Peer probes FSA aspartame study as costs double

The study - commissioned by the Food Standards Agency last year - is not testing the safety of aspartame, "which has already been established​", but is designed to address "anecdotal reports​" from consumers claiming to have had adverse reactions to the high intensity sweetener (stomach aches and headaches).

However, Lord Clement-Jones (pictured) questioned whether the study represented an appropriate use of taxpayers’ money given the many competing demands on the FSA’s budget.

He was speaking to FoodManufacture.co.uk after it emerged that the scope of the study has just been extended, increasing the total cost to more than £322,000, despite the fact that only half of the target number of volunteers has been secured.

He added: "I​ cannot understand why the FSA is promulgating this kind of research​. I have asked several questions about how they are prioritising their funds when the number of people ​[claiming adverse reactions] is miniscule and the FSA is having to make substantial cuts in its budget​."

The fact that academics at the University of Hull conducting the study had struggled to attract enough participants also raised serious questions about the genuine scale of the problem the FSA was seeking to probe, he added. "I would just like the money to be spent on something more useful."​

Volunteers coming forward 'more slowly than anticipated'​

Responding in writing to a question tabled by Clement-Jones last month about the progress of the study, Parliamentary under-secretary of state, Department of Health, Earl Howe admitted: “Volunteers are coming forward to participate in the FSA-funded study on aspartame more slowly than anticipated. ​

 “As such the FSA is currently negotiating to extend the end date for this work by six months with the contractors at no additional cost. It is anticipated that the study will now complete in summer 2011.” ​

To date, just 25 self-diagnosed aspartame-sensitive individuals and 25 ‘controls’ have completed the study, which was initially targeting 100 volunteers (50 aspartame-sensitive people and 50 controls), FoodManufacture.co.uk understands.

Rising costs​

The cost of the study had also increased, said Earl Howe. “To date, £193,763 has been spent on this work and in total the project will cost the FSA £287,693 in addition to £35,000 to develop an appropriate cereal bar. The study was originally costed at £150,728. ​

 “Following consultation of the European Food Safety Authority's national experts on aspartame, it was agreed that to maximise its usefulness the research should also investigate aspartame metabolism by analysing samples taken from the participants. This extension will result in an additional cost of £136,965.”​

Appropriate use of taxpayers' money?​

The FSA’s decision to conduct the study has puzzled many industry observers given that EFSA recently concluded there was "no need to further review the safety of aspartame​" and no reason to revise acceptable daily intakes.

Indeed, FSA chief executive Tim Smith, who took the helm in April 2008, himself recently highlighted the aspartame study as an example of where the agency may not have allocated resources appropriately.

Speaking at Food Manufacture’s Emerging Food Safety Issues conference​ in London in October, Smith said: “Looking back, there has been a bit of a mismatch between the real risks out there and the resources​ [that the FSA has] allocated to them. ​

"Look at aspartame for example. We spent quite a bit of money looking at aspartame, but were we spending nearly enough on the real issues of food-borne illness? No we weren’t.”​

Sensitivity, not safety​

The study is being conducted by the University of Hull in collaboration with the Hull York Medical School and Hull and East Yorkshire Hospitals NHS Trust.

Project leader Professor Stephen Atkin told FoodManufacture.co.uk: “This study is not to determine whether aspartame can be consumed safely; this has already been established by the FSA and EFSA, but rather to see whether certain people are sensitive to it."​

The study was looking at immediate reactions to aspartame, and not the effects of sustained exposure, he added: "Subjects eat a bar that may or may not contain 100mg of aspartame (equivalent to that in a can of soft drink) and stay in the department for four hours, filling in symptom sheets. ​

"Blood is taken at the beginning and end and a urine specimen taken at the beginning, the end and after 24 hours. After a minimum of one week, subjects come back for the next bar."​

It had been a struggle to secure sufficient numbers of 'aspartame sensitive' volunteers, he admitted. "Initially 149 volunteered but 141 withdrew."​

As to whether the study represented a good use of taxpayers' money, he said: "It is the responsibility of the FSA to consider the concerns of the public and that is what this study is doing."​

Increasing knowledge​

FSA chief scientist Dr Andrew Wadge said: "The agency’s view remains that aspartame can be consumed safely and we are not recommending any changes to its current use. ​

"However, we know that some people consider that they react badly to consuming this sweetener so we think it is important to increase our knowledge about what is happening."​