Regulatory Issues: Aspartame gets scrutinized again
The sweetener is the most scrutinized food additive present in the diet. Regulatory bodies around the world have agreed many times on its safety.
By David Joy, Contributing Editor | 08/08/2007
Hopefully you missed it, but Italy’s Ramazzini Foundation recently publicized yet another study purporting to raise concerns about the safety of the intense sweetener aspartame.
Aspartame receives an extraordinary amount of attention from conspiracy theorists and those who are generally apprehensive about food safety and the food industry. The only real ill effect that can be associated with aspartame is this unhealthy obsession to disprove its safety.
In the most recent study, rats were exposed to aspartame in feed at concentrations of either 400 parts per million (ppm) or 2,000 ppm. Male and female control groups consumed feed with no added aspartame. For rats in the treatment groups, exposure to aspartame was intended to begin in utero, with aspartame administered via feed to female breeders.
As with other Ramazzini studies, the rats were not sacrificed at the end of two years; they were allowed to live out their natural lives. The Ramazzini Foundation interprets the study results as showing a statistically significant increase in the number of cancers in rats consuming aspartame compared to those that did not consume aspartame.
A controversial aspect of the Ramazzini studies is that by continuing the studies until the rats’ natural deaths, they observe many age-related cancers that are not caused by the test substance. The influence of old age on tumor formation confounds interpretation of the study results.
Ramazzini’s methodology should be validated before any conclusions can be drawn from this type of study. We do not know whether Ramazzini’s methodology yields truly reproducible results. We also do not know what to make of a tumor that begins to form only during the final days of a rat’s natural life.
The Ramazzini Institute appears to design its studies to favor a finding of carcinogenicity. Some might regard this as perfectly acceptable. Why not put the test substance under a microscope in this manner? The answer is that many safe and beneficial food ingredients, including those that occur naturally in the diet, might appear to induce cancer when tested in this manner.
Publication of the recent Ramazzini study was accompanied by calls for the FDA to review the data. FDA reviewed a previous Ramazzini study of aspartame in 2006 and found no reason to alter its opinion that aspartame is safe. At that time, FDA requested from the Ramazzini Institute a complete set of its data and also offered to review slides of animal tissue from the study. According to an FDA statement, Ramazzini supplied FDA with only a portion of the data requested and did not agree to FDA’s review of the slides.
The European Food Safety Authority (EFSA) also reviewed the previous Ramazzini study of aspartame and likewise concluded that it contained no information that called into question the safety of aspartame. EFSA went so far as to publish a 44-page opinion explaining its views.
Considering Ramazzini’s apparent desire to label substances as carcinogens, considering its tendency not to share its raw data openly with independent reviewers and considering that its basic methodology is unconventional by today’s standards, FDA should not devote much time or attention to this latest study.
Whether or not FDA attempts a complete review of Ramazzini’s latest study, aspartame is already the most scrutinized food additive present in the diet. Food safety regulatory bodies around the world have agreed many times on its safety.
The safety of aspartame is even supported by a human epidemiology study published in 2006. This study examined the eating habits of about a half a million older Americans and compared the occurrence of lymphoma, leukemia and brain cancer among consumers and non-consumers of aspartame-containing beverages. No correlation was found between aspartame consumption and risk of these cancers over a 15-year period.
Surely, this is more compelling data than a rat feeding study carried out under an unconventional protocol.
Unfortunately, certain consumers will remain distrustful of aspartame and will regard any honest and straightforward discussion of its safety as being inappropriately influenced by the food industry.
What is it about aspartame that has brought this about?
All food additives are likely susceptible to this type of problem for at least two reasons: fear mongering is often profitable, and, to paraphrase Mark Twain, an unfortunate misperception can get half way around the world before the truth even gets its boots on.
David Joy is a partner in the Washington, D.C., office of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.