AHPA develops guidance policies to advance our 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 AHPA’s guidance policies is not a condition of membership. Nevertheless, AHPA encourages its members and non-member companies to adopt each of these policies in the interest of establishing consistent and informed trade practices.
AHPA Guidance Policies
To
download this as a PDF click here.
Guidance
on Heavy Metals
(adopted October 2008; revised November 2009)
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 every 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, AHPA provides the
following as guidance on maximum quantitative limits:
§
for
inorganic arsenic; 10 mcg/day;
§
for
cadmium; 4.1 mcg/day;
§
for
lead: 10 mcg/day;
§
for
methyl mercury: 2.0 mcg/day.
For purposes of this guidance the
following definition applies:
§
“Herbal
supplement” means 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.
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 the event any such
specifications are set. This guidance is not, in fact, applicable for some herbal
supplements. In addition, it may not be relevant to test any specific herbal
supplement to determine the level of any or all of the heavy metals identified
in this guidance.
§
The
above quantitative limits are determined at the highest 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 with this guidance may require a warning in order to comply
with California Proposition 65’s listing of these chemicals.
[Note: Click here for more information on Proposition
65]
Guidance on Microbiology & Mycotoxins (adopted
June 2003; last revised November 2009)
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 examinations, if appropriate. This guidance discusses some
of the more commonly used ones. Not 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:
§
Total
aerobic plate count: 107 colony forming units/gram
§
Total
yeasts and molds: 105 colony forming units/gram
§
Total
coliforms: 104 colony forming units/gram
§
Salmonella
spp.:
not detected in 10 grams
§
Escherichia
coli:
not detected in 10 grams
§
Total
aflatoxins (B1 + B2 + G1 + G2):
20 µg/kg (ppb)
§
Aflatoxin
B1: 5 µg/kg (ppb)
and
(b) (i) for powdered extracts and for soft extracts, and (ii) for herbal
supplements in solid form consisting of powdered extracts or soft extracts:
§
Total
aerobic plate count: 104 colony forming units/gram
§
Total
yeasts and molds: 103 colony forming units/gram
§
Total
coliforms: 102 colony forming units/gram
§
Salmonella
spp.:
not detected in 10 grams
§
Escherichia
coli:
not detected in 10 grams
§
Total
aflatoxins (B1 + B2 + G1 + G2):
20 µg/kg (ppb)
§
Aflatoxin
B1: 5 µg/kg (ppb)
For purposes of this
guidance the following definitions apply:
§
“Dried
unprocessed herb” means an herb or other botanical that is dehydrated
from its fresh state and that has not been subjected to any further processing
other than cleaning, grading, or size reduction (e.g., cutting or powdering).
§
“Dietary
supplement” has the same meaning as described in 21 U.S.C. 321 (ff).
For purposes of this guidance a dietary supplement is a product in finished
form ready for consumer use.
§
“Herbal
supplement” means 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” means 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 various 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. pilular, 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 Salmonella spp. or E. coli,
failure to detect a microorganism may be reported as “absent,” “not detected,”
“negative,” or “less than” the detection limit.
§
For
dried, unprocessed herbs for use as ingredients in dietary supplements, the
above quantitative limits may be exceeded in either of the following circumstances:
§
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.
§
When
acceptable techniques, such as steam sterilization, will be employed in subsequent
processing to eliminate pathogens. However, such treatment is not acceptable
if the untreated materials are spoiled prior to such treatment.
§
For
dietary supplements 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
containing other dietary ingredients (such as vitamins and minerals) and excipients.
Standardized Information on Dietary Ingredients
(SIDI)
(adopted July 2007)
AHPA
recommends that its members who buy and sell dietary ingredients use the
Standardized Information on Dietary Ingredients (SIDI) protocol as a standard
reporting form for providing information about these ingredients.
[Note: Click Here for more information 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 (GMO)1 as a tool in
agriculture is viewed by its proponents as providing the potential to meet
basic global food needs and deliver a wide range of health, environmental 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 ingredients 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 reasoning and also supports positions that favor a
sustainable approach to environmental issues and a responsible approach to
health issues related to commerce 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
encourages companies that grow, process, manufacture, market or sell herbal
products to refrain from using herbal raw agricultural products that are
cultivated with GMO technologies, 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 agricultural products knowingly and intentionally cultivated with GMO
technologies, or extracts and natural flavors thereof, in a manner that assures
that consumers are informed that the ingredient was cultivated with GMO
technology;
EXCEPT
THAT nothing in this policy is meant to comment on research
regarding GMO technology; and that nothing in this policy is meant to comment
on minimal and/or unintentional mixing of GMO and non-GMO crops; and that this
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.
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://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/ucm059098.htm,
last accessed on January 20, 2010).
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 flavor” 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 March 2006)
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 AHPA for additional
information regarding relevant analytical methods.
Article of Trade Adulterant
1. Eleuthero root (Eleutherococcus senticosus) 1. Periploca
sepium root
2. Plantain leaf (Plantago lanceolata) 2. Digitalis
lanata leaf
3. Skullcap herb (Scutellaria lateriflora) 3. Germander herb (Teucrium chamaedrys)
4. Stephania root (Stephania tetrandra)a 4. Aristolochia
fangchi root (guang fang ji)
5. Asian species of Cocculus, 5. Aristolochia
fangchi root (guang fang ji)
Diploclisia,
Menispermum and
Sinomenium root
6. Asian species of Akebia and Clematis stem 6. Aristolochia manshuriensis stem (guan mu tong)
7. Costus root (Saussurea costusb) 7. Aristolochia
debilis root (qing mu xiang)
8. Vladimiria
souliei root 8. Aristolochia
debilis root (qing mu xiang)
9. Black cohosh root/rhizome(Actaea racemosac) 9. Chinese
cimicifuga root/rhizomed (Actaea
spp.)
10. Ginkgo (Ginkgo
biloba) leaf extract 10. Ginkgo (Ginkgo
biloba) leaf extract with added
standardized to flavonol glycosides flavonol glycosides
or aglycones (e.g., rutin,
and terpenes quercetin,
etc.)
a. For a complete list of species that FDA has identified
as potentially adulterated with Aristolochia
spp. see
http://www.fda.gov/Food/DietarySupplements/Alerts/ucm095283.htm
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. heracleifolia, syn. C.
heracleifolia; and possibly other Asian species of Actaea.
Disclosure of herb use to healthcare providers (adopted October 2001)
AHPA recommends that consumers of
herbal supplements inform their healthcare provider(s) of such use. In the
interest of seeing this recommendation broadly accepted by consumers, AHPA encourages healthcare providers to receive such
communication with respect for the consumers’ healthcare choices. In addition, AHPA encourages healthcare providers to seek out
accurate and truthful information about herbs.
Product Labeling for St.
John's Wort (Hypericum perforatum) (adopted
July 2000)
AHPA recommends 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
drug(s) without the advice of your prescribing physician. Avoid excessive
exposure to UV irradiation (e.g., sunlight; tanning) when using this product.
Retail Labeling of Dietary Supplements
Containing Soft or Powdered Botanical Extracts (adopted
July 2000)
AHPA recommends 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
§
Extract
ratios. Listing
of the extract ratio of a soft or powdered botanical extract is not a mandatory
labeling requirement for retail products. There are differing opinions 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 number 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 extracts 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 extract manufacturer must correspond to the
actual variability that occurs from batch to batch of extract. 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") or "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 vary by
more than ± 20% from the stated average; and (b) The fact that the labeled value
represents the average of a range 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).
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.