an appropriate 

fit for the Commission’s regulation of 

MUSA claims on product labels for 

purposes of consumer disclosure. For 

example, there is ample evidence 

consumers care deeply about the source 

of the components used to manufacture 

drywall for construction projects. Under 

a substantial transformation analysis, 

drywall made wholly of materials from 

one nation, but substantially 

transformed in a different country, 

would be labeled as originating from the 

country where those materials were 

ultimately transformed into a final 

product. Marketers would not need to 

disclose the origin of the inputs other 

than labor (information highly material 

to many consumers). Thus, employing 

such a standard would in some cases 

conflict with the Rule’s purpose of 

ensuring consumers have the material 

information necessary to make informed 

purchasing decisions. 

Finally, the rule does not include an 

explicit carve-out for businesses that act 

in good faith. Courts have long held 

good faith is not a defense for a 

violation of Section 5 of the FTC Act,64

and the Commission intends to enforce 

the rule consistent with this precedent. 

Violative claims made in good faith can 

still deceive and cause significant harm 

to consumers. However, the FTC 

clarifies it will continue to: (1) Advise 

marketers that, if provided in good faith, 

marketers can rely on information from 

suppliers about the domestic content in 

the parts, components, and other 

elements they produce; 65 (2) generally 

conserve enforcement resources for 

intentional, repeated, or egregious 

offenders; and (3) provide informal staff 

counseling where appropriate. 

C. Requests for Additional Definitions 

and Other Clarifications 

The Commission received several 

comments arguing the proposed Rule 

was unclear or provided insufficient 

guidance for marketers. To remedy these 

asserted problems, several commenters 

urged the FTC to add definitions for 

particular terms, including ‘‘all or 

virtually all’’ and ‘‘significant 

processing.’’ Other commenters 

expressed concern the Rule was not 

sufficiently clear about the range of 

claims it would cover, suggesting the 

FTC list additional synonyms for ‘‘Made 

in USA’’ to which the rule would apply. 

Finally, others requested a delayed 

effective date to allow marketers to 

update materials and come into 

compliance. 

1. Definitions 

More than twenty commenters 

recommended adding definitions or 

providing more information to clarify 

the rule. Without definitions, the 

commenters feared marketers would 

‘‘lack clear guidance for verifying 

MUSA claims’’ and thus ‘‘may be 

deterred from’’ making them 

altogether.66 Some of these commenters 

offered clarifying edits or proposed 

definitions, often as fallback positions to 

their main arguments advocating 

alternative standards entirely.67

In particular, in addition to 

commenters who recommended 

specifying percentage thresholds for ‘‘all 

or virtually all,’’ several commenters 

requested the Commission generally 

define the phrase, without providing 

specific information on what that 

definition should include (e.g., factors 

considered, etc.).68 As AAEI elaborated: 

‘‘One of the FTC’s stated reasons for this 

proposed rulemaking is to ‘provide 

more certainty to marketers about the 

standard for making unqualified claims 

on product labels.’ Yet, the proposed ‘all 

or virtually all’ standard does not 

provide that certainty . . . It simply 

codifies the FTC’s already existing 

ambiguous standards.’’ 69 Two 

commenters specifically asked the 

Commission to incorporate information 

on whether marketers should consider 

the origin of product packaging into 

such a definition.70

Similarly, three commenters 

requested the Commission define 

‘‘significant processing.’’ 71 As Pacific 

Coast Producers explained, the 

‘‘significant processing’’ and ‘‘all or 

virtually all’’ ‘‘terms have always been 

ambiguous, and the proposed rule does 

not help to remove the ambiguity or 

provide any meaningful guidance to 

industry.’’ 72

Finally, more than thirty commenters, 

primarily representing the domestic 

shrimp industry, argued the 

Commission should clarify that the 

definitions of ‘‘mail order catalog’’ and 

‘‘mail order promotional material’’ 

include restaurant menus. As the 

Louisiana Shrimp Association (‘‘LSA’’) 

explained, ‘‘inappropriate practices by 

some restaurants in offering menu items 

that falsely indicate to customers that 

imported shrimp is domestic, such as 

‘Gulf Shrimp’. . . not only confuse 

consumers, but fatally undermine the 

marketing efforts of restaurants that do 

carry domestic shrimp.’’ 73 To solve this 

problem, SSA urged the Commission to 

‘‘exercise jurisdiction over ‘Made in 

U.S.A.’ statements on restaurant menus, 

as a form of ‘Mail order promotional 

material’ or ‘mail order catalog.’ ’’ 74

2. Covered Claims 

Several commenters suggested the 

Rule was not sufficiently clear about 

which U.S.-origin claims it covers. In 

particular, commenters requested a 

longer list of claims the Commission 

considers equivalent to ‘‘Made in USA,’’ 

as well as a specific statement that the 

Rule covers implied claims. 

One commenter suggested adding 

‘‘constructed,’’ ‘‘fabricated,’’ and 

‘‘assembled’’ to the list.75 Another 


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76R–CALF USA (588). 

77Salvatore J. Versaggi (496). 

78See, e.g., Shirley Boyd (6); Power Planter Inc. 

(325); AAM (611); American Shrimp Processors 

Association (‘‘ASPA’’) (633). 

79AAM (611). 

80ACA (666); McKenna Walsh (581). 

81As discussed in Section III, the Final Rule 

contains a provision clarifying that, in appropriate 

circumstances, covered entities may petition the 

Commission for an exemption from the Rule’s 

requirements. 

82See Policy Statement, 62 FR 63756, 63768 (Dec. 

2, 1997). 

83 16 CFR 323.1. 

84See generally https://www.ftc.gov/tips-advice/ 

business-center/advertising-and-marketing/madein-usa. The Commission has explained that prior to 

the 1990s, this standard was described as the 

‘‘wholly domestic’’ standard, and both ‘‘wholly 

domestic’’ and ‘‘all or virtually all’’ refer to the 

concept that ‘‘unqualified claims of domestic origin 

have been treated as claims that the product was in 

all but de minimis amounts made in the United 

States.’’ 62 FR 63756 (Dec. 2, 1997). 

proposed ‘‘processed,’’ ‘‘fabricated,’’ 

and ‘‘packaged.’’ 76 Finally, one 

commenter suggested, to deter 

unscrupulous marketers effectively, the 

list should include claims that products 

are ‘‘Distributed by:’’ a company name 

followed by a U.S. address.77

Several commenters also asked the 

Commission to clarify that the Rule 

covers implied claims.78 As AAM 

explained, ‘‘the use of iconography, 

such as the American flag, used in the 

promotion of products should also be 

considered for its potential to evoke the 

positive qualities consumers associate 

with ’Made in USA,’ as well as the 

prospect of such iconography being 

used in a deceptive manner.’’ 79

3. Effective Date 

Finally, two commenters requested 

the FTC provide an extended 

compliance period before the rule’s 

effective date. Specifically, ACA and 

McKenna Walsh argued companies 

would need time to come into 

compliance with the Rule. In their view, 

the FTC should delay implementation to 

give companies the opportunity to 

generate new marketing materials and 

run out old stock.80

4. Analysis 

After analyzing the comments, the 

Commission finds the rule and its 

coverage clear on its face, with 

sufficient flexibility to address a 

changing marketplace. Therefore, as 

discussed further below, the 

Commission issues the rule without 

additional definitions or clarifications, 

or a delayed effective date.81

i. Definitions 

The Commission declines to adopt 

definitions of ‘‘all or virtually all’’ and 

‘‘significant processing,’’ or to expand 

the existing definition of ‘‘mail order 

catalog’’ or ‘‘mail order promotional 

material.’’ The Commission has issued 

extensive guidance to help marketers 

understand the ‘‘all or virtually all’’ 

standard. As the Policy Statement 

explains, ‘‘A product that is all or 

virtually all made in the United States 

will ordinarily be one in which all 

significant parts and processing that go 

into the product are of U.S. origin.’’ In 

other words, where a product is labeled 

or otherwise advertised with an 

unqualified claim, it should contain 

only a de minimis, or negligible, amount 

of foreign content. Although there is no 

single ‘‘bright line’’ to establish when a 

product is or is not ‘‘all or virtually all’’ 

made in the United States, there are a 

number of factors to consider in making 

this determination. First, in order for a 

product to be considered ‘‘all or 

virtually all’’ made in the United States, 

the final assembly or processing of the 

product must take place in the United 

States. Beyond this minimum threshold, 

the Commission will consider other 

factors, including but not limited to the 

portion of the product’s total 

manufacturing costs attributable to U.S. 

parts and processing; how far removed 

from the finished product any foreign 

content is; and the importance of the 

foreign content to the form or function 

of the product. Accordingly, the 

Commission’s existing guidance and 

enforcement documents, including the 

Policy Statement, decisions and orders 

enforcing the ‘‘all or virtually all’’ 

standard, and staff closing letters, 

together provide ample guidance to 

marketers. 

