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FDA Cracks Down On Doctor Who Created Three Parent Baby

In a technique called spindle nuclear transfer, the nucleus of a donor egg is removed and the DNA of another woman’s egg is injected.

The FDA is taking a hard stance on a controversial fertility technique that involves genetically modifying embryos.

The New York-based doctor who helped a couple have a child using DNA from three people has been told by the U.S. Food and Drug Administration to stop the clinical trials meant to test the technique.

Last year, John Zhang, the founder of New Hope Fertility Center, pioneered a new type of in-vitro fertilization that involves transferring DNA from the mother’s egg into a hollowed-out egg donated by a younger woman. But the work violates federal legislation that forbids implanting genetically modified embryos, so after fertilizing the egg with the father’s sperm, Zhang went to Mexico, where he inserted the embryo into the mother’s womb. A healthy baby boy was born in April 2016.

FDA sends Zhang a letter

Zhang then requested a meeting with the agency to ask permission to carry out a clinical trial using the technique in the U.S. The agency subsequently denied the meeting. Zhang has since been marketing his fertility procedure to women with certain genetic diseases and older women having trouble conceiving through a new company called Darwin Life. Modifying embryos in a lab is not illegal under U.S. law as long as federal funds are not used to carry out the work. But implanting one in a woman’s womb so that a baby can develop is prohibited.

Vaping Industry Will Have Same Regulations As Tobacco Cigarettes

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The Food and Drug Administration will now treat electronic cigarettes and related tobacco products such as hookahs and cigars the same as traditional cigarettes. The move is expected to have a profound impact on those who make, sell and buy vaping products. Businesses who manufacture vaping products will be required to seek FDA approval before selling their wares. What’s more, manufacturers will now have to apply warning labels on their items regarding the addictive properties of nicotine. Sales to minors under the age of 18 are now prohibited, as are free samples and sales in vending machines in non-adult only areas.

The long-term health implications of vaping aren’t yet known although early reports have found high levels of chemicals such as formaldehyde and acetaldehyde in e-cig liquids, both of which have been linked to cancer.

The FDA is using a staggered timeline for enforcement that will allow manufacturers to continue to sell their products for up to two years while they submit (and an additional year while the FDA reveiws) a new tobacco product application.

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