In the area of food safety, there is some startling news: A key worldwide health agency is about to designate aspartame, a common artificial sweetener used in a variety of foods and beverages, a carcinogen.
The International Agency for Research on Cancer (IARC), a branch of the World Health Organisation (WHO), aims to reveal the results of a new examination of the product’s safety data in mid-July. Reuters reports that the EPA will label aspartame “possibly carcinogenic to humans.” A separate WHO committee that develops recommendations on how much of a product is safe (the Joint WHO and Food and Agriculture Organization’s Expert Committee on Food Additives) plans to release guidelines on how much aspartame consumers can safely consume at the same time.
The revelation has many consumers spitting out their diet sodas — and it has also left many people perplexed about what to do with what appears to be yet another wave of misleading and conflicting information about a food product.
As we strive to figure out what to put in and what to leave out of our shopping carts, it’s important to understand how aspartame gets from the lab to our refrigerators. It’s also worth considering what distinguishes an IARC declaration about a product’s safety from assessments issued by other organisations that customers rely on to make these decisions.
Aspartame instruction has a long history of being frightening, contradictory, and difficult to believe.
It might be difficult for concerned consumers to know who to believe when it comes to the safety of aspartame. That’s because the product’s creators — and the industry that now reaps massive revenues from its sale — have worked to influence its acceptance for consumer usage since its inception.
When G.D. Searle, an American pharmaceutical corporation, attempted to get aspartame approved by the US Food and Drug Administration (FDA) in 1973, it was denied: Independent scientists claimed the substance could induce a variety of neurologic diseases, and others claimed the company’s safety testing was not totally transparent.
Ronald Reagan was elected President of the United States in January 1981. Donald Rumsfeld, the then-CEO of G.D. Searle, was on his transition team. Although an independent FDA board warned in May that the medicine could cause brain tumours, the FDA’s newly installed director ignored them, and the pharmaceutical was approved for consumer use in July.
Scientists began to express concerns about the safety of aspartame in the 1990s. A neurologist published a study that suggested the medication may play a role in the development of brain cancer in people, and the FDA’s own toxicologist expressed worries about the product’s cancer-causing potential.
The Ramazzini Institute, an Italian nonprofit research facility, began examining the drug’s effects on rats in 1997 to better characterise its danger.
This is a standard first step in determining the safety of synthetic items intended for human consumption. However, this study was exceptionally high-quality in that it involved thousands of rats and administered a variety of aspartame doses to them. The goal was to see if adding more aspartame resulted in more outcomes, a finding that would strongly show that aspartame was a cause of those outcomes rather than just a byproduct.
What the Italian scientists discovered was not encouraging: Aspartame use resulted with greater levels of malignant tumours in many organs, including the kidneys, breasts, and nervous system. These outcomes were observed even at low doses of aspartame — exposures comparable to what US and European regulators consider appropriate daily aspartame intake.
What the Italian scientists discovered was not encouraging: Aspartame use resulted with greater levels of malignant tumours in many organs, including the kidneys, breasts, and nervous system. These outcomes were observed even at low doses of aspartame — exposures comparable to what US and European regulators consider appropriate daily aspartame intake.
The discovery sparked reams of debate in the scientific literature, with different groups of academics from across the world independently re-evaluating the tissue samples from the Italian investigations and reaching their own opinions about what they revealed.
Many of the scientists who questioned the Ramazzini Institute’s results were supported by business groups that profit from aspartame consumption, including the American Beverage Association, an aspartame supplier, and the Calorie Control Council, to mention a few.
The bottom line is that you don’t need to throw all of your diet soda into the sun just yet. The upcoming guidance may nevertheless imply that part of the product is safe to consume. Furthermore, being on this planet requires us to constantly balance our drive for pleasure with the vexing truth that many enjoyable activities are associated with some form of health danger.
Consumers, on the other hand, have the right to all of the safety information that firms use when deciding whether health risks are worth taking. And the industry that manufactures and profits from aspartame has made it difficult for consumers to obtain accurate information.
We deserve more transparency, and the IARC’s recommendations are likely to provide it.
Why is the IARC’s advice so authoritative?
If the safety of aspartame has been debated for so long, why is the IARC only now issuing a statement? Although this is not totally evident, experts believe that the manner in which IARC conducts its evaluations lends its assessments a particularly high level of integrity. That implies it’s important to pay heed to the agency’s perspective on product safety.
A group of Ramazzini Institute authors issued a new study in June describing a reanalysis of their initial results using the new WHO tumour classifications. According to the authors, the study results “confirm and reinforce” their earlier conclusions.
It’s unclear whether the IARC’s announcement was motivated by this study or by some other fresh science. Whatever the reason for the timing, Erik Millstone, a longtime scholar of food safety policy and professor emeritus of science policy at the University of Sussex in England, said the IARC’s assessment is not subject to the kinds of industry conflicts of interest that challenge the FDA or the analogous European Food Safety Authority (EFSA).
When these other agencies authorised aspartame, it was “on the basis of corporate data, most of which wasn’t in the public domain,” according to Millstone. He highlighted the EFSA’s own words in a letter to the agency, showing that it utilised unpublished data in its assessment.
On the other hand, he claims that the IARC is more selective in its use of unpublished, confidential commercial data, and that it takes better care to remove those with conflicts of interest from participating in its analyses.
Millstone and a co-author examined how the European Food Safety Authority weighed the 154 research on aspartame safety when it assessed the product in 2013. About half of the research supported the safety of aspartame, while the other half suggested it could be harmful.
The government had deemed all of the harm-suggesting studies “unreliable,” but only a fifth of the safety-affirming ones. And the EPA had applied laxer quality criteria to research indicating safety than to those indicating damage. Millstone’s assessment was challenged by agency reviewers. In any case, aspartame is still available on the European market.
Millstone is not alone in believing that the IARC has greater product safety criteria than other consumer product agencies. A senior scientist from the Centre for Science in the Public Interest independently assessed the European Food Safety Agency’s aspartame clearance procedure, concluding that the agency’s results were “not sound and not supported by science; they contradict established criteria and principles by the European Food Safety Agency.”
“In the early 1970s, US standards were noticeably higher than European standards,” Millstone explained. “However, the FDA has become increasingly subordinate to commercial interests over time.”
The FDA has measures in place to avoid conflicts of interest from occurring on its advisory groups. However, a recent ProPublica investigation discovered that McKinsey consultants worked for the FDA on drug safety monitoring initiatives while also working for pharmaceutical corporations directly affected by those studies. A recent congressional bill tries to reduce such clashes.
According to Millstone, because of industry involvement in consumer safety bodies, certain government agencies have bent over backwards to dismiss undesirable results. But there’s something else going on that’s much more difficult to overcome, according to him: “institutional inertia.”
“These ostensibly authoritative institutions are loath to admit that they have ever made a mistake in the past,” he explained, “especially if the evidence demonstrating that they are making a mistake was available earlier — and they had ignored it.”
It’s natural for consumers to reject information that evokes sentiments of fear or regret — to clap hands over ears in a living manifestation of the “hear no evil” emoji. However, if you want to make judgements based on high-quality information, the IARC’s statement is one to keep an eye on.