‘There is a dilemma in classifying herbs and botanicals as either food or drug. In fact there is considerable overlap between the use of herbs for medicinal purposes and the use for culinary or even cosmetic purposes. Herbs and botanticals marketed without medical claims as food ot for culinary purposes" will be controlled under food legislation. Herbs and botanicals ised in cosmetic preparations will be controlled undet cosmetic regulations. Herbs and botanicals used in “Folklore Medicine” based oft the vatious ethnic traditions (Ayurvedic, Chinese, Aftican, Creole, Catibbeatt elc.) will be classified as Traditional Herbal Remedies and will not require liscensing. Herbs and botanicals will be classified as Herbal Medicines depending on the implicit and explicit claims, the pharmacological properties of the constituents, and promotional literature including testimonials. The prohibitions fot clainis with tespect to the treatment, prevention of cure of arty of the diseases, disorders or abnormal physi mentioned int the First Schedule of the Food aiid Druys Act will apply. A tegis! system appropriate for herbal medicines will be established. Herbs and botatticals should be recognised as a sepatate category to modertt drugs based on the rationale that their claims are well founded in traditional antd historical use over thousands of years, and hot on full research protocol or clinical trials or double blitid cross over studies. il states: tion ‘The framework specific for the regulation of the trade in hetbs and botanicals will eticompass the criteria detailed below. This proposal offers # challenge to the industry to develop monographs for those products and substances that ate cohsideted important in promoting optimal healthcare and continue to provide the consumer with a choice of treatment options.DRAFT REGULATIONS FOR HERBAL PRODUCTS Food and Drugs (Amendment) Regulations Part VI - Herbal Products Definitions: ¢ “Botanical Name”: means the scientific name indicating the gents and species of a herb and used according to International Rules of Botanical Nomenclature as intetpreted by the National Herbarium of Trinidad and Tobago. “Common Name”; means the name by which a herb is known in the Caribbean, China, India or Aftica or in the English, French, Creole, Patois or Spanish language. “Herb” means any plant, including algae, fungi, grasses, lichens, shrubs or trees. “Herbalist” means 4 person who prepares or supplies herbal medicines to other individuals for use in treating their diseases or disorders, in accordance with his advice. “flerbal Medicine” means any labelled medicinal products that contain as the active ingredient(s) aetial or underground parts of plant(s) in the crude state or as preparations, and includes juices, gums, fatty oils and/or essential oils. “Traditional Herbal Remedies” means a system of medical practice based on the various ethnic traditions, and uses plant material which has only been subjected to the processes of drying, crushing or comminuting with or without any subsequent process of fabelling, capsule-making, tabletting ot diluting with water but not any other. Traditional Herbal Remedies 1) Aproduct when classified as a Traditional Herbal Remedy will be exempted from the registration requirements for drugs under the Food and Drugs Act and Regulations 2) No person shall offer for sale or use a ‘Traditional Herbal Remedy that is not safe, clean, wholesome of truthfully labelled. 3) Any person who offers for sale or use a Traditional Herbal Remedy and label the contents, shall use the latin botanical name and/or the common vernacular name, aeHerbal Medicines 4) (1) No person shalll offer for sale a herbal medicine unless it complies with all the legislation with respect to drugs under the Food and Drugs Act and Regulations, 5) (a) Any person who intends to manufacture, sell of distribute a herbal medicine e shall inform the Director in writing. (b) An Inspector should verify that the premises tised comply with existing Food and Drugs legislation and nothing exists on the premises that will render the product, unsafe for use. 6) Except as provided in this Part, the label of a Herbal Medicine shall carry on the maint panel of the outer label: : (a) (i) the name of the product and dosage form Gi) Latin botanical name of plant(s) (ii) common or vernacular name of plants, if applicable (iv) quantitative list of active ingredients, if applicable (¥) acorrect statement of the net contents in tetms of weight, measure or number (vi) dosage regimen and mode of administration (vii) expiry date, fot number, name and address of manufacturer or distributor (viii) storage conditions necessary to presetve the potency efficacy, safety or properties of the product throughout the stated shelf life, in the English Janguage (ix) major adverse effects, contra-indications and warnings, if applicable (b) All herbal medicines must have the following watning oh the main panel of the outer label to alert sensitive individuals to possible untoward effects. CAUTION: “Keep out of the reach of children”. “Lf pregnant or breast feeding ask a health professional before use”, 7) Any person who offers for sale a herbal medicine that is not labelled as required by Part 6 is guilty of an offense. -8) No person shall import, sell or advertise for sale « herbal medicine unless he has been granted a notice of approval by the Minister in accordance with section 9. sion for a notice of approval of a herbal medicine shall contain in