Saturday, April 15, 2017

High potency: What is high potency/

https://www.fda.gov/RegulatoryInformation/Guidances/ucm063064.htm

The following is adapted from the above web page for your convenience.

High Potency Claims

What is the definition of “high potency?”

The regulation states that the term “high potency” may be used in a claim on the label or in labeling to describe individual vitamins or minerals that are present at 100 percent or more of the Reference Daily Intakes (RDI) per reference amount customarily consumed (21 CFR 101.54(f)(1)(i)). This means a supplement may be labeled as “high potency” for each nutrient(s) that is present at 100% of the RDI per serving.

How should the label or labeling describe the nutrients that are the subject of the high potency claim?

When the term “high potency” is used to describe individual vitamins or minerals in a product that contains other nutrients, then the label or labeling must clearly identify which specific vitamins or minerals are being described as “high potency.” For example, “Botanical X with high potency vitamin E.” (21 CFR 101.54(f)(1)(ii))

Can I name an entire product “high potency” when not all ingredients are present at 100% or greater?

The term “high potency” may be used on the label or in labeling of a multi-ingredient product to describe the product (as opposed to describing the level of individual ingredients) if the product contains 100 percent or more of the RDI for at least two-thirds of the vitamins and minerals that are listed in 21 CFR 101.9(c)(8)(iv) and that are present in the product at 2 percent or more of the RDI. For example, “High potency multivitamin, multimineral dietary supplement tablets.” (21 CFR 101.54(f)(2)).

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