Like conventional foods and beverages, dietary supplements require nutrition labeling, but with different content and formatting. “Supplement Facts” charts identify only those nutrients that are present, as well as any additional “dietary ingredients” such as herbs, botanicals, and amino acids. In 2016, FDA introduced new labeling requirements for supplements. Among other aspects, the new rules require:
- Vitamin D and potassium to be listed on the label,
- A declaration for “Added Sugars”,
- Revised units of measure for vitamins A, D, and E,
- A footnote on products intended for children aged 1-3 stating “Percent Daily Values are based on a 1,000 calorie diet”.
As of this publication, FDA has proposed a deadline of January 1, 2020 for dietary supplement businesses grossing ten million dollars or more in annual sales to comply with new label rules. Small businesses are provided an additional year.
Supplement labels and advertisements are not permitted to bear claims that suggest they “treat, diagnose, prevent, or cure disease”. Such claims may result in FDA classifying them as drugs, which may require FDA approval and have stricter labeling requirements. Products shipped with these claims risk being charged as “unapproved new drugs” and subsequently detained. FDA’s regulatory procedures manual does not permit an “unapproved drug” to be relabeled or reconditioned in port, forcing the shipper to re-export or destroy the product.
