proposed amendment to the food and drug regulations notice of intent project no. 1577 schedule f the purpose of this notice of intent noi is to provide an opportunity for comment on the proposal to amend the current listings in parts i and ii of schedule f to the food and drug regulations by removing the listings for four medicinal ingredients thus allowing them to have non-prescription status. since the coming into force of the natural health products regulations in 2004 all naturally sourced substances meeting the definition of a natural health product are governed by these regulations. however products containing substances listed in schedule f to the food and drug regulations are explicitly excluded from the natural health products regulations. health canada has undertaken a review of the naturally sourced medicinal ingredients listed in schedule f. as part of this undertaking the departments drug schedule status committee the committee has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these medicinal ingredients could be regulated in whole or in part as non-prescription natural health products under the natural health products regulations. health canada is proposing that the following four medicinal ingredients be removed from schedule f to the food and drug regulations as none of the factors for listing in schedule f were found to apply. this would mean that products containing these medicinal ingredients would not require a prescription to be sold in canada and that manufacturers could apply for market authorization for these medicinal ingredients as natural health products pursuant to the natural health product regulations. description of the medicinal ingredients apiol oil of apiol oil is found in the essential oils of parsley seed dill seed and to a lesser extent in fennel seed sassafras root bark and other plant species. apiol oil is currently regulated as a prescription drug although there are presently no known marketed prescription products that contain apiol oil. a review of the available scientific literature indicates that there is a wide margin of safety between the therapeutic and toxic doses of apiol oil. it has toxic effects in humans exposed to doses of approximately 1 g day however the common presence of apiol oil in foods indicates a lack of toxicity at doses likely to be found in herbal medicines. no health hazards or side effects are known in conjunction with appropriate therapeutic dosages of parsley seed whose medicinal properties are largely attributed to the apiol volatile oil content and there are no reports of serious health risks associated with normal dietary ingestion or recommended medicinal use of parsley seed. centella asiatica extract and active principles thereof centella asiatica extract is derived from a small plant commonly known as gotukola. centella asiatica extract is a concentrated preparation. an active principle is the part of the drug upon which the therapeutic action of the drug depends. centella asiatica extract and active principles thereof have prescription status in canada although there are presently no known marketed prescription products that contain centella asiatica extract and active principles thereof. centella asiatica crude herb does not have prescription status and is regulated as a natural health product. it is also available as a vegetable in south asian markets. a review of the available scientific literature indicates that there is a wide margin of safety between the therapeutic and toxic doses of centella asiatica extract. centella asiatica extract and active principles thereof pose a low risk of undesirable or severe side effects. there is a very low percentage of adverse reactions compared to its length and frequency of use both in food and medicine. deanol and its salts and derivatives deanol also known as dimethylaminoethanol or dmae is a naturally sourced chemical found in salmon roe shellfish and fish oils. deanol and its salts and derivatives have prescription status in canada although there are presently no known marketed prescription products containing deanol. deanol is a precursor to choline a chemical in the body used to make acetylcholine a chemical that is found in the brain and other areas of the body. a review of the available scientific literature indicates that deanol does not have a narrow margin of safety between the therapeutic and toxic doses. theobromine and its salts theobromine is a naturally occurring chemical substance that is found in cocoa and chocolate and is also prepared synthetically for commercial purposes. theobromine and its salts have prescription status in canada although there are presently no known marketed prescription products that contain theobromine. theobromine affects humans similarly to caffeine but to a lesser degree. toxicity from the use of theobromine is very rare and is only seen at very high doses in humans therefore it does not possess a high level of risk relative to expected benefits. as well theobromine has no known severe side effects at normal therapeutic dosage levels. due to theobromines low potency as a drug and the availability of more effective treatments it is rarely used therapeutically anymore. schedule f is a list of medicinal ingredients the sale of which is controlled under sections c.01.041 to c.01.049 of the food and drug regulations. part i of schedule f lists ingredients that require a prescription for human use and for veterinary use. part ii of schedule f lists ingredients that require a prescription for human use but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.