Wednesday, October 14, 2020

October 2020: Rounding Rules


The Vitamin Consultancy eLetter
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Sodium and the DSHEA Label
Listing Sodium in the Supplement Facts Box

     Sodium Chloride -- table salt -- is listed as Generally Recognized As Safe (GRAS) as are a number of other forms of sodium.[1] 

     Sodium as a nutrient must be shown on the Nutrition Facts label [2]

     Sodium, like other nutrients, has a Daily Value  -- the DV is under 2300 mg/day.  The regulations require you to disclose the level of sodium in the product. You regularly see sodium disclosed on the Nutrient Facts Label for ordinary foods.

     For a DSHEA product Supplement Facts Label there is a list of what must be included at  21 CFR 101.36(b)(2)(i)(B).  This requirement includes disclosing Sodium if present.

     However, whether something is present may depend on how it is measured and how the measurement is rounded.  There are rounding-down rules for the SF label. [3] 

     So, if the product has less than 5 mg per daily serving (which is about 1/3 of 1% of the DV) the percent can be rounded down to zero and does not need to be included. (pg 129)

     How much sodium is in a serving of your product? That is the question. I can help you figure that out. -- for sodium or any other ingredient. For my regular retainer clients I am adding an SOP section on rounding rules...

[3] / 21 CFR 101.9(c)
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