As discussed above in Section II.B.3., 

‘‘all or virtually all’’ and ‘‘significant 

processing’’ intentionally incorporate 

flexibility to allow marketers to 

substantiate their claims consistent with 

consumer perception of their particular 

products. The Commission’s 

enforcement program has long 

recognized the need for such flexibility 

as described in the Policy Statement, 

which was based on the Commission’s 

decisions and orders. The Commission 

has continued to follow this flexible 

approach, and incorporated it into its 

post-Policy Statement decisions and 

orders. Adding specific definitions for 

these terms may increase clarity for 

marketers in the short term because the 

rule covers so many product categories 

across a range of circumstances, but the 

Commission has determined adding 

further specificity also increases the risk 

the rule would chill certain nondeceptive claims. Marketers seeking 

additional guidance may look to the 

Policy Statement, decisions and orders, 

and other Commission guidance to 

understand how the FTC has analyzed 

‘‘all or virtually all’’ and ‘‘significant 

processing.’’ 82

The Commission also declines to 

adopt a definition of ‘‘mail order 

catalog’’ or ‘‘mail order promotional 

material’’ that specifically incorporates 

restaurant menus. The Commission has 

not reviewed perception evidence 

regarding consumer understanding of 

MUSA claims on restaurant menus, and 

therefore declines to define such claims 

as covered ‘‘labels’’ for purposes of 

Section 45a. 

ii. Covered Claims 

The Commission also concludes it is 

unnecessary to revise the definitions to 

provide an expanded list of synonyms 

for the term ‘‘Made in U.S.A.,’’ or 

provide further clarification the rule 

covers implied claims. Section 323.1 as 

proposed already defines ‘‘Made in 

U.S.A.’’ as ‘‘any unqualified 

representation, express or implied, that 

a product or service, or a specified 

component thereof, is of U.S. origin, 

including, but not limited to, a 

representation that such product or 

service is ‘made,’ ’manufactured,’ ’built,’ 

’produced,’ ’created,’ or ’crafted’ in the 

United States or in America, or any 

other unqualified U.S.-origin claim’’ 

(emphasis added).83

The list of equivalents to ‘‘Made in 

USA’’ set forth in Section 323.1 is not 

exhaustive because the means of 

communicating U.S. origin are too 

numerous to list. The Commission 

believes the non-exhaustive list of 

examples given provide sufficient 

guidance on the scope of covered 

express and implied claims. These 

examples are based on the 

Commission’s decades of enforcement 

experience addressing MUSA claims. 

For other claims, the Commission will 

analyze them in context, including the 

terms used, their prominence, and their 

proximity to images and other text. 

iii. Effective Date 

Lastly, the Commission declines to 

delay the rule’s effective date. As 

discussed above in Section I, the rule 

codifies the FTC’s longstanding 

guidance on MUSA claims. The FTC has 

incorporated the ‘‘all or virtually all’’ 

standard into decisions and orders and 

guidance for industry and the public 

since the 1990s.84 Because the rule 

merely codifies these longstanding 

enforcement principles and imposes no 

new requirements on marketers, the 

Commission concludes a delayed 

effective date is unnecessary. 


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85North Dakota Farmers Union (412). 

86The Commission also received more than 150 

comments stating country-of-origin labeling should 

be mandatory for beef products. 

87See, e.g., Mexico’s National Confederation of 

Livestock Organizations (431); North American 

Meat Institute and Meat Importers’ Council of 

America (508); National Cattlemen’s Beef 

Association (589); Montana Stockgrowers 

Association (635); Embassy of Canada (637). Some 

of these stakeholders argued the FTC should 

specifically exempt meat labeling from the Rule’s 

coverage. 

88North American Meat Institute and the Meat 

Importers’ Council of America (508). See also 

National Cattlemen’s Beef Association (589) 

(‘‘remind[ing] FTC that the Federal Meat Inspection 

Act of 1906 (21 U.S.C. 601 et seq.) grants the U.S. 

Department of Agriculture (USDA) primary 

jurisdiction over all meat food product oversight 

activities, including the approval and verification of 

geographic and origin labeling claims.’’). 

89Montana Stockgrowers Association (635). 

90Mexico’s National Confederation of Livestock 

Organizations (431); National Cattlemen’s Beef 

Association (589); see also Embassy of Canada (637) 

(stating, in light of 2015 WTO proceedings, the 

Government of Canada ‘‘will continue to closely 

monitor the development of the proposed’’ Rule). 

91 7 CFR part 60. 

92 7 U.S.C. 1638(1). 

93 7 CFR 60.128. 

94ASPA (633) (citing 7 CFR 60.119). 

95See, e.g., Southern Shrimp Alliance (380). 

96ASPA (633), at 2. 

97See Memorandum of Understanding between 

Federal Trade Commission and the Food and Drug 

Administration, 36 FR 18539 (Sept. 16, 1971). 

98 15 U.S.C. 45a. 

99 21 U.S.C. 601(n)(1); 9 CFR 317.8(a) (prohibiting 

labels that convey ‘‘any false indication of origin’’). 

100See R. Edelstein Letter to E. Drake (Mar. 26, 

2020). 

D. Guidance for Specific Industries 

Some commenters requested tailored 

guidance for specific industries. 

Specifically, representatives of the beef 

and shrimp industries requested 

guidance on whether the Rule would 

apply to their products, and specific 

guidance on how to apply ‘‘all or 

virtually all’’ in these contexts. 

1. Beef 

The Commission received more than 

450 comments urging the Commission 

to clarify that the rule applies to beef 

products. These stakeholders, primarily 

U.S. ranchers and industry groups 

representing domestic ranchers, 

generally supported the rule and argued 

it should supersede United States 

Department of Agriculture (‘‘USDA’’) 

guidance on using ‘‘Product of USA’’ 

claims on beef product labels. Although 

they acknowledged the USDA’s 

longstanding authority over beef 

labeling, they expressed concern 

USDA’s Food Safety Inspection Service 

(‘‘FSIS’’) Food Standards and Labeling 

Policy Book currently authorizes 

producers to place ‘‘Product of USA’’ 

labels on beef products processed in the 

USA but comprised of cattle born, 

raised, and slaughtered overseas. These 

commenters argued such labels deceive 

consumers, and ‘‘put U.S. family 

farmers and ranchers at an unfair 

disadvantage in the marketplace, 

because they are not able to differentiate 

their domestically produced meat and 

meat products from foreign produced 

meat and meat products.’’ 85

Accordingly, they argued the ‘‘all or 

virtually all’’ standard should apply to 

beef products, and beef products should 

only bear a ‘‘Product of USA’’ label if 

they derive from animals born, raised, 

slaughtered, and processed in the 

United States.86

In contrast, five commenters argued 

Congress granted the USDA generally, 

and the FSIS specifically, authority to 

address country-of-origin labeling for 

meat and meat food products. Therefore, 

they argued, the FTC should defer to the 

USDA on this issue.87 The North 

American Meat Institute and the Meat 

Importers’ Council of America 

submitted a joint comment stating beef 

commenters’ concerns ‘‘are misplaced 

because they fail to recognize that the 

[USDA’s FSIS] has primary jurisdiction 

over the meat and poultry labeling 

through the authority provided in the 

Federal Meat Inspection Act (FMIA) and 

the Poultry Products Inspection Act 

(PPIA).’’ 88 The Montana Stockgrowers 

Association agreed, explaining that even 

though it ‘‘supports USA beef as being 

defined as born, raised, harvested, and 

processed in the USA . . . [its members] 

think the [USDA] should be the lead 

agency to address enforcement of labels 

that include all meat products.’’ 89

Moreover, some commenters raised 

concerns applying the FTC’s rule to beef 

products could lead to challenges in, or 

even sanctions by, the WTO, given past 

proceedings relating to beef labeling.90

2. Shrimp 

The Commission also received dozens 

of comments from representatives of the 

domestic shrimp industry. Most of these 

expressed general support for the 

proposed rule, and recommended the 

FTC allow MUSA labels only for shrimp 

caught, harvested, and processed in the 

United States. 

