Herbal medicinal products in the European Union - AESGP

is made. Because of the lack of patent protection and consequent lack of proprietary research
on herbal products (see point IX.3.1.), structure/function claims tend to be based on research
that is publicly available, conducted in other countries, or on a history of use. Under DSHEA,
manufacturers’ substantiation files are not required to be accessible to FDA. DSHEA does
not define how claims of nutritional support are to be substantiated. Without proposing that
the rulemaking be reopened, the President’s Commission on Dietary Supplement Labels
suggested that manufacturers’ substantiation files include the following items:
• a copy of the notification letter;
• the ingredients in the dietary supplement (including quantities and active principles
if known);
• evidence to substantiate the statements of nutritional support;
• evidence to substantiate safety;
• Good Manufacturing Practices followed; and
• qualifications of the individuals who reviewed the evidence.
FDA agreed with this guidance but has no plans for rule revisions at this time.
e ) Does your country relax the requirements for health claims or
structure/function claims with respect to certain indications, or where the
indications refer to the “traditional use” of the product?
“Indications” is a term applied to drugs and not to dietary supplements. Proof of efficacy is
not required for dietary supplements.
Health claims that have been approved by FDA in accordance with the Nutrition Labeling
and Education Act of 1990 (NLEA) are limited to a short list12 based on extensive scientific
data (on substances that would generally not be considered the active constituent i n
botanicals).
Regarding label claims, the President’s Commission on Dietary Supplement Labels
suggested that statements of nutritional support (i.e., structure/function claims) should be
backed by scientifically valid evidence. The Commission indicated that claims of
nutritional support based only on historical use should be “carefully qualified to prevent
misleading consumers.”
A history of safe use is considered valid evidence for purposes of establishing the safety of
new dietary ingredients.
f ) When assessing and reviewing herbal products, does your country now use any
of the following references? Does your country intend to use any of these
references?
• the monographs of the European Pharmacopoeia
• the monographs of the European Scientific Co-operative for Phytotherapy (ESCOP)
• the WHO Model Monographs
• the “WHO Guidelines on the Assessment of Herbal Medicines”
These references may be used to evaluate or substantiate structure/function claims for
dietary supplements. However, data from sources outside the United States may not be used to
establish OTC drug status.
g) How is the marketing of combination products containing several herbal
ingredients regulated in your country?
Combination products containing several herbal ingredients are governed by the same
regulations as all other dietary supplement products. As mentioned above under question 1.5,
12 Approved health claims for dietary supplements and conventional foods: Calcium and osteoporosis;
folate and neural tube defects; soluble fiber from whole oats and coronary heart disease; soluble
fiber from psyllium husks and coronary heart disease; and sugar alcohols and dental caries
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