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Understanding the New FDA Label Regulations
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Understanding the New FDA Label Regulations

Understanding the New FDA Label Regulations

Over the course of 2020, you may notice the rollout of changes to the supplement facts panels and formulas on some Pure Synergy® labels. We’ve made these changes to comply with new FDA nutrition and supplement labeling regulations. The rules have not been updated in over twenty years, and they reflect advances in nutrition science and attempt to provide more useful information to consumers.

Two key aspects of our labels have been affected: the recommended Daily Values (DV), as well as changes to the units of measurement for certain vitamins. Let’s break down these differences to help you understand what’s inside your dietary supplements.

Recommended Daily Values

Put your seatbelt on, we’re about to throw a bunch of acronyms at you in order to explain why recommended Daily Values (DV) have changed.

The Institute of Medicine (IOM) reviews dietary patterns of consumers and combines this data with scientific evidence to create Daily Reference Intake (DRI) reports. These include Recommended Dietary Allowances (RDA), or the average daily level of nutrient intake sufficient to meet the needs of most healthy people. The FDA then uses these RDAs to develop recommended Daily Values (DV), which represent how much of a nutrient a dietary supplement provides relative to a total daily diet.

The bottom line is that the DVs for most nutrients have changed. For example, the recommended DV for vitamin C has gone from 60 mg to 90 mg, or 50% more per day. The DV for calcium has gone up 30%, from 1000 mg to 1300 mg. The opposite is also true, and several of the DVs have gone down. The DV for vitamin B12, for instance, went from 6 mcg to 2.4 mcg. You can see a complete list of DV changes here.

We’ve made slight adjustments to our ingredient quantities and/or updated Daily Value percentages in response to these new DVs. Our extremely high quality and purity standards have remained the same, as has the way we make our vitamins and other ingredients.

Changes in Units of Measurement

Another key change the FDA has made to label regulations is the units of measurement for certain nutrients. International units (IU), currently used as the unit of measure for vitamins A, D, and E, are being updated to metric units.

Vitamin A will now be measured in mcg RAE, or micrograms Retinol Activity Equivalents. This new unit measure more accurately reflects the vitamin A activity of its many forms — where 1 RAE equals 1 mcg retinol, 12 mcg beta-carotene, and 24 mcg alpha-carotene. The old RDI for vitamin A went from 5000 IU to 900 mcg RAE (equivalent to about 3000 IU).

Vitamin D will now be measured in mcg (micrograms). The old RDI was 400 IU and has been updated to 20 mcg (equivalent to 800 IU).

Vitamin E will be measured in mg (milligrams). The old RDI was 30 IU and is now 15 mg (equivalent to about 22.35 IU).

Niacin will change measurement units from milligrams (mg) to mg NE (niacin equivalents) — where 1 mg niacin equals 60 mg tryptophan. The old RDI was 20 mg and is now 16 mg NE.

Folate will go from being measured in micrograms (mcg) to mcg DFE (dietary folate equivalent) with the same RDI as before of 400 mcg DFE.

In addition to this, choline is now considered an essential nutrient and must be added to the supplement facts panel with an established RDI of 550 mg.

 

As you can imagine, it took quite some time for us to accomplish this long list of changes to our labels and formulas. We hope that you now have a better understanding of what the changes all mean and feel more empowered when looking at the supplement facts panels. If you have questions regarding specific changes to each product, please don’t hesitate to reach out.

2 months ago