3 keys to novel pet food ingredient regulatory acceptance

If a novel pet food ingredient was used in foods prior to 1958 or is scientifically established as safe, FDA may accept that ingredient as GRAS.

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photo by alkir, BigStockPhoto.com
photo by alkir, BigStockPhoto.com

Novel pet food ingredients may draw consumers’ eyes and help differentiate dog and cat foods on crowded retail shelves. If a novel pet food ingredient was widely used in foods prior to 1958 or is scientifically established as safe, the United States Food and Drug Administration (FDA) may accept that ingredient as Generally Recognized As Safe (GRAS). The FDA released a draft guidance document on selecting a panel of experts to establish GRAS status, wrote David Dzanis, DVM, PhD, an American Association of Feed Control Officials member, in his Petfood Industry column Pet Food Insights.

1.  Expert panelists

The experts comprising a GRAS panel are essentially serving as proxies for the scientific community at large, wrote Dzanis. He recommended three types of experts specifically.

  • A toxicologist to address noxiousness, mutagenicity and carcinogenicity.
  • A nutritionist to evaluate not just how a novel pet food ingredient meets an animals’ metabolic needs, but also the amount of substances such as a preservatives will be ingested based on animals’ anticipated intake of the pet food or treat.
  • An expert on the specific ingredient in question, especially genetically engineered products, can speak to detailed issues with that ingredient.

2. Control bias

A panelist's conflict of interest could seriously damage the credibility of the entire panel. The proponent or organizer of the panel, its lawyer, agent or employee, or others that have a financial or other vested interest in the outcome (either directly or through relatives or other close associations) should be excluded from service.

3. Publicly available data

FDA recommends that GRAS panel organizers minimize the amount of non-public information made available to the panel, unless that information itself raises question as to the safety of the substance. Data not in the public domain cannot be used as pivotal evidence of safety, as anything critical in reaching a conclusion of GRAS needs to be publicly available. However, FDA regulations expressly allow for corroborative data from unpublished scientific studies and other sources to be considered in a determination of GRAS status.

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