where a herb is present in a concentrated form (extract, tincture), the specifications must be provided in the following manner:. the form used, as identified in the submission, (eg., powdered extract, liquid extract, powdered leaf, tincture.). the part of the plant in the product, as identified in the submission, (eg.,leaf, root, stem.). the reputed pharmacological action(s)/ therapeutic uses for the part of the plant used, as identified in the submission, (eg., leaf, root), and. photocopies of two herbal references (Appendix IV) are included with the title page (title, year, authorship, place of publication) and monograph indicating:. a herbal evaluation form, completed according to the instructions given in Appendix III, is appended to the submission:. herbal non-medicinal ingredients, that are identified as being unacceptable, are not included (Appendix II):. Information in the submission must support compliance as follows: A drug submission for a product intended for oral use and containing herbal non-medicinal ingredient(s) may be accepted for review if compliance with the policy, and with other requirements, is confirmed. 
In the case of two or more like-acting herbs, the pharmacological effects are considered to be additive and their combined activity must not exceed 10% for the same pharmacological action, based on the lowest documented therapeutic daily dose for each ingredient concerned.The amount of a non-medicinal ingredient of botanical origin contained in the daily dose must not exceed 10% of the lowest therapeutic daily dose documented in traditional herbal literature.
Note that this list is intended as a guide only and is not necessarily all inclusive. Some herbs that are considered unacceptable in this regard are identified in Appendix II. Only those ingredients of botanical origin that present negligible risk may be considered acceptable as non-medicinal ingredients in nonprescription drug products for oral use.
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