Take the Animal Health Supplement Act. Written partly by National Animal Supplement Council (NASC) leadership in the United States, the act, if passed, will significantly change how pet supplements are regulated.
The act will provide federal oversight similar to what the NASC already does.
“If a company is not a member of the NASC, you don’t really have to oversee the actual quality and efficacy of the product currently,” said Ronaldo Avella Lavado, business development, operations and regulatory affairs manager at Paul Dick and Associates.
Avella Lavado, who spoke at this year’s Probiota Americas conference, noted that Canada has a more stringent regulatory framework as compared to the United States, requiring pre-market authorization for pet supplements through Health Canada and its Veterinary Health Products Program. In the United States, it is not necessary to have a pre-market authorization for animal supplements, and biotics are included in that.
As for Canada’s premarket approval, Avella Lavado said it ensures a safer environment for companion animals, but the approval process can sometimes be tedious and lengthy.
“Whereas in the U.S., as a less regulated market, you can put your products on the shelves way faster,” he added. “As the FDA does not review all the products before getting to market, we oftentimes see products that are promising claims that are difficult to believe based on their ingredients.”
Biotics and allowable claims
The gut health segment of the companion animal supplement market is growing, according to Avella Lavado. The marketable claims go beyond general gut health support, expanding in recent years to include immunological, joint and even healthy aging support through a healthy microbiome.
“It’s quite a broad opportunity for the biotics space in the companion animal category,” Avella Lavado added.
He explained companies are allowed to run clinical trials to provide health claims around the profile of the microbiome, rather than only stating a supplement supports gut health.
There are some caveats, however.
“Generally speaking, you should avoid claims around shifting the microbiome because the idea of supplements in Canada and in the U.S. is to support health and not really promote very deep change of the microbiome in the animal,” Avella Lavado said.
As interest in the microbiome grows, companies developing biotic ingredients for companion animals will need to balance increasingly sophisticated science with evolving regulatory requirements on both sides of the border.