The data in question was published in the peer-reviewed International Journal of Occupational and Environmental Health on January 29 by Dr Morando Soffritti, director of the Ramazzini Institute in Bologna, Italy, who has been arguing for years that sucralose “induces a dose-related incidence of leukemia in male mice”.
‘This study is just not credible’
According to Gelov - who notes that sucralose has the thumbs up from the FDA, EFSA, Health Canada the WHO and the U.S. National Cancer Institute – the Ramazzini study does not in fact “show a dose-related risk of cancer in mice and, in fact, for groups of female mice reports lower cancer incidence”.
The Ramazzini Institute “has a history of conducting studies that are not reliable for safety assessments”, claims Gelov: “The study is just not credible and contradicts the overwhelming body of scientific research proving the safety of sucralose.”
He also attacks journalists for misrepresenting the results: “It was reported that mice … were given the equivalent of 10 cans of diet soda per day. The fact is they were given the equivalent of 70–2,000 cans per day depending on the group. This is equivalent to 400-12,000 SPLENDA packets per day, every day, for life. For comparison, the average frequent SPLENDA user consumes 3-5 packets per day.”
Dr Soffritti: Study ‘does not support previous data that sucralose is biologically inert’
According to the Ramazzini study* – which is discussed in detail HERE on our European site - five groups of male Swiss mice (457 in total) and five group of female Swiss mice (396 in total) were given sucralose prenatally (ie. via the mother's feed) and then throughout their lifespan, at concentrations of 0, 500, 2,000, 8,000, and 16,000 ppm.
The authors found a “significant dose-related increased incidence of males bearing malignant tumors (p < 0.05) and a significant dose-related increased incidence (p < 0.01) of hematopoietic neoplasias [which typically manifest as leukemias, lymphomas, and plasma cell disorders] in males, in particular at the dose levels of 2,000 ppm (p < 0.01) and 16,000 ppm (p < 0.01)”, a result that does “not support previous data that sucralose is biologically inert”, he said.
The results do not correlate with a 2000 study on CD-1 mice by Mann et al, which found that sucralose administered in doses of up to 30,000ppm "did not increase the incidence of any tumor or influence the types of tumors observed".
However, Dr Soffritti noted that the Mann et al study involved fewer subjects, began when the mice were adolescents, and finished when they were 110 weeks. Meanwhile, the mice on the sucralose diet also lost weight during the Mann study, which could factor into the results, Dr Soffritti argued: "It has long been known, of course, how body weight may influence the incidence of malignant tumors in humans and in mice and rats."
Addressing criticism of his decision to feed the animals throughout their lifespan, Dr Soffritti told FoodNavigator: "It is crucial to prolong observation until extreme old age.
"Regulatory agencies like the FDA and EPA, which demand that chronic animal studies be terminated after two years, may lose information that is important for extrapolation of the data from animals to humans, especially in the cases of carcinogenic agents with a long latency time (weak carcinogens).”
FDA: Significant shortcomings in the design, conduct, reporting in work on other sweeteners
In a 2011 review, the European Food Safety Authority (EFSA) drew attention to a series of flaws in Dr Soffritti’s work on aspartame and concluded it did not warrant a change to the sweetener’s regulatory status.
The FDA, meanwhile, identified “significant shortcomings in the design, conduct, reporting, and interpretation” of his work in 2007.
Speaking to us in 2013, however, CSPI senior scientist Lisa Y. Lefferts, MSPH, said a 2011 review by the [US government-backed]National Toxicology Program/Environmental Protection Agency of Ramazzini’s lab “found it to be a well-organized, clean facility that applied meticulous detail to the necropsy and to the recording, collecting, and archiving of materials and tissues and in general found everything there to be in good order”.
CSPI: Ramazzini study is ‘more powerful than the industry-funded studies’
Sucralose, which PepsiCo recently began using as the primary sweetener in Diet Pepsi after ditching aspartame, is on the ‘unacceptable ingredients lists’ of several food retailers and manufacturers, despite its seal of approval from all of the major health and regulatory agencies.
It is also on a list of ingredients to ‘avoid’ cultivated by the Center for Science in the Public Interest (CSPI), which claims that the Ramazzini study “is more powerful than the industry-funded studies, which tested fewer animals, started exposing the animals beginning at adolescence as opposed to in utero, and ended earlier in the animals’ lives.”
However, the CSPI also notes that “the risk posed by over-consumption of sugar and high-fructose corn syrup, particularly from soda and other sugar-sweetened beverages, of diabetes, heart disease, and obesity, far outweighs the cancer risk posed by sucralose and most other artificial sweeteners.”
In a recent court order banning Chobani from stating or implying in ads that some of rival Dannon’s products are unsafe or inferior because they contain sucralose, a New York judge said Chobani was not permitted “to disseminate the false message that sucralose renders Dannon's products unsafe to consume.”
However, Chobani’s chief marketing and brand officer Peter McGuinness observed that while Chobani had lost this particular legal battle, it was winning the war in the broader public debate over 'natural' vs 'artificial' ingredients.
What is sucralose?
Approved in the US in the late 1990s, zero-calorie sweetener sucralose is around 600 times sweeter than sugar and is used in soft drinks, baked goods, ice cream, tabletop sweeteners, and other products. Unlike aspartame, it does not break down at high temperatures and can be used in baked goods.
While it is made from sugar, the sugar molecule is chemically modified via a multi-step process that selectively replaces three hydrogen-oxygen groups on the sugar molecule with three chlorine atoms to make sucralose, which is classed as an artificial sweetener.
In the US, the acceptable daily intake set by the FDA is 5 mg/kg body weight/day. This means a 150lb person can consume 340 mg of sucralose every day over his or her lifetime without adverse effects.
* Sucralose administered in feed, beginning prenatally through lifespan, induces hematopoietic neoplasias in male swiss mice, International Journal of Occupational and Environmental Health (Authors: Soffritti M., Padovani M., Tibaldi E., Falcioni L., Manservisi F., Lauriola M., Bua L., Manservigi M. & Belpoggi F)