1. Too often we will opt to eat a meal that is full in taste but far from nutritious; instead of it being beneficial to our health it is, in fact, the opposite. Although we have a far greater knowledge of our bodies and what they need to keep healthy, it does not always follow that we use this knowledge wisely. Even though for many years now, correct nutrition has been taught in schools, it would seem that we nearly always fall prey to eating that unhealthy meal opposed to the healthy one.
2. To this end, food supplements were introduced. What this means is that some nutritional ingredients (dietary supplements), in powder or other form, are added to an otherwise less nutritious meal without too much disruption to the taste. For example, a popular supplement is whey. This is rich in nutrients, low in unhealthy fats and packed with protein, yet low in calories and carbohydrate.
3. The object of this legal analysis is to examine whether cannabis/hemp powder could be also considered a dietary supplement for the purposes of the Dietary Supplements Regulations 1985 and a commercial product for someone to develop in NZ? or is it a medicine and subject to the Medicines Act 1981?
What is the nutritional value of cannabis?
4. 1 The cannabis/hemp plants are not uniform in their nutritious value as different strains contain different ratios of nutrients and cannabinoids. Apart from its other fibrous and nutritional benefits, it is the only known plant in the world to provide supplementary cannabinoids that our body requires for the health of the human endocannabinoid system. In fact, the cannabis plant is now considered to be very nutritious; second only in nutritional value to the soy plant. Its nutrients are vast and varied from the many different stages of growth – from root to seed to leaf, stalk and flower, containing essential fatty acids, proteins, vitamins, calcium and other beneficial ingredients. It does also usually contain, though, THC. It is THC in cannabis that gives it its ability to give a high, create hallucinations, cause disorientation and/or promote misperception. Research and development in cultivation techniques, though, have now made it possible to reduce and even eliminate the THC content in a crop if desired.
So now, not only is it possible to produce a cannabis product rich in nutrients, yet devoid of THC, it is also possible to make it in several forms such as oil or powder, each with their own unique benefits.
4.2 An excellent and detailed chemical analysis of the 66 cannabinoids and other nutrients contained in cannabis can be found in Chemistry and Analysis of Cannabis Constituents by Rudolf Breneisen, from Forensic Science and Medicine: Marijuana and the Cannabinoids Edited by: M. A. ElSohly © Humana Press Inc., Totowa, New Jersey.
4.3 The seeds are known to be the most nutritious part of the plant. 30–35% of the weight of hempseed is oil containing 80% of the unsaturated essential fatty acids (EFAs), linoleic acid (LA, 55%) and linolenic acid (ALA, 21–25%). These are not manufactured by the body and must be supplied by food. The proportions of linoleic acid and linolenic acid in hempseed oil are perfectly balanced to meet human requirements for EFAs, including gamma-linoleic acid (GLA). Unlike flax oil and others, hempseed oil can be used continuously without developing a deficiency or other imbalance of EFAs.
4.4 Hemp also contains 31% complete and highly-digestible protein, 1/3 as edestin protein and 2/3 as albumin protein. This protein profile is second only to raw uncooked soybeans (35% vs. 31%), and the amino acid profile is superior to soybean, human milk, and cow’s milk, and similar to egg whites.
4.5 The ALA contained in plant seed oils by itself is sufficient for nutrition, as your body is capable of converting it into other fatty acids. Cannabis is said to have the perfect ratio of omega 3, 6, and 9 fatty acids for conversion to the human body’s best needs and health.
