AHPA Guidance Policies

 

AHPA develops guidance policies to advance their Mission to promote responsible commerce in herbal supplements. These policies address a variety of labeling and manufacturing issues and reflect the consensus of AHPA’s members and its Board of Trustees. Unlike AHPA’s trade recommendations, compliance with AHP A’s guidance policies is not a condition of membership. evertheless, AHP A encourages its members and non-member companies to adopt each of these policies in the interest of establishing consistent and informed trade practices.

Guidance on Heavy Metals (adopted October 2008; revised July 2012)
Dietary supplement manufacturers determine what, if any, tests or examinations are appropriate for their products, whether to meet specifications established for these products or for other purposes. With respect to herbal supplements, there are a variety of heavy metals for which companies may consider implementing tests or examinations, if appropriate. This guidance discusses some of the more commonly used ones. Not all of these, however, are applicable to eve1y herbal supplement, and others not included here may be relevant for some such products. Where manufacturers choose to establish one or heavy metal specifications for herbal supplements, AHP A provides the following as guidance on maxinmm quantitative limits:

• for inorganic arsenic; 10 mcg/ day; for cadmium; 4.1 mcg/ day;
• for lead: 6 mcg/ day;
• for methyl mercury: 2.0 mcg/ day .

 

• “Herbal supplement” means a dietaiy supplement, as described in 21 U.S.C. 321 (ff), that contains one or more herbal ingredients (i.e., ai1 herb or 0U1er botanical, or a concentrate, extrnct, or combination of an herb or other botanical). An herbal supplement may or may not contain additional non-herbal dietary ingredients (e.g., vitamins, minerals, amino acids, etc.) or excipients.

 

In addition, for purposes of this guidance the following limitations and conditions apply

• This guidance is not intended to suggest that manufacturers should establish specifications for any or all of the identified heavy metals in any specific herbal supplement, but is rather intended to provide guidance for limits in U1e event any such specifications are set. Tilis guidai1ce is not, in fact, applicable for some herbal supplements. In addition, it may not be relevai1t to test any specific herbal supplement to determine U1e level of any or all of U1e heavy metals identified in Uus guidance.
• The above quantitative limits are deternlined at U1e lughest labeled dose of a supplement, and are applicable only to herbal supplements that are consumed in a total daily amount of 5 grams or less.
• A product in compliance wiU1 Ulis guidance may require a wai·ning in order to comply wiU1 Ca.lifonlia Proposition 65′ s listing of these chemicals.
  http://www.alwa.org/Default.aspx?tabid=214 Click this link for information on Proposition 65

Guidance on Microbiology & Mycotoxins (adopted June 2003; last revised July 2012)
Food ingredient suppliers, dietary ingredient suppliers, and dietary supplement manufactures determine what, if any, tests or examinations are appropriate for their ingredients and products, whether to meet specifications established for these ingredients and products or for other purposes. With respect to herbal ingredients and supplements, there are a variety of microbiological characteristics and mycotoxins for which companies may consider implementing tests or exantinations, if appropriate. Titis guidance discusses some of the more commonly used ones. ot all of these, however, are applicable to every herbal ingredient and supplement, and others not included here may be relevant for some herbal ingredients or supplements. Where manufacturers choose to establish one or more microbiological and/ or mycotoxin specifications for herbal ingredients or dietary supplements identified in this guidance, AHPA provides the following as guidance on maximum quantitative limits:

(a) (i) for dried, unprocessed herbs for use as ingredients in dietary supplements, and (ii) for herbal supplements in solid form consisting of dried, unprocessed herbs:(a) (i) for dried, unprocessed herbs for use as ingredients in dietary supplements, and (ii) for herbal supplements in solid form consisting of dried, unprocessed herbs:

• Total aerobic plate count: 107 colony forming ml.its/ gram

• Total yeasts and molds: 105 colony fomting ml.its/ gram

• Total coli.forms: 104 colony fomting units/ gram

• Snlmonelln spp.: not detected in 25 grams

• Escherichin coli: not detected in 10 grams

• Total aflatoxins (B1 + B2 + Gi + G): 20 µg/kg (ppb)

