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Nutrition Facts Leeway?


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#1 aescroggins

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Posted 03 February 2016 - 09:55 PM

Hi,

 

I was wondering if others who create and maintain the nutrition facts panels for retail sale products could give me some input on what they do in this regard.  With some of our packaging we incur additional costs to make changes so we try not to change the packaging if possible.  

I am wondering if you have a set % difference in your nutrition facts panel where you decide that it must be changed to reflect new values?  For instance if we change our product formula or ingredients (but the ingredient statement remains the same) and the new calculated or analyzed information is different- at what point do you decide that the change must be made?  I know the FDA rules with compliance of nutritional data such as for Calories, Fat, Sodium- they should not exceed 20% of the declared value while those nutrients that individual's are typically trying to increase their intake of must be at least 80% of the stated value.  We have very few products with class 1 nutrients (fortified).  I have had these values in mind as cut off points for when the nutrition facts panel needs updated.  

However, I am wondering what information I should view as necessary in deciding to make changes to the panel.  I use Genesis R& D software and occasionally send off for 3rd party testing for certain nutrients.  I typically receive nutrition information from suppliers- more often than not it is calculated and not analyzed info.  I have caught several big errors with this supplied calculated info- they left off a 0 or put the decimal in the wrong place...

 In addition, I have had issues with the lab analysis results: the lab we use has a variance of +/- 6% in the reported values.  On some things that we aim to keep low, like sodium, can be quite affected by that 6% deviation.  Another factor to take into consideration if I only sent in one sample for analysis is variance from lot to lot and that in the end the calculated information may be more reliable.  

I have been finding inconsistencies between supplier calculated information and the results from the lab.  

I guess I am wondering what information I should rely on and where I need to make guidelines that a change on the panel is necessary?  

If I have calculated information but also have analyzed information would the analyzed information trump using the calculated?  I feel obligated to use the higher values for a nutrient like sodium- but is that necessary?

I would really appreciate any guidance from others who have dealt with this!



#2 QAGB

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Posted 04 February 2016 - 01:17 PM

Hi,

 

I was wondering if others who create and maintain the nutrition facts panels for retail sale products could give me some input on what they do in this regard.  With some of our packaging we incur additional costs to make changes so we try not to change the packaging if possible.  

I am wondering if you have a set % difference in your nutrition facts panel where you decide that it must be changed to reflect new values?  For instance if we change our product formula or ingredients (but the ingredient statement remains the same) and the new calculated or analyzed information is different- at what point do you decide that the change must be made?  I know the FDA rules with compliance of nutritional data such as for Calories, Fat, Sodium- they should not exceed 20% of the declared value while those nutrients that individual's are typically trying to increase their intake of must be at least 80% of the stated value.  We have very few products with class 1 nutrients (fortified).  I have had these values in mind as cut off points for when the nutrition facts panel needs updated.  

However, I am wondering what information I should view as necessary in deciding to make changes to the panel.  I use Genesis R& D software and occasionally send off for 3rd party testing for certain nutrients.  I typically receive nutrition information from suppliers- more often than not it is calculated and not analyzed info.  I have caught several big errors with this supplied calculated info- they left off a 0 or put the decimal in the wrong place...

 In addition, I have had issues with the lab analysis results: the lab we use has a variance of +/- 6% in the reported values.  On some things that we aim to keep low, like sodium, can be quite affected by that 6% deviation.  Another factor to take into consideration if I only sent in one sample for analysis is variance from lot to lot and that in the end the calculated information may be more reliable.  

I have been finding inconsistencies between supplier calculated information and the results from the lab.  

I guess I am wondering what information I should rely on and where I need to make guidelines that a change on the panel is necessary?  

If I have calculated information but also have analyzed information would the analyzed information trump using the calculated?  I feel obligated to use the higher values for a nutrient like sodium- but is that necessary?

I would really appreciate any guidance from others who have dealt with this!

 

Hi aescroggins,

 

I understand revising the nutritional panel can be a pain. Sometimes you are better off using the supplier calculated information (pending they have everything correct). There also is the USDA website (very helpful to me) which holds the National Nutrient Database for a lot of products and ingredients. You may be able to find the common amounts per 100 grams and compare to supplier calculated information if needed. I have attached a link to the website below the post.

