Updated voluntary guidelines
CRN originally created voluntary guidelines in 2013 for its members and other dietary supplement companies regarding caffeine-containing dietary supplements, updated in 2015 and again in 2018. These guidelines recommend that companies disclose the amount of caffeine in a dietary supplement, provide label advisories about safe use of these products, and refrain from sale under certain conditions, such as refraining from marketing caffeine-containing dietary supplements in combination with alcohol and refraining from sale of supplements in certain forms that the FDA has considered dangerous due to potential misuse of the products. CRN has updated these voluntary guidelines in response to updated guidance provided by FDA in April 2018.
FDA’s updated caffeine dietary supplement guidance expanded the forms of caffeine, when used in dietary supplements, that FDA considers dangerous to include highly concentrated powder and liquid forms of caffeine when sold in bulk. Previously, FDA’s guidance only highlighted dangers associated with pure powdered caffeine when sold in bulk as a dietary supplement. FDA has expressed concerns about sale of caffeine-containing dietary supplements in these forms, as they require consumers to precisely measure out a safe dose of caffeine from a potentially lethal amount. CRN has updated their caffeine-containing dietary supplement voluntary guidelines to include restraints on sale for highly concentrated powder and liquid caffeine when sold in bulk, in addition to previous restraints for pure powdered caffeine when sold in bulk.
Whether added as a pure ingredient or incorporated from a naturally-occurring source1, caffeine is a safe dietary ingredient found in many dietary supplements. CRN supports consumer access to dietary supplements and consumers’ ability to make informed decisions about caffeine in the dietary supplements they purchase. Therefore, CRN recommends that its members follow these voluntary guidelines for their products that contain caffeine, and encourages all dietary supplement producers and marketers to follow these recommendations. These guidelines address disclosure of caffeine content and set forth consumer advisories to promote the safe, responsible use of dietary supplements.
In addition to compliance with applicable labeling laws and regulations, CRN recommends that its members adhere to the following guidelines for the labeling of caffeine-containing dietary supplements:
A. Disclosure of Total Caffeine Content
The purpose of this guideline is to provide consumers with information on the total caffeine content per serving in dietary supplements, whether from added or naturally occurring caffeine.
- Caffeine content from both added caffeine and naturally occurring caffeine combined should be declared in milligrams per serving either in the Supplement Facts Box or in a separate statement elsewhere on the label.
- This section does not apply to dietary supplements that contain no added caffeine and less than 25 mg per serving of naturally occurring caffeine.
B. Label Advisories for Conditions of Use
The purpose of this guideline is to provide consumers with additional information about the use of dietary supplements containing caffeine. As with all dietary supplements, consumers taking medication should consult a healthcare professional about the supplements they are taking.
- Any supplement with total caffeine content of more than 100 mg per serving should provide the following statements or equivalent language on the product label:
a. This product is not intended/recommended for children and those sensitive to caffeine.
b. Pregnant or nursing women, those with a medical condition, and those taking medication should consult a healthcare professional before use.
C. Serving Size and Daily Intake Recommendations
The purpose of this guideline is to encourage dietary supplement manufacturers and marketers to establish caffeine levels per serving and total servings per day that are consistent with current science and in compliance with applicable laws.
- Labeling should provide serving size and daily intake recommendations that are consistent with 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.
D. Restraints Against Marketing In Combination with Alcohol
The purpose of this guideline is to discourage marketing of caffeine-containing dietary supplements in a manner that encourages combination with alcohol.
- CRN members should 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.
E. Restraints Against the Sale and Marketing of Bulk Amounts of Pure or Highly Concentrated Caffeine in Powder or Liquid Form
The purpose of this guideline is to discourage the sale and marketing of bulk amounts of pure or highly concentrated caffeine in powder or liquid form directly to consumers.
- CRN 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 CRN 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.
- Effective immediately, CRN recommends that dietary supplement companies comply with these guidelines.
Effective Date: April 1, 2013; Amended, February 17, 2015; Amended, June 14, 2018
1 For purposes of this document, “added caffeine” refers to pure anhydrous caffeine. “Naturally occurring caffeine” refers to caffeine that occurs 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), available at, https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM604319.pdf