Although they expressed enthusiasm 

for the potential application of the 

proposed MUSA rule’s ‘‘all or virtually 

all’’ standard in shrimp labeling, 

commenters acknowledged that USDA’s 

Country of Origin Labeling (‘‘COOL’’) 

regulations 91 have primary authority in 

this space. The COOL regulations 

require ‘‘retail establishments’’ to 

provide country-of-origin information 

for wild and farm-raised fish and 

shellfish,92 and incorporate specific 

standards under which marketers can 

label shrimp as MUSA.93 However, 

commenters identified a possible gap in 

regulatory coverage, explaining that, 

pursuant to USDA Agricultural 

Marketing Service (‘‘AMS’’) regulations 

governing country-of-origin labeling for 

fish and shellfish, COOL does not apply 

to processed shrimp products, including 

breaded or marinated shrimp.94 In 

addition, as described above in Section 

II.C.1., these commenters noted that 

USDA COOL regulations do not apply to 

claims regarding shrimp or shrimp 

products on restaurant menus.95 Thus, 

these commenters urged the FTC to 

‘‘us[e] its authority to enforce the MUSA 

rule [with respect to these categories of 

shrimp products, thereby] . . . filling a 

void in federal labeling accountability 

and providing certainty to the seafood 

market during this time of widespread 

economic instability.’’ 96

3. Analysis 

The FTC shares jurisdiction over 

country-of-origin claims for agricultural 

products with the USDA and, in some 

instances, the Food and Drug 

Administration (‘‘FDA’’). USDA and 

FDA have primary jurisdiction over 

labeling issues for the food products 

within their purview.97 Section 45a 

specifically provides that ‘‘Nothing in 

this section shall preclude the 

application of other provisions of law 

relating to labeling.’’ 98 Accordingly, 

Section 323.5(a) of this rule makes clear 

that the rule does not supersede, alter, 

or affect the application of any other 

federal statute or regulation relating to 

country-of-origin labeling requirements, 

including but not limited to regulations 

issued under the FMIA, 21 U.S.C. 601 

et seq.; the Poultry Products Inspection 

Act, 21 U.S.C. 451 et seq.; or the Egg 

Products Inspection Act, 21 U.S.C. 1031 

et seq. 

Congress has granted the USDA’s 

FSIS specific authority to regulate 

agricultural products, including, among 

others, beef and chicken products. The 

USDA regulates labels on meat products 

sold at retail pursuant to the FMIA, 

which prohibits misleading labels.99

Although FSIS’s Policy Book has 

permitted voluntary claims of ‘‘Product 

of USA’’ for imported products under 

FSIS’s jurisdiction, including beef 

products, processed in the USA, FSIS 

recently explained this guidance ‘‘may 

be misleading to consumers and may 

not meet consumer expectations of what 

‘Product of USA’ signifies.’’ 100

Accordingly, the USDA announced 

plans to initiate a rulemaking to 

alleviate any potential confusion in the 


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101 Id. 102 7 U.S.C. 1638(1); 7 CFR 60.128. 103The FTC notes deceptive claims on restaurant 

menus appear to be largely a regional issue, and 

therefore are being addressed through state 

legislation. See, e.g., La. R.S. § 40:5.5.4 (requiring 

food service establishments to provide notice to 

consumers if crawfish or shrimp is imported); La. 

R.S. § 56:578.14 (‘‘No owner or manager of a 

restaurant that sells imported crawfish or shrimp 

shall misrepresent to the public, either verbally, on 

a menu, or on signs displayed on the premises, that 

the crawfish or shrimp is domestic.’’). FTC staff will 

continue to monitor this issue. 

104BWC (622); AAFA (675). Additionally, PCPC 

(589) argued the Rule should specifically preempt 

a private right of action. However, two commenters 

agreed with the section as drafted as a means to 

‘‘ensure regulatory certainty and consistency of 

product U.S. origin labels nationwide.’’ RILA (570). 

See also NAM (623) (recognizing the ‘‘value of 

utilizing preemption to create a uniform MUSA 

standard’’). 

105UIUC Accounting Group A13 (5); Shirley Boyd 

(6); UIUC—BADM 40—A02 (22); Senators (373); 

United Steelworkers (526); Women Involved in 

Farm Economics/Pam Potthoff Beef Chairman (672). 

106The Commission received 30 comments 

arguing country-of-origin labeling should be 

mandatory for all products. See, e.g., J R. Brookshire 

(9). Additionally, six commenters argued 

specifically in favor of mandatory country-of-origin 

labeling for all products sold online. See, e.g., Made 

in USA Foundation (2). 

107Twelve commenters requested coverage of 

qualified claims. See, e.g., Shirley Boyd (6); United 

Steelworkers (526); AAM (611); CPA (625). 

108Six commenters argued civil penalties should 

be linked to company size. See, e.g., Chris Posey (7). 

109See City of New York v. FCC, 486 U.S. 57, 64 

(1988) (‘‘The statutorily authorized regulations of an 

agency will pre-empt any state or local law that 

conflicts with such regulations or frustrates the 

purposes thereof.’’). 

110See, e.g., Mozilla v. FCC, 940 F.3d 1, 74–75 

(D.C. Cir. 2019). 

111See, e.g., Shirley Boyd (6) (‘‘The FTC’s final 

rules should apply to labeling, advertising and 

other promotional and marketing materials in 

addition to labels and mail order catalogs/ 

promotional materials.’’). 

112 15 U.S.C. 45(a), 52. 

113Made in USA Foundation (2). 

114United Steelworkers (526). 

marketplace.101 As that proceeding 

unfolds, the Commission remains 

committed to engaging with the USDA 

to ensure American consumers receive 

truthful and accurate information about 

the beef products they buy. 

Under its COOL regulations, USDA’s 

AMS has primary authority over 

country-of-origin labels for most fish 

and shellfish products.102 Because 

Section 45a’s general grant of 

rulemaking authority does not authorize 

the Commission to issue regulations that 

would preclude the application of 

existing statutes and regulations 

addressing agricultural product labeling, 

the FTC defers to AMS’s regulatory 

scheme for COOL for fish and shellfish. 

Section 323.5 makes clear the rule does 

not supersede, alter, or affect any other 

federal statute or regulation relating to 

country-of-origin labeling requirements. 

However, to the extent certain, limited 

categories of agricultural products fall 

outside USDA’s jurisdiction, the 

Commission will analyze claims on a 

case-by-case basis and consult with 

other agencies as appropriate.103

E. Other Proposals 

Some commenters proposed a series 

of other amendments, arguing variously 

that the Rule should preempt state law 

entirely; 104 cover MUSA advertising 

generally; 105 make country-of-origin 

labeling mandatory for all products; 106

incorporate provisions relating to 

qualified U.S.-origin claims; 107 and 

include language specifically correlating 

penalties to firm sizes.108 The 

Commission declines to adopt these 

changes, which are inconsistent with its 

rulemaking mandate under Section 45a. 

As discussed above, Section 45a grants 

the Commission authority to issue rules 

to prevent unfair or deceptive acts or 

practices relating to MUSA labeling. 

Specifically, Section 45a authorizes the 

Commission to issue rules to require 

MUSA labeling to ‘‘be consistent with 

decisions and orders of the Federal 

Trade Commission issued pursuant to 

[Section 5 of the FTC Act].’’ The FTC 

may seek civil penalties for violations of 

such rules. 

