(Slip Opinion)

1

Whether Section 564 of the Food, Drug, and Cosmetic 

Act Prohibits Entities from Requiring the Use of a 

Vaccine Subject to an Emergency Use Authorization

Section 564(e)(1)(A)(ii)(III) of the Food, Drug, and Cosmetic Act concerns only the 

provision of information to potential vaccine recipients and does not prohibit public or 

private entities from imposing vaccination requirements for a vaccine that is subject to

an emergency use authorization.

July 6, 2021

MEMORANDUM OPINION FOR THE 

DEPUTY COUNSEL TO THE PRESIDENT

Section 564 of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. 

§ 360bbb-3,1 authorizes the Food and Drug Administration (“FDA”) to 

issue an “emergency use authorization” (“EUA”) for a medical product,

such as a vaccine, under certain emergency circumstances. This authorization permits the product to be introduced into interstate commerce and 

administered to individuals even when FDA has not approved the product 

for more general distribution pursuant to its standard review process.

Section 564 directs FDA—“to the extent practicable” given the emergency circumstances and “as the [agency] finds necessary or appropriate to 

protect the public health”—to impose “[a]ppropriate” conditions on each 

EUA. FDCA § 564(e)(1)(A). Some of these conditions are designed to 

ensure that recipients of the product “are informed” of certain things, 

including “the option to accept or refuse administration of the product.”

Id. § 564(e)(1)(A)(ii)(III).

Since December 2020, FDA has granted EUAs for three vaccines to 

prevent coronavirus disease 2019 (“COVID-19”). In each of these authorizations, FDA imposed the “option to accept or refuse” condition by 

requiring the distribution to potential vaccine recipients of a Fact Sheet 

that states: “It is your choice to receive or not receive [the vaccine].

Should you decide not to receive it, it will not change your standard 

medical care.” E.g., FDA, Fact Sheet for Recipients and Caregivers at 5

(revised June 25, 2021), https://www.fda.gov/media/144414/download

 1 Because it is commonly referred to by its FDCA section number, and for the sake of 

simplicity, we will refer to this provision as section 564, rather than by its United States

Code citation.
45 Op. O.L.C. __ (July 6, 2021)

2

(“Pfizer Fact Sheet”). In recent months, many public and private entities 

have announced that they will require individuals to be vaccinated against 

COVID-19—for instance, in order to attend school or events in person, or 

to return to work or be hired into a new job. We will refer to such policies

as “vaccination requirements,” though we note that these policies typically are conditions on employment, education, receipt of services, and the 

like rather than more direct legal requirements.2

In light of these developments, you have asked whether the “option to 

accept or refuse” condition in section 564 prohibits entities from imposing such vaccination requirements while the only available vaccines for 

COVID-19 remain subject to EUAs. We conclude, consistent with FDA’s 

interpretation, that it does not. This language in section 564 specifies only 

that certain information be provided to potential vaccine recipients and 

does not prohibit entities from imposing vaccination requirements.

3

I.

A.

Federal law generally prohibits anyone from introducing or delivering 

for introduction into interstate commerce any “new drug” or “biological 

product” unless and until FDA has approved the drug or product as safe 

and effective for its intended uses. See, e.g., FDCA §§ 301(a), 505(a), 21 

U.S.C. §§ 331(a), 355(a); 42 U.S.C § 262(a). A vaccine is both a drug and 

a biological product. See FDCA § 201(g), 21 U.S.C § 321(g); 42 U.S.C. 

§ 262(i)(1). Consistent with section 564, we will generally refer to it here 

as a “product.” See FDCA § 564(a)(4)(C) (defining “product” to mean “a 

drug, device, or biological product”).

 2 For an example of the latter, see our discussion in Part II.B of a hypothetical military 

order to service members.

3 We do not address whether other federal, state, or local laws or regulations, such as 

the Americans with Disabilities Act (“ADA”), might restrict the ability of public or private entities to adopt particular vaccination policies. See, e.g., Equal Employment Opportunity Commission, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws (updated June 28, 2021), https://www.eeoc.gov/wysk/

what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws 

(discussing the ADA).
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

3

In 2003, Congress addressed a problem raised in emergency situations 

where “the American people may be placed at risk of exposure to biological, chemical, radiological, or nuclear agents, and the diseases caused 

by such agents,” but where, “[u]nfortunately, there may not be approved 

or available countermeasures to treat diseases or conditions caused by 

such agents,” even though “a drug, biologic, or device is highly promising 

in treating [such] a disease or condition.” H.R. Rep. No. 108-147, pt. 1, 

at 2 (2003). President George W. Bush had flagged this problem in his 

2003 State of the Union Address, in which he proposed Project BioShield, 

a legislative initiative “to quickly make available effective vaccines 

and treatments against agents like anthrax, botulinum toxin, Ebola, and 

plague.” Address Before a Joint Session of the Congress on the State 

of the Union (Jan. 28, 2003), 1 Pub. Papers of Pres. George W. Bush

82, 86 (2003). Among the principal components of the proposed Project 

BioShield legislation were provisions to enable FDA to authorize medical 

products for use during emergencies even before they are proven to be 

safe and effective under ordinary FDA review. See, e.g., H.R. 2122, 108th 

Cong. § 4 (2003). At that time, the only alternative to ordinary FDA 

approval was 21 U.S.C. § 355(i), which authorizes FDA to exempt drugs 

from the ordinary approval requirements where the drug is “intended 

solely for investigational use by experts qualified by scientific training 

and experience to investigate the safety and effectiveness of drugs.” Such 

a cabined investigational new drug (“IND”) exemption does not, however, 

allow the widespread dissemination of a drug for general public use in 

response to an emergency. See H.R. Rep. No. 108-147, pt. 1, at 2.

