Splenda = A Spoonful of BILE

November 7, 2006

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A Spoonful of BileFebruary 15 2005Trevor ButterworthThe Sugar Association pays for a "consumer" website to scare the public with pseudo-science about Splenda.

Splenda, the no-calorie sweetener, is not so splendid if you happen to be in the business of sugar. In December, the Sugar Association filed a lawsuit against Splenda's maker, McNeil Nutritionals, a division of Johnson and Johnson, charging that Splenda had "gained a competitive advantage by falsely advertising itself in a manner designed to imply that is natural, healthy and shares sugar's sweet taste." As James Murphy, Counsel for the Association, told Reuters, "We feel the public needs to be aware that Splenda is an artificial chemical sweetener. Splenda is created with chlorine, and the final product does not have sugar in it."

Splenda just happens to be fastest growing sugar–replacement sweetener in the market. General Mills, for instance, blends sugar and Splenda to reduce the sugar content of Cocoa Puffs and other cereals by 75 percent; and recently, Coca Cola announced that it would use Splenda to sweeten a new version of Diet Coke.

Not surprisingly, Splenda's success has gone down like a spoonful of bile with older sugar-substitute manufacturers too. Last November, Merisant Worldwide Inc, which distributes Equal, filed a lawsuit against McNeil Nutritionals, claiming false advertising (the line "it's made from sugar, so it tastes like sugar"). As the Chicago Tribune reported on Dec 2, Splenda has cut sales of Equal in half: "The market for Merisant's little blue packets has skidded to just 20 percent of sales to U.S. retailers and coffee shops, down from 40 percent before Splenda's arrival."Sucralose, the scientific name for Splenda, is created by substituting three chlorine atoms for three hydroxyl groups in a sucrose molecule (sucrose is the chief chemical component of cane or beet sugar). This sounds radical, but it is far from clear that McNeil have pimped the sucrose molecule so much that its fundamental relationship to sugar is unrecognizable. In fact, Splenda wouldn't taste like sugar if sucralose didn't retain much of the structure of sucrose. Think of it in terms of putting spoilers and a turbo charger on a Ford Focus. It looks pretty much like a Ford Focus… until you put your foot down.

While it will be up to the courts to decide where "natural" ends and "artificiality" begins, this battle over semantics is of questionable scientific relevance. We don't exactly walk into the fields and rip up some sugar cane to sweeten our morning coffee, do we? What is significant is whether a new food additive is safe or not. And this is where the Sugar Association's response to Splenda's success takes a decidedly unscientific turn. As the National Journal reported on Jan 22, The Sugar Association hired the Washington area PR company Qorvis Communications to create a web site,

The Truth About Splenda (TTAS).Predictably, the truth about Splenda– as Qorvis see it – is ghastly. In the section "Fact versus Fiction," the following "facts" about Splenda are all claimed as "fictions":

Splenda is safe to eat, even for children. Splenda has been thoroughly tested. Products made with Splenda do not need warning labels. Once eaten, Splenda simply passes through the body. The chlorine found in Splenda is similar to that found in other foods we eat.

Unfortunately, the average consumer reading "The Truth About Splenda" isn't going to have access to the safety research to see if what they've just read is indeed true, or merely a confection of half-truths, specious logic and innuendo. Which is why it is worth looking at some of these supposed "fictions" in detail.

Fiction: Splenda is safe to eat, even for childrenFact: There are no conclusive tests that support this statement. Again, there have been no long-term human studies conducted to determine the potential health effects of Splenda on humans, including children. But, animal tests reviewed by the FDA uncovered side-effects as a result of eating sucralose. The FDA witnessed damage to the immune system, including shrunken thymus glands and decreased white blood cell counts, enlarged livers, enlarged kidneys, and low birth weight in the animal studies they reviewed. Until long-term human studies are conducted, no one will know for sure whether Splenda is really safe or unsafe for humans to eat.

This is highly disingenuous. If these "side effects" were causally linked to sucralose, then the Food and Drug Administration would not have approved it for human consumption in 1998 – a truth about Splenda The Truth About Splenda conveniently overlooks. (Even the European Union, which has taken a hyper-cautious line on human exposure to chemicals – managed to approve Splenda in 2004.)

