FDA rounding rules
Hi all,
I am having troubles of finding FDA's newest rounding rules..
All I could find is these documents published back in 2013 or even earlier than 2013, which doesn't seem right.
For example this one
https://www.fda.gov/...e/ucm265446.pdf
I am trying to know what is the rounding rules for potassium.
https://www.accessda...ch.cfm?fr=101.9 states that 8) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and may be arrayed vertically as shown in paragraph (d)(12) of this section (e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 235 mg 6%) or may be listed horizontally. When listed horizontally in two columns, vitamin D and calcium should be listed on the first line and iron and potassium should be listed on the second line, as shown in paragraph (d)(12) of this section in the side-by-side display. When more than four vitamins and minerals are declared voluntarily as shown in paragraph (d)(12) of this section in the label which illustrates the mandatory plus voluntary provisions of paragraph (d) of this section, they may be declared vertically with percentages listed under the column headed "% Daily Value."
I thought the potassium rounding was nearest 10mg instead of 5mg...where can I find this one the accessdata? Please help!
up
www.labelcalc.com/food-labeling/a-guide-to-using-fda-rounding-rules-for-your-food-label/
www.fda.gov/iceci/inspections/inspectionguides/ucm114098.htm
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm513734.htm
http://drupaltesty.f...nding-rules.pdf
Hopefully one of these will help
https://www.fda.gov/...s/ucm114098.htm
This link, if you scroll down, it says the daily value of total fat is 65, which is incorrect. The latest daily value of 2018 for total fat is 78.
If you scroll up a bit, it says potassium rounding rule is > 140 mg - express to nearest 10 mg increment. Now please tell me why in the example I gave previously shows potassium as 235 mg e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 235 mg 6% ? It doesnt make sense to me.
www.labelcalc.com/food-labeling/a-guide-to-using-fda-rounding-rules-for-your-food-label/
www.fda.gov/iceci/inspections/inspectionguides/ucm114098.htm
www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm513734.htm
http://drupaltesty.f...nding-rules.pdf
Hopefully one of these will help
I see what you're saying....old document still linked on FDA website
Maybe this Q and A will help
www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM535372.pdf
If not, you're local MAXXAM or such laboratory will be able to help you quickly
This old inspection guide appears to be supported by all of FDA's example labels.
https://www.fda.gov/...s/ucm114098.htm
However the CFR was amended so that potassium doesn't fall with sodium anymore but with vitamins and minerals.
(iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. Quantitative amounts and percentages of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement "Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients)" or "Contains <2 percent of the Daily Value of this (these) nutrient (nutrients)." Alternatively, except as provided for in paragraph (f) of this section, if vitamin D, calcium, iron, or potassium is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement "Not a significant source of--(listing the vitamins or minerals omitted)" is placed at the bottom of the table of nutrient values. Either statement shall be in the same type size as nutrients that are indented. The quantitative amounts of vitamins and minerals, excluding sodium, shall be the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and the levels of significance given in paragraph ©(8)(iv) of this section, except that zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole milligrams, but the quantitative amount may be declared in tenths of a milligram).
c.8.iv refers to the table below that section, which defines the unit of measure for potassium to be milligrams and does not show more than two sig figs in any of the values.
Ergo, even though all the guidance floating around still refers to the sodium rounding rules for potassium, the actual CFR basically says that you can use whatever levels of significance you want on "vitamins and minerals".
Frankly, I think decimal points in nutrition facts panels tend to be red flags for regulators, they dont' look legit. I'd stick with the old rounding rules for the sake of not confusing some regulator who hasn't read the CFR like you have, and +/-5 mg of potassium isn't going to be significant in the scope of the RDI of 4700mg.
I found this handy table to use as a guide.
Attached Files
Yes I find this one handy too. However, the rounding rules of potassium conflicts with the examples from the FDA website. 8) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and may be arrayed vertically as shown in paragraph (d)(12) of this section (e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 235 mg 6%) or may be listed horizontally. When listed horizontally in two columns, vitamin D and calcium should be listed on the first line and iron and potassium should be listed on the second line, as shown in paragraph (d)(12) of this section in the side-by-side display. When more than four vitamins and minerals are declared voluntarily as shown in paragraph (d)(12) of this section in the label which illustrates the mandatory plus voluntary provisions of paragraph (d) of this section, they may be declared vertically with percentages listed under the column headed "% Daily Value."
Please see the potassium here is 235 mg. If we round based on this handy book, it supposed to be either 230 mg or 240 mg. I also think 235 mg is a valid number because I have seen this nearest 5 mg patassium rounding rules somewhere else too. I am not able to find that information anymore and I am really confused.
I found this handy table to use as a guide.
Thank you.
How strange is that? They have old and new regulations and examples at the same time!
This old inspection guide appears to be supported by all of FDA's example labels.
https://www.fda.gov/...s/ucm114098.htm
However the CFR was amended so that potassium doesn't fall with sodium anymore but with vitamins and minerals.
c.8.iv refers to the table below that section, which defines the unit of measure for potassium to be milligrams and does not show more than two sig figs in any of the values.
Ergo, even though all the guidance floating around still refers to the sodium rounding rules for potassium, the actual CFR basically says that you can use whatever levels of significance you want on "vitamins and minerals".
Frankly, I think decimal points in nutrition facts panels tend to be red flags for regulators, they dont' look legit. I'd stick with the old rounding rules for the sake of not confusing some regulator who hasn't read the CFR like you have, and +/-5 mg of potassium isn't going to be significant in the scope of the RDI of 4700mg.
Thank you.
How strange is that? They have old and new regulations and examples at the same time!
Not strange. FDA puts no support into its guidance documents, they stay out there forever. Always defer to the actual code of federal regulations.