FDA Label Requirements

Have you noticed our NEW LOOK?

Let us explain...

Although our label designs have been updated, with few exceptions, formulas of all supplements are the same. However, you may have also noticed the supplement facts on the back of the label have changed due to the FDA’s new regulations, which are based on a variety of factors. All manufactured foods and supplements will be making these same changes by 2020; We’re getting a head start....

Old Metabolic Bottle Label Design

Old Look

Old Metabolic Bottle Label Design

Updated Look

Supplement Fact Breakdown

Measurements vs. Percentages

The amounts of each component within our formulas have mostly remained the same. Because of new recommended daily intake values however, we have adjusted levels of vitamin D in a few select formulas. What has changed universally, however, are the units of measurement by which the FDA requires us to report the amount of each ingredient.

Vitamins A, D, and E used to be measured in IU (International Units), however, the size of an “IU” was different for each vitamin. IU was not a standard measurement across the board. Amounts of all vitamins will now be measured and reported in metric mass (milligrams, mg; micrograms, mcg; etc.). In addition, these new reported measurements for vitamin A and folate have been adjusted specifically to their bioactivity.

Vitamin A will now be reported in mcg RAE (Retinol Activity Equivalents).  The RAE unit of measurement more accurately reflects the actual vitamin A activity of its many forms, including retinoids (e.g., retinol) and carotenoids (e.g., beta-carotene).

Folate has a new unit of measure called Dietary Folate Equivalents (DFE). Supplemental sources of folate are more potent than dietary folate, so they will have a higher DFE than folate in food. Even though the amount of folate in our formulas has not changed, you will see an increase in label claim and percent Daily Value (%DV) due to this difference in potency. To make the conversion, multiply the previous folate claim by 1.7. The following image shows how these changes appear on the new label as compared to the old.

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Because of the bioavailability of supplemental folate, the same 15 mg now represents a higher percentage of the FDA’s recommended daily value.

1.

Although the number has increased from 15 mg to 25 mg DFE due to the unit of measurement conversion, the amount of folate in the formula is still 15 mg.

If you would like to understand how the new units of each vitamin have been converted from old units of measurement, please use the information in the table below.

Nutrient Old Unit of Measure New Unit of Measure Conversion Equation
Vitamin A IU mcg RAE ___ mg RAE/0.3 = ___ IU
Folate mg mg DFE ___ mg DFE/1.7 = ___ mg
Vitamin D IU mg ___ mcg x 40 = ___ IU
Vitamin E IU mg ___ mg x 1.49 =___ IU

Changes in Percent Daily Value (%DV)

As observable in the folate example above, the FDA has changed the total recommended daily intake (RDI) for some nutrients. Choline has also been added to the list of nutrients with a recommendation. Therefore the percent daily value (%DV) may now be higher or lower for certain nutrients on a label, even though the measured amount of that nutrient has remained the same within our supplement formula. Specifically, If the RDI for a particular nutrient has been increased and the amount in our product has remained the same, the new %DV will now be a lesser percentage than before (nutrients include vitamins C, and K). If the RDI has decreased and the amount in our product has remained the same, the new %DV will be greater than before (nutrients include vitamin A, B12, chromium). If both the RDI and the amount in our product have remained the same, but the product measurements reflect greater bioactivity (such as methylfolate DFEs) the new %DV will be greater than before.

A list of evidence-based RDI updates are detailed below.

300 mcg55 mcg
Nutrient Previous RDI Updated RDI
Vitamin A 5000 IU 900 mcg (comparable to 3000 IU)
Vitamin C 60 mg 90 mg
Vitamin B6 2 mg 1.7 mg
Vitamin B12 6 mcg 2.4 mcg
Vitamin D 400 IU 20 mcg (comparable to 800 IU)
Vitamin E 30 IU 15 mg (comparable to 22.4 IU)
Vitamin K 80 mcg 120 mcg
Thiamin 1.5 mg 1.2 mg
Riboflavin 1.7 mg 1.3 mg
Niacin 20 mg 16 mg
Folate 400 mcg 400 mcg DFE (comparable to 240 mcg)
Biotin 300 mcg 30 mcg
Pantothenic Acid 10 mg 5 mg
Calcium 1000 mg 1300 mg
Iron 18 mg 18 mg
Phosphorus 1000 mg 1250 mg
Iodine 150 mg 150 mcg
Magnesium 400 mg 420 mg
Zinc 15 mg 11 mg
Selenium 70 mg 55 mcg
Copper 2 mg 0.9 mg
Manganese 2 mg 2.3 mg
Chromium 120 mcg 35 mcg
Molybdenum 75 mcg 45 mcg
Chloride 3400 mcg 35 mcg
Sodium 2400 mcg 2300 mg
Potassium 3500 mg 4700 mg
Choline No RDI 550 mg

If you have any further questions, they may be answered by the FDA’s website by clicking the button below.