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.

1. Voluntary St. John's Wort Label Statement: If you are taking a prescription drug, ask a health professional (see 2.c.).
2. 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:
   1. Scope: Dietary supplements containing St. John's wort
   2. Exemptions: None.
   3. 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.
   4. 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).
   5. 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.