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(b)(2)-dietary ingredients

FDA (b)(2) dietary supplements

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#1 jaj478

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Posted 02 February 2016 - 06:31 PM

We are a small dietary supplement manufacturer of liquid mineral supplements.  I am trying to understand how to list the ingredients on the label.

 

101.36(b)(2)(i) The (b)(2)-dietary ingredients to be declared, that is, total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 101.9©. Calories from saturated fat and polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they shall be declared when a claim is made about them. Any other vitamins or minerals listed in 101.9©(8)(iv) or ©(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 101.9©, shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.

 

All our minerals are added for purposes of supplementation and most have claims made about them.  So I can declare other minerals that are less than 2 percent of RDI or DRV, or don't have established RDI or DRV (b)(3).

 

However, it appears that I cannot declare sodium, calcium or iron when they are less than 2 percent of RDI.  This is a problem because we have claims about them.  Even our calcium liquid mineral product is less than 2% (just calcium and water).  

 

(Please put aside the topic of "why small amounts".  This is the formula I have to work with.)

 

Am I understanding this properly?  Sodium, Calcium or Iron are not to listed if they are less than 2%.  They can't even be listed with "less than 1% of DV".

 

I appreciate any advice offered.

 

Thanks,

Jane

 



#2 QAGB

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Posted 03 February 2016 - 04:58 PM

We are a small dietary supplement manufacturer of liquid mineral supplements.  I am trying to understand how to list the ingredients on the label.

 

101.36(b)(2)(i) The (b)(2)-dietary ingredients to be declared, that is, total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 101.9©. Calories from saturated fat and polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they shall be declared when a claim is made about them. Any other vitamins or minerals listed in 101.9©(8)(iv) or ©(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 101.9©, shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.

 

All our minerals are added for purposes of supplementation and most have claims made about them.  So I can declare other minerals that are less than 2 percent of RDI or DRV, or don't have established RDI or DRV (b)(3).

 

However, it appears that I cannot declare sodium, calcium or iron when they are less than 2 percent of RDI.  This is a problem because we have claims about them.  Even our calcium liquid mineral product is less than 2% (just calcium and water).  

 

(Please put aside the topic of "why small amounts".  This is the formula I have to work with.)

 

Am I understanding this properly?  Sodium, Calcium or Iron are not to listed if they are less than 2%.  They can't even be listed with "less than 1% of DV".

 

I appreciate any advice offered.

 

Thanks,

Jane

 

Hi Jane,

 

I've been trying to read the eCFR information on this, since I work in food and the dietary laws are different. You're making a claim about sodium, calcium, and iron. According to the eCFR for 101.9 and 101.36, you have the following bits of information (also found in links attached):

 

"Any other vitamins or minerals listed in §101.9©(8)(iv) or ©(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them." Here's the list:

 

101.9 ©(8)(iv)

Vitamin A, 5,000 International Units

Vitamin C, 60 milligrams

Calcium, 1,000 milligrams

Iron, 18 milligrams

Vitamin D, 400 International Units

Vitamin E, 30 International Units

Vitamin K, 80 micrograms

Thiamin, 1.5 milligrams

Riboflavin, 1.7 milligrams

Niacin, 20 milligrams

Vitamin B6, 2.0 milligrams

Folate, 400 micrograms

Vitamin B12, 6 micrograms

Biotin, 300 micrograms

Pantothenic acid, 10 milligrams

Phosphorus, 1,000 milligrams

Iodine, 150 micrograms

Magnesium, 400 milligrams

Zinc, 15 milligrams

Selenium, 70 micrograms

Copper, 2.0 milligrams

Manganese, 2.0 milligrams

Chromium, 120 micrograms

Molybdenum, 75 micrograms

Chloride, 3,400 milligrams

 

101.9 ©(9)

 

Food component
  • Fat
  • Saturated fatty acids
  • Cholesterol
  • Total carbohydrate
  • Fiber
  • Sodium
  • Potassium
  • Protein

 

Based on the information you've given, you're making claims for items that have less than 2% of the RDI, and all three of these are found in 101.9 section c lists. It looks like you can state these contain less than the 2% daily value, and then meet your claim. It does seem contradictory of the point that (b)(2)dietary ingredients shall not be declared when less than 2% of RDI. In order to make a claim, I would think it has to be listed. Nutritional labels are such headaches sometimes. Maybe someone else with supplement labeling experience could clarify.

 

 

http://www.ecfr.gov/...2.0.1.1.2.3.1.1

 

http://www.ecfr.gov/...L#se21.2.101_19

 

QAGB



#3 jaj478

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Posted 03 February 2016 - 06:25 PM

Thanks for you help, QAGB.  

 

But it looks like 101.36 takes precedence over 101.9.

101.9(j) The following foods are exempt from this section or are subject to special labeling requirements:

(6) Dietary supplements, except that such foods shall be labeled in compliance with 101.36.

 

Which takes me back to 101.36(b)(2)(i).

Any other vitamins or minerals listed in 101.9©(8)(iv) or ©(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about themAny (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 101.9©, shall not be declared

 

Is there someone out there with supplement labeling experience or does anyone know of a great forum like this for dietary supplements?

 

Thanks for any advice you can give.



#4 QAGB

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Posted 03 February 2016 - 06:52 PM

Thanks for you help, QAGB.  

 

But it looks like 101.36 takes precedence over 101.9.

101.9(j) The following foods are exempt from this section or are subject to special labeling requirements:

(6) Dietary supplements, except that such foods shall be labeled in compliance with 101.36.

 

Which takes me back to 101.36(b)(2)(i).

Any other vitamins or minerals listed in 101.9©(8)(iv) or ©(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about themAny (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 101.9©, shall not be declared

 

Is there someone out there with supplement labeling experience or does anyone know of a great forum like this for dietary supplements?

 

Thanks for any advice you can give.

 

Hi Jane,

 

That pretty much sums up the misery that is reading anything on the FDA site. The way I am understanding it is, the dietary supplements are exempt from the total of the food labeling requirements (as dietary supplements have special labeling requirements), and should follow 101.36; which states that other vitamins and minerals listed in section c of 101.9 (which I listed), shall be declared when a claim is made. The word "except" in this case is what is throwing me off. Trying to understand their jargon makes it very difficult to know exactly what they mean, but that would be the way I understand it.

 

QAGB







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