If a sugar substitute is on the market, doesn’t that mean it has been tested and approved by the government as safe?
Almost all the safety testing of most sugar substitutes, like other food additives, is conducted by the manufacturers (or companies hired by the manufacturers). Many additives, including sugar substitutes, have not been thoroughly tested. And not all sugar substitutes and other additives have been formally approved by the government.
Thanks to a loophole in the law, in some cases, the manufacturers (or people hired by the manufacturers), not the government, can declare that an additive is “Generally Recognized As Safe” (GRAS) and start adding it to food. The company may notify the government that it has determined that an additive is safe (GRAS), but even that isn’t required.
However, all sugar substitutes used in the United States are known to the government. The government recommends the kinds of testing companies should do to demonstrate scientifically that a substance is “generally recognized as safe,” but in practice, usually not all the recommended tests are conducted.
That said, some sugar substitutes and other additives have gone through a more formal government approval process. But as it turns out, even that is no guarantee of safety. Several food additives, including several sugar substitutes, that have gone through a formal government approval process are the subject of swirling controversies and are in our “avoid” category.
Are animal studies that use extremely high doses relevant to people?
Chemicals usually are tested for an ability to cause cancer by feeding large dosages to small numbers of rats and mice. Large dosages are used to compensate for the small numbers of animals that can be used (a few hundred is considered a big study, though it is tiny compared to the U.S. population of more than 315 million people). Also, the large dosages can compensate for the possibility that laboratory animals may be less sensitive than people to a particular chemical (as happened with thalidomide).
Some people claim that such tests are improper and that large amounts of any chemical would cause cancer. That is simply not true. Huge amounts of most chemicals do not cause cancer. When a large dosage causes cancer, most scientists believe that in most cases a smaller amount would also cause cancer, but less frequently.
It would be nice if lower, more realistic dosages could be used, but a test using low dosages and a small number of animals would be extraordinarily insensitive. And studies that used hundreds of thousands of animals would be too costly. Ideally, scientists would use quick, economical test-tube tests—not using any animals—that could accurately identify risky chemicals.
While some progress has been made in that direction for a number of health problems, when it comes to cancer, those tests have not prov¬en reliable. Thus, the standard high-dosage cancer test on small numbers of animals is currently the only practical, reasonably reliable way to identify food additives (and other chemicals) that might cause cancer.
Other relevant links:
• What you need to know about sweetness enhancers. See: What are Sweetness Enhancers, and How Do They Replace Sugar in Food?
• Important infographic about the FDA and food additive regulation. See: Not So Safe: How the FDA Lets Food Safety Slip Through the Holes
• Here are the sugar substitutes we have found to be safe. See: Sugar in Food: Sugar Substitutes that are Safe