Congress enacted a version of the Project BioShield legislation’s EUA 

provision in the National Defense Authorization Act for Fiscal Year 2004 

as section 564 of the FDCA. See Pub. L. No. 108-136, § 1603(a), 117 

Stat. 1392, 1684 (2003) (codified at 21 U.S.C. § 360bbb-3).4 Section 564 

authorizes the Secretary of Health and Human Services (“HHS”)—who 

has delegated to FDA the authorities under the statute at issue here—to 

authorize the introduction into interstate commerce of a drug, device, or 

biological product intended for use in an actual or potential emergency 

even though the product has not yet been generally approved as safe and 

 4 The statute has been amended since, including when Congress enacted the Project 

BioShield Act the following year. See Pub. L. No. 108-276, § 4(a), 118 Stat. 835, 853 

(2004).
45 Op. O.L.C. __ (July 6, 2021)

4

effective for its intended use. FDCA § 564(a)(1)–(2); see also FDA, 

Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders at 3 n.6 (Jan. 2017) 

(“EUA Guidance”) (noting delegation of most of the Secretary’s authorities under section 564 to FDA).5

The most pertinent part of section 564 for purposes of your question 

has remained materially the same since Congress first enacted the statute 

in 2003. Subsection (e)(1)(A),6 titled “Required conditions,” provides:

With respect to the emergency use of an unapproved product, the 

Secretary, to the extent practicable given the applicable [emergency] 

circumstances . . . , shall, for a person who carries out any activity 

for which the authorization is issued, establish such conditions on an 

authorization under this section as the Secretary finds necessary or 

appropriate to protect the public health, including [certain specified 

conditions].

 5 The current version of section 564(a)(1) provides in full:

Notwithstanding any provision of this chapter and section 351 of the Public Health 

Service Act, and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use 

in an actual or potential emergency (referred to in this section as an “emergency 

use”).

The “declaration under subsection (b)” refers to a declaration by the Secretary “that the 

circumstances exist justifying” an EUA, which must be made “on the basis” of one or 

more types of emergencies or threats. FDCA § 564(b)(1). FDA can grant an EUA where, 

“based on the totality of scientific evidence available to the Secretary, including data from 

adequate and well-controlled clinical trials, if available,” FDA finds that “it is reasonable 

to believe,” among other things, that “the product may be effective in diagnosing, treating, or preventing” a “serious or life-threatening disease or condition” caused by a “biological, chemical, radiological, or nuclear agent or agents” (a standard less onerous than 

for final approval of the product); that “the known and potential benefits of the product,

when used to diagnose, prevent, or treat such disease or condition, outweigh the known 

and potential risks of the product”; and that “there is no adequate, approved, and available 

alternative to the product for diagnosing, preventing, or treating such disease or condition.” FDCA § 564(c).

6 Subsection (e)(1) applies to a product that FDA has not approved as safe and effective for any intended use, whereas subsection (e)(2) applies to an unapproved use of an 

otherwise approved product. The COVID-19 vaccines fall under the former category, but 

the statute applies the condition at issue here to the latter category as well. See FDCA 

§ 564(e)(2)(A).
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

5

The statute then lists a number of such conditions, including “[a]ppropriate conditions designed to ensure that individuals to whom the 

product is administered are informed” of certain information. FDCA 

§ 564(e)(1)(A)(ii). This information includes the fact that FDA “has 

authorized the emergency use of the product,” “the significant known and 

potential benefits and risks of such use,” and “the extent to which such 

benefits and risks are unknown.” Id. § 564(e)(1)(A)(ii)(I)–(II). Most 

relevant here, section 564(e)(1)(A)(ii)(III) directs FDA to impose conditions on an EUA “designed to ensure that individuals to whom the product

is administered are informed . . . of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are 

available and of their benefits and risks.”

In the same section of the 2004 National Defense Authorization 

Act, Congress also enacted another provision, codified as 10 U.S.C. 

§ 1107a, which is specific to the U.S. military and which expressly refers 

to the “option to accept or refuse” condition described in section 

564(e)(1)(A)(ii)(III). Pub. L. No. 108-136, sec. 1603(b)(1), § 1107a, 117 

Stat. at 1690. Subsection (a) of this law provides that when an EUA 

product is administered to members of the armed forces, “the condition 

described in section 564(e)(1)(A)(ii)(III) . . . and required under paragraph (1)(A) or (2)(A) of such section 564(e), designed to ensure that 

individuals are informed of an option to accept or refuse administration of 

a product, may be waived only by the President” and “only if the President determines, in writing, that complying with such requirement is 

not in the interests of national security.” 10 U.S.C. § 1107a(a)(1).