1. Preemption 

The Commission intends to preempt 

state statutes or regulations that are 

inconsistent with the Commission’s 

rules only to the extent of the 

inconsistency.109 When it enacted 

Section 45a, Congress declined to 

expressly preempt state regulation or 

otherwise demonstrate a clear intent for 

federal law to occupy the field of 

regulation in question.110 Accordingly, 

Section 323.5 of the Rule preempts a 

state statute, regulation, order, or 

interpretation ‘‘to the extent that such 

statute, regulation, order, or 

interpretation is inconsistent with the 

provisions of this part, and then only to 

the extent of the inconsistency.’’ 

Moreover, the rule makes clear that a 

state statute, regulation, order, or 

interpretation is not inconsistent with 

the rule if the protection such statute, 

regulation, order, or interpretation 

affords any consumer is greater than the 

protection provided by the rule. 

2. MUSA Advertising Generally 

Some commenters encouraged the 

Commission to expand the proposed 

rule to cover all advertising that 

includes any U.S.-origin claim, rather 

than focusing as proposed on MUSA 

labeling.111 Section 45a, however, is 

directed at labels on products declaring 

that a product is ‘‘in whole or 

substantial part of domestic origin’’ and 

thus may be labeled ‘‘Made in the 

U.S.A.,’’ or the equivalent thereof. The 

statute does not explicitly address 

general advertising claims beyond the 

context of labeling. Accordingly, in 

enacting this rule, the Commission has 

not focused on advertising more 

generally, but retains the proposed 

rule’s focus on MUSA claims on labels 

or in mail order or catalog advertising, 

including in online marketplaces, that 

depict a product label. However, the 

FTC’s general authority under Sections 

5 and 12 of the FTC Act covers 

advertising, including advertising of 

qualified and unqualified MUSA 

claims.112

3. Mandatory Country-of-Origin 

Labeling 

Other commenters recommended the 

Commission make country-of-origin 

labeling mandatory. For example, the 

Made in USA Foundation proposed that 

the Rule should require that all 

advertisements for specified categories 

of products, including all products 

advertised for sale on the internet, 

disclose the country of origin of the 

products in a clear and prominent 

manner.113 While the Commission 

acknowledges that many consumers 

may find such information to be 

valuable in many circumstances, 

Section 45a does not authorize the 

Commission to establish a mandatory 

country-of-origin labeling scheme. The 

statute grants the Commission authority 

to issue rules to ensure that Made in 

USA claims are not deceptive and are 

consistent with the Commission’s 

decisions and orders defining unfair or 

deceptive acts or practices under 

Section 5. Accordingly, the Commission 

lacks authority under Section 45a to 

enact this proposal. 

4. Qualified U.S.-Origin Claims 

Some commenters also argued that 

the rule should also address qualified 

U.S.-origin claims. The United 

Steelworkers asserted that, ‘‘[a]s firms 

with global supply chains seek to 

benefit from the value consumers place 

in products with American content, we 

must ensure that qualified claims 

accurately represent the level of value 

creation in the United States.’’ 114

Section 45a, however, is directed to 

labels on products declaring that a 

product is ‘‘in whole or substantial part 

of domestic origin,’’ and therefore the 

Rule is directed to unqualified claims, 

rather than more varied qualified 

claims. Accordingly, the FTC will 

continue to address deceptive qualified 

U.S.-origin claims under its general 


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115 15 U.S.C. 45(a). 

116Chris Posey (7). 

117See 15 U.S.C. 45(m)(1)(A) (establishing civil 

penalties for violations of Commission rules); see 

also 16 CFR 1.98 (stating currently applicable 

maximum civil penalty amounts). 

118 15 U.S.C. 45(m)(1)(C). 119See 16 CFR 1.25. 

120 5 U.S.C. 603–605. 

121Anonymous (24) (commenter is unaware of 

small entities affected by the NPRM); UIUC—BADM 

403—A02 (25) (commenter is unaware of small 

entities affected by the NPRM); Family Farm Action 

Alliance (543) (anticipating positive economic 

outcomes for small business entities as a result of 

the rule); Leo McDonnell (578) (anticipating 

benefits for small businesses, including ranchers 

and feeders); McKenna Walsh (581) (stating the 

Rule will be helpful for small businesses lacking 

resources to engage in MUSA litigation); Natural 

Continued 

authority in Section 5 of the FTC Act.115

Marketers should continue to consult 

the Policy Statement for guidance on the 

application of the Commission’s Section 

5 analysis to such claims including, but 

not limited to, ‘‘Assembled in USA,’’ 

claims indicating the amount of U.S. 

content (e.g., ‘‘60% U.S. Content’’), 

claims indicating the parts or materials 

that are imported (e.g., ‘‘Made in USA 

from imported leather’’), or claims about 

specific processes or parts (e.g., claims 

a product is ‘‘designed,’’ ‘‘painted,’’ or 

‘‘written’’ in the United States). 

5. Civil Penalties 

Some commenters argued that larger 

businesses may not be sufficiently 

deterred by the current maximum civil 

penalty amounts for violations of 

Commission rules and recommended 

that civil penalties should be increased 

for larger firms.116 The Commission 

lacks authority, however, to establish 

civil penalty maximums that depart 

from the levels provided by statute. 

Civil penalty amounts for violations of 

the Commission’s rules are established 

by the FTC Act.117 Nonetheless, the 

Commission believes that its civil 

penalty authority generally provides an 

effective deterrent against rule 

violations, and notes that civil penalties 

for violations of a rule are assessed per 

violation. Moreover, the FTC Act 

establishes a series of factors for courts 

to consider in assessing appropriate 

civil penalty amounts in individual 

enforcement matters, including ‘‘the 

degree of culpability, any history of 

prior such conduct, ability to pay, effect 

on ability to continue to do business, 

and such other matters as justice may 

require.’’ 118 To the extent firm size is an 

appropriate consideration within one or 

more of these factors, the Commission 

will take that factor into account in 

seeking civil penalties. 

III. Final Rule 

For the reasons described above, the 

Commission has determined to adopt 

the substantive provisions of the rule as 

initially proposed. Specifically, the rule 

covers labels on products that make 

unqualified MUSA claims. It codifies 

the Commission’s previous MUSA 

Decisions and Orders and prohibits 

marketers from making unqualified 

MUSA claims on labels unless: (1) Final 

assembly or processing of the product 

occurs in the United States, (2) all 

significant processing that goes into the 

product occurs in the United States, and 

(3) all or virtually all ingredients or 

components of the product are made 

and sourced in the United States. The 

rule also covers labels making 

unqualified MUSA claims appearing in 

mail order catalogs or mail order 

advertising. 

To avoid confusion or perceived 

conflict with other country-of-origin 

labeling laws and regulations, the rule 

specifies that it does not supersede, 

alter, or affect any other federal or state 

statute or regulation relating to countryof-origin labels, except to the extent that 

a state country-of-origin statute, 

regulation, order, or interpretation is 

inconsistent with the rule. 

Finally, the Commission has adopted 

a new Section, 323.6, to address 

commenter concerns about the 

applicability of the ‘‘all or virtually all’’ 

standard across product categories. This 

provision allows marketers and other 

covered persons to seek full or partial 

exemptions if they can demonstrate 

application of the rule’s requirements to 

a particular product or class of product 

is not necessary to prevent the acts or 

practices to which the rule relates. The 

Commission’s rules of practice 

governing petitions for rulemaking 

provide the procedures for submitting 

such petitions.119 Pursuant to this 

process, interested persons may file 

relevant consumer perception evidence 

and data with the Commission. If the 

Commission deems the petition 

sufficient to warrant further 

consideration, it will follow the 

procedures outlined in Section 1.25 of 

its rules. 

IV. Paperwork Reduction Act 

The Paperwork Reduction Act 

(‘‘PRA’’), 44 U.S.C. 3501 et seq., requires 

federal agencies to seek and obtain 

Office of Management and Budget 

(‘‘OMB’’) approval before undertaking a 

collection of information directed to ten 

or more persons. The Commission has 

determined that there are no new 

requirements for information collection 

associated with this final rule. 

V. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

(‘‘RFA’’), as amended by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, requires that the 

Commission provide an Initial 

Regulatory Flexibility Analysis with a 

proposed rule, and a Final Regulatory 

Flexibility Analysis with the final Rule, 

unless the Commission certifies that the 

proposed Rule will not have a 

significant impact on a substantial 

number of small entities.120

The Commission recognizes some 

affected entities may qualify as small 

businesses under the relevant 

thresholds. However, the Commission 

anticipates that the final Rule will not 

have the threshold impact on small 

entities. First, the rule includes no new 

barriers to making claims, such as 

reporting or approval requirements. 

Second, the rule merely codifies 

standards established in FTC 

enforcement Decisions and Orders for 

decades. Therefore, the Rule imposes no 

new burdens on law-abiding businesses. 

Accordingly, the Commission certifies 

that the final rule will not have a 

significant economic impact on a 

substantial number of small businesses. 

Although the Commission certifies 

under the RFA that the amendment will 

not have a significant impact on a 

substantial number of small entities, the 

Commission has determined, 

nonetheless, that it is appropriate to 

publish a Final Regulatory Flexibility 

Analysis in order to explain the impact 

of the amendments on small entities as 

follows: 

A. Description of the Need for and 

Objectives of the Rule 

The Commission proposed the MUSA 

Labeling Rule for two primary reasons: 

To strengthen its enforcement program 

and make it easier for businesses to 

understand and comply with the law. 

Specifically, by codifying the existing 

standards applicable to MUSA claims in 

a rule as authorized by Congress, the 

FTC will be able to provide more 

certainty to marketers about the 

standard for making unqualified claims 

on product labels, without imposing any 

new obligations on market participants. 

In addition, enactment of the Rule will 

enhance deterrence by authorizing civil 

penalties against those making unlawful 

MUSA claims on product labels. 

B. Issues Raised by Comments in 

Response to the IRFA 

The Commission received six 

comments specifically related to the 

impact of the Rule on small 

businesses.121 Of those six, all 


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Products Association (618) (stating the rule would 

require small dietary supplement businesses to 

relabel products). 

122Natural Products Association (618). 123 Id. 

anticipated the rule would benefit small 

businesses, with the exception of the 

Natural Products Association, which 

argued that the Rule would impose costs 

on dietary supplement manufacturers 

that would have to relabel products.122

The FTC notes that the rule imposes no 

new requirements on dietary 

supplement manufacturers, and that 

products requiring relabeling as a result 

of the FTC’s rule were likely deceptively 

labeled prior to the Rule’s publication. 

The Chief Counsel for Advocacy of the 

Small Business Administration did not 

submit comments. 

C. Estimate of Number of Small Entities 

to Which the Rule Will Apply 

The Small Business Administration 

estimates that in 2018 there were 30.2 

million small businesses in the United 

States. The rule will apply to small 

businesses that make MUSA claims on 

product labels. The Commission 

estimates the rule will not have a 

significant impact on these small 

businesses because it does not impose 

any new obligations on law-abiding 

businesses; rather, it merely codifies 

standards established in FTC 

enforcement Decisions and Orders for 

decades. 

D. Projected Reporting, Recordkeeping, 

and Other Compliance Requirements, 

Including Classes of Covered Small 

Entities and Professional Skills Needed 

To Comply 

The rule imposes no affirmative 

reporting or recordkeeping 

requirements. The rule’s compliance 

requirements, consistent with the Policy 

Statement and longstanding 

Commission case law, require that 

marketers may not make unqualified 

U.S.-origin claims on product labels 

unless final assembly or processing of 

the product occurs in the United States, 

all significant processing that goes into 

the product occurs in the United States, 

and all or virtually all ingredients or 

components of the product are made 

and sourced in the United States. The 

small entities potentially covered by the 

rule will include all such entities that 

make MUSA claims on product labels. 

The rule codifies the standard for 

MUSA claims established in 

Commission Decisions and Orders, and 

no new obligations are anticipated. 

E. Description of Steps Taken To 

Minimize Significant Economic Impact, 

if Any, on Small Entities, Including 

Alternatives 

The Commission sought comment and 

information on the need, if any, for 

alternative compliance methods that 

would reduce the economic impact of 

the rule on such small entities. Several 

commenters proposed alternatives to the 

proposed rule including: (1) Introducing 

a percentage-of-costs standard; (2) 

adopting a standard that makes 

allowances for imported parts or 

materials not available in the United 

States; (3) aligning with CBP’s 

substantial transformation standard; or 

(4) adding a safe harbor for ‘‘good faith’’ 

efforts to comply. Other commenters 

proposed that the Commission provide 

for a delayed effective date to allow 

businesses additional time to comply. 

As discussed above, the Commission 

has declined to adopt these alternatives 

because it believes they would 

undermine the effectiveness of the rule. 

In addition, the Natural Products 

Association recommended the FTC 

incorporate an example specific to 

dietary supplements.123 The 

Commission has declined to include 

examples specific to any particular 

industry in the Rule. The rule codifies 

the standards articulated in Commission 

enforcement decisions that have been 

applicable to MUSA claims for decades. 

FTC guidance and enforcement 

decisions provide numerous examples 

demonstrating how to apply the ‘‘all or 

virtually all’’ standard in a variety of 

industries. Accordingly, the 

Commission has concluded that it is 

unnecessary to provide industryspecific examples in the Rule. 

As described previously, the rule 

merely codifies standards already 

established in FTC enforcement 

Decisions and Orders. It does not 

impose new substantive obligations on 

businesses that have already been 

complying with their obligations to 

avoid deceptive claims under Section 5 

of the FTC Act. Under these 

circumstances, the Commission does 

not believe a special exemption for 

small entities or significant compliance 

alternatives are necessary or appropriate 

to minimize the compliance burden, if 

any, on small entities while achieving 

the intended purposes of the rule. 

Nonetheless, the Commission has 

adopted a provision allowing covered 

persons to petition the Commission for 

an exemption from the Rule if 

application of the rule’s requirements is 

not necessary to prevent the acts or 

practices to which the rule relates. 

VI. Other Matters 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs has 

designated this rule as not a ‘‘major 

rule,’’ as defined by 5 U.S.C. 804(2). 

VII. Final Rule Language 

List of Subjects in 16 CFR Part 323 

Labeling, U.S. origin. 

■ For the reasons stated in the preamble, 

the Federal Trade Commission adds part 

323 to subchapter C of title 16 of the 

Code of Federal Regulations as follows: 

PART 323—MADE IN USA LABELING 

Sec. 

323.1 Definitions. 

323.2 Prohibited acts. 

323.3 Applicability to mail order 

advertising. 

323.4 Enforcement. 

323.5 Relation to Federal and State laws. 

323.6 Exemptions. 

Authority: 15 U.S.C. 45a. 

§ 323.1 Definitions. 

As used in this part: 

(a) The term Made in the United 

States means any unqualified 

representation, express or implied, that 

a product or service, or a specified 

component thereof, is of U.S. origin, 

including, but not limited to, a 

representation that such product or 

service is ‘‘made,’’ ‘‘manufactured,’’ 

‘‘built,’’ ‘‘produced,’’ ‘‘created,’’ or 

‘‘crafted’’ in the United States or in 

America, or any other unqualified U.S.- 

origin claim. 

(b) The terms mail order catalog and 

mail order promotional material mean 

any materials, used in the direct sale or 

direct offering for sale of any product or 

service, that are disseminated in print or 

by electronic means, and that solicit the 

purchase of such product or service by 

mail, telephone, electronic mail, or 

some other method without examining 

the actual product purchased. 

§ 323.2 Prohibited acts. 