• Aflatoxin B1: 5 µg/kg (ppb)

 

For purposes of this guidance the following definitions apply

• “Dried m1processed herb” menns an herb or other botanical that is dehydrated from its fresh state and that has not been subjected to any ftu1:her processing other than cleaning, grading, or size reduction (e.g., cutting or powdering).
• “Dieta1y supplement” !-ins the snme meaning ns described in 21 U.S.C. 321 (ff). For purposes of this guidance a dietary supplement is a product in finished form ready for consun1.er use.
• “Herbal supplement” rnenns a dietary supplement, as described in 21 U.S.C. 321 (ff), that contains one or more herbal ingredients (i.e., an herb or other botanical, or a concentrate, extract, or combination of an herb or other botanical). An herbal supplement may or may not contain additional non-herbal dietary ingredients (e.g., vitamins, minerals, amino acids, etc.) or excipients.
• “Botanical extract” menns the complex, multi-component mixture obtained after using a solvent to dissolve components of an herbal or other botanical biomass. Botanical extracts may be in dry, liquid or semi-solid form. Excipients may be added to botanical extracts for vadous technical purposes (e.g., to adjust concentration; enhance stability; limit microbial growth; or improve drying, flow or other manufacturing characteristics). Botanical extracts are not the same as expressed juices, pure chemicals isolated from an herb, or synthetically modified plant constituents (though it should be noted that some chemical modifications might occur as the natural consequence of the extraction process).
• “Powdered extract” means a botanical extract that has been dried into a powder.
• “Soft (a.k.a. pilula1·, semi-solid, or solid) extract” means a botanical extract having a consistency of a thick liquid or paste.

In addition, for purposes of this guidance the following limitations and conditions apply

• This guidance is not intended to suggest that manufacturers should establish specifications for any or all of the identified microbiological characteristics or mycotoxins in any specific herbal ingredient or supplement, but is rather intended to provide guidance for limits in the event any such specifications are set. This guidance is not, in fact, applicable for some herbal ingredients and supplements. In addition, it may not be relevant to test any specific herbal ingredient or supplement to determine the level of any or all of the microbiological characteristics or mycotoxins identified in this guidance.
• In determining whether Salmonella spp. and E. coli are not detected, the sample size may vary depending on the method used.
• Depending on the analytical methods used to detect Salrnonelln. spp. or E. coli, failure to detect a nticroorganis1n may be reported as “absent,” “not detected,” “negative,” or
  “less than” the detection lintit.
• For dried, unprocessed herbs for use as ing1:edients in dietaiy supplements, the above quantitative limits may be exceeded in either of the following circumstances:

1.  When, due to naturally occurring conditions, an individual herb requires higher limits on total aerobic plate count, total yeasts and molds, and/ or total coliforms.
2.  When acceptable teclmiques, such as steam sterilization, will be employed in subsequent processing to elintinate pathogens. However, such treatment is not acceptable if the untreated materials are spoiled prior to such treatment.

• For herbal products in solid form, the above quantitative limits do not apply to products where boiling water is added before use, and may not apply to products contailting other dietary ingredients (sud1. as vitamins and minerals) and excipients.

Standardized Information on Dietary Ingredients (SIDI) (adopted July 2007)

AHP A recommends that its members who buy and sell dietary ingredients use the Standardized Information on Dietary lngi·edients (SIDI) protocol as a standard reporting form for providing information about these ingredients. http://ww.v.ahpa.org/SIDI/index.html Follow this link for more infonnation on SIDI and to be taken to the SIDI website.

