What enforcement discretion actually is

The phrase, and what it is not

Enforcement discretion is a statement of intent. An agency says what it does not currently plan to act against, usually while conditions are met.

It is not a change in the law. The statute that made something a violation still says what it said, and the regulation under it is unamended. What has changed is a published expectation about the agency's own behavior.

Two things follow from that, and both matter more than the phrase itself. The document carrying the statement is not binding on anyone, and it can be withdrawn.

Three primary sources answer the rest. The section of the food and drug law that governs guidance documents, the regulation written under it, and the separate regulation covering the one kind of statement that does bind the agency.

The document it usually arrives in

Statements of enforcement intent almost always live in a guidance document, and the regulation defines that term.

Guidance documents are prepared for agency staff, applicants and sponsors, and the public, and they describe the agency's interpretation of or policy on a regulatory issue.

The definition then lists subjects, and one of them is the point here. Guidance documents include those relating to inspection and enforcement policies.

The same definition has an exclusion list, and it is worth reading beside the article on letters. Guidance documents do not include warning letters, memoranda of understanding, or other communications directed to individual persons or firms.

So a letter to one company is not a policy. It is a communication to that company, and the regulation says so by putting it outside the definition.

Binding on nobody, in both directions

The regulation asks the question in its own heading and answers it in one word.

Are you or the agency required to follow a guidance document? No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or the agency.

The statute says the same from the other end. Guidance documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the agency's jurisdiction.

You may also depart from one. The regulation says a person may choose an approach other than the one set out in a guidance, with one condition attached: the alternative approach must comply with the relevant statutes and regulations.

That condition is the whole architecture. The guidance was never the requirement. The statute and the regulation were, and they still are.

So what is it worth

More than nothing, and the regulation is precise about how much.

Although guidance documents do not legally bind the agency, they represent its current thinking. Agency employees may therefore depart from them only with appropriate justification and supervisory concurrence.

The statute repeats that duty. Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees do not deviate from such guidances without appropriate justification and supervisory concurrence.

There is also a bar on informal announcements. The agency may not use documents excluded from the guidance definition to communicate new or different regulatory expectations to a broad public audience for the first time.

A statement of enforcement intent is therefore a real signal about how staff are expected to behave. It is simply not a permission, and it confers nothing on the person reading it.

How to read the words inside one

Two drafting rules make a guidance document readable once you know them.

Every guidance must prominently display a statement of its own nonbinding effect. That is the box on the cover page most readers skip, and it is required to be there.

The second rule governs the verbs. A guidance document must not include mandatory language such as shall, must, required or requirement, unless the agency is using those words to describe a statutory or regulatory requirement.

Read that as a reading key. A should in a guidance is a recommendation. A must in a guidance is a pointer to a duty that lives somewhere else, and the somewhere else is the thing to look up.

The same discipline applies to a statement of enforcement intent. It is normally phrased as what the agency does not intend to do, followed by the conditions under which that holds. The conditions are part of the sentence, not decoration around it.

It can end, and ending is not a change in the law

Because a guidance was never the source of the obligation, withdrawing one does not create a new obligation. It restores the position that was there the whole time.

The regulation builds that in. The agency reviews existing guidance documents periodically to decide whether they need changing or withdrawing, and reviews them when significant changes are made to the statute or regulations.

This is the part that surprises people watching a market change. Nothing about the underlying rule had to move for the practical position to move. A published intention was withdrawn, and what the statute always said became the operative fact again.

It is also why a seller quoting a guidance is quoting the agency's current thinking, at the date of that document, and not a settled entitlement.

The kind of statement that does bind the agency

There is one, and the contrast is sharp enough to be worth carrying.

A separate regulation covers advisory opinions. An advisory opinion represents the formal position of the agency on a matter and, with one exception, obligates the agency to follow it until it is amended or revoked. The Commissioner may not recommend legal action against a person or product for an action taken in conformity with an advisory opinion that has not been amended or revoked.

The exception is narrow and cannot be delegated. In unusual situations involving an immediate and significant danger to health, the Commissioner may take civil enforcement action contrary to an advisory opinion before amending or revoking it.

The regulation also names the documents that count as advisory opinions, and the list includes compliance policy guides. An opinion may be amended or revoked at any time, and where that happens, action already undertaken in conformity with it remains acceptable unless substantial public interest considerations say otherwise.

Even so, it is not a rule. An advisory opinion may be used in administrative or court proceedings to illustrate acceptable and unacceptable procedures or standards, but not as a legal requirement.

And a conversation is worth less again. A statement or advice given by an agency employee orally, or in writing outside these procedures, is an informal communication representing that employee's best judgment at that time. The regulation states it does not necessarily represent the formal position of the agency, and does not bind or otherwise obligate or commit the agency to the views expressed.

What a reader can actually do with all this

Four things, and none of them requires a lawyer.

Find the nonbinding statement on the document being quoted at you, because it is required to be prominent and it says what the document is.

Read past the sentence that was quoted to the conditions attached to it. A statement of what an agency does not intend to do almost always carries them.

Check the date on the guidance. Current thinking is dated by definition, and the agency commits to reviewing and revising its guidances rather than leaving them fixed.

And know that the process is open. A person may comment on any guidance document at any time, and may suggest at any time that one be revised or withdrawn. Where someone at the agency treats a guidance as a binding requirement, the regulation gives a route through a center or office and its ombudsman. The statute separately requires an effective appeals mechanism for complaints that guidance documents are not being developed and used as the law directs.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. United States Code Title 21, Section 371(h), Regulations and hearings, guidance documents, 2024 Main Edition — Office of the Law Revision Counsel, U.S. House of Representatives, January 2025
2. Title 21 Code of Federal Regulations section 10.115, Good guidance practices — Electronic Code of Federal Regulations, Office of the Federal Register, March 2018
3. Title 21 Code of Federal Regulations section 10.85, Advisory opinions — Electronic Code of Federal Regulations, Office of the Federal Register, November 2014