 

You definitely need to make changes to your nutritional panel if you find that the changes are significant enough to change the mandatory items on your panel. Considering the rules are so stringent, there really isn't a % variance I could give you. As an example:

 

The rules for calories are as follows: Round to the nearest 5 calories up to and including 50, nearest 10 calories above 50, and levels below 5 calories round to 0. Say you had 227 calories per serving in your product before (which would round to 230 on your panel), and now you have 221 calories (which rounds to 220), you would need to change your panel. The difference in calories really isn't that much, but the rules require you to change your panel.

 

It's really hard to say whether the analyzed panel always trumps the calculated panel, because as you said, there can be lot to lot variance. You also stated the margin of error to be 6%, which is fairly high (especially on items with small amounts to begin with). I personally like to use the calculated panel because I have all the information I need (and the results are in most cases listed as "typical results per 100g") in case we reformulate or there are specific questions being asked.

 

I would say you could also average your nutritional data if you buy one ingredient from more than one supplier. For example, if you buy salt from 3 different suppliers that you may use interchangeably, you can average the nutritional data for the 3, and use that information as part of your panel (which could possibly help you if one supplier changes their specs a little). If you can explain how the results are obtained for the panel, you should be fine. I do that for some of our ingredients in which we have several suppliers.

 

 

 

 

 

 

 

http://ndb.nal.usda....ndb/search/list

 

 

QAGB



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#3 EssentialFA

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Posted 04 February 2016 - 04:29 PM

Hi,

 

I have a follow up question that I believe fits in this topic as well. Don't the rounding rules sometimes set you up for failure in case the FDA inspects and analyzes your products?

for example:

One of our products has an average of 0.8g of saturated fat per servings, with values ranging from 0.7 to 0.9g. Because of the rounding rules we have to round it up to 1g per serving. If the FDA tests products and they come at 0.7g, we would be out of the 80-120 range, right?

Is it this black and white?

 

I asked this question to the FDA inspector when they paid us a surprise visit a couple of months ago and he was stumped by it.

 

Second question:

when calculating calories, in what order should I calculate and round the values? Should I calculate the calories on unrounded values, then round the calories according to the rules or use the rounded values to calculate calories, and then again round the calories values? I feel like it could make a (small) difference.

 

Thanks for your help in advance,



#4 QAGB

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Posted 04 February 2016 - 04:48 PM

Hi,

 

I have a follow up question that I believe fits in this topic as well. Don't the rounding rules sometimes set you up for failure in case the FDA inspects and analyzes your products?

for example:

One of our products has an average of 0.8g of saturated fat per servings, with values ranging from 0.7 to 0.9g. Because of the rounding rules we have to round it up to 1g per serving. If the FDA tests products and they come at 0.7g, we would be out of the 80-120 range, right?

Is it this black and white?

 

I asked this question to the FDA inspector when they paid us a surprise visit a couple of months ago and he was stumped by it.

 

Second question:

when calculating calories, in what order should I calculate and round the values? Should I calculate the calories on unrounded values, then round the calories according to the rules or use the rounded values to calculate calories, and then again round the calories values? I feel like it could make a (small) difference.

 

Thanks for your help in advance,

 

 

Hi EssentialFA,

 

To answer your first question, it really depends on how picky your auditor/inspector is. If you can explain that typical values put the product at 0.8, and that is the number you use to calculate your values, then you should be fine. I would really hope that no one would take exception to this. Most things are based on justification. I would think they would find more of an issue if your product was exhibiting trace amounts per serving or something like 3g per serving and you are reporting 0.8g. If it stumped your FDA inspector, it probably wouldn't be something brought up.

 

To answer your second question, you would calculate calories based on unrounded values for each ingredient in the product, total the calories for each ingredient, and then round your final number according to the labeling rules.

 

QAGB



#5 aescroggins

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Posted 04 February 2016 - 09:38 PM

Hi QAGB,

 

Thank you for the reply.  I guess I was hoping there was more play room with the panel values.  I guess I can make sure to cover my self by cross checking the suppliers calculated information against the USDA nutrient database-which is what I typically do and how I have found some major mistakes with supplier information but there are many ingredients that unfortunately are not listed in the database.  I will do my due diligence and at least create new nutrition panels (if warranted by ingredient changes, ect.) and submit them to the creative team to at least show that I am doing my part.  Now, it will be another matter on whether or not the packaging gets updated in a timely manner...  I am inquiring with another 3rd party lab to find out if their testing has a lower variance then the other lab.  

Thanks!






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