§9.4 Formatting Dietary Ingredient Labels and Labeling

• Jurisdiction: United States
• Publication year: 2022

§9.4 Formatting Dietary Ingredient Labels and Labeling

Section 7 of DSHEA stated that misbranding for dietary supplements occurs when the label or labeling fails to list the name of the dietary ingredients and the weight amounts of each ingredient.⁴⁰ At paragraph (b), the statute set forth a format for presenting the dietary ingredients on the label or labeling.⁴¹ The statute exempted dietary supplements containing new formulas or trade secret formulation ("proprietary blends") from the requirement of weight for all ingredients in favor of the total weight amount of the proprietary blend.⁴²

The intent of Section 7 was to allow a dietary supplement to include directions for use and warnings on its label without the supplement being classified as a drug.⁴³

In response to Section 7, the FDA promulgated final rules for the labeling of dietary supplements in 1997,⁴⁴ following proposed rules in 1995.⁴⁵ Codified in 21 CFR Part 101, the rules created the following regime.

§9.4.1 "Dietary Supplement" as Part of the Statement of Identity

§101.3 requires the term "dietary supplement" to be used as part of the statement of identity; however, the word "dietary" may be replaced by the name of the dietary ingredient.⁴⁶ The allowance to replace "dietary" was in response to comments received after the proposed rules and the FDA's interpretation of the statute.⁴⁷ "Vitamin C Supplement," "Multivitamin Supplement," and "Herbal Supplement" were given as appropriate examples of "dietary" being replaced by modifying terms. "Food Supplement" or "Energy Bar" were not deemed appropriate as they do not identify or describe a dietary ingredient.⁴⁸

§9.4.2 Nutrition Information and Dietary Ingredient Information

At Section 7, DSHEA requires the nutrition information to precede the ingredient information.⁴⁹ Nutrients are required to be listed in the nutrition listing if they are present in weight amounts greater than zero.⁵⁰ In the ingredient information, dietary ingredients are to be listed in their common or usual name⁵¹ in descending order of predominance by weight.⁵² Other ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders should be included separate from nutrition information and dietary ingredient information.⁵³

§9.4.3 Botanicals

Botanicals (including fungi and algae) shall be listed in dietary ingredient information as their common or usual names in accordance with the Herbs of Commerce and shall include the part of the plant from the ingredient...