the 9) Asubs prescribed form the following: (a) the name of product under which it is proposed to the sold. (b) astatement of all ingredients, including the Latin binomial name of the plant(s) and botanicals used in the preparation. (6) the product specifications corresponding to recognised pharmacopoeial standards, and details of the tesis applied to control potency, purity and safety, if available. (@) the name and address of the manufacturer or distributor. (e) astatement of the claims made, the proposed dosage regimen and the route of administration. (f) astatement of known adverse reactions, toxicological risks, and established pharmalogical effects of the active ingredient(s), if available. (@) samples of the herbal medicine inthe finished pharmaceutical form in which it is to be sold. (1) a statement on the shelf life of the herbal medicine in the final marketing container and the storage conditions necessary to preserve the efficacy, purity and safety of the product. 10) The Minister may refuse to issue, ot may cancel or suspend a notice of approval as he ‘considers necessary, to ensure that any herbal medicine for which a notice of approval has been granted will not be unsafe for use. 7 11) No person shall import, sell or advertise for sale, a herbal medicine that is contaminated with foreign matter, and/or harmful levels of heavy metals, pesticides, radioactivity and microbial matter. 12) No person shall import, sell or adyertise for sale a herbal medicine containing constituents which are parts of the flora ard fauna on the Endangered Species List il form the Convention of International Trade in the Exotic Species (C.L.T.E.S.). % a13) No person shall import seeds for cultivation of herbs in Trinidad and ‘Tobago unless authorised to do so by the Ministry of Agriculture. 14) (@ Noperson shall prepare, manufacture, import, sll or distribute for use by other persons any herbal medicine made from # plant listed in Schedule B, except as prescribed. (b) Herbs restricted or banned from medical use in Canada, the United States of ‘America, the European Cominunity, ot by advice from the World Health Organisation would also be restricted from medical use in Trinidad and Tobago. 15) Notwithstanding section 14, (@) herbs listed in Schedule B may be prepared and used as herbal medicines in research projects approved by the Drug Advisory ‘Committee. (by herbs listed in Schedule B may be authorised for non-pharmaceutical uses by the Director. 16) Herbal medicines containing herbs listed in Schedule R must be registered according to section 9 and are considered useful and fairly safe, only if used under the supervision of a pharmacist or medical practitioner. 17) Any person who represents the therapeutic claims of «herbal medicine as being approved or etidorsed by the Division will be guilty of an offense. | 1 , |SCHEDULE B Herbs considered unsafe or otherwise unfit for human consumption. Prohibited from direct addition or use in human food. Not to be used as teas. ‘Common Name Botanical Name (Plant) “Toxic Agent/Adverse Effect ‘Aconilte ‘Acinitum napellus Toxic alkaloids (whole plant) ie Belladona Atropa belladonna Hallucinogens (whole plant) Borage Borago officinalis Hepatotoxic, carcinogenic (leaves and tops) Calamus Acorus calamus Carcinogenic (thizome, oils, extracts) ' Collsfoot Tussilago farfara Hepatotoxic, carcinogenic ! (leaves and heads of flowers) ' Comfrey Symphytum officinale Hepatotoxic, carcinogenic | (rhizome, roots and leaves) i Crotalaria Crotalaria all species Hepatotoxic (whole plant) i Datura Datura stramonium Hallucinogenic (whole plant) Duboisia Duboisia all species Hallucinogenic (whole plant) Germander Teucrium chamaedrys Hepatotoxic (leaves and roots) Gravel Root Eupatorium purpureum Hepatotoxic, carcinogenic (root) Henbane Hyoscyamas niger Hailucinogens (leaves and stems) Lantana Lantana camara Hepatotoxic (leaves, stems, flowers) Life Root Senecia aureus Hepatotoxic, genotoxic, (whole plant) carcinogenic Poke Root Phytolacca americana Mitogenic, toxic proteins (root) Ragwort Senecio all species Hepatotoxic (whole plant) Sassafras Sassafras albidum Carcinogenic safrole, genotoxic (root bark) Strophanthus Strophanthus kombe Cardioactive steroids (whole plant)SCHEDULE R Herbs that must be registered formally and are fairly safe if used under supervision. May be harmful if used incorrectly. Pharmacy only products. ‘Common Name ‘Botanical Name ‘Toxic Agent/Adverse Effect Chenopodium Chenopodium ambrosoides var | Toxic anthelminticum (leaves) Devil’s Claw Harpogophytum protecumbens | Cardiotoxic, oxytoxic, hypotensive, (root) hyperglycaemic, hypertension, diabetes & thyroid disease - unsafe for sufferers of, Ephedra Ephedra sinica Hypotensive, Heparin antagonist (green stems) . Golden Seal Hydratis condensis Gastric upset, berberine: cardioactive (root, rhizome) alkaloid, cardioactive Hawthom Crataegus oxyacanthoides _| Tytamine: cardiotonic amitie, (Geuit) hypotensive Mandrake Podophyllum pellatum Oxytoxic, photosensitisation, alkaloids, cardioactive Motherwort Leonurus cardiaca Phototoxi¢ dermatitis, (whole herb) catdiacglycoside constituents, sedative & antispasmodic properties Mugwort Artemisia vulgaris ~ Santonica Artemisia cina Savin Juniperis sabina Initant, Hypoglycaemic invivo Coil) ‘Strophantus Strophantus (all species) Squill Drimia maritima Cardiacglycoside constituents, (bulb, red & white) digitalis, irritant, cardioactive, saponins Wormwood Artemisia absynthum Yohimbe Bark Pausinystatia yohimbe