Google-backed company 23andMe was recently asked by the U.S. Food and Drug Administration (FDA) to cease selling genetic tests, reports Reuters.

“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act),” read the first paragraph of the FDA warning letter.

The letter, addressed to Founder and President Anne Wojcicki states that the products are devices that are regulated by the FDA, requiring marketing clearance or approval prior to sale.  The FDA points to the Saliva Collection Kit and Personal Genome Services as concerning because the personal health risk information can lead to drastic medical decisions by the patient.  Before such products are used, they should be properly vetted.

The personal genomics company was also recently issued a patent for technology described as “gamete donor selection based on genetic calculations.”  The patented system could identify a donor that would be preferred based on those selected characteristics.  While donors already undergo some genetic analysis to check for serious inheritable diseases, this technology includes controversial non-medical trait selection, which is already illegal in the U.K. and Canada.  Of course, simply selecting a preference and increasing the likelihood does not mean parents will get what they hope for.  The genetic foundations of traits like hair color or athleticism are markedly more complex than that.  23andMe states that they do not plan to use this technology to create designer babies.

The National Human Genome Research Institute states that the human genome contains 23 pairs of chromosomes that are made up of deoxyribonucleic acid (DNA) base pairs arranged in a specific sequence. Each nucleated cell within the human body contains these pairs of chromosomes, of which half were derived from the mother and half from the father. Each chromosome houses hundreds to thousands of genes, which are segments of DNA that contain a code for a specific protein. The sex chromosomes make up one of the 23 pairs of chromosomes, and normal females have two X chromosomes while normal males have one X and one Y chromosome.

Only 0.4 percent of the human genome differs between individuals. The potential for genomics lies in unlocking how these differences impact disease prevention and treatment. Family history is still one of the most important measurable risk factors for many conditions. For example, genetics tests are popular for evaluating risk for cancer, especially certain breast and ovarian cancers. That information can be used to seek dramatic surgery, removing breasts and reproductive organs before cancer appears. However, genetic information can also provide non-medical information.  Designer babies would encompass selection of that genetic information.  Ultimately, there are no certainties about the genetic makeup of the baby after fertilization.