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Warning On Outerspace Medicine One4b

29 January 2001

DIRECTOR GENERAL OF HEALTH PRIVILEGED STATEMENT UNDER SECTION 37 OF THE FOOD ACT 1981

Director General of Health, Dr Karen Poutasi, today warned the public not to consume any product containing 1,4 butanediol because of the potential risk of severe adverse reactions, including death.

In New Zealand there have been reports of three people becoming unconscious as a result of taking One4b, a product that contains 1,4 butanediol.

One4b is currently being sold by an Auckland-based organisation called Outerspace.

The Ministry of Health is currently investigating the organisation and suspects that the sale of One4b breaches the Food Act 1981, and possibly other legislation such as the Medicines Act 1981. The Ministry is working closely with the Police.

While the investigation is underway, the Ministry of Health is acting to stop distribution of this product because of the potential harmful effects of this substance.

The United States Federal Drug Administration warns 1,4 butanediol is a chemical that can cause dangerously low respiratory rates, unconsciousness, vomiting, seizures and death.

The effects of ingesting 1,4 butanediol are potentially dangerous as it contains chemicals that produce a powerful hypnotic which can produce unconsciousness and respiratory depression which can be fatal. The substance also increases the effects of alcohol and/or sedative medications. The risk of severe respiratory depression and collapse are accentuated when 1,4 butanediol is taken in combination with alcohol or any central nervous system depressant drugs.

Anyone who has products containing 1,4 butanediol should contact a health protection officer at the public health service at their nearest hospital where they can arrange for safe disposal.

The Police advise that people who have purchased One4b have not committed an offence.


signed by:
Dr Karen O Poutasi,
Director-General of Health

For more information contact:

Selina Gentry, Media Advisor, ph: 04-496-2483, pager: 025-277 5411 Internet address: www.moh.govt.nz/media.html

Further Information about the FDA warnings go to: http://www.fda.gov/bbs/topics/ANSWERS/ANS00953.html

Background Information:

Misuse of Drugs Legislation

In mid November 2000 the Misuse of Drugs Amendment Act was enacted.

This new law enables Parliament to respond far more quickly to emerging drug threats than was previously the case. Previously, scheduling of substances under the Act could only be done by way of introducing draft legislation to Parliament. The passage of amendments to legislation can take some time.

In future, scheduling of substances will be able to be undertaken by the Governor-General issuing Orders-in-Council on the advice of the Minister of Health.

Expert Advisory Committee on Drugs

The Act establishes a simple and expeditious process to classify drugs. A vital part of this process will be the Expert Advisory Committee on Drugs (EACD), which will be established to advise the Minister of Health. The EACD will:

carry out medical and scientific reviews of controlled drugs and other narcotic or psychotropic substances make recommendations to the Minister about whether and how such substances should be classified, and the level at which the presumption for supply should be set for any substances; increase public awareness of its work by (for instance) releasing papers, reports and recommendations

The EACD will comprise up to 10 people and include a variety of professional experts. The key areas of expertise being sought include: pharmacology, toxicology, drug and alcohol treatment, psychology, and community medicine. A person representing the views of consumers of drug treatment services will also be appointed. In addition, government officials with expertise in public health, the appropriateness and safety of pharmaceuticals and their availability to the public will be appointed along with representatives from the New Zealand Custom Service and the Police.

Nominations for the committee were called over Christmas. Advice will be provided to the Minister of Health in the next couple of weeks on the possible composition of the Committee.

Criteria for Classification Decisions

The Act now requires classification of illicit drugs to be based on the risk of harm to individuals or society. Drugs posing a:

very high risk of harm should be scheduled as 'Class A'. high risk of harm should be scheduled as 'Class B. moderate risk of harm should be scheduled as 'Class C'.

When considering a particular drug, the EACD will be required to consider the following matters:

the likelihood or evidence of drug abuse the specific effects of the drug the risks to public health the therapeutic value the potential to case death the ability to create physical or psychological dependence the international classification and experience any other matters

Timing for reviews of first substances Government agencies are developing advice on a number of substances that we are obliged under international conventions to classify, or about which safety concerns have been raised recently. These substances will be considered by the EACD and recommendations made on their classification.

The committee will meet as soon as it is established and advice will be provided to the Minister as soon as possible thereafter.

Background Information about Dietary Supplements

A dietary supplement contains substances normally found in food (such as vitamins and minerals) but presented in a concentrated form, such as a capsule. It is taken by mouth to supplement the dietary intake and maintain good health.

Dietary supplements are regulated under the Dietary Supplement Regulations 1985, made under the Food Act 1981.

There is no pre-market approval process for dietary supplements but manufacturers have an obligation under the Food Act 1981 to ensure their products are safe for human consumption.

As with medicines, dietary supplements should be taken in line with the doseage instructions on the packet. Dietary supplements are required to be labelled with daily dose instructions and a warning where a danger exists if an overdose is taken.

Under the Act it it illegal to sell a product as a food if it is harmful to health.

END

Selina Gentry Media Liaison Communications Corporate & Information Directorate Ministry of Health DDI: 04 496 2483

mailto:selina_gentry@moh.govt.nz


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