B.

In the years after Congress enacted section 564, FDA issued dozens of 

EUAs in response to various public-health emergencies. See, e.g., Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information; Availability, 74 Fed. Reg. 56,644 

(Nov. 2, 2009) (antiviral drug to treat swine flu). The agency’s use of 

EUAs increased dramatically with the onset of the COVID-19 pandemic 

in 2020. As of January 2021, the agency had issued more than 600 EUAs 

for products to combat COVID-19, including drugs, tests, personal protective equipment, and ventilators. See FDA, FDA COVID-19 Pandemic 
45 Op. O.L.C. __ (July 6, 2021)

6

Recovery and Preparedness Plan (PREPP) Initiative: Summary Report

at 6 (Jan. 2021); cf. id. at 24 (noting that FDA issued 65 EUAs prior to 

COVID-19). More importantly for present purposes, the agency has 

granted EUAs for three COVID-19 vaccines manufactured by Pfizer, 

Moderna, and Janssen, respectively. See Authorizations of Emergency 

Use of Certain Biological Products During the COVID-19 Pandemic; 

Availability, 86 Fed. Reg. 28,608 (May 27, 2021) (Janssen); Authorizations of Emergency Use of Two Biological Products During the COVID19 Pandemic; Availability, 86 Fed. Reg. 5200 (Jan. 19, 2021) (Pfizer and 

Moderna).

As we have explained, section 564 of the FDCA contemplates that each 

EUA will be subject to various conditions. For the three COVID-19 

vaccines, FDA implemented the “option to accept or refuse” condition 

described in section 564(e)(1)(A)(ii)(III) in the following manner: In 

each letter granting the EUA, FDA established as a “condition[] of authorization” that FDA’s “Fact Sheet for Recipients and Caregivers” be made 

available to potential vaccine recipients. See, e.g., Letter for Pfizer Inc. 

from RADM Denise M. Hinton, Chief Scientist, FDA at 6, 9 (updated 

June 25, 2021), https://www.fda.gov/media/150386/download (“Pfizer 

EUA Letter”). The Fact Sheet in question states (to take the Pfizer vaccine 

as an example): “It is your choice to receive or not receive the PfizerBioNTech COVID-19 Vaccine. Should you decide not to receive it, it will 

not change your standard medical care.” Pfizer Fact Sheet at 5. We understand that this approach is consistent with FDA’s general practice for 

EUAs. See EUA Guidance at 24–25 (discussing the use of fact sheets to 

inform recipients of EUA products “[t]hat they have the option to accept 

or refuse the EUA product and of any consequences of refusing administration of the product”).

As access to the COVID-19 vaccines has become widespread, numerous educational institutions, employers, and other entities across the 

United States have announced that they will require individuals to be 

vaccinated against COVID-19 as a condition of employment, enrollment, 

participation, or some other benefit, service, relationship, or access.7 For 

 7 See, e.g., Rukmini Callimachi, For Colleges, Vaccine Mandates Often Depend on 

Which Party Is in Power, N.Y. Times (May 22, 2021), https://www.nytimes.com/2021/05/

22/us/college-vaccine-universities.html; Tracy Rucinski, Delta will require COVID-19 
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

7

instance, certain schools will require vaccination in order for students to 

attend class in person, and certain employers will require vaccination as 

a condition of employment.

Some have questioned whether such entities can lawfully impose such 

requirements in light of the fact that section 564 instructs that potential 

vaccine recipients are to be informed that they have the “option to accept 

or refuse” receipt of the vaccine.

8 In the past few months, several lawsuits 

have also been filed challenging various entities’ vaccination requirements on the same theory.9 The only judicial decision to have addressed 

this issue so far summarily rejected the challenge. See Bridges v. Houston 

Methodist Hosp., No. 4:21-cv-01774, 2021 WL 2399994, at *1–2 (S.D. 

Tex. June 12, 2021), appeal docketed, No. 21-20311 (5th Cir. June 14, 

2021).

II.

A.

We conclude that section 564(e)(1)(A)(ii)(III) concerns only the provision of information to potential vaccine recipients and does not prohibit 

public or private entities from imposing vaccination requirements for 

vaccines that are subject to EUAs. By its terms, the provision directs only 

that potential vaccine recipients be “informed” of certain information, 

including “the option to accept or refuse administration of the product.”

 

vaccine for new employees, Reuters (May 14, 2021, 9:16 AM), https://www.reuters.com/

world/us/delta-will-require-covid-19-vaccine-new-employees-2021-05-14/.

8 See, e.g., Letter for Thomas C. Galligan Jr., Interim President, Louisiana State University, from Jeff Landry, Attorney General of Louisiana (May 28, 2021); see also 

Advisory Committee on Immunization Practices, Summary Report at 56 (Aug. 26, 2020), 

https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2020-08-508.

pdf (reporting a CDC official as saying that EUA vaccines are not allowed to be mandatory).

