Labeling of gummy dietary supplements

BACKGROUND:

Dietary supplements in the form of gummies (also referred to as chewable gels) are increasingly popular in the marketplace. The candy-like look of gummy dietary supplements may be attractive to children and potentially lead to unsupervised access to dietary supplements that are not intended for children to self-administer. Additional guidance on the proper use of such supplements may be beneficial to consumers, therefore, CRN has developed voluntary guidelines that address labeling recommendations for gummy dietary supplements. CRN recommends that its members follow these voluntary guidelines for gummy products marketed for children and other age groups and encourages all dietary supplement producers and marketers to follow these recommendations. PRINTABLE PDF

VOLUNTARY GUIDELINES:

In addition to compliance with applicable labeling laws and regulations, CRN recommends that its members adhere to the following guidelines for labeling gummy dietary supplements marketed for children and other age groups. Producers and marketers should determine the intended users of their products and include applicable labeling statements.

A.  Labeling Recommendations¹
Firms should use these guidelines to design appropriate labeling statements for their products. Although the recommended statements may be replicated in wording, firms have the flexibility to use alternate phrasing that convey the key messages of the recommended statements. Firms should use discretion in determining formatting, such as bolding of specific statements, and
placement of labeling statements.
 

1.  Products intended for children:

• Product labels should indicate the product’s intended age group(s).
• Product labels should include, but are not limited to, the following statements or similar language:
  • Keep out of reach of children.
  • Take only as directed/Do not exceed recommended intake/Do not exceed suggested serving [unless recommended by a healthcare professional].
  • Instruct your child to fully chew each gummy before swallowing.
     
• Labels of products intended for children under 4 years of age should include, but are not limited to, the following statement or similar statement:
  • If not chewed properly, this product is a potential choking hazard.
     

2.  Products intended for other age groups:

• Product labels should indicate the product’s intended age group(s).
• Product labels should include, but are not limited to, the following statements or similar language:
  • Keep out of reach of children.
  • Take only as directed/Do not exceed recommended intake/Do not exceed suggested serving [unless recommended by a healthcare professional].

B.  Implementation
CRN recommends its members comply with these guidelines as soon as practicable, but no later than 24 months after adoption of the guidelines by the association.

Approved by CRN’s Board of Directors: March 28, 2024

¹ These guidelines do not include packaging recommendations. However, to reinforce recommended labeling statements, firms may consider packaging products in containers with child deterrent closures.