Vol. 24 No. 3 June 2004

There are a lot of rules relating to animal-and-plant-treating preparations. The body that looks after the relevant Acts and Regulations is the Agricultural Compounds and Veterinary Medicines (ACVM) Group, a division within the New Zealand Food Safety Authority. The Homœopathic Society wrote to the ACVM Group asking lots of questions on the interpretation of the Acts, Regulations, Codes, etc, that can be found on the ACVM Group’s website. Here are some of the questions and answers.I urge all people prescribing for animals to take great care not to make explicit therapeutic claims for homœopathic medicines, particularly suggesting on labels or in leaflets that such-and-such a remedy cured a specific, named condition.

Question: Homœopathic pharmacies sell remedies that may be used by both humans and animals. Is it okay for them to make up kits of remedies which may be used more especially on animals and sell with a name as, say, “Twenty Animal Remedies”?

Answer: Any product intended for use on an animal must either be registered under the ACVM Act or fit the criteria of being exempted from the requirement for registration. The ACVM Group offer a discretionary “class determination” service at a cost that will confirm the status of a particular product. Information to assist undertaking your own class determination is available on the website at http://www.nzfsa.govt.nz/acvm/subject/reqistration/index.htm, along with the information requirements should you wish the ACVM Group to undertake this activity. The ACVM Group consideration includes claims made about the products in question. If a homœopathic product makes claims about the treatment of diseases or conditions that trigger the animal welfare thresholds, it may require registration and be subject to the relevant standards.

Question: Can a pharmacy, or an individual, give out written advice (as distinct from an advertisement) on the use of such preparations? That is, describing symptoms for which they could be prescribed, without even implying their effectiveness.
It is our understanding that such advice could be considered to be making a claim associated with the specific product. Depending on what the product and associated claim were, it could attract our interest.

Answer: It may be useful to refer to the document “Guidelines for Risk Assessment and Hazard Analysis under the ACVM Act 1997″ which details the thresholds and criteria for regulatory interest. It is available at http://www.nzfsa.govt.nz/acvm/publications/standards-guidelines/index.htm.

Question: Can a pharmacy, or indeed anyone, 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 cause of glanders.

Answer: The ACVM Group would likely consider that a product with this type of name is a veterinary medicine and could be implied to be making a claim. In such instances we are likely to take advice from, or work with, the Commerce Commission to resolve our concerns.

Question: What about a preparation labelled Bovine Mastitis Nosode, made from cultures of bacteria implicated in bovine mastitis?

Answer: See previous response

Question: Practitioners of the Biodynamic system of agriculture make homoeopathic-like preparations from quartz, decomposed cow manure and the like and employ them as a kind of fertiliser – is this within your orbit? Ditto the same sorts of things are made with the claim that they kill weeds and insect pests – what can you say about that?

Answer: The ACVM Group considers that this [the Act’s definition of “agricultural compound”] covers fertiliser and pesticide products and substances. The products must either be registered, or fit the criteria for exemption from the requirement for registration.

Question: Some people would say the definition of “non-medicated” offered fits those homœopathic preparations which are diluted (potentised) beyond a point where no material agent (substance) can be detected. Do you believe there could be a degree of dilution that may give homœopathic preparations a special status?

Answer: We are not clear what “special status” is being sought by the Society but we are happy to meet and discuss this further. It is our understanding that homœopathic products are exempted from registration, except where they make claims to treat diseases or conditions that trigger the threshold for registration.

Bruce Barwell