Jun 20, 2025
Voluntary Labeling Program for Dietary Supplements Proposed St. John's Wort Information Statement
Members of the Consumer Healthcare Products Association (CHPA)1 who market dietary supplements containing St. John's wort initiated a voluntary labeling program April 2, 2000, which related to the use of the following label statement (or its reasonably substantial equivalent) on dietary supplement products containing St. John's wort:
If you are taking a prescription drug, ask a health professional.
This statement (or its reasonably substantial equivalent; see 2.c.), when included in the labeling of dietary supplement products defined by the voluntary program, will be prominent and conspicuous and may appear in one of a number of alternative forms which convey essentially the same information intended by the label statement cited above (see below re: Alternative Statements).
The implementation time for this program is at the next label printing, but no later than April 2, 2001.
- Voluntary St. John's Wort Label Statement: If you are taking a prescription drug, ask a health professional (see 2.c.).
- Provisions: The following provisions apply to the voluntary use of this label information statement by CHPA members marketing dietary supplements containing St. John's wort:
- Scope: Dietary supplements containing St. John's wort
- Exemptions: None.
- Alternate Statements: As with other CHPA voluntary label statements, this proposed statement may be used in reasonably substantially equivalent wording, such as:
- ask (or, consult; or, contact)2 a (or, your) doctor (or, health professional; or, health care practitioner) if you are taking a prescription medicine (or, drug);
- ask (or, consult; or, contact) a (or, your) doctor (or, health professional, or doctor or other health professional; or, health care practitioner) before using this product if you are taking a prescription medicine (or, product);
- if you are taking a prescription medicine (or, product), ask (or, consult) a (or, your) doctor (or, health professional, or doctor or other health professional; or, health care practitioner)";
- if you are taking (or, currently taking) a prescription medicine (or, product), ask (or, consult; or, contact) a (or, your) doctor (or, health professional, or doctor or other health professional; or, health care practitioner) before using (or, before using this product); or
- other reasonably substantially equivalent statements.
- Combination of the Voluntary St. John's Wort Label Statement with Other Similar Voluntary Label Statements: The voluntary St. John's wort label statement may be combined with other voluntary labeling statements, such as the CHPA pregnancy/nursing label statement, provided the combined language creates a logical construct (e.g., If you are taking a prescription medicine, or if you are pregnant or nursing a baby, ask a doctor).
- Implementation Date: At the next label printing, but not later than April 2, 2001.
1 CHPA, founded in 1881, represents manufacturers and distributors of dietary supplements. CHPA has over 200 members across the manufacturing, distributing, supply, research testing, and advertising sectors of the self-care industry.
2 Words in italics represent examples of reasonably equivalent wording and are not to be considered inclusive of all possible reasonably equivalent statements.