The U.S. Food and Drug Administration is reviewing the findings of a recent study that found the popular chemical sweetener sucralose damages DNA, according to a lengthy email response from an agency spokesperson to The Epoch Times.
It said the agency does not generally comment on specific studies but evaluates them among a “body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
“The FDA is reviewing the study findings,” it went on to say. “FDA scientists evaluate all relevant literature and use a weight-of-the evidence approach to our assessment. For most additives, including sucralose, there are dozens of studies available.”
It’s unclear what the review will entail or whether there will be any findings released to the public. The FDA did not reply to follow-up questions before publication.
The most popular brand of sucralose is Splenda, consumed by 51.4 million Americans in 2020 among more than 168 million people using sugar substitutes. The brand sells a variety of sweeteners, as well as its own tea and protein shake for diabetics.
The study prompting the review, published May 29 in the Journal of Toxicology and Environmental Health, suggested that sucralose could be genotoxic, meaning it breaks up DNA, when it metabolizes. The study’s corresponding author, whose initial studies on the artificial sweetener found it can damage gut microbiota, called on the FDA to re-evaluate its use and at least label the product with a warning.
When the sweetener is digested, previous rat studies show it forms a metabolite called sucralose-6-acetate (S6A). But the product itself has also been found to contain trace amounts of sucralose-6-acetate, according to the study. Researchers exposed human cells to sucralose-6-acetate and observed that it increased expression of genes associated with inflammation, oxidative stress, and cancer.
Splenda Responds
A spokesperson for Heartland Food Products Group, which makes Splenda, issued this statement: “The FDA and health organizations across the globe have confirmed that sucralose is safe after years of research and over 100 studies. The researchers behind this flawed study did not test Splenda or find S6A in Splenda because there is no S6A in Splenda, which is manufactured in the U.S. and rigorously and routinely tested.
“Any suggestion that this study proves that S6A poses a health risk to those who consume Splenda is false and irresponsible fearmongering. Millions of consumers rely on Splenda as an important part of achieving their health goals and they deserve accurate information, supported by sound science, so they can safely manage their personal health.”
Sucralose, which is about 600 times sweeter than table sugar, is used in 15 food categories including beverages, baked goods, gum, gelatins, and frozen desserts. Its food additive petition to the FDA was approved in 1998.
Post-Market Reviews
The FDA reviews food ingredients after they are on the market in two ways: through a petition or notice to change regulations and through its own initiatives.
“When FDA scientists identify new research that calls into question the safety of a food ingredient or food contact substance, we reassess and take action as needed,” an FDA spokesperson said in the statement.
Study author Susan Schiffman, who is an adjunct professor in the joint department of biomedical engineering at North Carolina State University and the University of North Carolina–Chapel Hill, was surprised to learn the FDA will review the study given years of “total runaround” she said the agency has given her previous work.
She thought her first study on the gut microbiome would get the FDA’s attention because of her own absolute surprise. Years later, she had an overview study of biological issues with sucralose that got nearly 44,000 views. “I think I spent about two days trying to get a hold of someone, and I never did,” Schiffman said. “I want them to do their job and protect the public. At the very least, this product has got to have a warning on it.”
She has never filed a formal petition, and the FDA confirmed there have been no formal requests that the agency amend the food additive regulations regarding the use of sucralose in food. But Schiffman has no doubt that sucralose is metabolizing in the intestines based on earlier research in rats.
One issue researchers face, she said, is being ethical and careful with studies—both to follow FDA regulations and to avoid exposing humans to a compound that can cause severe health problems.
“I did exactly the kind of studies they claim should be done,”Schiffman said.
Toxic Concerns
The European Food Safety Authority has a threshold of toxicological concern for all genotoxic substances of 0.15 micrograms per person per day. The Epoch Times asked the FDA if such a standard exists for the United States. No direct answer was given, but links to a document appear to indicate the same standard.
In its statement, the FDA said it “has a more stringent standard than the European Food Safety Authority with respect to food additives found to be genotoxic carcinogens.”
It referenced statutes saying that food additives cannot be found to induce cancer, whether ingested by man or animal, after appropriate testing.
The FDA spokesperson said the provision, referred to as the Delaney Clause, “limits the FDA’s discretion to determine the safety of food additives, in that it prevents the FDA from finding a food additive to be safe if it has been found to induce cancer when ingested by humans or animals, regardless of the probability, or risk, of cancer associated with exposure to the additive or of the extent to which the experimental conditions of the animal study or the carcinogenic mode of action (e.g., genotoxic or nongenotoxic) provide insight into the health effects of human consumption and use of the additive in question.”
More Funding for Reviews
Finally, the FDA said greater funding is needed so that it is able to conduct complete reviews of chemicals after they are approved and on the market. It is hoping to adopt a new approach to reviewing after-market food chemicals, which will rely on industry data and funds for additional staff.
“This, combined with additional authorities to require industry to share new data and information, would allow the FDA to prioritize based on risk and better target our resources toward chemicals that we think warrant in-depth post-market review,” the spokesperson said.
Schiffman said sucralose warrants immediate consideration because of the millions of people worldwide who consume it, including some who use it in multiple products daily.
“The initial data [used to approve sucralose] were incorrect, and in this way, you can’t fault the FDA. Now, there should be a relative priority to look at it,” she said. “It doesn’t even take a day to look through the literature and see there’s a problem.”