Vivos Inc (RDGL)

[West Coast Snapper]

Risks of Animal Drugs Marketed as Animal Devices

An animal device does not go through a rigorous scientific review before it is marketed. With no pre-market review of a product by FDA, there is no way for veterinarians, pet owners, and animal producers to know if a product is safe and effective or if its manufacturing process is adequate to maintain the product’s quality and consistency from batch to batch.
Also, federal law doesn’t require companies to report problems with an animal device, which may lead to a delay between when the product causes harm and when FDA becomes aware of problems with the product.

Companies that market animal drugs under the guise of animal devices are really selling unapproved animal drugs that have not been reviewed by FDA for safety and effectiveness. Companies that engage in this practice unfairly compete against companies that sell approved animal drugs.

There is often a financial advantage for companies to market unapproved animal drugs as animal devices because the companies do not always:

Conduct all appropriate tests on the product before marketing it; or
Manufacture the product under strict manufacturing standards.
Also, companies must pay FDA user fees to review animal drugs but not animal devices.
Companies that market unapproved animal drugs as animal devices are ignoring their obligation to obtain legal marketing status for their products. These companies also potentially put the health of animals and people at risk. If this practice continues, fewer products that have been reviewed by FDA for safety and effectiveness will be available to veterinarians, pet owners, and animal producers.

https://www.fda.gov/animalveterinary/guidancecomplianceenforcement/complianceenforcement/unapprovedanimaldrugs/ucm229088.htm