Ingredients that are or are produced from genetically modified organisms (GMOs) (adopted July 2007)

WHEREAS, the use of genetically modified organisms (GM0)1 as a tool in agi’iculture is viewed by its proponents as providing the potential to meet basic global food needs and deliver a wide range of health, enviromnental and economic benefits;

WHEREAS, concerns have been expressed about the potential impact of agricultural use of GMO on the environment and health, such that the European Union requires labeling of novel foods or foods containing ingi-edients as “no longer equivalent to an existing food or food ingredient” and has proposed additional laws regarding labeling of foods that are derived from GMO crops;

WHEREAS, AHPA supports positions that are based on scientific 1·easoning and also supports positions that favor a sustainable approach to environmental issues and a responsible approach to health issues related to conunerce in herbs and herbal products;
WHEREAS, AHPA supports consumers’ right to be informed on issues that affect their purchasing decisions;
THEREFORE, BE IT RESOLVED THAT AHPA encomages companies that grow, process, manufacture, market or sell herbal products to refrain from using herbal raw agricultural products that are cultivated with GMO teclmologies, or extracts and natural flavors thereof,2 at least until such time as the above identified concerns have been suitably addressed;
BE IT FURTHER RESOLVED THAT AHPA supports labeling of consumer goods to identify any ingredients that are herbal raw agi·icultural products knowingly and intentionally cultivated with GMO teclmologies, or extracts and natural flavors thereof, in a maimer that assures that consumers are informed that the ingi·edient was cultivated with GMO technology;
EXCEPT THAT nothing in tlus policy is meant to collU11ent on researcl1 regarding GMO teclmology; and that notlung in tlus policy is meant to conunent on minimal and/ or unintentional nuxing of GMO and non-GMO crops; and that tllis resolution does not create an obligation for any AHPA member.

1.  GMO is used here as it is a commonly recognized term that refers to genetically modified materials (also known as genetically engineered). Genetically modified is defined as: Made with techniques that alter the molecular or cell biology of an organism by means that are not possible under natural conditions or processes. Genetic modification includes but is not limited to recombinant DNA, cell fusion, micro-and macro-encapsulation, gene deletion and doubling, introducing a foreign gene and changing the position of genes. The term as used here does not include breeding, conjugation, fermentation, hybridization, in-vitro fertilization and tissue culture. Definition adapted from the International Federation of Organic Agriculture Movements (/FOAM) http:l/www.ifoam.org/press/positions/geposition.html. accessed March 15, 2007. FDA has developed a Draft Industry Guidance that includes comments for use of the term GMO (Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering,1) GMO is used here as it is a commonly recognized term that refers to genetically modified materials (also known as genetically engineered). Genetically modified is defined as: Made with techniques that alter the molecular or cell biology of an organism by means that are not possible under natural conditions or processes. Genetic modification includes but is not limited to recombinant DNA, cell fusion, micro-and macro-encapsulation, gene deletion and doubling, introducing a foreign gene and changing the position of genes. The term as used here does not include breeding, conjugation, fermentation, hybridization, in-vitro fertilization and tissue culture. Definition adapted from the International Federation of Organic Agriculture Movements (/FOAM) http:l/www.ifoam.org/press/positions/geposition.html. accessed March 15, 2007. FDA has developed a Draft Industry Guidance that includes comments for use of the term GMO (Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering,http:l!www.cfsan.fda.gov/-dmslbiolabgu.html. accessed on March 19, 2007).
2. This is inclusive of extracts made from GMO herbal raw materials and excipients, fillers, carriers, etc. used to make, or that are present in, extracts. “Natural flavo( ingredients are those composed of the essential oils, oleoresins or natural extractives of herbs and spices, and various undisclosed excipients, which could include corn or soy-based carriers (e.g. maltodextrin or lecithin).

Known Adulterants {adopted July 1997; revised July 2012)

AHPA recommends that appropriate steps be taken to assure that the raw materials in the following table are free of the noted adulterant. This list identifies herbs and potential adulterants that are known at this time to have been encountered in trade. Additional information may be added if further such instances are observed. Marketers of products that contain herbal ingredients are responsible for assuring accurate identification of all ingredients. Contact AHP A for additional information regarding relevant analytical methods or follow this link
{http://www.ahpa.org/Default.aspx?tabid=242) for more information from the AHPA website -also found under the Technical Guidance/Scientific Affairs/ Adulteration Information menu.

a. For a complete list of species that FDA has identified as potentially adulterated with Aristo/ochia spp. see

http://www.cfsan.fda.gov/-dms/ds-bot2.html

b. Synonym = Saussurea lappa

c. Synonym= Cimicifuga racemosa

d. Also known as sheng ma or Rhizoma Cimicifugae; consists of Actaea cimicifuga, syn. Cimicifuga foetida; Actaea dahurica, syn. C. dahurica; A. herac/eifo/ia, syn. C. heracleifo/ia; and possibly other Asian species of Actaea.

