FDA has issued guidance for industry in the form of a Q&A addressing “high potency” and “antioxidant,” while clarifying the meaning of 21 CFR 101.60 relating to the use of “sugar-free” claims on dietary supplement labeling. The guidance, “A Small Entity Compliance Guide,” is straightforward and easily accessible to persons or companies wanting to make a claim at www.cfsan.fda.gov. While the definitions may tend more toward the supplement category, the guidance and the definitions are applicable to use of the terms in the labeling of conventional foods as well. The guidance should be read and applied in conformity with 21 CFR 101.54.

High-potency Claims

  • 100% (or more) of the Reference Daily Intake (RDI) per reference amount consumed (RACC) of each nutrient identified.

  • The nutrient must be named on the label.

  • A multi-ingredient product may be labeled “high potency,” if two thirds of the vitamins and minerals are present at 100% RDI (present at 2% or more).

  • For conventional foods, the fortification which supports the “high potency” claim must conform to 21 CFR 104.20.

    Antioxidant (Nutrient Content) Claim

  • “Antioxidant” claims may be made only for nutrients for which 21 CFR 101.9 has established an RDI, but only to those nutrients listed which have an antioxidant activity.

  • The basic nutrient content definitions apply: “excellent,” “high” and synonyms at 20%; “good,” “contains” and synonyms: 10-19% of the DRV or RDI.

  • The amount of vitamin A present determines the eligibility of beta-carotene for a nutrient content claim.

  • The antioxidant present must be identified by name in the nutrient content claim itself or elsewhere on the same panel.

    Sugar-free Clarification

  • “Sugar free” and synonyms may be used on dietary supplements, when the supplement meets the “dietary usefulness” type claim criteria.

    Marketing to Children

    The Federal Trade Commission (FTC) has issued “Marketing Food to Children and Adolescents—A Review of Industry Expenditures, Activities, and Self-Regulation—A Report to Congress.” The report aggregates and summarizes the responses of 44 companies selected and required by the FTC to provide specific requests for information. 

    As the report confirms, much is spent marketing to children and adolescents, particularly for carbonated beverages ($229 million), restaurants ($161 million) and breakfast cereals ($113 million), which comprised 63% of expenditures. These are followed by advertising for juice and non-carbonated beverages, snack foods, candy/frozen desserts, prepared foods and meals, baked goods, dairy products, and fruits and vegetables. However, when marketing expenditures devoted to youth are compared to amounts spent by the responders in total, baked goods represent the greatest proportion of total spending committed to youth advertising. On the other hand, carbonated beverages and restaurant food spending to attract youth constituted a “relatively small percentage” of those responders’ overall ad spending.

    The report details expenditures by activity:
  • Traditional media.
  • New media.
  • Packaging and in-store marketing.
  • Premiums.
  • Other traditional promotional activities.
  • In-school marketing.
  • Use of cross-promotions and celebrity endorsements.

    The report explored “Target Companies’ Market Research on Child and Teen Audiences,” finding:

    1. “Product placement within the storyline...can be highly successful in achieving product recognition, ad recall and purchase intent.”
    2. “Children like ads with dramatic, action-filled and to-be-continued storylines.”
    3. “(Children) also like ads that link to websites and afford an opportunity to play games...or win prizes.”
    4. “Animated characters...seem to be an important factor in getting children to ask their parents to buy a product.”
    5. “...Children like animated characters...to be both ‘fun’ and ‘cool.’”
    6. “...Children like premiums with food products.”
    7. Associating food with “fun” appeals to children; “taste” has more appeal to adolescents.
    8. “...Some of the research found statements that imply a product is healthy or nutritious, or healthier than other comparable products, generally do not generate appeal to children or adolescents, because they are concerned the taste will be compromised.”

    “Whether there is a link between food marketing to children and childhood obesity is a question not addressed by this report,” the authors assert on page 81. However, the report does include “general recommendations”:

  • “All companies that market food or beverage products to children should adopt and adhere to meaningful, nutrition-based standards for marketing their products to children under 12.”

  • Advertising directed to children under 12 should meet the nutrition-based standard.

  • The Children’s Food and Beverage Initiative is singled out, and its importance acknowledged. However, the report suggests it could be expanded and strengthened.

  • The report supports and recommends expansion of industry self-regulation.

    Any company marketing to children or adolescents should secure a copy of the report and review it with particular attention to Section IV (Assessment of Food Company Health Initiatives and Recommendations) and Section V (Conclusion). The report will no doubt serve as the central starting point of public comments and debate—and, potentially, additional interest by Congress and states in the obesity debate.