NOTE: Certain of these recommendations are in need of revisions to conform to regulatory modifications that have occurred since their adoption. It is nonetheless expected that members comply with the implied intention of all trade recommendations.

1. LADY'S SLIPPER (JULY, 1988; REVISED NOVEMBER, 1999)

Whereas the roots of Lady's Slipper, Cypripedium spp. (notably Cypripedium acaule, C. pubescens 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);

AHPA hereby encourages and requests its members and all other businesses and individuals in the horticultural and herb trade to refrain from trade in wild-harvested Lady's Slippers.

AHPA further encourages its members and others in the herb trade to support research in ecology, demographics, and cultural methods, plus sexual and asexual propagation of Cypripedium species.

2. HERBS OF COMMERCE (1992; REVISED NOVEMBER, 1999)

AHPA recommends the use of the standard common names listed in Herbs of Commerce (1992) to comply with the federal labeling requirements for identification of ingredients in foods and in dietary supplements by their common or usual names, as such requirements are specified in 21 CFR S 101.4(a)1 and 21 CFR S 101.4(h).

3. CHAPARRAL (JANUARY, 1995)

In the interest of consumer education and well being, the AHPA Board of Trustees recommends that, if member companies choose to sell chaparral (Larrea tridentata), all consumer labeling contain the following informational language, as well as the phone number shown below for reporting unusual conditions associated with the ingestion of chaparral:

"Seek advice from a health care practitioner before use if you have had, or may have had, liver disease. Discontinue use if nausea, fever, fatigue or jaundice (e.g., dark urine, yellow discoloration of the eyes) should occur. (To report unusual conditions, call (301) 588-1171)."

4. STIMULANT LAXATIVES (JULY, 1995)

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, any product that contains as an ingredient any of the herbs listed below should 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:

Botanical Name

Common Name

Plant Part

Aloe spp.

aloe

dried latex

Rhamnus catharticus buckthorn

fruit

Rhamnus frangula

frangula

bark

Rhamnus purshiana

cascara sagrada bark

Rheum officinale

Chinese rhubarb root

Rheum palmatum

Chinese rhubarb root

Senna spp.

senna

leaf

Senna spp.

senna

fruit or pod

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. The following statement should be included on the label of all products which contain any of the above ingredients in sufficient quantity to warrant such labeling:

NOTICE: Do not use this product if you have abdominal pain or diarrhea. Consult a health care provider prior to use if you are pregnant or nursing a baby. Discontinue use in the event of diarrhea or watery stools. Do not exceed recommended dose. Not for long-term use.

NOTE: The State of California has established labeling requirements that supercede the AHPA recommendation for products sold in California. All dietary supplements that contain any amount of the above listed ingredients are required to bear the following label:

NOTICE: This product contains (name of substance(s) and common name(s) if different). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. Consult your physician if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition.

5. EPHEDRA (MARCH 1994; REVISED SEPTEMBER, 1995)

a. Labeling

The following statement is to be included on the labels of all finished consumer goods which contain any species of Ephedra, unless such product is documented to be free of all ephedra alkaloids or is labeled in conformity with relevant OTC monographs:

Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking an MAO inhibitor or any other prescription drug, Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not intended for use by persons under 18 years of age. Do not exceed recommended dose. KEEP OUT OF THE REACH OF CHILDREN.

b. Dosage

Members' products are not to contain in excess of 25 mg of total ephedra alkaloids per dose; usage instructions should limit daily consumption to 100 mg of total Ephedra alkaloids.

c. Herbs of Commerce Conformity

Label identification must be in conformity with the standard common name listed in Herbs of Commerce, that is: "ephedra." It is acceptable to list ma huang as an additional or parenthetical common name, but not as an alternative to "ephedra."

d. Synthetic ingredients

Raw material suppliers of ephedra and preparations of ephedra and manufacturers of consumer goods containing ephedra will refrain from selling or using any ingredients that contain added synthetically derived ephedra alkaloids.

6. PYRROLIZIDINE ALKALOIDS (JUNE, 1993; REVISED JULY, 1996)

The AHPA Board of Trustees recommends that all products with botanical ingredients which contain toxic pyrrolizidine alkaloids(1) bear the following cautionary statement on the label:

For external use only. Do not apply to broken or abraded skin. Do not use when nursing.

(1)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 gramwell), 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.

7. KNOWN ADULTERANTS (JULY, 1997)

The Board of Trustees recommends that appropriate steps be taken to assure that the following raw materials are free of the noted adulterant:

Herb in Commerce

Adulterant

1. Siberian Ginseng root 1. Periploca sepium root

(Eleuherococcus

senticosus)

2. Plantain leaf

2. Digitalis lanata leaf

(Plantago lanceolata)

3. Skullcap herb

3. Germander herb

(Scutellaria lateriflora) (Teucrium chamaedrys)

4. Stephania root

4. Aristolochia fangchi

(Stephania tetranda)

root

AHPA's Standards Committee is in the process of establishing appropriate testing methods to differentiate between each of the above listed herbs and its known adulterant. Also, the AHPA Botanical Raw Materials Committee has initiated the development of a Botanical Adulteration Manual that will provide information on all herbs in trade for which adulteration is known to be an issue.

8. KAVA (SEPTEMBER, 1997)

The Board of Trustees recommends the following dosage and labeling for products containing kava (Piper methysticum):

1. Products containing kava should be formulated and labeled to limit consumption of total kavalactones to 300 mg per day;

2. Labels of all products containing kava should bear the following statement:

Caution: Not for use by persons under the age of 18. If pregnant, nursing or taking a prescription drug, consult a health care practitioner 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.

9. GOLDENSEAL (MARCH, 1998)

The Board of Trustees recommends that AHPA members refrain from labeling or marketing products that contain Goldenseal (Hydrastis canadensis) in any manner that suggests that the product masks drug testing.

10. BOTANICAL SAFETY HANDBOOK (JULY, 1998)

The Board of Trustees recommends that any products that contain herbs classified in the Botanical Safety Handbook in Class 2b or 2c be labeled according to the labeling classification for those classes. Class 2b is defined as not for use in pregnancy unless otherwise directed by an qualified expert; Class 2c herbs are those that are not to be used while nursing unless similarly otherwise directed.

11. CONSTITUENT DECLARATION

Whereas the federal labeling regulations for dietary supplements require that all ingredients of a dietary supplement list all ingredients in order of predominance, AHPA recommends, 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.

Article copyright American Botanical Council.

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By Michael McGuffin