21 CFR 101.5 requires the label of every packaged food to state the name and place of business of the manufacturer, packer, or distributor. This information must appear on the information panel (or PDP) and must be sufficient to allow FDA and consumers to identify and contact the responsible party.

The Core Requirement

Under 21 CFR 101.5(a), the label must bear:

• The name of the manufacturer, packer, or distributor

• The place of business — including street address, city, state, and ZIP code

The place of business must be the principal place of business if the company has multiple locations.

When the Street Address May Be Omitted

Under 21 CFR 101.5(b), the street address may be omitted if it is listed in a current city directory or telephone directory. In practice, most brands include the full street address because city directories are no longer universally accessible, and FDA inspectors routinely look for a complete address.

The ZIP code must always be included regardless of whether the street address is present.

Who Must Be Named

The regulation permits the label to bear the name of the manufacturer, packer, or distributor — giving brands flexibility in which entity is identified. In practice:

The co-packer's name and address does not need to appear on the label if the brand's name and address are present. However, many brands use qualifying language to clarify the relationship.

"Manufactured For," "Distributed By," and "Packed By" Language

Under 21 CFR 101.5(d), when a food is manufactured by one company but sold under the label of a different company, the label must qualify the relationship using a phrase such as:

• "Manufactured for [brand name and address]"

• "Distributed by [brand name and address]"

• "Packed by [packer name and address] for [brand name and address]"

This qualifying language is required when the entity named on the label is not the actual manufacturer. It informs consumers and regulators about where to direct inquiries, and it protects the named entity from being assumed to be the manufacturer in regulatory contexts.

Address Format Requirements

The place of business must include:

• Street address (unless omitted under the directory exception)

• City

• State (two-letter USPS abbreviation is acceptable)

• ZIP code

For imported foods, the country of origin may be required under separate regulations — 21 CFR 101.5 addresses domestic responsible party information, but does not substitute for country of origin labeling requirements under the Tariff Act and COOL regulations.

Placement on the Label

Under 21 CFR 101.2(b), the name and place of business must appear on the information panel (the panel immediately to the right of the PDP) or on the PDP itself. It must be grouped with other required labeling elements — not isolated on a separate panel or the bottom of the package.

Brands that place the manufacturer/distributor address only on the bottom or back of a package, separated from the ingredient list and Nutrition Facts panel, may violate the grouping requirement under 21 CFR 101.2(e).

Common Compliance Failures

The most frequent violations related to 21 CFR 101.5:

• Missing ZIP code: Omitting the ZIP code even when the rest of the address is present

• Missing qualifying language: Label names a distributor/brand but omits "manufactured for" or "distributed by" language

• P.O. Box only: Using only a P.O. Box with no street address (not compliant unless the entity is in a directory)

• Wrong entity: Listing the co-packer rather than the brand, or listing a parent company address for a subsidiary brand

• Outdated address: Address on the label reflects a prior location after the brand moved

Dietary Supplement Applications

Dietary supplement labels must comply with 21 CFR 101.5 in the same way as conventional food labels. The name and address on a supplement label determines who FDA contacts in the event of adverse event reports, recalls, or inspections. Brands that sell through contract manufacturers and do not update their label address after relocating are a common source of compliance gaps.

How Truli Helps with Name and Address Compliance

• Address completeness check: Truli verifies that name and address fields include all required components — name, street, city, state, ZIP

• Qualifying language verification: Truli flags labels where a distributor or brand is named without the required "manufactured for" or "distributed by" qualifier

• Placement audit: Truli confirms name and address appears on the information panel grouped with other required elements

Related Regulations

• 21 CFR Part 101 — FDA food labeling overview

• 21 CFR 101.2 — Information Panel — Placement and grouping requirements for all mandatory label elements

• 21 CFR 101.3 — Statement of Identity — The food name requirement on the PDP

• 21 CFR 101.4 — Ingredient List — Ingredient declaration requirements on the information panel

Frequently Asked Questions

Can I use a P.O. Box instead of a street address?
Only if your business is listed in a current city directory or telephone directory at that P.O. Box. In practice, P.O. Box–only addresses are risky — directories are not universally accessible, and FDA inspectors may flag the absence of a street address. Best practice is to include the full street address.

My company moved. Do I need to update labels immediately?
Yes. Using an outdated address on food labels is a misbranding violation. If you have existing label inventory with an old address, you should work through that inventory as quickly as possible and update new label print runs with the current address. FDA recognizes practical transition timelines but does not exempt outdated addresses from misbranding classification.

Our brand name is on the label but a co-packer makes the product. Whose address goes on the label?
Your brand's address — since your name is on the label as the distributor. You must include qualifying language such as "Manufactured for [Your Brand Name], [City, State ZIP]" or "Distributed by [Your Brand Name], [City, State ZIP]." The co-packer's address does not need to appear.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. Reflects 21 CFR 101.5 as of April 2026. Book a demo to see how Truli monitors food label compliance.