Last year, I wrote about a supplement marketed for dogs and cats with kidney failure, RenAvast. AT the time, the Bottom Line conclusion for this supplement was this:
The ingredients in RenAvast™ are deliberately not disclosed by the company beyond the fact that they are amino acids and some sort of peptide. Therefore, it is impossible to evaluate the plausibility of the proposed mechanisms of action or any preclinical research on these ingredients.
The only data presented for safety and efficacy is a poor quality, small trial with clear and significant risk of bias that is essentially useless as evidence. There are, of course, plenty of testimonials and anecdotes suggesting the product works, but that is true for every therapy ever invented, so either no idea in medicine ever fails, or anecdotes are very reliable.
There is no way to determine at this point if the product is safe or effective. However, the way that it has been marketed shows a clear disregard for both the regulations intended to prevent inappropriate and unproven claims for dietary supplements and the basic principles of medical research. The combination of secrecy and misuse of sloppy science suggests a great deal of skepticism is in order when dealing with this company and its products.
I also pointed out that in 2012, the FDA had warned the company about making illegal claims about the safety and efficacy of the product which had not been proven by appropriate clinical trials. Clearly, as of last year the company was still ignoring the law and defying this warning. Well, the wheels of regulatory enforcement turn slowly, but three years later the FDA has finally taken action against this firm:
On July 10, 2015, the United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.
According to the complaint filed with the consent decree, the defendants have marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. It is illegal to market new animal drugs without first requesting FDA pre-market review and obtaining legal marketing status. The FDA pre-market review process evaluates whether products are safe and effective for their intended use, can be consistently manufactured, and are truthfully and completely labeled.
The decree, filed on FDA’s behalf by the U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney’s Office for the District of Nevada, prevents Bio Health Solutions LLC and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce. The firm would not be able to market the drug unless and until it obtains an approved new animal drug application or meets the requirements for an investigational new animal drug exemption.
“The Federal Food, Drug, and Cosmetic Act’s new animal drug approval requirements provide important protections for consumers and their animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “We believe consumers should be able to trust that the drug products they administer to their pets have been proven to be safe and effective.”
It remains to be seen how the company will respond to this legal injunction, but hopefully this product will be taken off the market until and unless real clinical trial evidence is available to establish any risks or benefits it has. Sadly, that leaves scores of other similar products out there, but it is good to see that at least occasionally the FDA is willing to take action to prevent such flagrant illegal marketing of snake oil to pet owners.