4.6 The typical nutritional analysis of shelled hempseed is as follows:
Calories/100 g 567
Protein (Nx5.46) 30.6%
Saturated fat 5.2%
Monounsaturated fat 5.8%
Polyunsaturated fat 36.2%
Oleic 18:1 (Omega-9) 5.8%
Linoleic 18:2 (Omega-6) 27.56%
Linolenic 18:3 (Omega-3) 8.68%
Total dietary fiber 6.0%
Vitamin A (B-Carotene) 4 IU/100 g
Thiamine (Vit B1) 1.38 mg/100 g
Riboflavin (Vit B2) 0.33 mg/100 g
Vitamin B6 0.12 mg/100 g
Vitamin C 1.0 mg/100 g
Vitamin D 2277.5 IU/100 g
Vitamin E (dl-A-Tocopherol) 8.96 IU/100 g
Sodium 9.0 mg/100 g
Calcium 74.0 mg/100 g
Iron 4.7 mg/100 g
4.7 Expressed in terms of a 30 gram Serving (2 scoops) %RDA a typical nutritional analysis would be:
Protein 14g 30%
Total Fat 4g 6%
Omega 6(2% GLA) 2.6g
Omega 3 0.8g
Cholesterol 0g 0%
Saturated 0.5g 3%
Monounsaturated 5.0g 15%
Polyunsaturated 3.4g 85%
Carbohydrates 8g 2%
Sugar 1g <1%
Dietery Fibre 5g 20%
Vitamin A <1%
Vitamin C 1.5%
Vitamin E 33%
Vitamin B6 12%
4.8 Thus, cannabis/hemp contain the vitamin and nutrient levels to come within the requirements of it being a dietary supplement under the Dietary Regulations. More than this, Cannabis/Hemp is high in carbohydrates and fiber, both of which assist in the control of blood sugars resulting in that “fuller” feeling and, most importantly, cannabis/hemp contains at least 66 cannabinoids and is the only known plant in the world to do so.
4.9 It is for this reason that if cannabis/hemp could be considered a legal “dietary supplement”, it would be the only product of its type to not only provide vitamins and minerals but other compounds necessary for human health and the endocannabinoid system.
What is dietary supplement in law?
5.1 Dietary supplements are controlled under the Dietary Supplement Regulations 1985 ( hereafter called the Dietary Regulations) which have themselves been issued under the Food Act 1981.
5.2 Regulation 2A of the Dietary Regulations defines a dietary supplement as follows:
2A Meaning of dietary supplement
(1) In these regulations, dietary supplement means something to which subclauses (2) to (6) apply.
(2) It is an amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin.
(3) It is sold by itself or in a mixture.
(4) It is sold in a controlled dosage form as a liquid, powder, or tablet (which might be described on the label as a cachet, capsule, lozenge, or pastille instead of as a tablet).
(5) It is intended to be ingested orally.
(6) It is intended to supplement the amount of the amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin normally derived from food.
5.3 So, in practical terms, a dietary supplement is an edible substance, in a controlled dosage form, which is intended to supplement the intake of substances normally derived from food.
5.4 Section 3 of the Dietary Regulations sets out the maximum dosage any dietary supplement can contain of any of the vitamins and minerals listed.
5.5 Section 18 and Section 19 of the Dietary Regulations list what are considered vitamins and minerals respectively for the purpose of any dietary supplement.
5.6 Since the nutritional analysis is in accordance with the required vitamins and minerals listed in order to become a dietary supplement, and complies with the maximum dosages naturally, it would be possible to manufacture cannabis/hemp, perhaps in to a powdered form, and sell it as a dietary supplement.
5.7 Looking good so far but there is a marketing hitch: A product marketed as a dietary supplement may not be promoted with a therapeutic claim.
What is a “Therapeutic Claim?”
6.1 Section 11 of the Dietary Regulations provides:
11. Therapeutic claims
(1) Except as permitted by the Medicines Act 1981 and any regulations made under that Act, no dietary supplement or package or container containing a dietary supplement shall be advertised or labelled with a statement relating to any of the following matters:
(a) treating or preventing disease:
(b) diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition:
(c) altering the shape, structure, size, or weight of the human body:
(d) otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way.
6.2 A product is considered to be intended for a therapeutic purpose if a therapeutic claim is stated or implied in the product labelling or promotional material, or where an active ingredient clearly has a pharmacological action.
6.3 A statement that a product is intended to give relief from a disease or symptoms associated with a disease is likely to be a therapeutic claim.
6.4 A statement relating to the normal nutritional, biochemical or physiological function of a substance is unlikely to be therapeutic claim*.
6.5 Dietary Supplements can be sold through any retail outlet.
6.6 Dietary supplements do not require any form of formal consent from any regulatory body, but composition, labelling and advertising rules as specified in the Fietary Supplements Regulations must be adhered to.
