Voluntary Program for Dietary Supplements: Caffeine

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Voluntary Codes and Guidelines |

Adopted:
June 18, 2013
Amended:
June 25, 2015 (added “Restraints Against the Sale and Marketing of Powdered Pure Caffeine”); April 2019 (added information on restraint against sale of bulk amounts of pure or highly concentrated liquid caffeine)

Caffeine is found naturally in a wide variety of beverages (coffee, tea, cola) and food (chocolate) and is an added active ingredient contained in a number of prescription and over-the-counter drugs. Manufacturers of dietary supplements are responsible for ensuring the safety of their products.

This guideline applies specifically to caffeine-containing dietary supplement products. In addition to complying with applicable labeling laws and regulations, CHPA members marketing caffeine-containing dietary supplements agree to adopt these voluntary guidelines addressing labeling, packaging, and promotion to ensure safe and responsible use of these products.

  1. Disclosure of Total Caffeine Content per Serving (mg/serving)
    1. Total caffeine content, resulting from both added caffeine and naturally-occurring caffeine1, should be declared in milligrams per serving either in the Supplement Facts Box or in a separate statement elsewhere on the label.
    2. Caffeine disclosure provisions in this section apply only to dietary supplements containing added caffeine and ≥25 mg per serving of naturally occurring caffeine.  
  2. Labeling Information
    1. Any supplement containing >100 mg total caffeine per serving should provide the following statements or equivalent language on the product label:
      1. This product is not intended/recommended for children or those sensitive to caffeine.
      2. Pregnant or nursing women, those with a medical condition, and those taking medication should consult a healthcare professional before using this product. 
  3. Serving Size and Daily Intake Recommendations
    1. Labeling should provide serving size and daily intake recommendations that are consistent with current safety information about caffeine established by competent and reliable scientific evidence.
      • Serving size and daily intake recommendations should comply with Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act, which requires product ingredients to be safe under the conditions of use recommended in labeling, or if no conditions of use are recommended in the labeling, under ordinary conditions of use.
  4. Restraints Against Marketing In Combination with Alcohol
    1. CHPA members will not advertise, market, or otherwise promote the use of caffeine-containing dietary supplements in combination with alcohol, or to counter the acute or immediate effects of alcohol.
  5. Restraints Against the Sale and Marketing of Bulk Amounts of Pure or Highly Concentrated Caffeine in Powder or Liquid Form
    1. CHPA members should not sell or market bulk amounts of pure or highly concentrated caffeine in powder or liquid form directly to consumers.2  This section is not intended to limit CHPA members from marketing or selling bulk amounts of pure or highly concentrated caffeine in powder or liquid form to a business entity as part of a business transaction.
  6. Implementation
    1. The implementation time for this program is at the next label printing or no later than 12 months following adoption.

 


1 “Added caffeine” refers to pure anhydrous (powdered) caffeine. “Naturally occurring caffeine” refers to caffeine occurring naturally in other dietary ingredients, including, but not limited to green tea, guarana, cocoa, kola nut, and yerba mate.

2 For purposes of this document, “bulk amounts of pure or highly concentrated caffeine in powder or liquid form” shall have the same meaning as described in the FDA guidance document Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry (April 2018).

 

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