Voluntary Programs

Voluntary Program for Dietary Supplements: Adulterants, Known

Consumer Healthcare Products Association (CHPA) members agree voluntarily to take appropriate steps to assure that the following raw materials have not been substituted in whole or in part with known toxic adulterants, noted below. These steps are to be based on validated analyses by the processor or manufacturer, or, in lieu of such analysis, a guarantee or certificate of analysis from a supplier provided that the processor or manufacturer establishes the reliability of the supplier’s analysis:

Adopted: March 8, 2001

Voluntary Program for Dietary Supplements: Goldenseal

Consumer Healthcare Products Association (CHPA) members agree voluntarily to refrain from labeling or marketing products that contain goldenseal (Hydrastis canadensis) in any manner that suggests that the product masks drug testing. Adopted: March 8, 2001

Voluntary Program for Dietary Supplements:

Kava Consumer Healthcare Products Association (CHPA) members agree voluntarily to market products containing kava (Piper methysticum) with the following dosage and labeling:

• Labeled Content: Products containing kava should be formulated and labeled to limit consumption of total kavalactones to 300 mg per day;
• Labeling: Labels of all products containing kava should bear the following statements, or their substantial equivalent and where appropriate consistent with other CHPA voluntary labeling programs.

Caution: Not for use by persons under the age of 18. If pregnant, nursing a baby, or taking a prescription drug, ask a health professional prior to use. Do not exceed recommended dose. Excessive consumption may impair ability to drive or operate heavy equipment. Not recommended for consumption with alcoholic beverages.

Adopted: March 8, 2001

Voluntary Program for Dietary Supplements: Lady’s Slipper

Whereas the roots of lady’s slipper, Cypripedium spp. (notably C. acaule and C. parviflorum) have historically been traded as wild botanicals and, given the recognition of the threatened status of these and other orchids (resulting from extirpation for commercial purposes and other causes), Consumer Healthcare Products Association (CHPA) members agree voluntarily to refrain from trade in wild-harvested lady’s slippers.

Adopted: March 8, 2001

Voluntary Program for Pyrrolizidine Alkaloids

Consumer Healthcare Products Association (CHPA) members agree voluntarily to the following provisions pertaining to pyrrolizidine alkaloids. All products with botanical ingredients which contain toxic pyrrolizidine alkaloids * should not be taken orally and should therefore bear the following cautionary statement on the label:

“For external use only. Do not apply to broken or abraded skin. Do not use while nursing.”

Including but not limited to: Alkanna tinctoria (alkanet), Anchusa officinalis (bugloss), Borago officinalis* (borage), Crotalaria spp., Cynoglossum spp., Erechtites hieraciifolia, Eupatorium cannabinum (hemp agrimony), Eupatorium purpureum (Joe Pye), Heliotropium spp., Lithospermum officinale (European gromwell), Packera candidissima, Petasites spp. (e.g., Butterbur), Pulmonaria spp. (e.g., lungwort), Senecio jacobaea (European ragwort), Senecio vulgaris (groundsel herb), Symphytum spp. (comfrey), and Tussilago farfara (coltsfoot).

*Borage seed oil is specifically exempt from the above label recommendation.

In view of the fact that by statutory definition botanicals that are not orally ingested are not dietary supplements, pyrrolizidine alkaloids encompassed by this voluntary program are not dietary supplements.

Adopted: March 8, 2001

Voluntary Program for Dietary Supplements: Stimulant Laxatives

With the exception of those products containing senna, cascara sagrada, or aloe that are labeled in accordance with the Tentative Final Monograph for OTC laxatives, or the leaf gel of Aloe vera, Consumer Healthcare Products Association (CHPA) members agree voluntarily that any product that contains as an ingredient any of the herbs listed below shall include the following information on its label:

1. The standard common name and plant part should be listed on all labeling and literature as follows:

NOTE: Senna was formerly listed in the genus Cassia, including the following species: Cassia angustifolia, C. obtusifolia, C. senna, and C. tora. Bulk raw materials labeled as a species of Cassia should be identified on finished consumer packages as “senna.”