6.7 Therapeutic claims can not be made but wellness claims can. Since cannabinoids make you well and do not alter any natural functioning in the body (that is what happens without cannabinoids) I see the Dietary Supplement as the way forward subject to the requirement in the Medicines Act for any “related product” to not include a medicine..
6.8 Since the composition reference must be made to other legislation such as the Medicines legislation, to ensure the product is suitable as a Dietary Supplement, the fact that its composition includes CBD – a medicine listed under the Medicines Regulations – makes its being sold as a Dietary Supplement only, and so without need for regulation, doubtful.
6.9 The Dietary Supplements Regulations are said to be being replaced in 2014 by the Natural Health Products Act. Let us hope that cannabis with its CBDs are recognised under this Act as a nutritional necessity and can be sold as a natural health product.
6.10 Companies wishing to make therapeutic claims for dietary supplements must apply for consent to distribute the product as a medicine or related product under the Medicines Act 1981 (the Act).
What is a Medicine?
7.1 The terms medicine, new medicine and prescription medicine are defined under section 3 of the Medicines Act 1981 ( hereafter called the Act).
7.2 A medicine is essentially a substance or article which is manufactured, imported, sold or supplied wholly or principally for a therapeutic purpose or in accordance with a standing order. The term can include an ingredient used in the preparation of any therapeutic product. Except in the case of certain specified exemptions contained in sections 25 to 34 of the Act, the consent of the Minister of Health is required before a new medicine can be distributed in New Zealand.
7.2.1 A standing order includes a written instruction issued by a practitioner or registered midwife, in accordance with any applicable regulations, authorising any specified class of persons engaged in the delivery of health services to supply and administer any specified class or description of prescription medicines or controlled drugs to any specified class of persons, in circumstances specified in the instruction, without a prescription, where “practitioner” means a medical practitioner or a dentist and “medical practitioner” means a health practitioner who is registered with the Medical Council of New Zealand as a practitioner of the profession of medicine.
7.3 A new medicine is a medicine for which the Minister of Health has not yet given consent to distribute. New medicines also include products which are referred to the Minister under section 24 (5) of the Act and any medicine which has not been “generally available” in New Zealand during the preceding 5 years. The term excludes medicines that were generally available before the commencement of the Act. A product is a new medicine if additional active ingredients are added to an existing medicine or if active ingredients within an existing medicine are replaced.
7.4 A prescription medicine is a medicine that is declared by regulations made under the Act and sold by retail, or circumstances corresponding to retail, under a prescription given by a practitioner or designated prescriber.
7.4.1 A designated prescriber means a person who belongs to a class of registered health professionals authorised by regulations made under the Act to prescribe any specified class or description of prescription medicines and satisfies any applicable requirement relating to competency, qualifications, or training specified in or imposed under regulations made under the Act.
7.4.2 A registered health professional means a health practitioner who is registered with an authority established or continued by the Health Practitioners Competence Assurance Act 2003 as a practitioner of a particular health profession (see sections 179 to 189 for the Acts under which such persons must be registered).
7.5 If a product is administered to humans and contains a substance that exerts a therapeutic effect, that product is considered to be a medicine, irrespective of whether therapeutic claims are made on the label or in advertising material. For example, a product containing a hormone is a medicine, regardless of the purpose for which it is being promoted. In addition, any substance included in the Schedule 1 to the Medicines Regulations 1984 (hereafter called the Regulations) is a medicine when used for a therapeutic purpose.
7.6 The term therapeutic purpose is defined under section 4 of the Act. It includes treatment, prevention and diagnosis of disease, alteration of the shape, structure, size or weight of the human body and otherwise prevention or interference with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way.
7.7 A product is considered to be intended for a therapeutic purpose if a therapeutic claim is stated or implied in the product labelling or promotional material, or where an active ingredient clearly has a pharmacological action.
7.7.1 A statement that a product is intended to give relief from a disease or symptoms associated with a disease is likely to be a therapeutic claim.
7.7.2 A statement relating to the normal nutritional, biochemical or physiological function of a substance is unlikely to be therapeutic claim.
