FDA Approves First Over-the-Counter CRISPR Gene Therapy Kit for Lactose Intolerance
March 15, 2035SILVER SPRING, Md. — The U.S. Food and Drug Administration today approved DairyDelete™ Home Edition, the first direct-to-consumer CRISPR-Cas13 gene editing kit designed to permanently treat lactose intolerance in adults. This historic approval marks the first time a gene-altering therapy has been made available without a prescription, signaling a major shift in the "Biohacking for All" regulatory framework established in 2032.
The product, manufactured by CRISPR-Snacks Inc., is a single-dose, cherry-flavored chewable gummie containing viral vectors that target intestinal lactase production. Within 48 hours of ingestion, the therapy edits the LCT gene in the small intestine lining, restoring the body's ability to digest dairy products.
The FDA’s approval is based on clinical trials involving 40,000 participants, where 98.4% achieved full lactase persistence. The administration notes that while the product is safe for general use, consumers must carefully follow the included augmented-reality (AR) instructions to avoid off-target edits.
Important Safety Information
DairyDeleteâ„¢ should not be taken by individuals currently undergoing other gene therapies or those with a subscription to Neuralink Premium, as signal interference may occur.
Common side effects include mild abdominal glowing (bioluminescence) lasting up to 3 days, a temporary desire to consume grass, and sudden proficiency in Sudoku. In rare cases (less than 0.01%), users may accidentally edit their hair color to neon blue. The FDA emphasizes that this product is somatic-only and will not be passed down to offspring, though your newfound love of Gouda likely will be.
"We want to remind the public that while this CRISPR kit is approved for lactose intolerance, 'jailbreaking' the viral vector to attempt height enhancement or night vision is a violation of federal law and voids the warranty," added FDA Commissioner Dr. A.I. Smith.
DairyDeleteâ„¢ is expected to hit shelves at pharmacies, gas stations, and autonomous drone delivery kiosks nationwide by April 1st.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco and cyber-enhancement products.