The New Supplement Label: What's Ahead in 2020

Starting in January 2020 the FDA will implement changes to U.S. Nutrition Facts and Supplement Facts labels, which will require changes to be made to reflect current thinking on nutrition and consumer habits. Supplement labels have remained relatively unmodified since the Dietary Supplement Health and Education Act of 1994 (DSHEA) which had specifications on supplement labels including: quantity, identification, weight of the proprietary blend (if containing one), nutrition information known as the supplement facts panel and an ingredient list.

These new regulations will have wide spread changes for many of the labels that you are familiar with. To review all the changes that are taking effect you can review the guidance from the FDA. For Integrative Therapeutics the most notable changes will be:

International Units (IU) to Metric Measurements

The unit of measure for vitamin A, vitamin D, and vitamin E will be now be represented in micrograms or milligrams rather than International Units (IU).

Vitamin A was previously measured in IU but will now be measured in metric units, based on the ingredient's RAE (Retinol Activity Equivalents). Vitamin E, previously in IU will now be in milligrams (mg).

Vitamin D is now required on all labels and will be moving from IU to mcg on the label, but IU is still allowed to be listed in parentheses. You will see mcg as well as IU listed on all Integrative Therapeutics products that contain vitamin D. The conversion formula along with an example is shown below.

Folate Now Considered Dietary Folate Equivalent (DFE)

Folate is now listed under a new unit of measure known as Dietary Folate Equivalent (DFE) and measured in micrograms (mcg). Previously, folic acid and folate were considered equivalent in dosage and quantity; this will be changing and will be listed on the label to reflect these changes. Folate contents will now be listed now as well as the source of folate.

*Example SFB

Definition of Dietary Fiber

Another significant change to the supplement facts panel relates to dietary fiber. Prior to the current update, dietary fiber, which includes both soluble and insoluble fiber, was allowed to be listed on supplement facts labels regardless of whether the type of fiber had been proven to benefit human health or not. The FDA is now seeking to establish more rigorous definitions of dietary fiber. Another new addition will be an increase in the daily reference value for dietary fiber, increasing from 25 grams per day to 28 grams per day. Therefore, the percent daily value on all supplement facts labels will reflect these new changes and requirements.

Dietary fiber is now defined by the FDA to have physiological effects that are beneficial to human health. Under the new regulations, dietary fiber still includes non-digestible carbohydrates that are naturally found in plants and fibers, which have been shown to have health benefits.

Isolated non-digestible carbohydrates, which align with the definition of dietary fiber, will be listed as dietary fiber on the label in addition to being included as part of the reported total carbohydrates. The following are the fibers (non-digestible, isolated, or synthetic) which are considered dietary fiber:

• International Units (IUs) to metric measurements such as milligrams (mg) or micrograms (mcg)
• The daily value of the nutrient Choline is now included on the supplement label
• Change in nomenclature and calculation of folate
• Vitamin K1 (phytonadione) is the only form of vitamin K that contributes towards the percent daily value (DV)
• Updated definition of dietary fiber

The following isolated/synthetic fibers have not yet been officially added to the definition but the FDA has proposed that they will be added so Integrative will factoring them into our dietary fiber calculations:

• Beta-glucan soluble fiber
• Psyllium husk
• Cellulose
• Guar gum
• Pectin
• Locust bean gum
• Hydroxypropylmethylcellulose

Bottom Line

Some of our favorite formulas will look different on the label in the not-so-distant future, but in most cases, our original product formulas will not be changing. Because of changes to units, we will have to train ourselves and our patients to understand accurate dosing. Just like any significant change, you may find yourself referring to the "old way” for some time. However, the first time you recommend 125 mcg of Vitamin D rather than 5,000 IUs is when you will know you have adopted the new way.