Label Application & Submission

USDA requires that food labels under its jurisdiction (products containing more than 2% cooked meat or poultry or 3% raw meat or poultry) be approved by its Food Safety and Inspection Service (FSIS) staff in Washington D.C.

There are four types of label approval: Sketch (label is in draft or proof form), Final (actual printed label), Temporary (slight inaccuracies on the label), and Extension (a second consecutive temporary).  All Temporary and Extension labels along with most Sketches must be approved at FSIS in Washington D.C.  Final labels get approved in-house, as well as those Sketches which qualify for Generic Approval. 

When submitting a label application to FSIS in Washington D.C., the packet should contain USDA's coversheet (Form 7234-1) and the actual label to be approved.  Submission of the application packet may be sent directly to FSIS' offices in Washington D.C., or to a label expediter (such as Prime Label Consultants) for faster approval time.

To complete the application packet:

1. Download and complete FSIS Form 7234-1, following the instructions for the individual blocks below.   
2. Make sure that your label lists ingredients in descending order of predominance, that the Net Weight statement complies with Regulations 317.2d and 317.2h for meat, or 381.116b, 381.116c and 381.121 for poultry, and that your printer has an approved Inspection Legend and has followed graphic specifications for the Nutrition Facts panel (NFP). (USDA reviews these intensely for detail. Sloppy legends and NFPs are not accepted.)
    
   
3. Make sure that Temporary & Extension labels are the actual label; full-color photocopies or lithographs may be acceptable.  For Sketch approvals, photocopies of the label are acceptable. 
4. Attach label/sketch to the back of Form 7234, facing outward, with one staple. (This leaves blocks #1, #2, #3 free for the reviewer's stamp and helps the reviewer compare formula and processing procedures with label statements.) Please remove all carbon paper before submitting application.
5. If you have a previously approved ("prior") label or sketch similar to the submitted item, include a copy of the stamped 7234 form and the label. Send a cover letter explaining any unusual history of your label.  When requesting a temporary approval, fill out a temporary approval form.  
6. Send two complete applications (Form 7234 and label/sketch) (USDA keeps one copy, and returns the other to you), unless special conditions below require more:
   
   CONDITION           APPLICATIONS NEEDED
   
   Child Nutrition                        4
   Import/Export                         3      (English translation required)
   Special Claims                       3      (Animal Production, Organic, etc.)
   
   
7. Submit application packet to FSIS, Labeling and Consumer Protection Staff, at 1400 Independence Ave SW, Room 614 - Annex Building, Washington, D.C. 20250 or to Prime Label Consultants (with an Order Form) for faster approvals.

Blocks 1, 2, and 3

These blocks are for expediting company's name and address (block 1, if applicable) and FSIS use only; nothing should be written in these areas. FSIS will place the appropriate stamp of approval in blocks 2 and 3.

Block 4: Establishment Number

Block 4 is for the establishment number and/or the ports of entry. Domestic establishments should put their USDA establishment number in this block (include "P-" if for poultry plants). Plants located outside the United States must list establishment number and country.

Block 5a: Product Name 

This block is designated for the true product name as it appears on the label. Use common or descriptive product names (such as "Meat Patties in Gravy", "Frankfurter, Cereal Added", etc.) and be sure to include qualifiers such as "with rib meat" and "a pork, water, and beef product," which are considered part of the product name.  Trade brand names, coined names, code numbers, and fanciful product names (such as "Joe's Corn Dogs", etc.) should be omitted. 

Block 5b: HACCP Process Category

Indicate the HACCP Process Category applicable to the product: “Slaughter--all species,” “Raw product—ground,” “Raw product—not ground,” “Thermally processed—commercially sterile,” “Not heat treated—shelf stable,” “Heat treated—shelf stable,” “Fully cooked—not shelf stable,” “Heat treated but not fully cooked—not shelf stable,” or “Product with secondary inhibitors—not shelf stable.”  See 9 CFR 417.2(b)(1).

Block 6 is utilized to inform FSIS of what type of approval is being requested. There are essentially two choices: sketch or temporary approval. A third choice, an extension, is merely a second consecutive temporary approval. (Final labels don't use this form - they are approved in-house).

• Sketch approval is requested when the label is in "draft" or "proof" form (before the label has been printed). Sketch approvals are designed to save industry money in printing costs due to incorrectly printed labels. A sketch approval receives an approval number and all corrections deemed necessary by FSIS should be made before the labels are printed. Final approvals are given in-house.
• Temporary approvals may be requested when a printing error has been made on the label, slight formula change has been made, or similar circumstances which render the label inaccurate in some sense. Temporaries are also granted when a label displays a "new & improved" type claim. FSIS decides on a case-to-case basis which labels may receive temporaries. Whenever temporaries are requested, fill out a temporary approval form. The prior approval number, number of labels on hand, and number of days requested should be entered into the appropriate space in Block 6. A copy of the prior approved, stamped 7234 form and label should be attached. Finally, specify the detailed reason for the request - either in Block 9 or on an attachment.  

Block 7a: Area of Principal Display 

The area of principal display is the surface area of the package panel which will most likely be displayed to the consumer at point of purchase. It is the entire side of the package to which the label is affixed, not just the area covered by the label. This information is used to determine the correct size of the net weight statement. If the product is for institutional use, "N/A" (not applicable) should be entered in block 7 since non-retail packages do not have restrictions on net weight statement size.  

Block 7b: Total Available Labeling Space 

Block 7b is used to record the total amount of space, in square inches, which could bear labeling. Depending on the shape of your packaging, this could include front, back, sides, top and bottom. 

Block 8: Product Formula 

Pay special attention to the product formula in Block 8.  Ingredients should be shown in descending order of predominance by either weight or percentage. It is preferable to show the formula by percentage, just make sure that numbers add up to 100. If the formula is expressed by weight, use only one unit (do not mix pounds and ounces, etc.).  You may use pounds, grams or kilograms, but not units of volume such as gallons, pints, cups, teaspoons, etc.  Express all numbers as decimals carried to two places; do not use fractions.  Be sure that the Total Weight equals the weights of the individual units.  Also be sure to include any fill specifications, restricted ingredients, batter-to-water ratio, and percentage pump when applicable. If a product consists of several components (e.g. a frozen dinner), list each component separately and indicate the percentage or amount of each component.

Block 9: Processing Procedures 

Another key area of the form is that of Processing Procedures.  FSIS does not generally require a detailed description here. Key words such as "chop," "grind," "form," "battered and breaded," "smoked," etc. are sought. If the product is cooked, be sure to include an internal temperature of the cooked meat or poultry. If the product is smoked, be sure to include the smoking procedures. MPR of the product (if any) is also included in this block. If the 7234 is for a temporary approval, you may give the detailed reason for the request in this block or on an attachment. Be sure that the ingredients mentioned in Block 9 agree with those in Block 8 (formula). 

Block 10: Address of Firm

This block should bear the address of the establishment which will be producing the product (must match the establishment number in block 4).  Do not show the addresses of marketing firms or brokerages here.

Block 11: Signature and Date

Block 11 must be signed and dated by a plant representative before submitting the application to FSIS.

Block 12: Conditions Applying to Use 

This block is reserved for FSIS restrictions or comments as to how the label is used.  FSIS asks that this block usually remain clear; however, pertinent comments such as "net weight to be applied prior to retail sale" or "for institutional use only" may help in FSIS’ review of the label.