7.7.3 Paragraph 1.10 of The New Zealand Regulatory Guidelines for Medicines provide guidance on the interpretation of therapeutic purpose and the sorts of claims that may be made for certain types of product.
7.8 Both Cannabidiol (CBD) and Tetrahydrocannabinol (THC) are listed at numbers 295 and 1721 respectively as prescription medicines under Part 1, Schedule 1 of the Medicines Regulations 1984 (hereafter called the Regulations). Cannabis comprises over sixty cannabinoids (CBD) and tetrahydocannabinoid (THC) and may be considered a prescription medicine. Indeed, prescriptions for cannabis and cannabis-related products have indeed already been known to have been issued by registered health professionals in at least one case.
7.9 However, it is important to note that:-
(a) although Schedule 1 is a useful guide to determining whether or not a product is considered to be a medicine, that listing of a particular medicine in Schedule 1 does not necessarily mean that it is currently approved for distribution in New Zealand but, rather, that it would be classified as indicated if it were approved for distribution. (Unapproved medicines are discussed further at paragraph 8 below.); and
(b) that Section 109(4) of the Act states that where a product is controlled under both the Act and the Misuse of Drugs Act 1975, the Misuse of Drugs legislation takes precedence in the event of any inconsistency.
7.9.1 This is relevant insofar as any vendor supplying cannabis from within New Zealand would require a license to do so under section 14 of the Misuse of Drugs Act 1975 and its Regulations. Were it not for section 109(4) of the Act, but subject to section 29 of the Act regarding unapproved medicines (see paragraph 8 below), a license would not necessarily have been required if an exception for a license were permitted to pharmacists under section 26 of the Act.
7.9.2 In addition, any prescription requiring the medicine prescribed to be imported is limited to one month’s supply in accordance with section 8(l) of the Misuse of Drugs Act. This limited period of one month is also consistent with importing laws where a controlled drug may be imported with a prescription without the need for an importing license.
7.10 Thus any cannabis and cannabis-related products, because they would contain CBD and so regardless of any therapeutic claims actually made, would come within the scope of their having a therapeutic purpose as defined under the Act and would be considered a medicine under the Act and Regulations. Whether cannabis comes within the exclusion of being defined as a new medicine under the Act very much depends on whether cannabis was used as a medicine that was generally available in the preceding 5 years or before the commencement of the Act.
7.10.1 A brief search in to the history of medicinal cannabis in New Zealand confirms that cannabis use in New Zealand dates back to the end of the nineteenth century, when it was both inexpensive and widely available. Known then as “Indian hemp”, and not classed as a poison or subject to customs duties, the leaf and resin were commonly used by doctors, nurses and midwives, and often included in drug companies’ products (Yska 1990). In the 1900s hemp-seed oil was a common ingredient in imported patent medicines, being prescribed for ailments such as gastric illnesses, rheumatism, headaches, and menstrual cramps. However, by World War I hemp was increasingly associated with opium and crime and in response to a growing international clamour for legislative curbs on use, cannabis sale and use was made illegal under the Dangerous Drugs Act 1927. Use then virtually disappeared until the drug’s revival in the 1950s and 1960s, reflecting increased cannabis use in other countries, and changing social norms. Whether cannabis was used as a medicine or for recreational purposes during this period however is difficult to determine and it is arguable that the two purposes are not necessarily mutually exclusive in any event. What can be agreed is that cannabis was certainly generally available prior to the commencement of the Misuse of Drugs Act 1975 but it is debatable whether it was generally available as a medicine (in terms of the Act).
7.10.2 The Medsafe Regulatory Guidelines provide assistance here:
“Evidence that a medicine has been generally available
An applicant wishing to show that a product is not a new medicine because it has been “generally available” must support that claim by providing:
evidence of one or more sales during the relevant period (e.g. invoice); or
evidence of importation (e.g. customs clearance form); or
evidence of listing in a sales catalogue or price list from the relevant period; or
a statement identifying regulatory activity for the product; such as a CMN.
The claim must be supported by a declaration from a person in New Zealand that the evidence is genuine, and that any documents provided are true copies of the original documents. The original documents must be made available on request.”