Disclosure of herb use to healthcare providers (adopted October 2001)
AHPA reconunends that consumers of herbal supplements in.form their healthcare provider(s) of such use. In the interest of seeing this recommendation broadly accepted by consumers, AHP A encourages healthcare providers to receive such communication v.rith respect for the consumers’ healthcare choices. In addition, AHP A encourages healthcare providers to seek out accurate and truthful inforn1ation about herbs.

Product Labeling for St. John’s Wort (Hypericum perforatum) (adopted July 2000)
AHPA reconunends the following or similar language appear on the label of products containing St. John’s wort:

Notice: Do not use this product while taking any prescription dntg(s) without the advice of your prescribing physician. Avoid excessive e:xposure to UV inadiation (e.g., sunlight; tanning) when using this product.

 

Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts (adopted July 2000)
AHPA reconunends the following labeling standards:

 

•  Standardized statement of quantity. For soft or powdered botanical extracts listed in the Supplement Facts box (as defined by 21 CFR §101.36) the quantity stated shall correspond to the total amount of that extract included in the product (i.e., the quantity shall include carriers and other excipients.1) If they so choose, AHPA members may also disclose the percent of native extract for each extract listed in the Supplement Facts Box.2 • Standardized statement of quantity. For soft or powdered botanical extracts listed in the Supplement Facts box (as defined by 21 CFR §101.36) the quantity stated shall correspond to the total amount of that extract included in the product (i.e., the quantity shall include carriers and other excipients.1) If they so choose, AHPA members may also disclose the percent of native extract for each extract listed in the Supplement Facts Box.2
• Extract ratios. Listing of the extract ratio of a soft or powdered botanical extract is not a mandato1y labeling requirement for retail products. There are differing opirLions concerning the value of listing extract ratios on the retail label. However, where such ratios are stated, they shall conform to the following convention2: The first nwnber shall represent the amount of dried botanical starting material, the second number shall represent the amount of finished total extract. For example, a 4:1 extract is one in which each kilogram (or other unit) of finished total extract represents the extractives from four kilograms (or other unit) of dried botanical starting material.3 Where fresh rather than dried starting material is used in determining the ratio, this fact must be disclosed.
• Statement of manufacturing ranges. For soft or powdered ex’iracts where the percent native extract or the concentration ratio varies from lot to lot of extract, this variation may be expressed on the label in either of the following forms: The range.
• The range of percent of native extract or of concentration ratios described in the extract manufacturer’s product specification may be stated on the retail label. Any range specified by the exh:act manufacturer must correspond to the actual variability that occurs from batch to batch of exh:act. Where the percent native extract range or ratio is listed on the label, it shall be stated in the form “x-y% native” (e.g., “40-50% native”) 01′ “x-y:1” (e.g., “4-5:1)
• The average. The average of the range described in the extract manufacturer’s product specification may be stated on the retail label, so long as (a) The range does not vru.y by more thru.1 ± 20% from the stated average; ru.1d (b) The fact that the labeled value represents the average of a rru.1ge is disclosed on the label. If the range varies by more than 20% from the average, the average may not be stated on the label; rather, the entire range must be disclosed.

Where an average value is listed on the label, it shall be in the form “average % native” or “average x:1.” Where desired, the word “average” may be abbreviated to “av.” or “avg.”

1) Carriers and other excipients are required to be listed in the ingredients statement in accordance with §101.4(g).1) Carriers and other excipients are required to be listed in the ingredients statement in accordance with §101.4(g).

2) It is not meant to imply that the items discussed (i.e., listing of percent native extract and the extract ratio) are the optimal or proper way to describe the extract on the retail label.

