Voluntary Labeling Program for Dietary Supplements Proposed St. John's Wort Information Statement

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Adopted:
May 2000

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.

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