What is it used for?
Products standardized to protein
Source of (all) essential amino acids (i.e. histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine) for the maintenance of good health [Source note 2].
Source of branched chain amino acids for the maintenance of good health [Source note 3].
Source of (essential) amino acids involved in muscle protein synthesis [Source note 4].
(Excellent) Source of protein for the maintenance of good health [Source note 5].
(Excellent) Source of protein which helps build and repair body tissues [Source note 6].
(Excellent) Source of protein which helps build antibodies [Source note 7].
Products standardized to protein and minerals
Source of ((the) mineral(s)) calcium/magnesium/phosphorus/potassium/(and) zinc for the maintenance of good health [Source note 8].
Note: The above uses can be combined on the product label (e.g., Source of protein which helps build and repair body tissues and build antibodies).
What this guide covers
The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.
Who does this guide cover?
Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Quantities
The potency of protein on an "as is" weight basis is required to be indicated on the product documentation form and label.
Source of protein
2.6-90 grams of protein per day [Source note 9]
Excellent source of protein
16-90 grams of protein per day [Source note 10]
Source of amino acids/branched chain amino acids
3-90 grams of protein per day [Source note 11]
Source of minerals
Not to exceed 90 grams of protein per day [Source note 12]
and
| Minerals¹ | Minimum dose (mg/day) | Maximum dose (mg/day) |
|---|---|---|
| Calcium | 65 | 1,500 |
| Magnesium | 20 | 500 |
| Phosphorus | 62 | 2,000 |
| Potassium | 100 | 779 |
| Zinc | 0.7 | 50 |
¹Quantities for potassium are based on IOM 2005. Quantities for other minerals are based on the source authority Multi-vitamin/Mineral Supplements reference.
The use “Source of mineral(s) xxx” is only acceptable if indicated minerals are present at dosages at or above the minimum daily doses and not more than the maximum daily doses as listed in Table 2 above.
In order to have a use for a particular mineral, the active ingredient must list the respective mineral as potency on the product documentation form and label.
How is it used?
Take a few hours before or after taking other medications or health products [Source note 13].
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
All products
Contains milk by-products [Source note 14].
Ask a healthcare professional before use if you are pregnant or breastfeeding.
Products providing more than 30 g protein, per day
Ask a healthcare professional before use if you have a liver or kidney disorder [Source note 15].
When should it be avoided?
Products providing 100 mg or more potassium, per day
Do not use if you are taking other potassium-containing salt-substitutes or supplements [Source note 16].
Possible side effects
Products providing more than 30 g protein, per day
When using this product you may experience gastrointestinal discomfort/disturbance(s) [Source note 17].
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
Permitted combinations
active ingredients listed in Table 1 can be combined; however, the total amount of protein and minerals must meet the maximal quantities listed in this reference.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) |
|---|---|---|---|
| Whey protein isolate¹ | Whey protein isolate |
| Milk |
| Whey protein concentrate | Whey protein concentrate |
| Milk |
|
|
| Milk |
|
|
| Milk |
| Whey | Whey |
| Milk |
| Whey protein hydrolysate | Whey protein hydrolysate |
| Milk |
References: Proper names: US FDA 2024; FCC 2023; Common names: US FDA 2024; FCC 2023; Source information: ITIS 2024.
¹For isolates, the potency information should be equivalent to 90% or more protein on a dry weight basis.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Whey proteins, especially powders meant to be mixed with a liquid, often require lecithin to act as a dispersing/emulsifying agent. If present, lecithin must be added as a non-active ingredient.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
The active ingredient proper name should be determined by the potency of whey protein on a dry weight basis as published in the Food and Chemical Codex [Source note 18].
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- November 29, 2024
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
Taking a medication too?
Explore our supplement–medication interaction checker. Its coverage and review status are shown with the results; a missing finding does not establish that a combination is safe.