3) Any appropriate unit may be used, so long as the amounts of starting plant material and finished extract are expressed in the same unit of measure.

“Guidance for the Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts” is also available from the AHPA Bookstore, as part of AHPA’s Guidance Documents for the Manufacture and Sale of Botanical Extracts.

 

Guidance on Extract Labeling1 (adopted March 2010)

Any non-liquid herbal extract U1at discloses a quantitative extraction ratio stated as a ratio of two numbers represents fue first number as U1e weight of starting plant material and U1e second number as fue weight of U1e finished extract produced from fue starting plant material, and U1at irdormation on the condition of U1e starting material should be indicated when it is fresh and may be indicated when it is dried*. *Herbal extracts in liquid form are required by federal regulation, whether or not a concentration ratio is declared, to disclose the condition of the starting material when it is in a fresh state (21 CPR 101.36 (b)(3)(ii)(B) lSee additional information on A.HP A’s Trade Requirement for extract labeling in A.HP A’s Code Of Ethics

Guidance on Residual Solvents in Extracts (adopted October 2010, revised July 2011)

AHPA reconunends U1at herbal extracts marketed in U1e U.S. limit any contained residual solvents to the levels established by U1e current International Conference on Harmonization’s (ICH’ s) document, Impurities: Guideline for Residual Solvents, except that Uus guidance does not apply to fue ICH linlit of 50 mg per day for ilie class 3 solvent ethanol when it is present in liquid extracts formulated to contain eU1anol1 or for U1e class 3 solvent acetic acid when it is present in liquid extracts formulated to contain acetic acid or vinegar.

With regard to this guidance, solvents identified in U1e cited ICH document as class 1 solvents
(benzene;* carbon tetrachloride;* 1,2-dichloroethane;* l,l-dicluoroeU1ene; and 1,1,1-tricluoroethane), wluch are considered by ICH as unacceptably toxic or an environmental hazard1 are not appropriate for use, and should not be used, in U1e manufacture of herbal extracts. WiU1 regard to iliis guidance, solvents identified in ilie cited ICH document as class 2 solvents, which a.re considered by ICH to be inherently toxic, are listed in U1e table below with the ICH recorrunended upper limits for Pernlissible Daily Exposmes (PDE) and concentration limits given in ppm assunling a 10 gram daily dose.

 

Acetonitrile

Chlorobenzene                     410

Chloroform*                         360

Cyclohexane                            60

1,2-Dichloroethene             1870

Dichloromethane*               600
1,2-Dimethoxyethane           100

N,N-Dimethylacetamide*  1090

N,N-Dimethylformamide    880

1,4-Dioxane*                         380
2-Ethoxyethanol                  160

Ethyleneglycol                     620

Formamide                           220
Hexane                                  290
Methanol                            3000
2-Methoxyethanol                 50

Methylbutyl ketone*            50

Methylcyclohexane           1180
N-Methylpyrrolidone*      530

Nitromethane*                      50

Pyridine*                             200
Sulfolane                            160
Tetrahydrofuran Tetralin  720
Toluene*                                 890
1,1,2-Trichloroethene              80

Xylene                                 2170

 

With regard to this guidance, solvents identified in the cited ICH document as class 3 solvents, which are considered by ICH as having low toxic potential, should be limited to 50 mg/ day,t which equates to 5000 ppm 01· 0.5% in 10 grams. Their use should be limited by good manufacturing practice (GMP) or other quality based requirements. They are identified as the following:

 

Class 3 Solvents

Acetic acid            Ethanol*

Acetone                Ethyl acetate

Anisole              Ethyl ether

Ethyl formate

Formic acid

Heptane

Isobutyl acetate

Isopropyl acetate

Methyl acetate

 

 

tThis limit does not apply for ethanol when it is present in liquid extracts formulated to contain ethanol or for acetic acid when it is present in liquid extracts formulated to contain acetic acid or vinegar. Adherence to this AHPA guidance does not infer compliance with California Proposition 65. Several of these solvents are listed by the State of California as chemicals known to the State to cause cancer or reproductive toxicity, including, as of the date of the last revision of this guidance, at least those solvents marked with an asterisk(*). The listing of ethanol wiU1 regard to Califomia Proposition 65 refers only to its presence in alcoholic beverages.