2. A dietary supplement including a claim in an OTC monograph per the Final Rule on structure/function claims and containing a quantity of stimulant laxative to warrant such a claim, shall also include on the label all warnings pertaining to that claim as found in the applicable OTC monograph, as stipulated in FDA’s final rule on structure/function claims [Fed. Reg. 65: 1031, 2000].

Adopted: March 8, 2001

Voluntary Labeling Program for Dietary Supplements: Disclosure of Added Constituents

Whereas the Federal labeling regulations for dietary supplements require that the label of a dietary supplement list all ingredients in order of predominance, CHPA members recommend, for any botanical raw material, whether sold as a botanical or as a concentrate; metabolite; constituent; or extract of a botanical, that:

• The ingredient declaration of bulk botanical raw material declare all ingredients by their common or usual name and in order of predominance, including but not limited to botanical extractives; excipients; fillers; binders; solvents that have not been removed; and added constituents;
• Specification sheets for bulk botanical raw materials indicate for each such ingredient the percentage, or range of percentages, of the entire raw material represented by the ingredient, so that finished product manufacturers can determine the order of ingredients in a finished product containing the raw material;
• The common name of a botanical raw material to which a constituent has been added be in the form of: botanical; plant part; form; “with added” constituent, e.g., “guarana seed extract with added caffeine,” “goldenseal leaf powder with added berberine”;
• Manufacturers and marketers of finished products containing any botanical raw material as described here label such products to include all ingredients as described here in order of predominance.

Adopted: March 8, 2001

Voluntary Program for Dietary Supplements: Caffeine

Caffeine is found naturally in a wide variety of beverages (coffee, tea, cola) and food (chocolate) and is an added active ingredient contained in a number of prescription and over-the-counter drugs. Manufacturers of dietary supplements are responsible for ensuring the safety of their products.

This guideline applies specifically to caffeine-containing dietary supplement products. CHPA members marketing caffeine-containing dietary supplements agree to adopt these voluntary guidelines addressing labeling, packaging, and promotion to ensure safe and responsible use of these products.

1. Disclosure of Total Caffeine Content per Serving (mg/serving)
   1. Total caffeine content, resulting from both added caffeine and naturally-occurring caffeine¹, should be declared in milligrams per serving either in the Supplement Facts Box or in a separate statement elsewhere on the label.
   2. Caffeine disclosure provisions in this guideline apply to dietary supplements containing added caffeine and greater than 25 mg per serving of naturally occurring caffeine.
2. Labeling Information
   1. Any supplement containing >100 mg total caffeine per serving should provide the following statements or equivalent language on the product label:
      1. This product is not intended/recommended for children less than 18 years of age or those sensitive to caffeine.
      2. Pregnant or nursing women, those with a medical condition, and those taking medication should consult a healthcare professional before using this product.
   2. Serving Size and Daily Intake Recommendations
      1. Labeling should provide serving size and daily intake recommendations that are consistent with current safety information about caffeine established by competent and reliable scientific evidence.
         1. 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.
      2. Restraints Against Marketing In Combination with Alcohol
         1. CHPA members will 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.
      3. Restraints Against the Sale and Marketing of Powdered Pure Caffeine
         1. CHPA members should not sell or market powdered pure caffeine in bulk form directly to consumers². This section is not intended to limit CHPA members from marketing or selling powdered pure caffeine in bulk form to a business entity as part of a business transaction.
      4. Implementation
         1. The implementation time for this program is at the next label printing or no later than 12 months following adoption.

¹ “Added caffeine” refers to pure anhydrous (powdered) caffeine. “Naturally occurring caffeine” refers to caffeine occurring naturally in other dietary ingredients, including, but not limited to green tea, guarana, cocoa, kola nut, and yerba mate.
² Pure caffeine is a powerful stimulant and even very small amounts may cause an accidental overdose. In December 2014, FDA recommended that consumers not use powdered pure caffeine noting two recent deaths associated with the use of the product.

Adopted: June 18, 2013
Amended: June 25, 2015 (added “Restraints Against the Sale and Marketing of Powdered Pure Caffeine”)

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