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FDA Gives Tentative Approval to Food from Cloned Animals

The Food and Drug Administration (FDA) has concluded that food and meat from cloned animals “is as safe to eat as the food we eat every day.” The FDA’s determination is contained in its Draft Animal Cloning Risk Assessment report released near the end of 2006. But public interest groups, and many consumers, are concerned that risks to the public have not fully been examined.

Since 2001, there has been a voluntary moratorium on the sales of milk and meat from cloned cows, pigs, and goats, and from their offspring. The moratorium is expected to remain until the FDA completes its analysis of public comments on the draft report(comments are being accepted until April 2nd, 2007). The U.S. would become the first country to allow food from cloned animals to be sold in grocery stores should the FDA’s conclusions be formally accepted.

The FDA report relies heavily on the work of two animal-cloning companies-Cyagra and ViaGen-who stand to financially benefit from its conclusions and who supplied more than a quarter of the data used in the 700-page FDA draft.


Consumer, farm, and animal welfare groups have been sharply critical of the FDA’s decision and the science upon which it was based. Their criticisms include:

• Some form of abnormality is found in 64 percent of cattle, 40 percent of sheep, and 93 percent of cloned mice, with a large percentage of the animals dying during gestation or shortly after birth.
• High rates of late abortion and early prenatal death occur, with failure rates of 95 percent to 97 percent in most mammal cloning attempts.
• Defects such as grossly oversized calves, enlarged tongues, squashed faces, intestinal blockages, immune deficiencies, and diabetes are common experienced
• When cloning does not produce a normal animal, many of the pregnancies are difficult and cause physical suffering or death to the surrogate mothers.

The cloning process

The cloning process is accomplished through the implanting of an adult somatic cell from the preferred donor animal into the uterus of the female. The somatic cell is subjected to an electric current or a chemical treatment to spark cell division prior to its placement in the female. The animals birthed by the process carry the hopes of scientists and industry seeking replication and perpetuation of high-production dairy cows, superior breeding stock, and other prized genetic traits.

Loss of genetic diversity

Widespread adoption of cloning could lead to the dramatic loss of genetic diversity in livestock. “This,” notes Mark Kastel, Senior Farm Policy Analyst with The Cornucopia Institute, “may leave farmers and our nation’s food supply vulnerable to devastating epidemics due to an extremely narrow gene pool.” Cloning also depends on the heavy use of artificial hormones to facilitate the reproductive process and to induce labor in the mother.

A lack of labeling and tracking

According to Stephen F. Sundlof, the FDA’s chief of veterinary medicine, cloned foods are “virtually indistinguishable” from conventional foods. Despite public opinion surveys suggesting that many are suspicious of and don’t want to eat food from cloned animals, the FDA has announced no intention of requiring an identifying label on cloned food products. One recent opinion poll conducted by the Food Information Council found that 58 percent of Americans surveyed would be unlikelyto buy meat or milk from cloned animals, even if supported by FDA safety endorsements.

The FDA is also not proposing a tracking system for cloned foods that would allow for tracing back to the source any problems that may develop. “This is particularly troubling in that they assume that only food from healthy cloned animals will enter the food stream,” says Kastel.

While cloned animals may be virtually indistinguishable, this doesn’t mean that there are not subtle subclinical physiological anomalies. Scientists have suggested that such anomalies could include alterations in key proteins affecting the nutritional content of food, leading to dietary imbalances.

Jim Riddle, the former chair of the National Organic Standards Board, notes that “The absence of tracking or labeling protects technology companies and users of cloned animals from liability.” Without traceability, the determination of harm, should harm occur, is virtually impossible.

Offer your comments

FDA is seeking comments from the public until April 2nd, 2007. To submit electronic comments, visit Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments should include the docket number 2003N-0573. For more information, visit or