Food Law News - UK - 1998
2 April 1998: VITAMINS - Public to be Consulted on New Vitamin B6 Limit
MAFF News Release (135/98), 2 April 1998
Public to be Consulted on New Vitamin B6 Limit
Consumers will continue to be able to buy vitamin B6 food supplements in daily doses of 10 milligrams under new regulations proposed by the Government today. Products containing up to 49 milligrams per daily dose will still be available from pharmacies.
The Government's proposed regulations are designed to reduce the risk of people suffering harmful effects from food supplements containing high doses of vitamin B6.
The consultation exercise was announced by the Food Safety Minister, Jeff Rooker and the Minister for Public Health, Tessa Jowell on behalf of food safety and health Ministers in Great Britain.
Jeff Rooker said:
"There has been a lot of misinformation in the press and from campaigners saying that we are going to ban the use of vitamin B6. We are not planning to do anything of the sort. People will still be able to buy supplements containing vitamin B6 freely but we propose to limit the strength of those sold under food law to a maximum of 10 mg per tablet. Products containing 49 mg will be available from pharmacies on request in the same way as dozens of other popular remedies. Given the strong advice that we have received from two expert committees this is a sensible precaution and will protect consumers and their health."
Tessa Jowell said:
"Many people believe that supplements containing high doses of vitamin B6 can be beneficial. However, we have received very clear advice that high doses over a long period can be harmful. The proposed regulations will ensure that high dose products are subject to a proper risk/benefit analysis under medicines legislation and are only sold under the supervision of a pharmacist or prescribed by a doctor."
The new regulations, now out for public consultation, would limit the level of vitamin B6 in supplements sold under food law to a maximum of 10 mg per daily dose. The level set is higher than that allowed in many other European countries. Such supplements will also have to carry a warning about the risk of harmful effects from high doses of vitamin B6.
Under separate proposals products containing up to 49 mg per day licensed under medicines legislation will be able to be sold, like many other medicines, under the supervision of a pharmacist. Higher dose products licensed as medicines will be available on prescription. Manufacturers wishing to license products under medicines legislation are required to demonstrate that their products meet acceptable standards of safety, efficacy and quality before they can be put on the market.
Vitamin B6, also called pyridoxine, is an essential nutrient which is involved in the metabolism of protein in the body. It is found naturally in a wide variety of foods, such as cereals and cereal products, potatoes, milk and milk products, meat and meat products, and beers. Surveys show that the average intake from everyday foods is around 2 mg a day, which is more than sufficient for most people's needs.
The independent Committee on Medical Aspects of Food and Nutrition Policy (COMA) considers 1.4 mg/day to be sufficient to meet the needs of almost all individuals. The proposed limit of 10 mg per daily dose is seven times the amount that COMA recommends.
The decision to introduce new controls follows advice from the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) and the Food Advisory Committee. Both committees, made up of independent experts who advise the Government, recommended that daily doses should be limited to a maximum of 10 mg per day.
Alternatives to statutory regulation such as a voluntary 10 mg limit by manufacturers have been rejected by the industry.
The consultation period closes on 26 June 1998. Copies of the draft regulations are available from the Ministry of Agriculture, Fisheries and Food, Room 306B, Ergon House, c/o Nobel House, 17 Smith Square, LONDON SW1P 3JR. Tel: 0171 238 6992.
The following notes are included in the News Release:
- The Government's independent Committee on Medical Aspects of Food and Nutrition Policy (COMA) advised that 1.4 mg/day is enough for almost every individual, even those with high needs. Surveys show that average intakes of vitamin B6 in the UK from food (excluding supplements) are approximately 2 mg/day.
- Some people believe that higher doses are effective in treating a range of medical conditions, including Pre-menstrual Syndrome (PMS). However, many of the benefits ascribed to vitamin B6 are not proven. High doses taken over a prolonged period are associated with peripheral neuropathy, the symptoms of which include nerve damage in the extremities which leads to tingling, numbness and clumsiness, particularly in the hands and feet. Generally, people recover once they stop taking vitamin B6.
- The proposal to introduce new controls followed a review of the safety of vitamin B6 by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) - a committee of independent experts which advises the Government on the toxicity of chemicals in food. After looking at the data from scientific literature and that supplied by industry and complementary medicine interests it concluded that the lowest dose reported to have been associated with adverse effects in humans was 50 mg per day. Allowing for a safety factor and bearing in mind supporting animal toxicity data, the COT recommended that the maximum daily intake of vitamin B6 from dietary supplements sold under food law should be limited to 10 mg per day. This was endorsed by the Food Advisory Committee which also recommended that dietary supplements containing vitamin B6 should carry a warning label about the risk of harmful effects at intakes above 10 mgs a day.
- The regulations required to introduce the new controls are being sent for comment to organisations representing consumer, industry and complementary medicines groups. A Regulatory Appraisal also considers alternatives to legislation. One of these - a voluntary limit of 10 mg per day - has already been rejected by industry. The Regulatory Appraisal includes a provisional assessment of the financial impact of the controls on manufacturers and retailers of supplements based on information provided by industry trade associations.
- The Government announced in December last year that it was planning to look at the safety of high doses of other vitamins and minerals sold as food supplements. The review will be carried out by a new ad hod Expert Group whose membership will be drawn from COT, the Committee on Medical Aspects of Food and Nutrition Policy, the Committee on the Safety of Medicines and the FAC. Observers nominated by consumer, industry and complementary medicine interests will assist with the groups work. Further details are given in MAFF news release 405/97.
- The European Commission has also been looking at the controls on vitamins and mineral supplements. Although it is not committed to introducing legislation it has issued a discussion paper on the possible harmonisation of controls. These vary widely across the European Union with many countries restricting the level of vitamins and minerals in supplements sold under food law to the recommended daily allowance or a multiple thereof. This contrasts with the UK's controls which are amongst the most liberal.
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