9 See, e.g., Defendant’s Notice of Removal, Bridges v. Methodist Hosp., No. 4:21-cv01774 (S.D. Tex. June 1, 2021), 2021 WL 2221293 (referencing complaint); Complaint, 

Neve v. Birkhead, No. 1:21-cv-00308 (M.D.N.C. Apr. 16, 2021), 2021 WL 1902937; 

Complaint, Cal. Educators for Med. Freedom v. L.A. Unified Sch. Dist., No. 21-cv-2388 

(C.D. Cal. Mar. 17, 2021), 2021 WL 1034618; Complaint, Legaretta v. Macias, No. 2:21-

cv-00179 (D.N.M. Feb. 28, 2021), 2021 WL 909707; see also Complaint, Health Freedom Defense Fund v. City of Hailey, No. 1:21-cv-00212-DCN (D. Idaho May 14, 2021), 

2021 WL 1944543 (making a similar argument about a face-mask requirement).
45 Op. O.L.C. __ (July 6, 2021)

8

FDCA § 564(e)(1)(A)(ii)(III). In the sense used here, the word “inform” 

simply means to “give (someone) facts or information; tell.” New Oxford 

American Dictionary 891 (3d ed. 2010); see also, e.g., Webster’s Third 

New International Dictionary 1160 (2002) (similar). Consistent with this 

understanding, the conditions of authorization that FDA imposed for the 

COVID-19 vaccines require that potential vaccine recipients receive 

FDA’s Fact Sheet, see, e.g., Pfizer EUA Letter at 6, 9, which states that 

recipients have a “choice to receive or not receive” the vaccine, see, e.g., 

Pfizer Fact Sheet at 5. Neither the statutory conditions of authorization 

nor the Fact Sheet itself purports to restrict public or private entities from 

insisting upon vaccination in any context. Cf. Bridges, 2021 WL 2399994, 

at *2 (explaining that section 564 “confers certain powers and responsibilities to the Secretary of [HHS] in an emergency” but that it “neither 

expands nor restricts the responsibilities of private employers”).10

The language of another provision of section 564 reflects the limited 

scope of operation of section 564(e)(1)(A)(ii)(III). Section 564(l) provides that “this section [i.e., section 564] only has legal effect on a person

who carries out an activity for which an authorization under this section 

is issued.” This provision expressly forecloses any limitation on the 

activities of the vast majority of entities who would insist upon vaccination requirements, because most do not carry out any activity for which an 

EUA is issued.

To be sure, the EUA conditions effectively require parties administering the products to do so in particular ways—including that they only 

administer the products to individuals after providing them the informational Fact Sheets that FDA prescribes—and some of those entities, 

 10 Earlier-introduced versions of section 564(e)(1)(A)(ii)(III) in 2003 referred to “any

option to accept or refuse administration of the product” (as opposed to “the” option), a 

formulation that might have even more clearly conveyed the informational nature of the 

condition. See, e.g., S. 15, 108th Cong. § 204 (Mar. 11, 2003) (emphasis added). We have 

not found any explanation for why Congress revised the provision to refer to “the option,” 

so we ascribe little significance to the change—either for or against our reading of the 

statute. See Mead Corp. v. Tilley, 490 U.S. 714, 723 (1989); Trainmobile Co. v. Whirls, 

331 U.S. 40, 61 (1947) (“The interpretation of statutes cannot safely be made to rest upon 

mute intermediate legislative maneuvers.”). In 10 U.S.C. § 1107a(a), moreover, Congress 

used the alternative formulation “an option to accept or refuse” in referring to the condition in section 564(e)(1)(A)(ii)(III) as it relates to the armed forces. (Emphasis added.)

This discrepancy counsels further against assigning interpretive weight to the change from 

“any” to “the” in the legislative development of section 564.
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

9

such as universities, might also impose vaccination requirements (e.g., on 

their students and employees). There is no indication, however, that 

Congress intended to regulate such entities except with respect to the 

circumstances of their administration of the product itself. See, e.g., 

FDCA § 564(e)(1)(B)(ii) (authorizing FDA to establish “[a]ppropriate 

conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, 

and the circumstances under which, the product may be administered with 

respect to such use” (emphasis added)). And it would have been odd for 

Congress to have done so, for in that case the entities choosing to administer EUA products would be limited in their relations with third parties

(e.g., students, employees) in ways that analogous entities that did not 

administer the products were not.

This reading of the “option to accept or refuse” condition to be informational follows not only from the plain text of the provision, but also 

from the surrounding requirements in section 564(e)(1)(A)(ii). See, e.g.,

Lagos v. United States, 138 S. Ct. 1684, 1688–89 (2018) (relying on the 

canon of “noscitur a sociis, the well-worn Latin phrase that tells us that 

statutory words are often known by the company they keep”). In addition 

to requiring that potential recipients be informed of “the option to accept 

or refuse administration of the product,” the statute also requires that 

they be informed of “the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” FDCA § 564(e)(1)(A)(ii)(III).

Similarly, the two other provisions in subsection (e)(1)(A)(ii) require that 

individuals be informed of the fact that FDA “has authorized the emergency use of the product” and of “the significant known and potential 

benefits and risks of such use, and of the extent to which such benefits 

and risks are unknown.” Id. § 564(e)(1)(A)(ii)(I)–(II). These provisions 

all appear to require only that certain factual information be conveyed to 

those who might use the product.