So where did these "side effects" come from? One of the issues that emerged in animal studies of sucralose (and the trigger for extensive extra testing) was that giving rats very high doses on a daily basis led to marked loss of appetite. Researchers determined that it was the reduced food consumption and not sucralose which produced changes in the thymus glands and reduced white blood cell counts [Grice, Goldsmith "Sucralose — An Overview of the Toxicity Data, Food and Chemical Toxicology 38 (2000)].

Grice and Goldsmith also noted that research showing a statistically significant increase in the incidence of "enlarged kidneys" in female mice had no toxicological relevance to humans. And in terms of reproductive effects, there were only "minor developmental changes" in the offspring of rats dosed with "40,000 times the estimated maximum [human] intake level in the United States." As for the imputation that Splenda is unsafe for children, according to McNeil Nutritionals, a 20lb child would have to drink over 450 12-ounce drinks sweetened with Splenda per day to ingest the highest doses found to be harmless in animal studies.

Fiction: Splenda has been thoroughly testedFact: There has not been a single long-term human study to determine the potential health effects of Splenda on people. The FDA relied on a few short-term tests when it reviewed the safety of Splenda for human consumption. Worse, these human tests were all conducted by the manufacturer of Splenda, hardly an unbiased source. The vast majority of tests reviewed by the FDA to determine whether Splenda was safe for human consumption were conducted on animals, including rats and rabbits.

What The Truth About Splenda claims is some sort of scam is in fact normal protocol. Any manufacturer that creates a new food additive has to pay for rigorous testing by independent experts in universities and research labs, which is, in turn, carefully examined by the FDA. Animals are used because it is generally considered unethical to test new substances on people. Sucralose was tested on human volunteers only after the animal tests showed it to have very low toxicity. These tests found that humans absorb only a tiny amount of sucralose and that it does not accumulate in the body even when absorbed in much larger quantities than anyone would be likely to consume in the real world. In 2000, Food and Chemical Toxicology published the results of two randomized control trials where healthy human adult volunteers were tested for tolerance to sucralose. "No adverse experiences or clinically detectable effects were attributable to sucralose in either study," concluded the researchers. [baird, Repeated dose study of sucralose tolerance in human subjects.] "Sucralose was well tolerated by human volunteers in single doses up to 10mg/kg/day (milligrams per kilogram of body weight per day) and repeated doses increasing to 5mg/kg/day for 13 weeks. Based on these studies and the extensive animal safety database, there is no indication that adverse effects on human health would occur from frequent or long-term exposure to sucralose at the maximum anticipated levels of intake." (Note that according to Market Research Corporation data, the estimated mean consumption of sucralose for all ages would be 1.1mg/kg/day.)

Fiction: Products made with Splenda do not need warning labelsFact: Splenda is found in nearly 3,500 food products and amazingly, not all of these products list Splenda as an ingredient, and none of them say the product contains chlorine. Furthermore, none of the regulatory agencies or scientific review bodies that have confirmed the safety of sucralose require any warning information to be placed on the labels of products sweetened with sucralose.

Given that no regulatory body has found any reason to suspect that Splenda is unsafe for human consumption, and given that TTAS has not advanced any scientific evidence as to Splenda being a health risk, why should there be a warning label? As for highlighting the presence of "chlorine" in Splenda, as if this is something the public should be concerned about, it's a canard; the "chlorine" in Splenda is not absorbed by the body – unlike, say, the chlorine in potato chips or other common food items. If "The Truth About Splenda" seems like a desperate and transparently shoddy attempt to cast doubt on the research and regulatory mechanisms which found Splenda safe, it is. But it's also a clever tactic. Throwing virtual mud on the Internet means that such nonsense will stick around forever; in fact, a quick Google search shows that The Truth About Splenda has already spread like kudzu. And once the public is alerted to a "controversy" over the safety of a product, no matter how spurious or unscientific the charge, there's no going back. Most people tend to think about health risks as they do about celebrity gossip —"there 's no smoke without fire!" The irony here, is that everyone loses from a PR campaign that plays fast and loose with science – even the sugar industry, which is now being sued by McNeil Nutritionals, the maker of Splenda, for conducting a "malicious smear campaign."

http://www.stats.org/stories/spoonful_bile_feb15_05.htm