7.10.3 It is possible that GreenCross members and others could support one another in this if they have evidence of importation of cannabis oil or other cannabis products prescribed by their doctors and imported. There is one GC member who has published his cannabis prescriptions on fb already and stated that they were imported. It is possible that he could also share his customs clearance form and/or invoice also for the benefit of others. The result of this co-operation is that others would not need to seek Ministerial approval as a new medicine for their doctors’ same prescriptions.
7.11 Except as provided above or under the Exemption provisions contained in sections 25, 26(4), 28, 30, 31, and 32, distribution or sale of any new medicine requires the Minister’s approval under section 20 of the Act and in any proceedings for an offence against subsection 20(4) in which it is alleged that this section applies to a medicine by reason of subsection 20(1), it shall be presumed that the medicine is a medicine to which section 20 applies until the contrary is proved as stated above.
7.12.1 Section 25 Exemption for Practitioners
Section 25 of the Act is the exemption provision that I consider is most reliable as an exemption for a patient obtaining cannabis as a prescription medicine from his/her doctor but it is not the only provision that could be relied upon.
There is the ability to receive a standing order from the patient’s doctor (see paragraph 7.2.1 above) and there is also section 29 of the Act, regarding “unapproved medicines”, (see paragraph 8 below).
Section 25 of the Act is not mentioned in the Medsafe Regulatory Guidelines and this may be significant.
7.12.2 Section 25 of the Act reads as follows:
25 Exemptions for practitioners and others
(1) An authorised prescriber may—
(a) manufacture, pack, and label a medicine that is specially prepared for, or intended for administration to, a particular patient of that authorised prescriber:
(b) sell or supply, or procure the sale or supply of, any medicine to any such patient or to a person who has the care of the patient:
(c) administer, or procure the administration of, any medicine to any such patient:
(d) at the request of another authorised prescriber, pack, and label a medicine that is specially prepared for, or intended for administration to, a particular patient of that other authorised prescriber:
(e) at the request of another authorised prescriber, sell or supply a medicine to that other authorised prescriber, or to a person who has the care of the patient:
(f) at the request of another authorised prescriber, administer a medicine to a particular patient of that other authorised prescriber.
(2) Despite subsection (1), in relation to any new medicine the distribution of which is prohibited under section 20,—
(a) paragraphs (a) and (d) of subsection (1) do not apply:
(b) paragraphs (b), (c), (e), and (f) of that subsection apply only for the purpose of enabling the medicine to be administered to a particular patient who is known and identifiable at the time when the medicine is sold or supplied to the authorised prescriber.
(3) Subsection (1) applies despite sections 17 to 24, but is subject to the other provisions of this Act and any regulations made under this Act.
Subsection 25(1)(b) is the relevant subsection here. It avoids the need for consent by the Minister of Health for any new medicine PROVIDED THAT the medicine is sold, supplied or procured by the authorised prescriber/medical practitioner to his/her patient or the person who has the care of the patient.
8.1 An “unapproved medicine” is a medicine for which full or provisional consent for distribution has not been granted.
8.2 A general exemption from the consent provisions for new and changed medicines is provided in Section 29 of the Act, permitting the supply of any medicine (including an unapproved medicine) to a medical practitioner at his/her request, to treat a particular patient under his/her care. The supply must be initiated by the medical practitioner and the supplier may not advertise the availability of the medicine.
8.3 It should be noted that this exemption is not affected by the power of the Minister of Health under section 48 of the Act to prohibit any specified practitioner, veterinarian, registered midwife, or designated prescriber from prescribing prescription medicines or any particular class or description of prescription medicines (including an unapproved medicine),
(a) in the case of a medical practitioner, except on the recommendation of the Medical Council of New Zealand; or
(b) in the case of a dentist, except on the recommendation of the Dental Council of New Zealand; or
(c) in the case of a pharmacist, except on the recommendation of the Pharmacy Council; or
(d) in the case of a registered midwife or a nurse, except on the recommendation of the Midwifery Council or the Nursing Council of New Zealand; or
(e) in the case of a veterinarian, except on the recommendation of the Veterinary Council of New Zealand; or
(f) in the case of any designated prescriber to whom paragraphs (c) and (d) do not apply, except on the recommendation of the authority under the Health Practitioners Competence Assurance Act 2003, specified in regulations made under this Act, which has jurisdiction in respect of the class of registered health professional to which the designated prescriber belongs.