Indeed, if Congress had intended to restrict entities from imposing 

EUA vaccination requirements, it chose a strangely oblique way to do so, 

embedding the restriction in a provision that on its face requires only that 

individuals be provided with certain information (and grouping that 

requirement with other conditions that are likewise informational in 

nature). Congress could have created such a restriction by simply stating 

that persons (or certain categories of persons) may not require others to 
45 Op. O.L.C. __ (July 6, 2021)

10

use an EUA product. See Kloeckner v. Solis, 568 U.S. 41, 52 (2012) 

(rejecting a statutory interpretation positing that Congress took a “roundabout way” and an “obscure path” to reach “a simple result”); cf. Whitman 

v. Am. Trucking Ass’ns, 531 U.S. 457, 468 (2001) (Congress does not 

“hide elephants in mouseholes”).

Our reading of section 564(e)(1)(A)(ii)(III) does not fully explain why 

Congress created a scheme in which potential users of the product would

be informed that they have “the option to accept or refuse” the product.

The legislative history of the 2003 statute does not appear to offer any 

clear explanation. Perhaps Congress viewed section 564(e)(1)(A)(ii)(III) 

as a variation on the “informed consent” requirement that applies to 

human subjects in “investigational drug” settings,11 the only other context 

in which FDA may (in a limited fashion) authorize the introduction of 

unapproved drugs into interstate commerce. Or perhaps Congress included this condition to ensure that potential users of an EUA product would 

not misunderstand what the likely impact of declining to use that product 

would be.

The information conveyed pursuant to the “option” clause continues to 

be a true statement about a material fact of importance to potential vac-

 11 Section 355(i)(4) of title 21 provides that an IND exemption to the premarket approval requirement may only apply if the manufacturer or sponsor of an expert investigation requires the experts in question to certify

that they will inform any human beings to whom such drugs, or any controls used 

in connection therewith, are being administered, or their representatives, that such 

drugs are being used for investigational purposes and will obtain the consent of 

such human beings or their representatives, except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing 

poses no more than minimal risk to such human beings and includes appropriate 

safeguards.

Congress did not include this same “informed consent” requirement as part of the EUA 

provision in 2003, perhaps out of concern that it would not be practicable in emergency 

situations. See Project BioShield: Contracting for the Health and Security of the American Public: Hearing Before the H. Comm. on Gov’t Reform, 108th Cong. 33 (Apr. 4, 

2003) (statement of Mark B. McClellan, Commissioner, FDA, and Anthony S. Fauci, 

Director, National Institute of Allergy and Infectious Diseases) (“Because urgent situations may require mass inoculations and/or drug treatments, such informed consent 

requirements may prove impossible to implement within the necessary time frame when 

trying to achieve the public health goal of protecting Americans from the imminent 

danger.”); see also infra note 15 (explaining that the informed consent requirements 

contained in 21 U.S.C. § 355(i)(4) do not apply to EUA products).
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

11

cine recipients—virtually all such persons continue to have the “option” 

of refusing the vaccine in the sense that there is no direct legal requirement that they receive it. See Bridges, 2021 WL 2399994, at *2 (noting 

that an employer’s vaccination policy was not “coercive” because an

employee “can freely choose to accept or refuse a COVID-19 vaccine; 

however, if she refuses, she will simply need to work somewhere else”); 

Wen W. Shen, Cong. Research Serv., R46745, State and Federal Authority to Mandate COVID-19 Vaccination at 4 (Apr. 2, 2021) (“[E]xisting 

vaccination mandates—as they are typically structured—generally do not 

interfere with . . . an individual’s right to refuse in that context. Rather, 

they impose secondary consequences—often in the form of exclusion 

from certain desirable activities, such as schools or employment—in the 

event of refusal.” (footnote omitted)); Black’s Law Dictionary 1121 (7th 

ed. 1999) (defining “option” as relevant here as “[t]he right or power to 

choose; something that may be chosen”); The American Heritage Dictionary of the English Language 1235 (4th ed. 2000) (similar); cf. FDCA 

§ 564(e)(1)(A)(ii)(III) (directing that potential vaccine recipients be 

informed not only of “the option to accept or refuse administration of the 

product” but also of “the consequences, if any, of refusing administration 

of the product” (emphasis added)).

Importantly, however, and consistent with FDA’s views, we also read 

section 564 as giving FDA some discretion to modify or omit “the option 

to accept or refuse” notification, or to supplement it with additional information, if and when circumstances change. As noted above, the statute 

directs FDA to establish the section 564(e)(1)(A) conditions “to the extent 

practicable given the applicable [emergency] circumstances” and “as the 

[agency] finds necessary or appropriate to protect the public health.”