 

Trade Requirement and Guidance Policy for Labeling of Undiluted Essential Oils Used Topically and Offered for Retail Sale

(Trade Requirement adopted July 2009, revised July 2011; Guidance Policy adopted July 2012) Undiluted plant essential oils offered for retail sale and intended for topical use:

 

1. Do include all of the information and statements, or significantly similar statements, identified in tl1e table below as a “trade requirement,” directly on package labels;1. Do include all of the information and statements, or significantly similar statements, identified in tl1e table below as a “trade requirement,” directly on package labels;

2. May include any of tl1e information identified in the table below under “Guidance Policy,” either directly on package labels or on labeling.*

 

“Labeling” has the meaning ascribed in 21 U.S.C. 321(m) and means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

 

In addition, for purposes of these policies, the following notes apply

 

TI1ese policies do not address the safety of specific essential oils. Contraindications exist for the use of some essential oils in special populations, such as infants and children; pregnant and lactating women; and those with certain health conditions {e.g., hypertension). Such individuals should use essential oils under the supervision of a professional or qualified person.
All of the required storage and usage cautions can be stated succinctly, for example, as: “Keep away from children. No use orally, in eyes or mucus membranes, or undiluted on skin.”

 

Specific Types of Extraction

Types of Distillation

• Steam distillation: Natural raw material is placed in or above water in a retort and exposed to steam, which carries the volatile oils into a condenser where the mixture is cooled.1 The oils separate from tl1e water and can be collected.• Steam distillation: Natural raw material is placed in or above water in a retort and exposed to steam, which carries the volatile oils into a condenser where the mixture is cooled.1 The oils separate from tl1e water and can be collected.• Hydro distillation: Steam distillation in which the natural raw material is exposed to steam from above, rather than from below, the raw material.• Water distillation: Natural raw material is submerged in water. The water is then slowly heated and brought to a boil.• Dry distillation: Used primarily to obtain essential oils from wood. atural raw material is heated in a retort in the absence of liquid to release vapors or liquids. The heat applied to the retort is commonly direct flame. This process may or may not involve pyrolysis.

 

Types of Expression

 

• Cold-pressing: Used primarily to obtain citrus essential oils. Fruit is punctmed and then mechanically pressed. No external heat is applied during the extraction process.• Cold-pressing: Used primarily to obtain citrus essential oils. Fruit is punctmed and then mechanically pressed. No external heat is applied during the extraction process.• Sponge expression: Pulp is removed from the fruit and the remaining rind and pith are soaked in water. TI1e softened peel is pressed against a sponge, which absorbs the exuded oil.• Scarification (aka: Ecuelle a piquer): Outer peel of a fruit is scai·ified. The liquid exuding from the ruptured oil glands collects in stem.• Machine abrasion: Outer peel of a &uit is scaiified ai1d then removed by machine and dropped into a flow of water, which carries the result to a large centrifugal separator machine.

 

Types of Solvent

 

 

• Enfleurage: Flower petals are placed on solid sheets of wai·m fat that absorbs the essential oil from the flowers. A solvent, usually alcohol, is then added to tl1e saturated fat, which separates the essential oil from the fat.• Enfleurage: Flower petals are placed on solid sheets of wai·m fat that absorbs the essential oil from the flowers. A solvent, usually alcohol, is then added to tl1e saturated fat, which separates the essential oil from the fat.• Supercritical CO2: Carbon dioxide is liquefied and used as extraction solvent.• Solvent: Use of a solvent other tl1an tl10se mentioned Urns far, such as hexane. Solvent should be identified.• Extrait: Extraction of flower oils (generally organic) witl1out the use of harmful solvents, such as benzene and hexai1e, etc.

 

When the natural raw material is placed in water during steam distillation it is sometimes called “water and steam distillation.