8.4 There is, however, under section 37 of the Act, a power to the Minister of Health to prohibit import, manufacture, packing, sale, possession, supply, administration, or other use of medicines of any specified description either absolutely or subject to such conditions as he thinks fit, for any specified period not exceeding 1 year; but he shall not exercise this power more than once in respect of medicines so specified and shall, on the written request of any person, state his reasons for doing so. Any power is subject to administrative review by the Courts.
8.5 Medsafe’s web site lists unapproved medicines reported to Medsafe as being supplied in New Zealand, and includes further information about the responsibilities of the supplier and the medical practitioner and the rights of the patient involved in the supply of an unapproved medicine under the provisions of Section 29.8.6 The supplier (i.e. the New Zealand importer or manufacturer) must have a licence issued under the Act or the Misuse of Drugs Act 1975 which allows the supply of the medicine, or be exempt from this requirement under Section 26, and must also maintain complete and accurate records of the information listed below. The records must be stored in a secure and confidential manner in the supplier’s New Zealand office and be available for audit by Medsafe if required.
The information to be recorded and stored is:
name(s) of the medical practitioner(s) who requested supply of the medicine
name(s) of the patient(s) the medicine was required for
dose form(s) and strength(s) of the medicine supplied
date(s) on which the medicine was supplied
name(s) of the place(s) the medicine was supplied to.
Suppliers of unapproved medicines must also notify:
PO Box 5013,
as soon as practicable after the end of every month in which the medicine has been supplied, of the following:
international non-proprietary name (INN) of the medicine
trade name of the medicine pharmaceutical form
month and year of supply
The form for reporting to Medsafe the supply of unapproved medicines is provided here (Part E, Section 1.6 of the Medsafe Regulatory Guidelines).
* Paragraph 1.10 of The New Zealand Regulatory Guidelines for Medicines provide guidance on the interpretation of therapeutic purpose and the sorts of claims that may be made for certain types of product.
What is a Related Product?
9.1 A related product is a product that is primarily a food, dentifrice or cosmetic, but has a secondary therapeutic use.
9.2 This term is defined in Section 94 of the Act as follows:
94 (1) In this Part, unless the context otherwise requires, the term related product means any cosmetic or dentifrice or food in respect of which a claim is made that the substance or article is effective for a therapeutic purpose; but does not include—
(a) any medicine:
(b) any substance or article of a kind or belonging to a class that is declared by regulations made under this Act to be a kind or class of substance or article that is not a related product for the purposes of this Act.
(2) In this Part, unless the context otherwise requires, the term new related product means a related product that—
(a) is not identical with any related product that could have been sold lawfully immediately before the commencement of this Part for the same therapeutic purpose as that claimed in respect of the new product; or
(b) is of a kind that has been referred to the Minister under section 24(5) (as applied to related products by section 96(3).
9.3 This means that if the cannabis dietary supplement was described to have a therapeutic purpose, it would either become a medicine or a related product under the Act; and the consent of the Minister is required under section 20 of the Act before a new medicine or a related product can legally be distributed in New Zealand.
10.1 Cannabis/Hemp could be manufactured in NZ without regulation as a dietary supplement provided that no therapeutic claim were made.
10.2 Whether or not a therapeutic claim is made, however, because one of the constituent ingredients of the dietary supplement is CBD and this is listed as a medicine under Part 1, Schedule 1 of the Act, however, the dietary supplement would be considered a medicine and regulated by the Ministry of Health in accordance with the Medicines and Misuse of Drugs legislation.
10.3 As these products would be articles of commerce, they also need to comply with any other relevant consumer legislation (e.g.the Fair Trading Act 1986) administered by the Ministry of Economic Development.
10.4 Consent from the Minister of Health under section 20 of the Act is generally required for any new medicine. It would not be required under section 25 if the medicine were prescribed, supplied, sold or procured by a medical practitioner under the exemption provisions of section 25 or was supplied by a standing order or was an unapproved medicine and came within the exemption provisions of section 29 of the Act.