FDCA § 564(e)(1)(A). Both of these phrases—“to the extent practicable” 

and “as the [agency] finds necessary or appropriate”—are generally 

understood to confer discretion on an agency. See, e.g., GallegosHernandez v. United States, 688 F.3d 190, 195 (5th Cir. 2012) (per curiam) (“to the extent practicable”); Madison-Hughes v. Shalala, 80 F.3d 

1121, 1128 (6th Cir. 1996) (collecting cases on “necessary” and “appropriate”). Moreover, the portion of section 564 that deals specifically with 

informational conditions provides that FDA should establish “[a]ppropriate” conditions designed to ensure that potential vaccine recipients are 

informed of the “option to accept or refuse” an EUA product. FDCA 

§ 564(e)(1)(A)(ii). These qualifiers indicate that FDA’s responsibility to 
45 Op. O.L.C. __ (July 6, 2021)

12

impose the “option to accept or refuse” condition is not absolute and that

the agency has some discretion to modify or omit the condition when the 

agency finds the notification would not be “practicable” given the emergency circumstances, or to determine that changes to the notification are 

“necessary or appropriate to protect the public health.” See EUA Guidance at 24 n.46 (noting circumstances in which the “option to accept or 

refuse” notification might not be practicable).12 In addition, section 564 

gives FDA the authority to supplement the information that is conveyed 

to potential vaccine recipients, including information about “the consequences, if any, of refusing administration of the product.” FDCA 

§ 564(e)(1)(A)(ii)(III); see also id. § 564(e)(1)(B) (noting that FDA has 

the authority to impose additional conditions as the agency “finds necessary or appropriate to protect the public health”); EUA Guidance at 22 

n.40, 26–27 (noting this point). Together, then, these provisions of section 

564 give FDA the authority to adapt to changing circumstances and to 

ensure that the information conveyed to potential users of EUA products 

is accurate.13

Although many entities’ vaccination requirements preserve an individual’s ultimate “option” to refuse an EUA vaccine, they nevertheless 

impose sometimes-severe adverse consequences for exercising that option 

(such as not being able to enroll at a university). Under such circumstances, FDA could theoretically choose to supplement the conditions of authorization to notify potential vaccine recipients of the possibility of such 

consequences (or to make it even clearer that the consequences described 

 12 Indeed, FDA has recently exercised its discretion not to require certain of the statutorily specified conditions with respect to the current COVID-19 pandemic. We understand that FDA has amended or plans to amend the EUAs for the COVID-19 vaccines so 

as not to require compliance with several of the conditions—including the “option to 

accept or refuse” notification—when the vaccines are exported to other countries. See, 

e.g., Pfizer EUA Letter at 10.

13 Congress’s use of the phrase “Required conditions” in the title of subsection 

(e)(1)(A) and its specification of certain conditions in the statute suggest that Congress 

may have presumed that FDA would generally find that the specified conditions are 

“necessary or appropriate” and thus impose them. As we discuss above, however, the 

operative text of section 564 indicates that FDA has some discretion to modify, omit, 

or supplement the conditions in some circumstances. See Fulton v. City of Philadelphia, 

141 S. Ct. 1868, 1879 (2021) (“[A] title or heading should never be allowed to override

the plain words of a text.” (quoting A. Scalia & B. Garner, Reading Law: The Interpretation of Legal Texts 222 (2012)) (alteration in original)).
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

13

in the Fact Sheets are limited to consequences related to medical care). As 

we have noted, however, section 564 does not limit the ability of entities 

to impose vaccination requirements, and FDA would not be required to 

change the Fact Sheets in order to allow them to impose such requirements.14

* * * * *

As noted above, FDA agrees with our interpretation of section 564.

On a few occasions, however, FDA has made statements that could 

be understood as saying that the condition described in section 

564(e)(1)(A)(ii)(III) prohibits entities (particularly the U.S. military) 

from requiring the use of EUA products. In 2005, for instance, FDA 

issued an EUA that permitted the use of a vaccine for the prevention of 

inhalation anthrax by individuals between 18 and 65 years of age who 

were deemed by the Department of Defense (“DOD”) to be at heightened 

risk of exposure due to an attack with anthrax. As a condition of that 

authorization, the agency required DOD to inform potential vaccine 

recipients “of the option to accept or refuse administration of [the vaccine].” Authorization of Emergency Use of Anthrax Vaccine Adsorbed for 

Prevention of Inhalation Anthrax by Individuals at Heightened Risk of 

Exposure Due to Attack With Anthrax; Availability, 70 Fed. Reg. 5452, 

5455 (Feb. 2, 2005). That EUA continued:

With respect to [the] condition . . . relating to the option to accept or 

refuse administration of [the vaccine], the [immunization program] 

will be revised to give personnel the option to refuse vaccination.

Individuals who refuse anthrax vaccination will not be punished. Refusal may not be grounds for any disciplinary action under the Uniform Code of Military Justice. Refusal may not be grounds for any 

adverse personnel action. Nor would either military or civilian personnel be considered non-deployable or processed for separation 

 14 FDA further informs us that, wholly apart from FDA’s own authority to change the 

Fact Sheet, nothing in the FDCA would prohibit an administrator of the vaccine who also 

has a relationship with the individuals to whom the vaccine is offered (e.g., students in a 

university that offers the vaccine) from supplementing the FDA Fact Sheet at the point of 

administration with factually accurate information about the possible nonmedical consequences of the person choosing not to use the product (e.g., that she might not be permitted to enroll).
45 Op. O.L.C. __ (July 6, 2021)

14

based on refusal of anthrax vaccination. There may be no penalty or 

loss of entitlement for refusing anthrax vaccination.

