Politics & Policy

The FDA Is Turning Away from Science

(Martine De Graaf/Dreamstime)
The ‘precautionary principle’ is anti-scientific and blocks the use of helpful and important products.

On April 8, the FDA announced it was launching legal action to remove Carbadox from the marketplace. Carbadox is an antibiotic that has been safely used by veterinarians and pig producers for more than 40 years and is very effective for controlling bacterial diseases, including salmonella and swine dysentery. By helping pigs stay healthier, Carbadox also helps improve feed efficiency and weight gain. In fact, according to a 2012 USDA Animal and Plant Health Inspection Service report, this antibiotic is used by more than 40 percent of pig nurseries in the United States. It is one of the few antibiotics considered by swine veterinarians to be critically essential for the health and welfare of growing pigs.

Sadly, the FDA’s move is another example of a growing stream of executive actions by federal agencies succumbing to political and ideological agendas, including animal-rights activism, and turning against the longstanding tradition of sound, evidence-based science. Scientific and agricultural professionals are left to speak out and give the public factual information they can trust.

The FDA’s action is not about safety or protecting the health of people or pigs, and these growing attacks on the agricultural industry and food producers will have devastating costs to people and to our food supply.

The FDA press release revealed that the agency has been harassing the maker of Carbadox to prove that there is no potential risk to people who eat pork from pigs that have been given its antibiotic. The FDA says it is taking this latest action in response to the Food and Agricultural Organization of the United Nations/World Health Organization and its Codex Alimentarius Commission, which recently determined that “there is no safe level of residues of Carbadox in food that represents an acceptable risk to consumers.”

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Those who understand science will immediately identify the fallacy at work here. The instant we hear that “there is no safe level of exposure” to something, it’s a baloney alert that we’re being given junk science. Virtually everything can cause tumors in laboratory rats when administered in toxic doses. In fact, everything in life — from salt to sunlight — can be harmful in excessive amounts. But, that doesn’t mean we cannot safely enjoy them; they might even be essential for our survival. There is no such thing as “no safe level of exposure.” Remember, the dose makes the poison. Even water is deadly in excessive amounts. Medicine and poisons are just opposite ends of the spectrum of the science of toxicology (the Greek word pharmakon means both “remedy” and “poison”).

The instant we hear that ‘there is no safe level of exposure’ to something, it’s a baloney alert that we’re being given junk science.

It is important to understand how the United Nations and special interests have redefined “safe.” In deciding what is an “acceptable risk,” they now base it on a “reference dose.” They take the level where there is no observed effect (NOEL), even in rats– and then apply a safety factor of 100! This level cannot credibly be said to be the lowest exposure that is “safe,” but that’s what they are now using to impose burdensome and costly regulations. It is also the level that the public is being led to believe is the “safe” limit. People are being frightened to think that anything detectable above that level is dangerous.

Even the FDA admitted that Carbadox is not used in human medicine and does not pose antibiotic-resistance concerns. And as the FDA determined during the approval process, after extensive toxicity and residue studies, there are no residues of carcinogenic concern (30 parts per billion) detectable by any method in meats. The approved label includes a cautionary 42-day withdrawal period before a pig goes to market, and in accordance with the label, to date there has not been a single case of hazardous residues detected in pig meat.

#share#Nothing has changed except the scaremongering. What we are witnessing is the overzealous application of a concept called the “precautionary principle,” which originated in the United Nations environmental program in the 1980s. It demands proof of zero risk before something is considered safe.

RELATED: Dear FDA, Step Aside So That We May Live

This is a fallacy because absolute proof of 100 percent safety is impossible. Under the precautionary principle, the burden of proof is shifted away from those making unsupportable claims and is placed on the scientific community and industry to prove a negative. Sadly, people are being frightened into believing they are at risk based on nothing more than whimsical claims, suggestions, and scares. They’re led to fear that “if something isn’t certain, it must be dangerous and avoided.” Even when there is no evidence of even a link to a possible danger, the precautionary principle is being used to block advancement and technology — based on the suggestion of the remotest theoretical possibility of harm.

The precautionary principle goes against all the tenets of science, toxicology, and careful risk-benefit analysis.

The precautionary principle goes against all the tenets of science, toxicology, and careful risk-benefit analysis. The scientific process uses credible and scientifically verified evidence of risks to human health, safety, or the environment, along with rational analysis of the risks weighed against the potential benefits. The scientific process has served us well for the past century and has led to astounding breakthroughs in science, medicine, agriculture and food production, and energy. None of the advances we enjoy today would ever have been possible had people followed the precautionary principle.

Farmers and food producers devote their careers to feeding people and providing wholesome, affordable food. The precautionary principle does not make us safer. More often the precautionary principle has caused great harm, and tens of millions of people have died because of it by being denied life-saving medicines, food, efficient and affordable energy, and disease-fighting methods. All the precautionary principle really does is use fear to threaten modern life, make food more costly, leave more people struggling with hunger, and reduce the variety and availability of foods that are perfectly safe and wholesome and enjoyable.

— Sandy Szwarc has been a food-science professional, researcher, and writer for more than 30 years.


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