The European Food Safety Authority is moving up a review of the artificial sweetener aspartame originally scheduled for 2020. In doing so, EFSA will be writing another chapter in one of the longest running controversies over the safety of a food product.
The low-calorie, intense sweetener is used in beverages, desserts, dairy, chewing gums, and energy and weight control products, and probably is known best as a tabletop sugar substitute.
EFSA’s re-evaluation of aspartame, now scheduled for release in September 2012, is going to include more than 600 datasets that the European agency has collected since putting out a call for scientific data on the sweetener. The re-evaluation, which will include the 112 original studies, was accelerated at the request of the 27-nation European Commission.
The Food and Drug Administration first approved aspartame for use in the United States in 1974. More than 100 other regulatory agencies followed suit, approving aspartame for human use in their countries; European approval came in the early 1980s. But aspartame has continued to generate controversy in each of its four decades in the marketplace.
The EFSA has conducted four previous reviews of aspartame for the European Commission, repeatedly finding there was no reason to remove it from the market.
“Each time, the Authority reconsidered the need to re-evaluate the work on aspartame previously conducted by the Scientific Committee on Food (SCF),” says an agency statement. “Had any evidence been found that would have led EFSA’s expert Panel to reconsider the safety of aspartame, a re-evaluation would have been immediately initiated.”
In making a public call for scientific data, the ESFA may be making its latest review more transparent than the others.
It was Searle — the pharmaceutical company whose name was retired through a series of mergers and acquisitions — that invested in aspartame and readied it for the market as NutraSweet beginning in 1965. The U.S. Food and Drug Administration’s 1974 approval was contested, leaving Searle unable to break into the artificial sweetener market until 1981.
FDA spent much of the 1970s with its food additive approval process under scrutiny. Adding to the problem was that the safety of two earlier sugar substitutes, cyclamate and saccharin, was being questioned. U.S. sugar interests, however, apparently funded some of that research.
The Government Accountability Office (GAO), which conducts management audits for Congress, eventually found that FDA’s food additive process was properly followed.
But it was only the end of the beginning of the many debates about aspartame. A few of the more legendary controversies include:
— Betty Martini – Still active through her website, the aspartame opponent has made unsubstantiated claims that taking the substance in normal doses will bring about everything from blindness to depression and from birth defects to death.
— 60 Minutes – The popular CBS news magazine in 1996 re-visited the charges from 20 years earlier the Searle had withheld and falsified safety data to cover up possible effect on brain tumors.
— “Nancy Markle” – An Internet chain hoax, which some claim was written by Betty Martini, made rounds in late 1990s, blaming aspartame for Gulf War Syndrome, lupus and other problems for which there has been no basis.
— The Searle Conspiracy — FDA Commissioner Arthur Hall Hayes, who made the critical decision permitting aspartame to be used in dry foods in 1981, left the agency in 1983 for a job with Searle’s public relations agency. This happened after one of Searle’s law firms hired Samuel Skinner, the former U.S. District attorney for Northern Illinois, as FDA sought a grand jury investigation into whether Searle had falsified or partially concealed aspartame study data just before the statue of limitations expired. The Hayes/Skinner job decisions fueled conspiracy theories.
Most aspartame intake comes from diet soft drinks. Consumption studies in the U.S., Australia and Europe have found that even those who drink multiple diet soft drinks remain well below the safe levels for acceptable daily intake (ADI) of aspartame. That level is 50 milligrams per kilogram of body weight.
Although reports that aspartame might be a possible carcinogen were circulated in the 1970s and 1980s, no association has been found between aspartame and cancer, according to reviews by FDA, EFDA, and the National Cancer Institute. (FDA, EFDA, and the National Cancer Institute have discounted studies by the European Ramazzini Foundation that found malignancies in rats.)
The EC governs the European Union’s functions with a staff of about 38,000 including the EFSA from headquarters in Brussels and Luxemburg. The 27 EU countries share a common market and the euro currency.