Id.; see also id. (allowing DOD to inform recipients that “military and 

civilian leaders strongly recommend anthrax vaccination, but . . . individuals [subject to the vaccination program] may not be forced to be vaccinated” and that “the issue of mandatory vaccination will be reconsidered 

by [DOD] after FDA completes its administrative process.”). FDA included the same information in its later extension of that EUA. See Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of 

Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due 

to Attack With Anthrax; Extension; Availability, 70 Fed. Reg. 44,657, 

44,659–60 (Aug. 3, 2005).

In addition, although it is less than clear, certain FDA guidance could 

be read as saying that section 564 confers an affirmative “option” or 

“opportunity” to refuse EUA products. See EUA Guidance at 24 n.46 

(implying that the condition in section 564(e)(1)(A)(ii)(III)—which is 

subject to waiver for the armed forces under 10 U.S.C. § 1107a—protects 

“the option for members of the armed forces to accept or refuse administration of an EUA product”); Guidance Emergency Use Authorization of 

Medical Products, 2007 WL 2319112, at *15 (July 1, 2007) (stating that 

“[r]ecipients must have an opportunity to accept or refuse the EUA product”).

These statements do not affect our conclusion. Neither the 2005 anthrax 

vaccine EUA nor the later FDA guidance articulated a legal interpretation 

of section 564(e)(1)(A)(ii)(III)’s text. And FDA appears to have insisted 

upon the voluntariness requirement for DOD in the anthrax vaccine EUA 

because of then-recent litigation in which a court enjoined DOD from 

implementing a mandatory vaccination program based upon a different 

statutory provision that is inapplicable to EUAs. See Doe v. Rumsfeld, 341 

F. Supp. 2d 1 (D.D.C. 2004) (relying on 10 U.S.C. § 1107); Doe v. 

Rumsfeld, 297 F. Supp. 2d 119 (D.D.C. 2003) (same); see also 70 Fed. 

Reg. at 44,660 (requiring DOD to tell vaccine recipients the following:

“On October 27, 2004, the U.S. District Court for the District of Columbia 

issued an Order declaring unlawful and prohibiting mandatory anthrax 

vaccinations to protect against inhalation anthrax, pending further FDA 

action. The Court’s injunction means you have the right to refuse to take 

the vaccine without fear of retaliation.” (emphasis added)); 70 Fed. Reg. 
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

15

at 5454 (discussing litigation); see also infra note 15 (explaining that 10 

U.S.C. § 1107(f) is inapplicable to EUAs).

B.

Section 564(e)(1)(A)(ii)(III) also raises a question about how to understand its cognate provision regarding the use of EUA products by the 

armed forces. As we noted above, in the same 2003 legislation that first 

created section 564, Congress also added the following provision to title 

10 of the United States Code:

In the case of the administration of [an EUA] product . . . to members of the armed forces, the condition described in section 

564(e)(1)(A)(ii)(III) . . . and required under paragraph (1)(A) or 

(2)(A) of such section 564(e), designed to ensure that individuals 

are informed of an option to accept or refuse administration of a 

product, may be waived only by the President only if the President 

determines, in writing, that complying with such requirement is not 

in the interests of national security.

10 U.S.C. § 1107a(a)(1).

15 On its own terms, this provision appears to be 

consistent with—and even to support—our reading of section 564, as it

likewise describes the “option to accept or refuse” condition in purely 

informational terms. The language refers to the President’s authority to 

 15 Section 1107(f) of title 10—an earlier-enacted provision—contains a similar, but 

importantly different, waiver authority. Specifically, that provision authorizes the President, “[i]n the case of the administration of an [IND] or a drug unapproved for its applied 

use to a member of the armed forces in connection with the member’s participation in a 

particular military operation,” to waive “the prior consent requirement imposed under 

[21 U.S.C. § 355(i)(4)].” 10 U.S.C. § 1107(f)(1). That “prior consent requirement,” which 

is imposed for purposes of the human clinical trials for which FDA authorizes “investigational” use of unapproved drugs, see 21 U.S.C. § 355(i)(4), does not apply to EUA 

products, which typically are more widely available, see FDCA § 564(k); EUA Guidance 

at 24 (“informed consent as generally required under FDA regulations is not required for 

administration or use of an EUA product” (footnote omitted)). Thus, the waiver provision 

in section 1107(f) is inapplicable to EUA products. See 10 U.S.C. § 1107(f)(2) (explaining that this waiver authority applies only in cases in which “prior consent for administration of a particular drug is required” because the Secretary of HHS determines that the 

drug “is subject to the [IND] requirements of [21 U.S.C. § 355(i)]”); see also id.

§ 1107(f)(4) (defining the relevant consent requirements as those in 21 U.S.C. § 355(i)).
45 Op. O.L.C. __ (July 6, 2021)

16

waive a requirement to provide certain information, not to waive any right 

or affirmative “option” to refuse administration of the product itself.

On the other hand, the conference report on the legislation that created 

both section 564 of the FDCA and section 1107a of title 10 described the 

latter provision in the following way:

[This provision] would authorize the President to waive the right of 

service members to refuse administration of a product if the President determines, in writing, that affording service members the right 

to refuse the product is not feasible, is contrary to the best interests 

of the members affected, or is not in the interests of national security.

H.R. Rep. No. 108-354, at 782 (2003) (Conf. Rep.) (emphasis added).

