Send in the clones: FDA set to approve food from cloned animals

The US Food and Drug Administration (FDA) recently released a preliminary safety assessment that clears the way for marketing of meat and dairy products from cloned animals for human consumption. According to consumer groups, such as the Center for Food Safety, the assessment and the agency’s expected endorsement of cloned food comes despite widespread concern among scientists and food safety advocates over the safety of such products. The move to market cloned milk and meat also flies in the face of dairy and food industry concerns and recent consumer opinion polls showing that most Americans do not want these experimental foods.

The FDA’s draft risk assessment released in late December finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals. The FDA says that its risk assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health.

“Based on FDA’s analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day,” said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine.

The FDA will also not require labeling of foods from cloned animals.

“Lose-lose situation”
Consumer groups criticized the FDA’s decision. “Instead of doing its job, the Bush FDA has ignored the science and fast-tracked this decision for the benefit of a few cloning companies,” said Joseph Mendelson, Legal Director for the Center for Food Safety (CFS). “This is a lose-lose situation for consumers and the dairy industry.”

According to CFS, the FDA has refused to investigate health problems in animal clones on a US dairy farm. Greg Wiles, whose Williamsport, Maryland “Futuraland 2020” dairy was the first farm in the nation to have cloned cows, told FDA that one of his two cow clones was suffering from unexplained health problems. Wiles told Food Chemical News that the clone “just stopped growing...she just looks terrible,” but says that when he reported the problems to FDA and other federal officials, he was “paddled around like a tennis ball from agency to agency.” CFS has asked the Agriculture Department to intervene in the case to stop any sale and prohibit the slaughter of clones and their progeny for food.

CFS also cited several health and safety problems in animal cloning including:
Surrogate mothers are treated with high doses of hormones; clones are often born with severely compromised immune systems and frequently receive massive doses of antibiotics. This opens an avenue for large amounts of veterinary pharmaceuticals to enter the human food supply;
Imbalances in clones' hormone, protein, and/or fat levels could compromise the quality and safety of meat and milk;

The National Academy of Sciences warned that commercialization of cloned livestock for food production could increase the incidence of food-borne illnesses, such as E. coli infections;
Cloning commonly results in high failure rates and defects such as intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, brains, livers, and kidneys; respiratory distress; and circulatory problems.

Barb Glenn, a spokeswoman for the Biotechnology Industry Organization, told the Associated Press that cloning would be used primarily for breeding to make copies of exceptional animals. Food would be produced from the offspring of the clones, and not the clones themselves.

To date, FDA officials have asked farmers and cloning companies to keep clones out of the food supply.

Consumers uncomfortable with cloning
Other consumer groups expressed concerns about the FDA’s decision. Gregory Jaffe, biotechnology director at the Center for Science in the Public Interest, said, “To date, the cloning industry has not provided the public with any information about why cloned animals are needed in food production, who benefits from their use, and how they might benefit the consumer at all.”

Carol Tucker Foreman, director of food policy at the Consumer Federation of America told the Associated Press that the FDA is ignoring research showing that cloning results in more deaths and deformed animals than other reproductive technologies. She also said her federation will ask food companies and supermarkets to refuse to sell food from clones. “Meat and milk from cloned animals have no benefit for consumers, and consumers don’t want them in their foods,” said Foreman.

Surveys also show that consumers are overwhelmingly opposed to animal cloning. A recent survey by the Pew Initiative on Food and Biotechnology found that 61% of Americans who claim to have heard about animal cloning are uncomfortable with it. Those unfamiliar with animal cloning express greater reservations, with 68% of Americans indicating that they are uncomfortable.

A survey by the International Food Information Council (IFIC) also found that consumers oppose the notion of animal cloning as well as the use of cloned animals for breeding. Less than one-fifth (16%) of U.S. adults give a favorable rating for their impression of animal cloning, while over half (56%) give an unfavorable rating. In addition, the majority of consumers remain unlikely to purchase foods from cloned animals (58%) or their offspring (59%).

IFIC president Dave Schmidt told Reuters, “There’s something about the cloning term that makes consumers uncomfortable. ... There’s going to need to be more assurance for consumers.”
The IFIC survey is especially noteworthy because IFIC is a proponent of genetically modified foods and its surveys, including this one, always find consumer support for GM foods.

An editorial in The New York Times stated, “The Food and Drug Administration’s assessment that food from cloned animals is safe to eat is a victory for biotech companies and a loss for everyone else. Asking whether cloned meat and milk are safe is not even the right question. The right question is, why clone at all?”

Government and industry opposed
Some government leaders also oppose the use of clones and their offspring for food products. In November, Senator Barbara Mikulski sent a letter to the FDA requesting a complete overview of how the agency came to its decision of using clones in food. In early December, a bi-partisan group of seven senators led by Senator Patrick Leahy asked FDA to reconsider its assessment of cloned animals. 

Meanwhile, The International Dairy Foods Association, representing major dairies and food makers including Kraft, Nestle and others, also has opposed allowing products from cloned animals into the food supply at this time.

Organic food experts also oppose FDA’s action. “Cloning is not just about producing food for consumers. It’s about greed and patents,” said George Siemon, CEO of Organic Valley, the nation’s largest organic farmers cooperative. “The real question with cloning is who is going to benefit -- consumers? farmers? animals? Allowing animal cloning, like seeds, to be patented by profit-driven companies has too many unknown risks and is a detriment to farmers and the future of our food supply.”

Seeking public comments
In addition to the draft risk assessment on the safety of food from cloned animals, the FDA also issued a proposed risk management plan that addresses “uncertainties” associated with feed and food from animal clones and their offspring and a draft guidance for industry that addresses the use of food and feed products derived from clones and their offspring.

FDA is seeking comments from the public on the three documents for the next 90 days until April 2. To submit electronic comments on the three documents, visit

FDA will make a final decision on the documents after public comments are submitted.
(Sources: Associated Press, Reuters, The New York Times)

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