How to Fill Out and Submit FSIS Form 7234-1: LSAS, Mail, and Returns

FSIS Form 7234-1 is the USDA Food Safety and Inspection Service application meat, poultry, and egg product manufacturers use to get a label approved before selling the product. You file it when your label carries a special claim, covers a religious exemption or foreign commerce product, or needs temporary approval; otherwise the label likely qualifies for generic approval and no form is required. Submissions go through the online Label Submission and Approval System (LSAS) or by mail to FSIS headquarters in Washington, D.C., and there is no filing fee.

Confirm You Actually Need to File

Before filling anything out, check whether your label qualifies for generic approval under 9 CFR 412.2. A generically approved label carries only the mandatory features — product name, handling statement, ingredients statement, manufacturer’s name and address, net weight, the USDA inspection legend, safe handling instructions, and nutrition labeling — all formatted to federal regulations.1eCFR. 9 CFR 412.2 – Approval of Generic Labels No form, no submission.

Under 9 CFR 412.1, four categories require you to submit Form 7234-1:2eCFR. 9 CFR 412.1 – Label Approval

  • Sketch labels for religious exemption products, such as Kosher or Halal.
  • Sketch labels for export products whose labeling deviates from standard FSIS rules.
  • Final labels bearing special statements or claims as defined in 9 CFR 412.1(e).
  • Requests for temporary approval to keep using a label with a minor deficiency.

“Special statements and claims” is read broadly. It always includes “natural” claims, health claims, ingredient and processing method claims, structure-function claims, animal raising claims, organic labels, pathogen-related statements, and any claim not defined in FSIS regulations or the Food Standards and Labeling Policy Book. Common examples: “no antibiotics administered,” “high-pressure processing,” heart-healthy logos, “for cooking only.”

Some things sound like special claims but are not, and they can appear on a generically approved label without triggering a submission: allergen statements under the Food Allergen Labeling and Consumer Protection Act (“contains soy”); negative claims about ingredients not in the product (“No MSG Added,” “Preservative Free”); nutrient content claims that comply with Title 9 of the CFR (“low fat”); and geographical claims like country-of-origin statements, flags, or maps.

Gather Your Documentation First

Incomplete submissions are one of the most common reasons applications are returned, so assemble everything before opening the form.

  • Your FSIS establishment number for the processing facility.
  • A complete product formula: every ingredient with its percentage or weight, listed in order of predominance. For multi-component products like frozen dinners, list each component separately and show what percentage each represents of the total product.3U.S. Department of Agriculture Food Safety and Inspection Service. FSIS 7234-1 Application for Approval of Labels, Marking or Device
  • A legible label copy — either a printer’s proof or a reasonable facsimile showing all mandatory features. Sketch approvals must clearly show every required element.
  • The applicable HACCP process category for the product (for example, “heat treated – shelf stable”).
  • Supporting documentation for any special claim on the label.

Part 412 also requires every establishment to keep copies of all labels in use and make them available to FSIS inspectors on request.

Substantiation for Animal Raising and Organic Claims

Claims about how animals were raised must be documented so FSIS can evaluate whether they are truthful and not misleading.4USDA Food Safety and Inspection Service. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submissions

  • “Raised Without Antibiotics” or similar: documentation showing animals received no antibiotics at any point during production.
  • “No Hormones Administered” on poultry: the label must include a qualifying statement such as “Federal regulations prohibit the use of hormones in poultry.” Pork products labeled “raised without hormones” no longer require this qualifying statement.
  • “Free Range,” “Pasture Raised,” and similar poultry claims: documentation detailing actual raising conditions.
  • Organic claims (other than products where only individual ingredients are organic): third-party certification documentation such as a USDA Organic Certificate.

Filling Out the Form, Block by Block

The form has 15 blocks. Several are reserved for USDA use, so skip those.

  • Block 1 — Agent information. If an agent is submitting on your behalf, enter the company name, address, and phone. Otherwise leave blank.
  • Blocks 2 and 3 — Leave blank; USDA internal use.
  • Block 4 — Establishment number for the facility where the product is processed, or the foreign country if applicable.3U.S. Department of Agriculture Food Safety and Inspection Service. FSIS 7234-1 Application for Approval of Labels, Marking or Device
  • Block 4a — Type of product: Egg, Meat, Poultry, or Other (exotic species, non-amenable, voluntary).
  • Block 5a — Product name. Use the common or descriptive name, such as “Frankfurter, Cereal Added” or “Meat Patties in Gravy,” not a trade name like “Joe’s Corn Dogs.” If you use a coined name like “Corn Dogs,” also show the true product name, for example “Batter Wrapped Wiener.”
  • Block 5b — HACCP process category per 9 CFR 417.2(b)(1).
  • Blocks 6a and 6b — Type of approval. For temporary approval or an extension, enter the number of days requested and the number of labels on hand, attach any previously approved application and label, and explain the need on a continuation sheet.
  • Block 7a — Principal display panel area in square inches (the entire side of the package to which the label is affixed).
  • Block 7b — Total labeling space in square inches for the entire package.
  • Block 8 — Indicate whether the product includes a USDA-AMS Child Nutrition Program logo.
  • Block 10 — Check all boxes that apply for special claims, guarantees, or foreign language on the label. If you select “Other Claims,” specify the claim in the space provided.
  • Block 11 — Firm name and mailing address, using the two-letter state abbreviation and ZIP code.
  • Blocks 12 and 13 — Applicant or authorized agent signature and date.
  • Block 15 — Product formula. List every ingredient by percentage or weight in order of predominance. For multi-component products, list each component separately with its percentage of the total. If you need more room, check the “Continuation Sheet” box and attach additional pages showing the product name and block item number.

