Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Thank you in advance for your guidance.

For a product that has a Supplement Facts Panel, very low calories and protein, labeled as a Dietary Supplement and with no structure-function claims related to weight loss:  

• Is it required to add the following to the label: Notice: Use this product as a food supplement only. Do not use for weight reduction.
• If Calories and Proteins are added to Supplement Facts Panel, must the DV% and  * be added to the label with *Percent Daily Values are based on a 2,000 calorie diet.
• If Calories and Protein are not added to the Supplement Facts Panel, is the following required to add to the label: Notice: Use this product as a food supplement only. Do not use for weight reduction.

Here is the section from CFR 101.17 but I'm looking for nuances between labeling using Supplements Facts vs Nutritional Facts and marketing as Dietary Supplement vs Sports Nutrition.

(d) Protein products. (1) The label and labeling of any food product in liquid, powdered, tablet, capsule, or similar forms that derives more than 50 percent of its total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, and that is represented for use in reducing weight shall bear the following warning:

(2) Products described in paragraph (d)(1) of this section are exempt from the labeling requirements of that paragraph if the protein products are represented as part of a nutritionally balanced diet plan providing 400 or more Calories (kilocalories) per day and the label or labeling of the product specifies the diet plan in detail or provides a brief description of that diet plan and adequate information describing where the detailed diet plan may be obtained and the label and labeling bear the following statement:

(3) The label and labeling of food products represented or intended for dietery (food) supplementation that derive more than 50 percent of their total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, that are represented specifically for purposes other than weight reduction; and that are not covered by the requirements of paragraph (d) (1) and (2) of this section; shall bear the following statement:

Hi Anon.

My thought here is that you are in need of having a more nuanced answer than most of us are probably able to provide on this specific topic.  However, I do have a few thoughts that might help you think about the issue specifically noted in your request/questions:

Regarding the statement "Notice: Use this product as a food supplement only.  Don not use for weight reduction." would appear to be required since your product is a protein product with a very low caloric level and is being represented as a supplement.  Without this you end up with a problem because section (d) itself requires one of the three subparagraph notices/warnings to be on the package labeling.  Note that (3) where the label notice appears specifies that if the product obtains 50% or more of the calories from proteins or building blocks of proteins where the represented purpose is not weight reduction you need to include the notice on the label itself as part of the requirement of meeting the supplement regulations.  The only potential exemption here would appear to be either to have less than 50% of the calories from proteins or building blocks (not a potential from the way I read your original post) or be required to add one of the other two warnings on your label depending on whether they are better representative of your product label.

General requirements for the label of supplement facts are just that, general requirements.  If the product contains a supplement facts box and the statement is generally required as part of the supplement facts box label, then the DV% and what that percentage is based on would be necessary.  If these are optional then you need to really consider whether they are "optional" in your case or not.  That is going to need to be discussed more specifically with potential legal representation or with someone with far more specific experience than I have but I strongly urge you to consider whether these are "general requirements" or they are "optional" in your specific situation and the case of your label.

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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 06-Aug-2020 12:16
From: Anonymous Member
Subject: CFR Dietary Supplement Label Requirement - "Do not use for weight reduction"

This message was posted by a user wishing to remain anonymous

Thank you in advance for your guidance.

For a product that has a Supplement Facts Panel, very low calories and protein, labeled as a Dietary Supplement and with no structure-function claims related to weight loss:

• Is it required to add the following to the label: Notice: Use this product as a food supplement only. Do not use for weight reduction.
• If Calories and Proteins are added to Supplement Facts Panel, must the DV% and  * be added to the label with *Percent Daily Values are based on a 2,000 calorie diet.
• If Calories and Protein are not added to the Supplement Facts Panel, is the following required to add to the label: Notice: Use this product as a food supplement only. Do not use for weight reduction.

Here is the section from CFR 101.17 but I'm looking for nuances between labeling using Supplements Facts vs Nutritional Facts and marketing as Dietary Supplement vs Sports Nutrition.

(d) Protein products. (1) The label and labeling of any food product in liquid, powdered, tablet, capsule, or similar forms that derives more than 50 percent of its total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, and that is represented for use in reducing weight shall bear the following warning:

WARNING: Very low calorie protein diets (below 400 Calories per day) may cause serious illness or death. Do Not Use for Weight Reduction in Such Diets Without Medical Supervision. Not for use by infants, children, or pregnant or nursing women.

(2) Products described in paragraph (d)(1) of this section are exempt from the labeling requirements of that paragraph if the protein products are represented as part of a nutritionally balanced diet plan providing 400 or more Calories (kilocalories) per day and the label or labeling of the product specifies the diet plan in detail or provides a brief description of that diet plan and adequate information describing where the detailed diet plan may be obtained and the label and labeling bear the following statement:

Notice: For weight reduction, use only as directed in the accompanying diet plan (the name and specific location in labeling of the diet plan may be included in this statement in place of "accompanying diet plan"). Do not use in diets supplying less than 400 Calories per day without medical supervision.

(3) The label and labeling of food products represented or intended for dietery (food) supplementation that derive more than 50 percent of their total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, that are represented specifically for purposes other than weight reduction; and that are not covered by the requirements of paragraph (d) (1) and (2) of this section; shall bear the following statement:

Notice: Use this product as a food supplement only. Do not use for weight reduction.