Regulatory

- Regulatory

The Nutraceutical Alliance can assist with all of your regulatory submission and review needs. Products need to support health and be safe for use in both the short term and long term. Regulatory oversight helps to ensure that products brought to market are not only effective but safe.

United States

In the United Sates, ingredients in animal foods are regulated by the Food and Drug Administration (FDA) and administered by the Center for Veterinary Medicine (CVM). The regulations are enforced on a state-wide basis, and the governing body is the American Association of Feed Control Officials (AAFCO). The CVM has a very strong working relationship with the AAFCO.

Ingredients that have an approved AAFCO definition, or that are GRAS (generally recognized as safe) by the CVM, or that meet the requirements laid out in a Feed Additive Petition can be used in animal foods and supplements. The FDA requirements are that the ingredients and products are 1) safe and 2) there is reasonably good scientific information supported their intended use.

New ingredients for feeds and food can be notified in the following ways:

  • 1. New AAFCO ingredient application
  • 2. Feed Additive Petition (CVM)
  • 3. GRAS notification (CVM)

For supplements, these 3 approaches can also be used.  There is also a 4th option. The National Animal Supplements Council (NASC) is recognized by the FDA and deals specifically with ingredients, ingredients producers and suppliers, and supplement producers for supplements, not feeds or food. Like the FDA and AAFCO, there is a rigorous system of review for ingredients and suppliers.

Canada

Health Canada oversees human and animal food safety, and the regulations are enforced by the Canadian Food Inspection Agency (CFIA).  Pet foods and supplements are not presently regulated in Canada, however industry standards are high and there is a level of facility and product oversight conducted by both the CFIA and FDA (for those producers exporting to the USA).

Animal feed supplements, while not regulated, fall under the Veterinary Health Products program, which is a system of voluntary registration of ingredients and products.  New ingredients are carefully reviewed for safety and efficacy in target species and added to a growing list of ingredients deemed safe for use. New products notifications are reviewed and if requirements are met, then the product is issued a Veterinary Health Product notification number (NN). The NN must be shown on product labels, and VHP designation therefore lets the consumer know that the product is deemed safe – it is considered a very useful marketing tool.

Europe

The regulatory body of human and animal food (and supplement) safety in the European Union is the European Food Safety Authority (EFSA). New ingredients and products notifications are reviewed, and those that meet requirements are added to the database of ingredients and products deemed safe. The feed ingredient and feed additive categories differ from those used by the FDA. Dossiers of supporting the use of ingredients for a particular nutritional (ParNut) purpose are developed and maintained by producers. The Nutraceutical Alliance can develop these ParNut dossiers for you.

Australia

The body providing regulatory oversight animal nutraceutical ingredients and supplements is the Australian Pesticides and Veterinary Medicines Authority (APVMA). The notification and review program is similar to that of other countries, although care must taken of regulatory requirements of imported products.

Examples of completed regulatory projects

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