In connection with promoting or 

offering for sale any good or service, in 

or affecting commerce as ‘‘commerce’’ is 

defined in section 4 of the Federal Trade 

Commission Act, 15 U.S.C. 44, it is an 

unfair or deceptive act or practice 

within the meaning of section 5(a)(1) of 

the Federal Trade Commission Act, 15 

U.S.C. 45(a)(1), to label any product as 

Made in the United States unless the 

final assembly or processing of the 

product occurs in the United States, all 

significant processing that goes into the 

product occurs in the United States, and 


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1See 15 U.S.C. 45a. 

2See generally Statement of Commissioner Rohit 

Chopra Regarding Activating Civil Penalties for 

Made in USA Fraud (Apr. 17, 2019), https://

www.ftc.gov/public-statements/2019/04/statementcommissioner-rohit-chopra-regarding-activatingcivil-penalties. 

3Even without a final rule, Commissioners could 

have sought more in administrative settlements, 

given that much of the Made in USA fraud detected 

by Commission staff met the definition of 

‘‘dishonest or fraudulent’’ in Section 19 of the FTC 

Act. 15 U.S.C. 57b. Instead, Commissioners 

routinely accepted settlements with no meaningful 

relief at all. 

4The Commission received over 700 comments in 

response to its Notice of Proposed Rulemaking on 

Made in USA labeling. See FTC Seeks Comments 

on MUSA Rulemaking, Matter No. P074204, Docket 

ID FTC–2020–0056 (July 16, 2020), https://

www.regulations.gov/docket/FTC-2020-0056. 

5See ‘‘Made in USA’’ and Other U.S. Origin 

Claims, 62 FR 63756 (Dec. 2, 1997). 

6See 16 CFR 323.3. 

7See 7 U.S.C. 227. 

all or virtually all ingredients or 

components of the product are made 

and sourced in the United States. 

§ 323.3 Applicability to mail order 

advertising. 

To the extent that any mail order 

catalog or mail order promotional 

material includes a seal, mark, tag, or 

stamp labeling a product Made in the 

United States, such label must comply 

with § 323.2. 

§ 323.4 Enforcement. 

Any violation of this part shall be 

treated as a violation of a rule under 

section 18 of the Federal Trade 

Commission Act, 15 U.S.C. 57a, 

regarding unfair or deceptive acts or 

practices. 

§ 323.5 Relation to Federal and State laws. 

(a) In general. This part shall not be 

construed as superseding, altering, or 

affecting the application of any other 

federal law or regulation relating to 

country-of-origin labeling requirements, 

including but not limited to the Federal 

Meat Inspection Act, 21 U.S.C. 601 et 

seq., the Poultry Products Inspection 

Act, 21 U.S.C. 451 et seq., and the Egg 

Products Inspection Act, 21 U.S.C. 1031 

et seq. In addition, this part shall not be 

construed as superseding, altering, or 

affecting any other State statute, 

regulation, order, or interpretation 

relating to country-of-origin labeling 

requirements, except to the extent that 

such statute, regulation, order, or 

interpretation is inconsistent with the 

provisions of this part, and then only to 

the extent of the inconsistency. 

(b) Greater protection under State law. 

For purposes of this section, a State 

statute, regulation, order, or 

interpretation is not inconsistent with 

the provisions of this part if the 

protection such statute, regulation, 

order, or interpretation affords any 

consumer is greater than the protection 

provided under this part, as determined 

by the Commission on its own motion 

or upon the petition of any interested 

party. 

§ 323.6 Exemptions. 

Any person to whom this Rule applies 

may petition the Commission for a 

partial or full exemption. The 

Commission may, in response to 

petitions or on its own authority, issue 

partial or full exemptions from this part 

if the Commission finds application of 

the Rule’s requirements is not necessary 

to prevent the acts or practices to which 

the Rule relates. The Commission shall 

resolve petitions using the procedures 

provided in § 1.25 of this chapter. If 

appropriate, the Commission may 

condition such exemptions on 

compliance with alternative standards 

or requirements to be prescribed by the 

Commission. 

By direction of the Commission. 

April J. Tabor, 

Secretary. 

The following Appendices will not 

Appear in the Code of Federal 

Regulations. 

Appendix I: Statement of Commissioner 

Rohit Chopra Joined by Chair Lina 

Khan and Commissioner Rebecca Kelly 

Slaughter 

Today, the Commission has voted to adopt 

a final Made in USA rule. The final rule 

reflects a substantial number of comments 

from the public, which overwhelmingly 

supported this policy change by the 

Commission. By formally codifying this rule, 

the Commission has activated a broader 

range of remedies, including the ability to 

seek redress, damages, penalties, and other 

relief from those who lie about a Made in 

USA label. The rule will especially benefit 

small businesses that rely on the Made in 

USA label, but lack the resources to defend 

themselves from imitators. 

Absent this rule, the Commission would be 

unable to seek this full set of sanctions. 

Importantly, this is a ‘‘restatement rule,’’ 

which affirms longstanding guidance and 

legal precedent with respect to Made in USA 

labels—thereby imposing no new obligations 

on manufacturers and sellers. Because of the 

stricter sanctions they trigger, restatement 

rules such as this one will increase fraud 

deterrence and ensure that victims can be 

made whole. 

Background on the FTC’s Permissive Policy 

on Made in USA Fraud 

For decades, there has been a bipartisan 

consensus among Commissioners that Made 

in USA fraud should not be penalized. In my 

view, this policy posture was in direct 

contravention of both the letter and spirit of 

the law Congress enacted. 

In 1994, shortly after the North American 

Free Trade Agreement took effect, Congress 

enacted legislation to protect the integrity of 

our national brand by explicitly authorizing 

the FTC to trigger penalties and other relief 

for Made in USA fraud, but only after 

formally codifying a rule.1 However, the 

Commission never even proposed one.2

Instead, over the past quarter century, 

Commissioners implemented a highly 

permissive Made in USA fraud policy, where 

violators faced essentially no consequences 

whatsoever. Even in cases of blatant abuse of 

the Made in USA label, Commissioners 

routinely voted to allow wrongdoers to settle 

for no restitution, no forfeiture of ill-gotten 

gains, no admission or findings of liability, 

and no notice to victims.3 In adopting this 

rule, the Commission acknowledges that this 

longstanding policy was misguided and 

agrees that the codification of today’s final 

rule is long overdue. 

Noteworthy Provisions of the Final Rule 

In 2019, TINA.org filed a petition with the 

Commission to promulgate a rule, given the 

rampant Made in USA fraud across sectors of 

the economy. In 2020, the Commission 

issued a Notice of Proposed Rulemaking and 

then analyzed a substantial number of 

comments from producers, consumers, 

foreign governments, and others.4 After 

considering these comments, the 

Commission has adopted a rule consistent 

with the authority granted by Congress in 

1994. There are several aspects worthy of 

brief discussion. 

First, the Commission has codified the ‘‘all 

or virtually all’’ standard, consistent with the 

FTC’s longstanding Enforcement Policy 

Statement on U.S. Origin Claims.5 This 

standard covers unqualified claims. The 

Commission must protect the public from 

deception, and the agency declines to adopt 

alternative approaches, as explained in the 

final rule. 

Second, the Commission has outlined a 

definition of ‘‘label’’ consistent with the 

Commission’s expertise on labeling. While 

the Commission declines to adopt a 

definition that includes a list of specific 

examples, such as restaurant menus, the 

definition of label does extend beyond labels 

physically affixed to a product. As described 

in the rule, other depictions of labels are also 

covered; in some circumstances, labels 

appearing online may also be subject to the 

rule.6 The Commission declines to cover 

advertising more broadly, as this is 

inconsistent with the authority granted by 

Congress. 

Third, there was considerable interest in 

the rulemaking from farmers, ranchers, and 

others in the meat and agricultural industry, 

with the majority of comments arguing in 

favor of stricter standards. The rule declines 

to grant an exemption sought by the 

meatpacking industry, as this would be 

inconsistent with the Commission’s authority 

prescribed by Congress under the Packers 

and Stockyards Act.7 However, 

contemporaneous with the FTC’s vote today, 

the U.S. Department of Agriculture has 

announced that it will be conducting a topto-bottom review of its labeling standard. 

USDA has previously acknowledged that its 


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37034 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 

1 I have voted to support every MUSA 

enforcement action recommended to the 

Commission by staff since joining the Commission. 

