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FDA Label Review Checklist

FDA Labeling

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#1 williamw

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Posted 15 January 2014 - 08:51 PM

I could not find a forum section that seem to be relevant to this so I thought I would put it in the general catergory.

 

We have a nice routing system in place for reviewing and approving new label designs/label changes with several people reviewing and commenting electronically on the labels. What we are lacking is a solid checklist based on FDA requirements to help assure that every reviewer is checking all of the areas they should.  I started to put one togehter using the regulations and the FDA Food Labeling Guide as tools for doing so but quickly realized that to do it well is going to a very time consuming task. Rather than reinventing the wheel I thought I would ask if someone has one already done that they would be willing to share.

 



#2 RRF

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Posted 15 January 2014 - 10:01 PM

This is a great idea. I am also hoping someone has something out there to reference as we need something like this however we need it from an FSIS USDA standpoint.



#3 Pizza&Sandwich

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Posted 15 January 2014 - 10:19 PM

How specific do you need to be? What products?

 

Essentials: Name, qualifying statement, Net wgt., Ingredient Statement, Allergen Statement, Nutrition Facts Panel, Storage & Distribution requirements, safe handling instructions, USDA mark of inspection (only on inspected items), Manufacturer/Distributor name & address, etc.

 

Some of these are optional, depending on what your product is and who your customers are. If only for institutional use, you can get away with a lot less information.

 

 

 

I could not find a forum section that seem to be relevant to this so I thought I would put it in the general catergory.

 

We have a nice routing system in place for reviewing and approving new label designs/label changes with several people reviewing and commenting electronically on the labels. What we are lacking is a solid checklist based on FDA requirements to help assure that every reviewer is checking all of the areas they should.  I started to put one togehter using the regulations and the FDA Food Labeling Guide as tools for doing so but quickly realized that to do it well is going to a very time consuming task. Rather than reinventing the wheel I thought I would ask if someone has one already done that they would be willing to share.



#4 williamw

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Posted 16 January 2014 - 08:35 PM

I was looking for something that would provide guidance to the reviewer not just what to review. For example with the net weight statment the checklist would point to the proper formating (e.g. pounds and ounces for larger packages), the proper metric conversion and rounding policy (we always round down), the required font size etc.  When you look at all fo the things that have to be checked and try to do a "what do you need to know when you check it" it gets pretty involved.  Even though I have a good grasp of the regulations I still find myself, at times, missing things I should catch just because there are so many things to try and keep in mind. For the list to be helpful it at least needs to trigger you to think about all of the things you should.



#5 Urban Explorer

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Posted 31 January 2014 - 05:33 PM

A checklist is a good start, but all the reviewers should know what they're reviewing in the first place.  We have a lot of criticizers about labels but not one of them actually has read the regulations.  It's all in the labeling guidelines, all 120 pages or so.  Then you have FSIS descriptive names (Buffalo Chicken for example) to consider.  Other countries legislation to consider.  Font sizes.  Font colors. Vignettes. Special handling statements. You have to declare onion and garlic in the ingredients, they're not spices, etc. It's never ending.  Having an example label with the appropriate guidelines drawn out is also a consideration.

 

Regarding rounding: 8 oz x 28.35 = 226.8, written as 227 grams. I hope you're not rounding down to 226?

 

You should tailor it to your organization and the mental competency of the reviewers.



#6 John Antecki

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Posted 07 March 2014 - 08:17 PM

I just went here and plugged the relevant info in to and excel worksheet.

 

http://www.fsis.usda...ssion-checklist

 



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#7 Stephany

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Posted 01 December 2018 - 04:10 AM

Based on the FDA food facts guideline, I found some free Food label templates here. This might be of some help. 



#8 PropellerPete

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Posted 14 March 2019 - 03:29 PM

We have a cursory checklist that we created to be already tailored to the products we manufacture, based on the most current legislation and guidance available at this time. It is only applicable to our specific cup sizes, but could easily be adapted to other products. You'd just have to go through the legislation like we did and change the specs to fit your own products. The people reviewing need to have a solid knowledge of what to look for as well. I don't know how to add an attachment, but here is part of what's on our list:
 
 Label Compliance Checklist - FDA                                     Cup Size:   Square inches of label:                                    Main Area/Principal Display Panel             Area of PDP:                   Statement of Identity                 Bold, common name of the food must be used             Type size (at least 1/2 the size of the largest print on the label)         Must be parallel to the base of the package                                   Net Weight Statement                 Must include grams and ounces               Must be in the bottom 30% of PDP               Min. type size 1/8" (3.2mm) based on lowercase letter "o"           Must be prominent, conspicuous, easy to read                                 Information Panel                   Must be immediately to the right of the PDP             Name & address of Manufacturer or Distributor             Type size min. 1/16th high based on lowercase "o" (5-252" rule)         May not have any other material placed between the required labeling                             Ingredient List                     "Ingredients" bolded                 Listed by common name, in descending order by weight           1/16" minimum type size (1.6mm)               Blended spices must be listed by name                                   Nutrition Labeling                     Nutrition facts panel must be in a box shape             The words "Nutrition Facts" must be in type size larger than all other print in the nutrition label     (at least 10 pt. for tabular/linear, at least 16 pt. for standard format)       If single serving, omit the "servings per container declaration" use "Serving Size 1 container"     Serving Size + amount must be 10 pt. for standard, 9 pt. for tabular/linear (minimums) Right justify   Omit footnote "The percent DV tells you…."  and include "Percent Daily Values are based on      a 2,000 calorie diet." for packages less than 40 sq. inches of labeling space including PDP     Use linear(string) format on packages less than 40 sq. inches if the size/shape can't fit in columns   Abbreviations may be used.  See pg. 66 of food labeling guide           Amount per serving min. 6 pt. font all formats             Calories must be 16 pt. standard, 10 pt. tabular/linear (minimums)         Numeric Calorie value must be 22 pt. font standard, 14 pt. font tabular/linear (minimums)     % DV Heading must be at least 6 pt. font all formats             Nutrients and %DV values must be at least 8 pt. font all formats         Footnote, if used, must be at least 6 pt. font for all formats                               Allergen Labeling                     Allergens Declared with "CONTAINS:" (must have capital C and be bolded)       Tree nuts must be individually named (See reference guide if unsure of nut status)     Allergen alert for our facility is present (bolded and capital)           (ALLERGEN ALERT: Made in a facility that handles peanuts, treenuts, milk and soy)                             *If a foreign language is used anywhere, it must be used everywhere   P 1                     R1 02/19


Edited by PropellerPete, 14 March 2019 - 03:38 PM.


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