FDA Takes a Stance on Do-it-Yourself Kits to Edit Human Genes

The U.S. Food and Drug Administration (FDA) declared it illegal to sell do-it-yourself kits to edit human genes. According to the FDA website, the agency is “aware that gene therapy products intended for self-administration … are being made available to the public. The sale of these products is against the law.”

It is unclear what law selling such products would violate. STAT News spoke with Josiah Zayner, who runs The ODIN, a company that sells genetic engineering kits for bacteria as well as genetic material that could be used to modify human muscle cell growth. Although he does want customers to use his kits to experiment on themselves if they choose, even offering a “DIY Human CRISPR Guide” on his website, he doesn’t believe he is violating FDA regulations. For example, the human genetic material he sells is either encapsulated in bacteria or preserved in a chemical solution so it is useless when injected directly from the package into the body. “We’re not trying to promote people [using] them as is,” Mr. Zayner said. “We’re trying to promote … access to this technology.”

An FDA spokesperson declined to tell STAT News whether the agency is investigating any companies for selling the products it warns about in its online statement.

Source: STAT News, November 24, 2017.