FDA Approved Cloned Meat In 2008; Health Canada Pauses Consideration After ‘Significant Input’

Health Canada has indefinitely paused a proposal to reclassify meat and milk products from cloned animals and their offspring from the novel foods category, which would have bypassed any requirements for pre-market safety review or mandatory labeling. In 2008, the US FDA concluded that cloned meat is as safe as conventional meat, stating “meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food we eat every day.” In the US, meat and milk that come from cloned animals and their offspring have been considered legal without any safety or labeling requirements.

The European Union banned the practice of cloning farm animals for the purpose of selling agricultural products in 2015, citing animal welfare concerns. A decade ago, when the EU voted to ban the practice, they talked about the immaturity of the technology and the high mortality rate in animals that are cloned. In addition, it was noted that the animals often die within the first few weeks of life, and do so painfully.

Several reports have conflated cloned animals with lab-grown meat, but they are two separate processes. Cloned meat requires a surrogate mother to give birth after a cloned embryo is created. Lab-grown meat or cell-cultivated meat doesn’t require surrogates because the cells are placed in growth medium and rapidly multiply in bioreactors. The HighWire has reported on the FDA approval of lab-grown pork and salmon. Texas was the seventh state to enact a ban on lab-grown meat production and sales, citing a lack of long-term safety studies and the protection of traditional ranching.

Health Canada “rigorously” reviewed the scientific literature about cloned meat and concluded that “products made from these animals and their progeny are as safe and nutritious as foods from traditionally bred animals. This is consistent with the interpretation of other trusted jurisdictions.” However, there was significant pushback from Canadian consumers who did not want to see cloned meat enter the food supply without pre-market safety testing or labeling requirements. As a result, the department indefinitely paused the policy to “provide time for further discussions and consideration.”

The Center for Food Safety compiled public polls from the US prior to the FDA’s policy change in 2008. In 2006, 66% of US adults disapproved of cloning meat for food purposes. 69% were concerned about eating meat from cloned animals in 2007. In addition, 89% of consumers in 2007 wanted meat and milk derived from cloned animals to be labeled. It has been legal in the US for 17 years now, since the policy was updated by the FDA, and no labeling is required.

The CFS also responded to the FDA’s 968-page review of cloned meat safety and said the agency’s approach to evaluating safety is flawed. First, the CFS criticized the FDA for not finding enough peer-reviewed studies to support safety, including none for meat or milk from cloned cows or offspring of cow clones, none for meat from cloned pigs or their offspring, and none for meat or milk from cloned goats or their offspring.

Hydrops was observed in 42% of cloned pregnancies, which can lead to stillbirth. This condition is only observed in one out of 7,500 pregnancies in non-cloned cattle. Large Offspring Syndrome (LOS) was observed in up to 50% of cattle, but occurs in less than 1% of cases when breeding naturally.

Respiratory distress, organ abnormalities, musculoskeletal issues, and immune deficiencies were also observed at higher rates in the cloned cattle compared to naturally born cows. The FDA argues that the clone deformities normalize through offspring, but the National Academy of Sciences said in 2004 that there is little evidence to support that claim.

The FDA assessment also relied upon “unpublished data from two cloning companies and on studies that make use of this same data, without noting the inherent conflict in basing regulatory conclusions so heavily on submissions by the companies that have a financial interest in FDA approval.”

In the FAQ page, the FDA admits that it did not have long-term safety data to reach its safety conclusion. The FDA states that there is “no new substance to test” and that it isn’t possible to have people eat just meat or only drink milk to test the safety profile of the products derived from cloned farm animals.

While there is no regulation preventing the use of clones in the meat supply, the FDA said companies utilize clones for breeding stock and the offspring of the clones would be used for food production. Still, companies like Viagen have not been able to make the farm clone business profitable and have instead become profitable from cloning dogs, cats, and horses for people who want to keep the genetics of their favorite pet alive after they die.

Pet cloning is becoming more popular at a cost of $50,000 to $100,000, but it has significant ethical considerations. The LA Times reported last month that the success rate is 2-3%, so it could take dozens of attempts, or as many as 100, to get a “healthy,” viable puppy or kitten clone. The pet clones do not retain the personality of the animal they were cloned from.

Whether it involves farm animals or pets, each cloning process will require a significant number of failed pregnancies, miscarriages, stillbirths, neonatal deaths, and abnormalities after a “successful birth.” The process also may require dozens of surrogate mothers to attempt to bring one clone into the world that doesn’t have significant abnormalities.

Snuppy was the first dog clone and was produced 20 years ago after more than 1,000 embryos were surgically transferred to 123 surrogates. There were three pregnancies, which included one miscarriage and two carried to term. One clone that was born died within three weeks with neonatal respiratory distress, and the other clone born was Snuppy.

The Ethics and Religious Liberty Commission wrote a report about the ethical considerations of cloning, which ultimately applies to farm animals or pets. Veterinarian Katy Nelson said, “These animals are being kept against their will. They’re being kept hormonally supplemented, so that they can create these embryos at will.”

Hilary Bok, a Johns Hopkins bioethicist, said, “Cloning causes animals to suffer. Egg donors must have their ovaries artificially stimulated with hormone treatments and their eggs surgically harvested. Given the unusually high rates of late-term miscarriages and high birth weights among clones, the surrogate mothers are at greater risk of dying or suffering serious complications than animals that become pregnant naturally. The clones, themselves, however, suffer the most serious problems: They are much more likely than other animals to be miscarried, have birth defects, develop serious illnesses, and die prematurely.”

Canada has paused the consideration of removing cloned meat from the novel foods category, but could reverse course at any point in the future. 17 years after the FDA removed barriers between cloned meat and the food supply, there is no data on the amount of clone-derived products in American foods.

Organic food does not allow the use of cloned animals or offspring of cloned animals in the United States. It is the only way for Americans to ensure the meat on their dinner tables is not derived from clones, including the highly questioned ethical and safety implications.