Two copies of the label must be submitted, each stapled to a separate copy of the application, and the two applications then stapled together.5Food Safety and Inspection Service. Comprehensive List of Reasons for Label Modifications and Returns

Foreign Language Labels

If your label carries text in a language other than English, include an English translation with the application. Without it, FSIS will return the submission. The translation can be a separate attachment or placed elsewhere in the application as long as the reviewing officer can find it easily. If the entire label appears in both English and a foreign language and the foreign text is a direct translation, you can simply state that in the application instead of providing a separate translation document.6U.S. Department of Agriculture (USDA). FSIS Constituent Update

How to Submit

Online Through LSAS

The preferred method is the Label Submission and Approval System at lsas.fsis.usda.gov. You’ll first need a Level 2 USDA eAuthentication account, which involves registering through the USDA eAuthentication System and completing identity verification at a local USDA Registration Authority office.7Food Safety and Inspection Service. Label Submission and Approval System (LSAS) Once enrolled, you can file Form 7234-1 electronically, attach label images, and track progress through a dashboard.

By Mail

Paper applications go to:

USDA, FSIS, OPPD, LPDD
Labeling Distribution Unit
Stop Code 3786, Patriots Plaza III, 8-168
1400 Independence Avenue, SW
Washington, D.C. 202508U.S. Department of Agriculture Food Safety and Inspection Service. USDA FSIS Form 7234-1 Application for Approval of Labels, Marking or Device

Staple a label copy to each of the two application copies and staple the two applications together. FSIS charges no fee.

What Happens After You Submit

Reviewers verify that all claims and formulas comply with federal regulations, and your submission receives one of three statuses:

  • Approved. The label is cleared for use exactly as submitted.
  • Approved as Modified. You may use the label after making the specific changes noted by the reviewer in Block 14 of the returned application.
  • Returned. The application has deficiencies that prevent approval; correct them and resubmit before using the label.

Sketch approvals for religious exemption and foreign commerce labels use the parallel statuses “Sketch Approved,” “Sketch Modified” with required changes noted, and “Returned.”

As of the most recent FSIS guidance available, label evaluations were taking roughly 5 to 7 business days.9USDA Food Safety and Inspection Service. Constituent Update – May 21, 2021 Actual turnaround varies with agency volume and how complex your claims are; applications with multiple special claims or thin documentation take longer, and LSAS submissions generally process faster than mailed paper.

Common Reasons Applications Get Returned

FSIS publishes a full list of return reasons. The recurring ones are worth knowing before you send anything in:5Food Safety and Inspection Service. Comprehensive List of Reasons for Label Modifications and Returns

  • Incomplete formula: missing ingredients, missing percentages, or failing to break out components of multi-component products.
  • Applicable blocks left blank on the form.
  • Illegible applications or labels.
  • Missing label copies. You need two, each stapled to a separate application.
  • Product name issues: a trade name shown without the true product name, or lettering where the smallest letter in the product name is less than one-third the size of the largest.
  • Restricted ingredient limits exceeded, such as sodium nitrite (156 parts per million in comminuted product), sodium phosphate (5,000 parts per million in total product), or soy protein concentrate as a binder (3.5 percent of finished product weight).
  • “And/or” labeling of major components. Declare the ingredients actually used.

Temporary Approvals for Labels Already Printed

If labels are already printed and carry a minor deficiency, you can request temporary approval to keep using them while corrected labels are produced. Temporary approvals last up to 180 calendar days, and the label must meet all four conditions:10eCFR. 9 CFR 412.1 – Label Approval

  • The label does not misrepresent the product.
  • Using it would not create health, safety, or dietary problems for consumers.
  • Denying the request would cause undue economic hardship.
  • Granting it would not give you an unfair competitive advantage.

Request the temporary approval through Block 6, entering the number of days needed and labels on hand, and attach a continuation sheet explaining the necessity. Extensions past 180 days are possible if new circumstances arise that still meet the four conditions, but you must file a fresh request showing those changed circumstances.