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First CRISPR Law: Selling “Gene-therapy Kits” Will Be Illegal in California Unless They Carry a Warning

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Following unanimous support in the Legislature, the Governor Gavin Newsom signed the first bill into law addressing the emerging CRISPR technology. Authored by Senator Ling Ling Chang (R-Diamond Bar), Senate Bill 180 is a new consumer protection law that requires sellers of gene therapy kits known as “DIY CRISPR Kits” to include a notice prior to the point of sale, as well as a label, stating that CRISPR kits are not intended for self-administration.

“CRISPR technology is becoming widely available to the public but many in the scientific community have sounded the alarm that it could have negative consequences outside professional labs,” said Senator Chang. “The technology is moving faster than regulations, so it’s important to be proactive about preventing safety mishaps by amateur users of CRISPR kits. While I’m a huge proponent of supporting scientific curiosity and imagination, I’m very concerned about the amateur use of this technology and its impact on consumer and public safety.”

Use of CRISPR in garages and kitchens has been growing among so-called biohackers and many have made attempts to alter themselves with the technology.  The owner of one company selling DIY CRISPR Kits recently came under investigation by California’s Department of Consumer Affairs.

CRISPR, short for CRISPR-Cas9, is an acronym for “Clustered Regularly Interspaced Short Palindromic Repeats” which are unique DNA sequences found in some bacteria and other microorganisms.

The United States Food and Drug Administration has stated that the sale of gene therapy products with the intent of self-administration is against the law, and cites concerns about safety risks. There have been instances caught on video of individuals injecting themselves with CRISPR Cas-9 edited materials with the intention of editing their physiology.

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