FSA News Item, 8 March 2006
The Food Standards Agency has updated interested parties about the 2005 Tryptophan in Foods regulations after taking independent scientific advice from the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and requests from stakeholders.
The FSA advises that the current regulations will remain in place, allowing the use of tryptophan as a food supplement at a daily dose of 220mg.
This provides consumer choice in allowing a product back onto the market, but at the level allowed, will continue to protect consumers. Higher doses will remain available under medical supervision. The legislation will remain open to review if significant new evidence becomes available.
Background
The original Tryptophan in Food (England) Regulations, prohibiting the use of tryptophan in food, were put in place in 1990 following the occurrence of Eosinophilia-Myalgia Syndrome (EMS) in people taking dietary supplements containing tryptophan in the US and UK.
The Tryptophan in Food Regulations (1990) prohibited the addition of tryptophan to foods intended for human consumption, including food supplements. There were some exemptions for foods for particular nutritional purposes and for uses under supervision of healthcare professionals.
Following receipt of a submission of scientific evidence from The Institute for Optimum Nutrition (ION), on the cases of EMS associated with the use of tryptophan supplements in October 2002, the Food Standards Agency asked the COT to review the risks to health associated with tryptophan in food supplements.
Between July 2003 and June 2004, COT reviewed current literature on tryptophan and EMS . A report by COT was published in 2004, stating that on the balance of evidence, it was likely that L-tryptophan per se was not causal for EMS , and that EMS was due to one or more contaminants.
However the COT noted uncertainties, and it cannot entirely be ruled out that the apparent epidemic may have been due to the increased use of L-tryptophan supplements and the first recognition of EMS . COT concluded that laevorotatory tryptophan (L-tryptophan) as a dietary (food) supplement would not present an appreciable risk to health, provided that it met the purity criteria specified in the European Pharmacopoeia and that the maximum recommended daily intake for an adult was 220mg.
The level and purity criteria proposed by COT was therefore adopted into the above UK legislation to reintroduce the sale of tryptophan supplements in the UK , in the interests of consumer choice and safety.
As part of the original consultation and in recent months further representations have been made to the FSA and the Public Health Minister by the Institute for Optimum Nutrition and the Health Food Manufacturers' Association (HFMA), that the maximum daily dose level should be increased to 1000mg or more.
A review of the use of tryptophan in supplements in other member states indicates that the recommended daily dose varies from 45mg to 600mg.
Some member states have prohibited the use of tryptophan as a supplement or treat it as a medicine; others have no controls in place and no information on availability of tryptophan supplements.
The FSA asked the COT to review its recommendation and any new information on tryptophan since June 2004, including levels available in other Member States, and this was considered at the COT meeting on 6 December 2005 .
The agenda, background papers and draft minutes for this meeting are also available at the link below.
The COT maintained its position. It recognised that there are uncertainties with respect to the scientific data and these have been taken into account by the COT in recommending a level for use of tryptophan in supplements.
A meeting was held at the FSA with ION and HFMA to discuss their reasons for wanting higher levels of tryptophan, which may exceed those used for medically prescribed tryptophan, where patients are closely monitored.
The Medicines and Healthcare products Regulatory Agency also thought it possible that the product would fall within the definition of a medicinal product.
After taking COT's advice and stakeholders' requests into consideration, the Food Standards Agency advises that the current Regulations will remain in place, allowing the use of tryptophan as a food supplement at a daily dose of 220mg.
This provides consumer choice in allowing a product back onto the market, but at the level allowed, will continue to protect consumers. Higher doses will remain available under medical supervision. The legislation will remain open to review if significant new evidence becomes available.