And whose interests do regulators serve – those of industry or the public?

History of Food Safety Regulations

In Canada, as in the United States, all aspects of food safety are administered under the Food and Drugs Act. Accordingly, all foods in both countries are required to be free from any additives hazardous to human health. Introduced originally as the Adulteration Act in 1906, the Food and Drugs Act has gone through several revisions since then. The first revision to the Adulteration Act was legislated in 1938. Predicated by the death of 107 Americans in 1937, it was caused by a sulfonamide medication that a pharmaceutical manufacturer had unwittingly prepared by dissolving sulfonamide powder in a solvent, diethylene glycol, which turned out to be a deadly poison.

Eventually, the mystery of the sulfonamide disaster was solved by a Canadian physician, Frances Oldham Kelsey, who at the time was a post-graduate student at the University of Chicago. It was effectively her study on rats that proved it was not thalidomide itself that caused kidney failure and death but the solvent, diethylene glycol. The public outcry due to this incident led to a thorough revision of the Adulteration Act in both Canada and the U.S. It required companies to conduct animal toxicity studies on their products (in at least two species of laboratory animals), and submit the resulting research outcome to the relevant government authorities for their own evaluation. Failure to do so meant no approval of the product, and any falsification of the required data meant heavy fines and/or up to five years in jail. Full details of these revisions in both Canada and the U.S. were promulgated in 1945.

Pesticides Introduced to Increase Crop Yields

This was also the period when numerous pesticides, antibiotics, hormones, and various other products were introduced to augment food and agricultural production without any toxicological assessment. The most commonly employed pesticide was DDT. It was used as a wonder-insecticide to control malaria and typhus fever following World War II. Shortly thereafter, DDT was approved to not only kill mosquitoes and fleas carrying these diseases but also virtually all insects in parks, forests, schools, and other publicly held lands – so much so that it was sprayed over thousands of miles via airplanes and helicopters. Scientists hailed it as a miracle discovery to increase food and agricultural production.

In 1962, an American biologist, Rachel Carson, who for quite some time had been studying the environmental and public health impacts of DDT and other pesticides, published a book, titled Silent Spring. She described in this book how DDT and other pesticides induced cancer in humans, and how their agricultural use was a threat to wildlife. This led to vicious attacks on her personal credibility as a scientist by the pesticide industry. Nevertheless, by the late 1950s Carson had authored several books to indicate that some environmental problems were caused by synthetic pesticides, which brought unprecedented public demand to ban them.

In regard to DDT, Carson never actually called for an outright ban on this pesticide. However, she argued that, even if DDT and other pesticides produced no harmful effects, their overuse would create resistance to those pesticides, which would make them useless in eliminating the target insects.

Eventually, the media hailed Silent Spring as a great service to humanity. Notably, just before its publication, the story of the birth-defect-causing drug thalidomide broke, which invited comparisons between Carson and the doubly famous Frances Oldham Kelsey; firstly, because of her 1938 study on sulfonamide disaster; and secondly, because of her refusal to approve thalidomide to treat morning sickness in pregnant women (at the time (1962) Kelsey was medical evaluator of drugs at the U.S. FDA.)

Hormones Introduced to Increase Meat Yields

Three additional products that the U.S. FDA and Health Canada had approved since around 1945, with no questions asked, were growth hormones, antibiotics, and slaughterhouse wastes fed to livestock to obtain more copious production of beef, pork, and poultry meats. Each of these products represented very serious risks to human health, but no one seemed to care as long as it generated extra profit for the food and drug industries. In other words, no lessons were learned from the sulfonamide disaster.

But then the specter of another  potential thalidomide-like disaster forced the last and final revision of the Food and Drug Regulations in 1967 by both the U.S and Canada. Henceforth, manufacturers of foods, drugs, and cosmetics were obligated to investigate each product for its potential to cause birth defects and cancer and submit thus-produced results to obtain regulatory approval.

During the course of these events, things seemed to improve for the safety of food and drugs. For instance, starting in 1960, Dr. Frances Oldham Kelsey was retained as a key Medical Officer on the U.S. FDA’s staff. Subsequently, in 1962, she was bestowed the highest civilian award by President John, F. Kennedy, due to her refusal to approve thalidomide. But, no such recognition was awarded to Rachel Carson for her excellent work until 1972, by President Jimmy Carter, which was eight years after her death in 1964.

Growth Hormones Linked to Cancer

Ironically, although thalidomide was banned throughout the world in 1962, no such action was taken against an equally dangerous hormone called Diethylstilbestrol (DES). Starting around 1945, doctors used to routinely prescribe it to prevent miscarriage, which it failed to do. Instead, it caused the daughters of those mothers to become relatively more prone to endometriosis and vaginal/cervical cancer. Studies showed an approximately forty-fold increased risk in vaginal/cervical cancer in young women who were exposed to DES in their mother’s womb. Also, daughters born to similarly treated women were reported to carry an increased risk of breast cancer. Eventually, under pressure from the public, DES was banned for any such use throughout the world (1971).

Aside from being prescribed for women, DES was also utilized in various livestock animals to bolster meat production. Cattle, swine, and poultry received it in their feed, and by injection. These agricultural uses of DES resulted in a concomitant increase of numerous, usually uncommon, disorders in children. Hence, oral use of DES was banned in 1972, and its implants in the following year. But, no such action was taken against six additional hormones used to stimulate beef production.

In regard to the Food and Drugs Act, regulations were passed in 2012 under which – prior to the approval of any product entering the food chain – manufacturers were required to report the Maximum Residue Limits (MRLs) that people could swallow, daily, without suffering any ill effects. However, under pressure from the industry lobby, these requirements remained unenforced for numerous products such as hormones with the potential to cause various chronic diseases, including cancer. The lobbyists argued that MRLs for anything causing cancer could not be determined since a single molecule attached to a single cell could induce cancer.

European Regulators Protect Their Citizens

In contrast to the U.S. FDA and Health Canada, the European regulators, led by Denmark, adopted a more precautionary stance. Insisting on being safer than sorry, not only did they ban all beef growth hormones, but they also banned non-therapeutic antibiotic uses in any food-producing animals. The matter concerning beef hormones has been the subject of a prolonged litigation in the World Trade Organization (WTO) between the European Union and U.S./Canada, since 1988. With neither side willing to budge on this issue, the WTO Appellate Body has finally allowed each side to go its own way. That is where the matter rests, as of now.

Meanwhile, the EU has also been exercising a complete ban on slaughterhouse wastes being fed back to any food-producing animals, in order to avoid another mad-cow like disaster. But, not so in the U.S. and Canada!

Therefore, the question that we, the people, must ask is – Whose interests do the European versus North American regulators serve: those of the industry or those of the public? Anything short of a proper answer to this question would be tantamount to outright corruption on their part to serve purely the private interests.


• Joseph Robert: The insider story of transgenic bovine growth hormone, Common Ground Magazine, November, 2013.
• Shiv Chopra: Five Pillars of Food Safety, Vitality Magazine, July/August Issue, 2014.
• Anonymous: Pure Food and Drug Act, Wikipedia.
• Anonymous: Elixir sulfanilamide, Wikipedia.
• Ingrid Peritz: Canadian doctor averted disaster by keeping thalidomide out of the U.S. Globe and Mail, Nov. 12, 2014.
• Anonymous: Frances Oldham Kelsey (Biography), Wikipedia.
• Anonymous: Rachel Carson (Biography), Wikipedia.
• Newsroom: “Win-win ending the hormone beef trade war”, WTO Plenary Session, March 14, 2012.

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