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Oral Nutritional Compounds

One of the areas of greatest uncer-tainty and misunderstanding in the transition to the ACVM Act is in regard to oral nutritional compounds. This is primarily because of the way some proprietors make products that have the characteristics of oral nutritional compounds but want to:

• market them as medications to prevent, control or cure conditions characterised by pain or distress; or
• include ingredients that have or purport to have therapeutic or pharmacological effects. 

Proprietors want to create the expec-tation of a medication, but cannot or do not want to provide information to show that the products work.

Regulatory rules

Recognising the wide range of oral nutritional products, and the varied claims that are made about such products, the following regulatory rules will be applied.

Non-medicated oral nutritional compounds will be exempt from registration. If they contain therapeu-tic or pharmacological substances then they are medicated and must be registered. If they contain only nutrients and feed additives, but they make therapeutic or pharmacological  claims, they are not just oral nutri-tional compounds and will have to be registered, unless they fit the definition of some other type of product that is exempt from registration.

Oral nutritional compounds can contain only:

• substances that are known to be nutrients or for which a case is made that each substance is a nutrient and has been incorporated into the product to achieve a nutritional benefit as defined in the ACVM Regulations 2001; or
• feed additives that are listed in part A, schedule 7 of the ACVM Regulations 2001.

If a substance is not a nutrient and is not in part A schedule 7, then a person can apply to the ACVM Group to have it listed in the schedule. The ACVM Group will ask for expert advice and state its intention to the public, with an opportunity for the public to comment, before recom-mending that the substance be listed.

If a trade name product has a sub-stance in it that is not a nutrient or an approved feed additive, then it is not an exempt oral nutritional compound.

Claims

Oral nutritional compounds can make non-specific health claims without jeopardising the exempted status of the product. Claims would include such things as improved production or performance, enhanced flexibility or mobility, enhanced disease resistance or non-specific stimulation of the immune system if the claims can be attributed to a nutritional benefit.