See In the Matter of Gennex Media, LLC No. C–4741 

(Apr. 2021), https://www.ftc.gov/system/files/ 

documents/cases/2023122gennexmediafinalorder.

pdf; In the Matter of Chemence, Inc., et al., No. 4738 

(Feb. 2021), https://www.ftc.gov/system/files/ 

documents/cases/2021-02-10_chemence_admin_

order.pdf; In the Matter of Williams-Sonoma, Inc., 

No. C–4724 (July 2020), https://www.ftc.gov/ 

system/files/documents/cases/2023025c4724

williamssonomaorder.pdf; U.S. v. iSpring Water 

Systems, LLC, et al., No. 1:16–cv–1620–AT (N.D. 

Ga. 2019); https://www.ftc.gov/system/files/ 

documents/cases/172_3033_ispring_water_systems_

-_stipulated_order.pdf; In the Matter of Sandpiper 

Gear of California, Inc. et al., No. 182–3095, https:// 

www.ftc.gov/enforcement/cases-proceedings/182- 

3095/sandpiper-california-inc-et-al-matter; 

Underground Sports d/b/a Patriot Puck, et al., No. 

182–3113 (April 2019), https://www.ftc.gov/ 

enforcement/cases-proceedings/182-3113/ 

underground-sports-inc-doing-business-patriotpuck-et-al; In the Matter of Nectar Sleep, LLC, 

No.182–3038 (Sept. 2018), https://www.ftc.gov/ 

enforcement/cases-proceedings/182-3038/nectarbrand-llc. 

2Conf. Rep. on H.R. 3355 (filed in House 

(8/21/1994)). 

3Several commenters echoed the concerns I 

raised in my statement when the Commission 

sought comment on this proposed Rule and those 

raised by Commissioner Phillips. See Council for 

Responsible Nutrition Comment; Personal Care 

Products Council Comment; National Association of 

Manufacturers Comment; Anonymous Comment 

592. 

4See Part 323.1(b). 

5See Part 323.3. 

6 Guidance on the definition of ‘‘label’’ can be 

found in analogous FTC rules and guides in a 

variety of contexts. There, ‘‘labels’’ repeatedly have 

been defined as a distinct subcategory of advertising 

(in other words, not coterminous with advertising)1 

and have been described as objects attached to a 

product or its packaging.1 Given both the statutory 

guidance Congress provided when it drafted this 

statute, and precedent concerning the term ‘‘label’’ 

in FTC rules and guides, the Commission has ample 

landmarks to draft a Rule that falls within its 

jurisdictional boundaries. 

7Statement of Commissioner Christine S. Wilson 

Concurring in Part, Dissenting in Part, Notice of 

Proposed Rulemaking related to Made in USA 

Claims (June 22, 2020), https://www.ftc.gov/system/ 

files/documents/public_statements/1577099/ 

p074204musawilsonstatementrev.pdf. 8Report: Americans Going Online . . . Explosive 

Growth, Uncertain Destinations, Pew Research 

Center (Oct. 16, 1995) (noting ‘‘most consumers are 

still feeling their way through cyberspace . . . [and] 

have yet to begin purchasing goods and services 

online’’), available at: https://www.peoplepress.org/1995/10/16/americans-going-onlineexplosive-growth-uncertain-destinations/. 

9U.S. Innovation and Competition Act, S. 1260, 

Section 2510, 117th Cong. (June 8, 2021), https:// 

www.democrats.senate.gov/imo/media/doc/ 

DAV21A48.pdf. 10See UIUC Accounting Group Comment; Shirley 

Boyd Comment; UIUC—BADM Comment; Senators 

Comment; United Steelworkers Comment; Women 

Involved in Farm Economics/Pam Potthoff Beef 

Chairman Comment. 

‘‘Product of USA’’ designation may be 

deceptive. I am extremely grateful to 

Secretary Tom Vilsack and USDA staff for the 

action they are taking. 

I hope the USDA will study the FTC’s 

rulemaking record carefully and come to the 

same conclusion I have: The USDA’s Product 

of USA standard is misleading and distorts 

competition in the retail market for beef and 

other products. I also believe that unqualified 

‘‘Product of USA’’ claims for meat products 

are only appropriate when the animal was 

born, raised, and slaughtered in the United 

States. Given our shared jurisdiction, I expect 

that the Commission will deepen its 

partnership with the USDA and closely 

coordinate on any enforcement proceeding 

with respect to retail sales of meat and other 

products. 

Conclusion 

The Commission appreciates the 

substantial public interest in protecting the 

Made in USA brand. The final rule provides 

substantial benefits to the public by 

protecting businesses from losing sales to 

dishonest competitors, and protecting 

families seeking to purchase American-made 

goods. More broadly, this long-overdue rule 

is an important reminder that the 

Commission must do more to use the 

authorities explicitly authorized by Congress 

to protect market participants from fraud and 

abuse. I thank my fellow Commissioners and 

members of the Commission staff who 

contributed to the development of this final 

rule, as well as members of the public for 

their thoughtful contributions. 

Appendix II: Dissenting Statement of 

Commissioner Christine S. Wilson 

Today the Commission announces a Final 

Rule with respect to ‘‘Made in USA’’ (MUSA) 

labels. I support the FTC’s prosecution of 

MUSA fraud 1 and supported its 

consideration of a rule that addresses 

deceptive MUSA claims on labels, consistent 

with the authority granted to the FTC by 

Congress in Section 45a. The Rule 

announced today, however, exceeds that 

authority. 

Section 45a of the FTC Act—the provision 

pursuant to which we advance this Rule— 

authorizes the Commission to issue rules 

governing MUSA claims on products ‘‘with 

a ‘Made in the U.S.A.’ or ‘Made in America’ 

label, or the equivalent thereof.’’ The 

provision is titled ‘‘Labels on products’’ and 

repeatedly references ‘‘labels.’’ The 

Commission nonetheless has chosen to 

promulgate a rule that could be read to cover 

all advertising, not just labeling. 

This Rule is not supported by the plain 

language of 45a. It is clear Congress intended 

to extend rulemaking authority over the 

many potential variations (or ‘‘equivalents’’) 

of ‘‘Made in the U.S.A.’’ or ‘‘Made in 

America’’ claims that may be found on labels, 

not labels and claims made in advertising or 

marketing. The legislative history for Section 

45a supports this interpretation. Specifically, 

the Conference Report on H.R. 3355 

discusses any label characterizing ‘‘a product 

as ‘Made in the U.S.A.’ or the equivalent 

thereof,’’ signaling Congress’ intent that the 

statute should cover not just literal 

invocations of ‘‘Made in the U.S.A.,’’ but also 

equivalents to that claim (i.e., Made in 

America, American Made, and so on).2

The Commission’s Rule defines the term 

far more broadly than any FTC precedent, 

and in a way that, in my view, exceeds our 

statutory grant of rulemaking authority.3 The 

Rule we issue today will cover not just labels, 

but all: 

‘‘materials, used in the direct sale or direct 

offering for sale of any product or service, 

that are disseminated in print or by 

electronic means, and that solicit the 

purchase of such product or service by mail, 

telephone, electronic mail, or some other 

method without examining the actual 

product purchased’’ 4 that include ‘‘a seal, 

mark, tag, or stamp labeling a product Made 

in the United States.’’ 5

This language could bring within the scope 

of the Rule stylized marks in online 

advertising or paper catalogs and potentially 

other advertising marks, such as hashtags, 

that contain MUSA claims.6

In the statement I issued when the 

Commission sought comment on this 

proposed Rule, I noted that were Congress 

drafting this statute now, it might choose 

language to encompass those broader 

contexts, including online advertising.7 But 

there was no plausible argument to be made 

that the ordinary meaning of the text when 

enacted in 1994 encompassed online 

advertising—a period when online shopping 

was largely unfamiliar to most consumers.8

As it happens, the Senate recently passed the 

Country of Origin Labeling Online Act 

(COOL Act), which prohibits deceptive 

country-of-origin representations. There 

Congress did, in fact, specify its application 

to labeling as well as other forms of online 

advertising: 

it shall be unlawful to make any false or 

deceptive representation that a product or its 

parts or processing are of United States origin 

in any labeling, advertising, or other 

promotional materials, or any other form of 

marketing, including marketing through 

digital or electronic means in the United 

States.9

This language, in contrast to Section 45a, 

leaves no doubt it applies to labeling and 

advertising and confirms Congress views 

‘‘labeling’’ as distinct from ‘‘advertising or 

other promotional materials,’’ including in an 

online context. 

