Note: This article pertains to the United States. Products sold elsewhere are subject to different country/region-specific regulations.
Mandatory label compliance deadlines are drawing near. If you sell, or are planning on selling, a dietary supplement or food in the U.S., here is what you need to know about the updates required and how you can comply.
In addition to the changes to nutrition labeling, due for most companies January 1, 2020, FDA has set an official “uniform compliance date” of January 1, 2022 for final food and dietary supplement label regulations issued in 2019 and 2020. This compliance date also applies to the National Bioengineered Food Disclosure Standard.
With so many label updates coming in the near future, will your brand ready?
The most pressing change required—the revised nutrition labeling—affects both conventional foods and dietary supplements. The updates are intended to consider new scientific information and to make it easier for consumers to make more informed food choices.1 Changes include:
- Revised Daily Values
- Required nutrients to be declared
- Modifications for fat, fiber, and sugars declarations
- Revised units of measure
- Revised format
- Revised serving sizes and label requirements for certain package sizes.2
Below is a summary of additional changes for dietary supplements specifically.
Overview of changes to Supplement Facts Label for dietary supplements3
- Vitamin D and potassium replace Vitamin A and vitamin C as required for declaration
- Calories from fat declaration no longer required
- “Sugars” will now be “total sugars” in the list of dietary ingredients and “added sugars” is required
- Dietary fiber declared must meet the regulatory definition
- A new order will be required for listing of vitamins and minerals
- Daily Values and units of measures will require updates
- A footnote will be required for labels of certain products represented or purported to be for use by children 1 through 3 years of age
- Calorie declaration will not need to be displayed in larger type size or in bolded type in the Supplement Facts Panel, as is required for the Nutrition Facts Panel for foods.
Understanding these detailed changes can be overwhelming, but ensuring compliance is paramount to your brand’s success and reputation in the marketplace.
Need help? Contact our regulatory team for assistance with updating your food or dietary supplement labels, having your isolated or synthetic fiber recognized as dietary fiber, compliance with the National Bioengineered Food Disclosure Standard, and other regulatory concerns for dietary supplements and foods in the United States.
Amy Mozingo, MS, is Director of Operations at GRAS Associates (a Nutrasource subsidiary). She has over 15 years of experience in industry and consulting, holds a certificate as a Preventive Control Qualified Individual (PCQI), and is trained and experienced in ingredient approvals (GRAS, NDIN, FAP, CAP), product label, formulation reviews, and current good manufacturing requirements for dietary supplements. Amy is also an Associate with RNI Consulting and serves as international regulatory liaison for Nutrasource and GRAS Associates. Connect with Amy on LinkedIn.