Almost 20 years ago, a controversial company called Lifestyle Pets (formerly Allerca) claimed to have produced hypoallergenic cats using conventional breeding. For a mere $4000–28,000, you too could own one of these cats. Unfortunately, they were not hypoallergenic, as detailed in a rather damning 2013 Australian Broadcasting Commission (ABC) expose,2 which revealed the cats to be no more hypoallergenic than normal domestic cats. Interestingly, the entity ABC used to assess this claim was none other than Indoor Biotechnologies, a company that specializes in manufacturing biologics for allergy and asthma.
InBio is not proposing to produce gene-knockout kittens but rather proposes to develop an injectable gene therapy to reduce the expression of Fel d 1 in pet cats.3 Perhaps unexpectedly, these two rather disparate approaches to produce a hypoallergenic cat—a gene-knockout kitten and an injectable gene therapy to reduce the level of Fel d 1 in pet cats—would both have to be regulated as new animal drugs by the U.S. Food and Drug Administration (FDA).
It might be difficult to envision a cat as a drug, but it is in fact the targeted knockout, or more specifically the “intentional genomic alteration” that would be considered a regulated article, as it affects “the structure or any function of the body of man or other animals.”
This law has been applied previously to a genetically modified pet. “GloFish,” a trade name for several species of genetically engineered fluorescent aquarium fish, are marketed in all 50 American states under enforcement discretion.
FDA’s Center for Veterinary Medicine’s (CVM) has said that it may exercise enforcement discretion4 for new animal drugs on a case-by-case basis if, after a risk-based review, it determines that the product or category of products is low risk to humans, animals, and the environment.
Related on the SLP
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Conceivably the developer of hypoallergenic cats will be posed with the question of whether such cats pose a greater threat to the environment of the United States than their allergenic unmodified counterparts?
