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FDA regs for single-ingredient on label


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#1 jaj478

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Posted 13 January 2016 - 07:38 PM

This is my first post.  I have been trying to find the FDA regulation that says you don't have to have an ingredient list for single-ingredient food.  I see it stated everywhere but no one sites the regulation.  Can someone point me to that regulation?

 

Also, the product is maca tea leaves and I found the exclusion for the Nutrition Facts box when it contains insignificant amounts of all of the nutrients, provided it bears no nutrition claims.  In your opinion, would the statement "30+ Vitamins & Minerals" be considered a nutrition claim?

 

Thanks for any help you can provide.


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#2 umop ap!sdn

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Posted 13 January 2016 - 07:51 PM

"30+ Vitamins & Minerals" is indeed a nutritional claim, if you say that then you definitely need to include a Nutritional Facts label.


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#3 QAGB

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Posted 13 January 2016 - 09:20 PM

This is my first post.  I have been trying to find the FDA regulation that says you don't have to have an ingredient list for single-ingredient food.  I see it stated everywhere but no one sites the regulation.  Can someone point me to that regulation?

 

Also, the product is maca tea leaves and I found the exclusion for the Nutrition Facts box when it contains insignificant amounts of all of the nutrients, provided it bears no nutrition claims.  In your opinion, would the statement "30+ Vitamins & Minerals" be considered a nutrition claim?

 

Thanks for any help you can provide.

 

 

"30+ Vitamins & Minerals" is indeed a nutritional claim, if you say that then you definitely need to include a Nutritional Facts label.

 

 

Hi Jaj478,

 

I agree with Umop, that is a nutritional claim. Also, we work with many single-ingredient items in my company, and we do list the ingredient statement on the label. The FDA does not have any such statement about disregarding single-ingredient items, that I am aware of. There are some exclusions for non-retail ingredients that will be used in further processing for a food plant. However, anything retail (to my knowledge) will have an ingredient statement on it.

 

QAGB


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#4 jaj478

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Posted 13 January 2016 - 09:29 PM

I found this reference "Because honey is a single ingredient food, you do not need to include an ingredient statement on the label." in a Guidance for Industry document for Honey products.  Since it referenced "single ingredient food", I thought other foods might qualify.

http://www.fda.gov/f...n/ucm389501.htm


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#5 umop ap!sdn

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Posted 13 January 2016 - 09:52 PM

Is Maca leaf tea considered a food or dietary supplement?

 

If it is a dietary supplement,  It looks like no ingredient list is required:

 

http://www.ecfr.gov/...101.a&r=SUBPART

 

"(3) On labels of single-ingredient dietary supplements that do not include an ingredient list, the identification of the Latin binomial name, when needed, and the part of the plant may be prominently placed on the principal display panel or information panel, or included in the nutrition label."


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#6 jaj478

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Posted 13 January 2016 - 11:48 PM

In this case, it is in the food category.


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#7 QAGB

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Posted 14 January 2016 - 12:54 PM

I found this reference "Because honey is a single ingredient food, you do not need to include an ingredient statement on the label." in a Guidance for Industry document for Honey products.  Since it referenced "single ingredient food", I thought other foods might qualify.

http://www.fda.gov/f...n/ucm389501.htm

 

 

In this case, it is in the food category.

 

 

 

Hi Jaj478,

 

That is indeed puzzling based on the guidance document you attached. I can't find it listed anywhere in 21CFR 100 or 21CFR 101 that a single-ingredient item does not need an ingredient statement. We list it on our labels, and I would just say that a safe bet here would be to include an ingredient statement on the label. It's better to do it than not to do it and have issues.

 

Also as far as the nutritional panel is concerned, I do believe you have to include a nutritional panel on the product even if the nutrients are in small amounts.

 

Per FDA Guidance Doc:

 

"A simplified Nutrition Facts label may be used if at least eight of the following nutrients are present in insignificant amounts: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron (slightly different rules for labeling foods intended for children less than 2 years). The five core nutrients, shown in bold in the adjoining example, must always appear on all Nutrition Facts labels regardless of amounts present in the food. In addition, any of the nutrients required on the full Nutrition Facts label that are naturally present or are added to the food must be declared on the simplified Nutrition Facts label. 21 CFR 101.9(f) - List of nutrients; 101.9(f)(1) – “Insignificant” defined; 101.9© – “Insignificant” levels listed for nutrients."

 

Serving Size, Calories, Total Fat, Sodium, Total Carbohydrates [Including Sugar], and Protein must be listed. I thought that was the case, but if you could tell me where you found that particular exemption you mentioned, that would be great. The link to the guidance document I referenced is below. There are some exemptions to labeling if you are a small company, making an ingredient for further reprocessing downstream, etc. I would try to do a nutritional panel for the label as well, because more work is better in this case. Labeling laws are so dense and confusing, that I wouldn't want to miss something in the process of trying to follow exemptions and simplifications.

 

QAGB

 

 

http://www.fda.gov/F...htm#simplified


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#8 jaj478

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Posted 14 January 2016 - 07:50 PM

This is a great forum with so many helpful replies.  

I am going to be safe and list the one ingredient.  I will use the simplified version for the tea because it meets the exception.

Thanks for your help.  


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