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Cloning and FDA Regulation: A Need to Take a Firmer Stand

Monica Sethi

Issue date: 4/15/08 Section: Perspectives
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On December 28, 2006, the United States Food and Drug Administration (FDA) declared in its release entitled Animal Cloning: A Draft Risk Assessment (DRA) that meat and milk from cloned animals are safe to eat.  The FDA spent several years compiling data and engaging in extensive review of the food consumption risks resulting from edible products of clones and their progeny.  In the process, they found that cloned food is not materially different than products from sexually-derived animals, and decided that it will not require a special label on such foods.  Yet, the public’s anxiety over eating foods from cloned animals, as well as medical and ethical concerns relating to the issue of cloning is a surefire sign that the labeling requirement is not just a matter for the FDA.

 

Senator Barbara A. Mikulski (D-Md.) and Representative Rosa DeLauro (D-Conn.) have been in the forefront on the labeling requirement issue.  On January 26, 2007 they introduced the Cloned Food Labeling Act (CFLA). If passed, this act would amend the Food, Drug, and Cosmetic Act (FDCA) and the Meat Inspection Act (MIA) to require labels on products from cloned animals and their offspring.  And even if this one isn’t passed, there is a good chance that a loophole-type act, allowing products to be labeled as “clone-free,” will.

 

The latter scenario is a realistic possibility given FDA’s track record. In the past, the organization has yielded to consumer demands by allowing labels on dairy products from animals that are not treated with recombinant somatotropin (rbST), a hormone given to cows to boost milk production, despite the fact that milk from rbST-treated cows is indistinguishable from the untreated variety. From this example, it is possible to draw a parallel to the situation of products from cloned animals, as they too cannot be distinguished in taste or nutritional value from their non-cloned counterparts. Nonetheless, for now, consumers can do nothing more than make the analogy – an act that would support such labeling practices is still quite far from reality.

 

Labeling aside, consumers are also concerned about how the FDA will monitor the evolving technology of animal cloning.  In an effort to allay their fears, the FDA has established a strategy, described in its Risk Management Plan (RMP), for continuously staying up to date on cloning technology.  The RMP relies on the collaboration with biotechnology companies and breeders to keep abreast of the latest developments in the science and technology of cloning.  However, the plan cannot really accomplish what it sets out to do because it does nothing more than “strongly encourage” cloning companies to inform the FDA of any changes to the procedures. As a result the FDA receives only the information that their sources choose to share, as there is no requirement for the mandatory disclosure.

 

But while the FDA continues to show reluctance when it comes to regulating products derived from cloned animals, other countries appear to be taking a much firmer stance on the issue. In response to consumer concerns over the long-term health and environmental risks that come with eating products with genetically-modified ingredients, countries of the European Union, as well as China, Australia, New Zealand, Japan, and Brazil have already passed laws requiring labels on such foods. 

 

What does that mean?

 

It means that it is time for the American public to crank up the pressure on the FDA to make regulatory changes in the industries producing cloned products. After all, as consumers, we have the right to make a well-informed decision, but how can we do that, if we don’t have all the relevant information?

 


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