Why Are Caution Statements on Labels?The specific cautions are on the glucosamine and chondroitin products or products containing sources of GAGs (e.g., perna) because of information FDA/CVM has on file for the FDA-approved INJECTABLE products for dogs and horses, i.e., Adequan and Legend. The NAERS database with now over one BILLION ORAL administrations of products with these ingredients does not contain any reports of these types of serious adverse events in dogs, cats or horses.
NASC members will be notified of any new developments. Also, with the NASC Newsletter coming out monthly, it will be a good resource for updates on regulatory issues affecting companies making animal health supplements.
With all the data supporting safe use of GAG-containing products from NASC members, there has been discussion of deleting some of the cautions from the labeling templates in the future. But, it isn’t a priority at this time for NASC issues involving FDA/CVM – especially with all the competing companies and internet sites making drug claims for joint products. FDA/CVM has said they are stepping up enforcement activity against these types of products. This is an issue affecting all NASC members with joint products – a majority of members – and a much higher priority than removing the stone caution statement.
The Adequan label contains a warning for clotting disorders. There are scientific papers covering insulin resistance and glucosamine – most studies are in rodent models or in vitro. The urinary tract stone caution is from FDA/CVM information that we do not have access to. We do not know the product associated with the report made to FDA. FDA wanted this caution on supplement products with GAGs when NASC worked with them years ago to get their input on the labeling templates NASC was developing. FDA did not give specific reasons to NASC justifying why they wanted these cautions – only the explanation about what they had on file for these types of products.