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ACVM Group FAQs on: homeopathic preparations

Dec 2004

Disclaimer:
This publication is intended only as a guide.
It is not a legal interpretation of the legislation discussed.

The questions and answers below, which relate to homeopathic preparations, should be easier to understand if you read this background information first.

Background

The purpose of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 is to:

a. prevent or manage risks associated with the use of agricultural compounds –

• risks to trade in primary produce

• risks to animal welfare

• risks to agricultural security;

b. ensure that the use of agricultural compounds does not result in breaches of domestic food residue standards;

c. ensure the provision of sufficient consumer information about agricultural compounds.

ACVM products must be registered or exempted from registration, depending on the risks they pose. Schedule 2 of the ACVM Regulations 2001 (products exempt from registration) lists preparations “prepared by a process of solution, extraction, or titration of an active ingredient followed by strictly regimented serial dilution” as exempt from registration. However, the preparation must comply with certain conditions:

• it does not claim to prevent, control, or cure a specific disease characterised by pain or distress in animals

• it is identified as a homeopathic preparation

• it includes a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice, and

• it must meet the information requirements listed in Schedule 6 of the Regulations.

1. Is the definition of preparation given in Schedule 2 intended to be a definition of a homeopathic preparation?

Yes, it is intended to be a general description of a homeopathic preparation.

2. In the ACVM Regulations, what does ‘prepared’ mean?

The ACVM Group interprets ‘prepared’ to mean the standard dictionary definition: to make by a regular process, to manufacture. In the context of homeopathic preparations, ‘prepared’ requires strict adherence to homeopathic protocols for compounding.

3. Are preparations that are labelled ‘homeopathic’ but contain some non-homeopathic components exempt from registration?

No. Such preparations no longer meet the definition in the ACVM Regulations and are not exempt.

4. If written material provided with a product mentions a specific disease, is the product still exempt from registration?

No. If material provided specifically mentions a disease to be treated or obviously implies that it can be used to treat a specific disease characterised by pain or distress, the product is no longer exempt from registration.

Sometimes the wording is ambiguous, and the ACVM Group offers (at a cost) a discretionary ‘class determination’ service that will confirm the status of a particular product. The ACVM Group’s consideration for claims about a specific product includes the packaging, any material supplied with the product (all considered part of the ‘label’), and information provided on websites that are under the control of the proprietor of the product.

Information requirements needed for the ACVM Group to undertake this activity and information to assist undertaking your own class determination are available on the ACVM website (http://www.nzfsa.govt.nz/acvm/subject/registration/index.htm).

5. Is there a list of diseases you consider characterised by pain and distress? Some ‘diseases’, such as mastitis, may be present but not manifesting in pain and distress.

The ACVM Group has worked with the Animal Welfare Group in the Ministry of Agriculture and Forestry to agree the thresholds for our animal welfare concern. The information is in the document Guidelines for Risk Assessment and Hazard Analysis under the ACVM Act 1997. It is available on the website (http://www.nzfsa.govt.nz/acvm/publications/standards-guidelines/index.htm).

6. What restrictions apply to making a preparation of material collected from an individual diseased animal and processed according to the directions found in official homeopathic pharmacopoeia?

The ACVM Regulations do not restrict the material that homeopathic veterinary medicine preparations can be made from, but products must be prepared in strict accordance with homeopathic protocols.

7. Does the ACVM legislation give the power to restrict the sale of books telling how to use homeopathic medicines to treat animals?

The ACVM Act regulates homeopathic veterinary medicine preparations; it does not regulate the transfer of information about homeopathic therapy in general. Therefore, books that are not (or could not be interpreted as) advertising for specific homeopathic veterinary medicine preparations are not regulated under the ACVM Act. Any material that appears to be advertisement or promotion of particular homeopathic veterinary medicine preparations is regulated and must comply with the ACVM Regulations or registration conditions.

The ACVM Group has had specific examples where books are produced by the manufacturer/distributor of products and are considered ‘associated material’. The book is used to market the products. Where books contain specific references to trade name products and the content and or publication of the book is under the control of the manufacturer, distributor or retailer of the products, we treat them as advertising. We do not prevent published literature being provided on request but treat it as advertising when provided with or used in the promotion of a product.

8. Some veterinarians prescribe homeopathic medicines for animals. What legal restrictions apply?

Because homeopathic veterinary medicine preparations that comply with exemption from registration can be sold or used by any person, there are no specific obligations imposed on veterinarians under the ACVM Act. However, prescribing of medicines for animals by veterinarians may also be regulated under other legislation, such as the Veterinarians Act 1994 and the legislation mentioned in question 9. Veterinarians are subject to relevant regulatory control under those Acts.

9. Are lay people who prescribe homeopathic medicines for animals regarded the same as veterinarians?

As above, homeopathic preparations that comply with the ACVM Regulations are ‘over-the-counter’ products that can be sold/purchased by anyone, but requirements in the Animal Welfare Act 1999, Biosecurity Act 1993 and Animal Products Act 1999 apply to any person responsible for an animal. Everyone must comply with any control on use of products on animals. Conditions that must be met relate to supply and/or use of the product. There are no restrictions on prescribing, which relates to the decision on which product should or could be used.

