Voluntary Labeling Program for Dietary Supplements Proposed Pregnancy/Nursing Label Statement

Members of the Consumer Healthcare Products Association (CHPA) which market dietary supplements formally initiated a voluntary labeling program on March 22, 2000 which relates to the use of the following label statement on dietary supplement products:

If you are pregnant or nursing a baby, ask a health professional.

This statement (or its reasonably substantial equivalent; see 2.b.), 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). Certain dietary supplements logically do not need such a label statement because, for example, their intended uses are not for women of child-bearing age, or because they have recognized uses for women of child-bearing age (e.g., prenatal vitamins and minerals) or have data to support the use of the product by women who are pregnant and/or nursing a baby. Types of products that fall in these categories are listed below under "Exemptions."

The implementation time for this program is at the next label printing, but no later than April 2, 2001.

1. Voluntary Pregnancy/Nursing Statement: If you are pregnant or nursing a baby, ask a health professional.
2. Provisions: The following provisions apply to the voluntary use of this label information statement by CHPA members marketing dietary supplements:
   1. Scope: This label information statement is intended for use on dietary supplements defined by the Dietary Supplement Health and Education Act (DSHEA), with certain exemptions:
      1. DSHEA Definition of Dietary Supplements: "a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients."
      2. Exemptions:
         1. Dietary supplements with recognized nutrient value that have adult recommended daily intake values (RDIs) and are labeled at or below the RDI, subject to 2.c. below;
         2. Dietary supplements with recognized nutrient values which are intended for prenatal use and/or for use during nursing and which solely contain vitamins and minerals with RDIs at levels safe for these intended uses;
         3. Dietary supplements that may be used during pregnancy and/or by nursing mothers based on recognized compendia and/or based on determinations or pending recommendations of other authoritative bodies such as the National Academy of Sciences and United States Pharmacopeia or others and/or based on company-generated research, or information, etc.;
         4. Dietary supplements that are labeled exclusively for pediatric use;
         5. Dietary supplements that are labeled exclusively for postmenopausal women; and
         6. Dietary supplements that are labeled exclusively for use by men.
            1. Stay of Use of Structure/Function Claims for Certain Conditions Associated with Pregnancy: Under this voluntary program, member companies would not make claims relating to edema associated with pregnancy.
   2. Alternate Statements: As with other CHPA voluntary label statements, this proposed pregnancy/nursing statement may be used in reasonably substantially equivalent wording, such as:
      • consult (or, ask; or contact) a (or, your) doctor (or, health professional; or, health practitioner) if you are pregnant or nursing (or, breast feeding) a baby;
      • before using (or, before using this product) consult (or, ask; or contact) a (or, your) doctor (or, health professional; or, health care practitioner) if you are pregnant or nursing a baby (or, lactating; or, breast feeding);
      • ask (or, consult; or contact) a (or, your) doctor (or, health professional; or, health care practitioner; or, doctor or other health professional) before using (or, before using this product) if you are pregnant or nursing a baby;
      • if you are pregnant or nursing a baby, ask (or, consult; or, contact) a (or, your) doctor (or, health professional; or doctor or other health professional; or, health care practitioner);
      • not for use during pregnancy and lactation, unless directed by a health care practitioner (or, doctor; or, doctor or other health professional); or
      • other substantially equivalent statements.
3. Combination of the Voluntary Pregnancy/Nursing Label Statement with Other Similar Voluntary Label Statements: The voluntary pregnancy/nursing label statement may be combined with other voluntary labeling statements 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).
4. Implementation Date: At the next label printing, but not later than April 2, 2001.

Words in italics represent examples of reasonably equivalent wording, and are not to be considered inclusive of all possible reasonably equivalent statements.