This language indicates that the conferees may have believed that section 

1107a concerns some “right” of members of the armed forces to refuse 

the use of EUA products. And that belief may help to explain why section 

1107a allows only the President to exercise the waiver authority.

Consistent with this legislative history and the vesting of the waiver 

authority in the President, DOD informs us that it has understood section 

1107a to mean that DOD may not require service members to take an 

EUA product that is subject to the condition regarding the option to refuse, unless the President exercises the waiver authority contained in 

section 1107a. See DOD Instruction 6200.02, § E3.4 (Feb. 27, 2008) (“In 

the event that an EUA granted by the Commissioner of Food and Drugs 

includes a condition that potential recipients are provided an option to 

refuse administration of the product, the President may . . . waive the 

option to refuse for administration of the medical product to members of 

the armed forces.” (emphasis added)). Moreover, we understand that 

DOD’s position reflects the concern that service members, unlike civilian 

employees, could face serious criminal penalties if they refused a superior 

officer’s order to take an EUA product. See 10 U.S.C. § 890; see also 

United States v. Kisala, 64 M.J. 50 (C.A.A.F. 2006) (upholding a soldier’s 

punishment for refusing to take a vaccine). In this way, service members 

do not have the same “option” to refuse to comply with a vaccination 

requirement as other members of the public.

As noted above, it does appear that certain members of Congress 

thought that section 1107a concerned a prohibition against requiring 

service members to take an EUA product—perhaps on the view that the 
Requiring the Use of a Vaccine Subject to an Emergency Use Authorization

17

waiver authority in section 1107a paralleled the one in 10 U.S.C. 

§ 1107(f), which does effectively prohibit the administration of an IND 

product in a clinical trial without first obtaining the individual’s affirmative, informed consent. See supra note 15 (distinguishing these waiver 

authorities).

16 As explained, however, that intent or expectation is not 

realized in the text of section 564(e)(1)(A)(ii)(III), which section 1107a 

expressly cross-references. Cf. Steinle v. City & Cty. of San Francisco, 

919 F.3d 1154, 1164 n.11 (9th Cir. 2019) (“[T]he plain and unambiguous 

statutory text simply does not accomplish what the Conference Report 

says it was designed to accomplish.”); Goldring v. Dist. of Columbia, 416 

F.3d 70, 75 (D.C. Cir. 2005) (“A sentence in a conference report cannot 

rewrite unambiguous statutory text[.]”).17 We therefore conclude that 

section 1107a does not change our interpretation of section 564 of the 

FDCA.

As for DOD’s concern about service members who would lack a meaningful option to refuse EUA products because of the prospect of sanction, 

including possibly prosecution, we note that any difference between our 

view and the assumption reflected in the conference report should have 

limited practical significance. Given that FDA has imposed the “option to 

accept or refuse” condition for the COVID-19 vaccines by requiring 

 16 It is possible the conferees assumed that the new EUA legislation would, in effect, 

carry over from the earlier IND provision of the FDCA, see supra Part I.A and note 11, 

the condition that a covered product may not be administered to an individual without that 

person’s express, informed consent—a condition that applies to the military when it 

undertakes the sort of clinical trial with an IND that 21 U.S.C. § 355(i) governs, see supra 

note 11. Congress did not include such a consent requirement in section 564, however, 

perhaps because EUA products are not limited, as INDs are, to use in human clinical 

trials, but are instead authorized for more widespread use in the case of a declared emergency. See supra Part I.A and notes 11 & 15.

17 Moreover, the legislative history as a whole is not uniform on this point. The earlier 

House report, for instance, described the condition in purely informational terms. See

H.R. Rep. No. 108-147, pt. 3, at 33 (2003) (“New section 564(k) [an earlier but similarly 

worded version of what became 10 U.S.C. § 1107a] pertains to members of the Armed 

Forces and, among other things, it specifies that the President may waive requirements 

designed to ensure that such members are informed of the option to accept or refuse 

administration of an emergency use product, upon certain findings[.]” (emphasis added)); 

see also Milner v. Dep’t of the Navy, 562 U.S. 562, 574 (2011) (noting that “[l]egislative 

history, for those who take it into account, is meant to clear up ambiguity, not create it,” 

and thus, “[w]hen presented, on the one hand, with clear statutory language and, on the 

other, with dueling committee reports, we must choose the language”).
45 Op. O.L.C. __ (July 6, 2021)

18

distribution of its Fact Sheet containing the “[i]t is your choice to receive 

or not receive” language, DOD is required to provide service members 

with the specified notification unless the President waives the condition

pursuant to 10 U.S.C. § 1107a. And because DOD has informed us that it 

understandably does not want to convey inaccurate or confusing information to service members—that is, telling them that they have the “option” to refuse the COVID-19 vaccine if they effectively lack such an 

option because of a military order—DOD should seek a presidential 

waiver before it imposes a vaccination requirement.

III.

For the reasons set forth above, we conclude that section 564 of the 

FDCA does not prohibit public or private entities from imposing vaccination requirements, even when the only vaccines available are those authorized under EUAs.

DAWN JOHNSEN

Acting Assistant Attorney General

Office of Legal Counsel