10. Do any restrictions apply when making homeopathic preparations for your own animals?

A person may prepare a homeopathic remedy for use on his/her own animals on his/her own land without registration (Schedule 1 of the ACVM Regulations [products exempt from registration if applicable codes of practice are complied with]). The ACVM Standard for Own Use of Agricultural Compounds is the ACVM-approved code of practice that must be complied with in conjunction with this exemption. This can be found on the ACVM website. Requirements in the legislation mentioned in question 9 also apply.

11. Is it allright to give or sell homeopathic preparations you have made for your own animals to someone else?

No. The exemption mentioned in question 10 applies only to preparations used by persons on their own animals. These are ‘compounds’ rather than trade name products, which are subject to the conditions in Schedule 2 of the ACVM Regulations regarding such things as labelling, claims and information.

12. Are homeopathic pharmacies allowed to sellremedies that may be used for both humans and animals?

Homeopathic pharmacies must sell only homeopathic preparations that comply with Regulations. Under the ACVM Regulations, there is no prohibition on the same product being sold for use on animals and humans. However, there may be other requirements related to use as a human medicine, e.g. under the Medicines Act.

13. Are pharmacies (or anyone else) permittedto make up kits of remedies for animals and sell with a name such as ‘Twenty Animal Remedies’?

There is no prohibition on kits. However, each remedy in the kit must comply with the ACVM Regulations for exemption or be registered. (See question 4 for information on ‘class determination’ service.)

14. Can a pharmacy, or an individual, give out written advice (as distinct from an advertisement) on the use of homeopathic preparations, i.e. describing symptoms for which the preparations could be prescribed, without implying their effectiveness? And would it make any difference if such information was abstracted from what are regarded in homeopathic circles as reputable textbooks?

Such advice may be given as long as it could not be considered to be advertising or promotion for a specific product. See answer to question 7.

15. Can a pharmacy, or an individual, distribute a preparation which by its name suggests it might be intended as an animal remedy? For instance:

• Hippozaenum, which is made from material collected from a horse heavily infected with Actinobacillus mallei– the causative agent in glanders; or

• Bovine Mastitis Nosode,made from cultures of bacteria implicated in bovine mastitis.

The ACVM Group would likely consider that products with this type of name are veterinary medicines and could be implied to be making a treatment claim. In this case they must be registered.

16. Are products that are homeopathic-like preparations, e.g. biodynamic products, regulated by the ACVM legislation?

Yes, they are regulated under ACVM legislation. Only if biodynamic protocols are actually consistent with homeopathic protocols can such products be considered homeopathic preparations exempt from registration. Products sold as pesticides must be registered at present but the ACVM Group is working on an amendment to the ACVM Act that would exempt homeopathic pesticides from the requirement for registration.

17. Practitioners of the biodynamic system of agriculture make homeopathic-like preparations from quartz, decomposed cow manure and the like and employ them as fertilisers. Are these regulated by the ACVM legislation?

Yes. Products sold as fertilisers must be registered or fit the criteria for exemption for fertilisers (Regulation 9).

18. Does the ACVM Group require proof that homeopathic veterinary medicine preparations work, i.e. achieve the claims made?

For a homeopathic veterinary medicine preparation to be exempt from registration, it must not make any specific treatment claims. If it does make such claims, it is not exempt and evidence must be provided to the ACVM Group to support the claims as part of the registration process (the product must be supported by all of the data requirements for a product registration including the demonstration of efficacy).

The ACVM Group requires evidence that any veterinary medicine making a claim about treating a specific disease characterised by pain or distress actually works.

Suspicions or allegations of failure to achieve the general claims that are permitted are more relevant to requirements under the Fair Trading Act. Concerns in this area would be passed on to the Commerce Commission to resolve.

What is an agricultural compound?

The ACVM Act provides the following definition: “Agricultural compound means any substance, mixture of substances, or biological compound, used or intended for use in the direct management of plants and animals, or to be applied to the land, place, or water on or in which the plants and animals are managed, for the purposes of

a. managing or eradicating pests, including vertebrate pests; or

b. maintaining, promoting, or regulating plant or animal productivity and performance or reproduction; or

c. fulfilling special nutritional requirements; or

d. the manipulation, capture, or immobilisation of animals; or

e. diagnosing the condition of animals; or

f. preventing or treating conditions of animals; or

g. enhancing the effectiveness of an agricultural compound used for the treatment of plants and animals; or

h. marking animals and includes any veterinary medicine, any substance, mixture of substances, or biological compound used for post-harvest pest control or disinfestation of raw primary produce, and any substance, mixture of substances, or biological compound declared to be an agricultural compound for the purposes of this Act by Order in Council made under subsection (2)”.

Where can I get more information?

For more information visit the ACVM Group website (www.nzfsa.govt.nz/acvm) or contact the ACVM Group directly at:

ACVM Group
New Zealand Food Safety Authority
PO Box 2835, WELLINGTON
Phone: 04 463 2550, fax: 04 463 2566

If you are interested in general ACVM information, subscribe to the ACVM Group’s free newsletter, Agvetlink, which is also available on the website.

Comments on discussion documents or any other matter related to agricultural compounds and/or veterinary medicines are always welcome.