To the extent the Commission seeks to 

issue a broader prohibition on Made in USA 

fraud, as Commissioner Chopra asserted 

when the Commission sought comment on 

this Rule, it has other options. The 

Commission can institute a rulemaking 

proceeding pursuant to Section 18 of the FTC 

Act. Several commenters suggested that 

rather than promulgate a limited rule for 

labeling claims, the Commission should 

conduct a full proceeding to address all 

advertising claims.10 The Commission has 

not taken this action. The Commission 

alternatively could work with Congress to 

effectuate the passage of the COOL Act, 

which would appear to moot this Rule if 

enacted. 

Accordingly, because this Rule exceeds the 

scope of authority granted by Congress to the 

FTC, I dissent. I do not support creatively 

and expansively interpreting the agency’s 

jurisdiction with respect to rulemaking 

authority. 

The Commission, for more than 80 years, 

built a comprehensive program to ensure 


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Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 37035 

11The FTC has issued over 150 closing letters to 

companies making misleading U.S.-origin claims. 

Made in USA Workshop Report at 3 (June 2020). 

Companies only receive closing letters if they 

demonstrate to staff they will come into compliance 

with the FTC’s Enforcement Policy Statement on 

‘‘Made in the USA.’’ The staff’s workshop report 

explains ‘‘companies often produce substantiation 

for updated claims to the FTC staff, and then 

present a plan that includes training staff, updating 

online marketing materials (e.g., company websites 

and social media platforms), updating hardcopy 

marketing materials (e.g., product packaging, 

advertisements, tradeshow materials), and working 

with dealers, distributors, and third-party retailers 

to ensure downstream claims are in compliance.’’ 

Id. at 3 n.7. The FTC has also settled over 25 

enforcement actions, charging that companies 

refused to come into compliance or engaged in 

outright fraud. Id. 

12 I would note as well that seeking civil penalties 

for deceptive MUSA claims, as defined under the 

Commission’s Rule, could have adverse market 

effects. Excessive penalties, divorced from harm, 

can result in over-deterrence. Importantly, the costs 

associated with over-deterrence are likely to 

increase with the expansiveness of the definition of 

labelling. 

13AMG v. FTC, slip op No. 19–508 (Apr. 22, 

2021), https://www.supremecourt.gov/opinions/ 

20pdf/19-508_l6gn.pdf. 

14See Federal Trade Commission Improvements 

Act of 1980, Public Law 96–252, 94 Stat. 374 (1980) 

(reforming the ability of the FTC to promulgate 

rules by requiring a multi-step process with public 

comment and subject to Congressional review). This 

Act also authorized $255 million in funding for the 

Commission and was the first time since 1977 the 

agency was funded through the traditional funding 

process after the backlash from Congress over its 

rulemaking activities. See Kintner, Earl, et al., ‘‘The 

Effect of the Federal Trade Commission 

Improvements Act of 1980 on the FTC’s 

Rulemaking and Enforcement Authority,’’ 58 Wash. 

U. Law Rev. 847 (1980); see also J. Howard Beagles 

III and Timothy J. Muris, FTC Consumer Protection 

at 100: 1970s Redux or Protecting Markets to Protect 

Consumers?, 83 Geo. Wash. L. Rev. 2157 (2015) 

(describing the ‘‘disastrous failures’’ of the FTC in 

the 1970s and the 1980s from enforcement and 

regulatory overreach and quoting Jean Carper, The 

Backlash at the FTC, Wash. Post, C1 (Feb. 6, 1977) 

(describing the backlash from Congress at the FTC, 

after a period of intense rulemaking activity 

culminating in the agency’s being dubbed the 

‘‘National Nanny’’)); see also Alex Propes, Privacy 

and FTC Rulemaking: A Historical Context, IAB 

(Nov. 6, 2018) (discussing how the FTC’s 

rulemaking history could be influencing 

Congressional comfort with vesting the FTC with 

additional privacy authority), https://www.iab.com/ 

news/privacy-ftc-rulemaking-authority-a-historicalcontext/. 

15See Transcript: Oversight of the Federal Trade 

Commission: Strengthening Protections for 

Americans’ Privacy and Data Security (May 8, 

2019), available at: https://docs.house.gov/ 

meetings/IF/IF17/20190508/109415/HHRG-116- 

IF17-Transcript-20190508.pdf. At this Hearing, Rep. 

McMorris Rogers stated: ‘‘In various proposals, 

some groups have called for the FTC to have 

additional resources and authorities. I remain 

skeptical of Congress delegating broad authority to 

the FTC or any agency. However, we must be 

mindful of the complexities of this issue as well as 

the lessons learned from previous grants of 

rulemaking authority to the Commission.’’ 

Transcript at 8–9. Rep. Walden similarly stated: ‘‘it 

has been a few decades, but there was a time when 

the FTC, as we heard, was given broad rulemaking 

authority but stepped past the bounds of what 

Congress and the public supported. This required 

further congressional action and new restrictions on 

the Commission.’’ Transcript at 62. 

consumers can trust ‘‘Made in the USA’’ 

claims.11 My colleagues believe the 

Commission’s 80 year MUSA enforcement 

program was a failure and only a rule and the 

imposition of penalties will deter false 

MUSA claims. I believe administrative 

consents, which were an integral part of this 

program, can be an appropriate remedy to 

address deceptive MUSA claims, consistent 

with the views of bipartisan Commissions 

during the last 25 years. I support seeking 

monetary relief where appropriate but cannot 

support acting outside the constraints of our 

legislative authority.12

I fear as well this Commission’s desire to 

promulgate or utilize our regulatory authority 

in ways that exceed the boundaries of 

underlying statutes and corresponding 

Congressional intent will continue. The 

Supreme Court’s recent decision in AMG 13

has eliminated the FTC’s ability to seek 

equitable monetary relief under Section 13(b) 

of the FTC Act to compensate consumers. 

Thus, the temptation to test the limits of our 

remaining sources of authority is strong. I 

urge my colleagues to pause. Previous FTC 

forays into areas outside its jurisdictional 

authority have resulted in swift 

condemnation from the courts and 

Congress.14 Expansive interpretations of our 

rulemaking authority will not engender 

confidence among members of Congress who 

have in the past expressed qualms about the 

FTC’s history of frolics and detours.15

[FR Doc. 2021–14610 Filed 7–13–21; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No. FDA–2020–F–1289] 

Food Additives Permitted in Feed and 

Drinking Water of Animals; 

Selenomethionine Hydroxy Analogue 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is amending the regulations for 

food additives permitted in feed and 

drinking water of animals to provide for 

the safe use of selenomethionine 

hydroxy analogue as a source of 

selenium in feed for beef and dairy 

cattle. This action is in response to a 

food additive petition filed by Adisseo 

France S.A.S. 

DATES: This rule is effective July 14, 

2021. See section V of this document for 

further information on the filing of 

objections. Submit either electronic or 

written objections and requests for a 

hearing on the final rule by August 13, 

2021. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. 

Electronic objections must be submitted 

on or before August 13, 2021. The 

https://www.regulations.gov electronic 

filing system will accept objections until 

11:59 p.m. Eastern Time at the end of 

August 13, 2021. Objections received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting objections. 

Objections submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

objection will be made public, you are 

solely responsible for ensuring that your 

objection does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

objection, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an objection 

with confidential information that you 

do not wish to be made available to the 

public, submit the objection as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper objections 

submitted to the Dockets Management 

Staff, FDA will post your objection, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–F–1289 for ‘‘Food Additives 

Permitted in Feed and Drinking Water 


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