Revoked interim product approvals – Official questions and answers

Written by Legal Highs NZ on . Posted in Interim Licences, Interim Product Approvals, Psychoactive Substances

The Psychoactive Substances Regulatory Authority has revoked the interim approval and issued a recall for five psychoactive products.

The Authority have released an official questions and answers page on their website, you can see it on the official website or click here for a local mirror.

The Psychoactive Substances Regulatory Authority (the Authority) has revoked the interim approval and issued a recall order to the product applicants of the following five psychoactive products: Karma P0004, Anarchy P0002, Voodoo P0003, AK47 P0008, Northern Lights Primo P0038.

These five psychoactive products are now banned under the Psychoactive Substances Act (the Act) and the Authority has issued a recall order to three companies requesting a full recall of these products.

If people have bought products and are concerned about their health effects they should contact the Healthline 0800 611 116, their nearest medical centre, or the National Poisons Centre 0800 POISON (0800 764 766) – this number is printed on all approved products.

Further information is provided in the questions and answers below or for further information please email psychoactives@moh.govt.nz

Questions and answers

  1. What action has the Psychoactive Substances Regulatory Authority taken?
    The Psychoactive Substances Regulatory Authority (the Authority) has revoked the interim approval and issued a recall order to the product applicants of the following five psychoactive products: Karma P0004, Anarchy P0002, Voodoo P0003, AK47 P0008, Northern Lights Primo P0038.These five psychoactive products are now banned under the Psychoactive Substances Act (the Act).
  2. Why has the Authority taken this action?
    The interim approvals have been revoked following reports of adverse reactions to the Centre for Adverse Reactions Monitoring (CARM) and the National Poisons Centre. These reports demonstrate each of the five products pose more than a low risk of harm to the consumer.
  3. When will the products be taken off the market?
    The Authority has issued a recall order to three companies requesting a full recall of these products.In line with the treatment of food and medicine recalls, it is the responsibility of product applicants to recall their products from the market.The Authority will work closely to ensure suppliers adhere to the strict conditions around recalls set out in the Act. If there are concerns a product supplier is not acting in accordance with the recall requirements of the Act the Police have powers to seize and remove any product which has been recalled.As an additional measure the Authority has written to all retailers advising the recall is in place and to contact suppliers if they haven’t heard from them already.
  4. What sorts of reactions have been reported?
    The reports include nausea and vomiting, insomnia, acute psychotic reaction, and prolonged withdrawal.
  5. What do people do if they have bought these products?
    If people have bought products and are concerned about their health effects they should contact the Healthline 0800 611 116, their nearest medical centre, or the National Poisons Centre 0800 POISON (0800 764 766) – this number is printed on all approved products.For information about getting control over drug problems contact the Alcohol Drug Helpline (ADA) phone 0800 787 797If people have remaining products that are now banned they can return these to the retailer or local police.
  6. How are psychoactive products assessed for interim approval?
    Products are assessed according to the Risk Assessment Score Table (available on the Ministry of Health website) which includes information on product ingredients and the number and type of minor to severe reactions reported. A risk score is given to each event/reaction and the total represents the risk score.  Any product that scores over 2 is not approved.  All products that have received interim approval have scored 2 or under.
  7. Who are the suppliers of these products?
    • Approvals for Anarchy, Voodoo and Karma are held by Everson’s International Limited
    • The approval for AK47 is held by Gizmos Holdings Limited
    • The approval for Northern Lights Primo is held by Planet Nature NZ Limited
  8. Where are these products sold?
    There are currently 153 retailers with interim retail licences approved by the Authority. These range from adult stores, novelty stores and retail outlets specialising only in the sale of legal highs. There are also websites which retail psychoactive products.Information that specifically identifies which retailers currently sell Anarchy, Voodoo, Karma, AK47 and Northern Lights Primo is not collected by the Authority as this is subject to change by the retailers and suppliers which are private commercial entities.See a full list of holders of interim licences to retail
  9. When was the Authority advised that these products caused adverse reactions
    An assessment of the reports of adverse events received by the Authority takes place on a rolling basis following receipt of reports from the National Poisons Centre and the Centre for Adverse Reactions Monitoring (CARM) which is located within the New Zealand Pharmacovigilance Centre (NZPhVC). These decisions have been taken based on the collation of data collected in October, November and December 2013.
  10. Where did these people buy the products that caused the adverse reactions?
    Patient specific information (including regional information) is not released to the Authority in accordance with privacy laws.  The Authority does not collect information on the sale of products by region.
  11. What happens to the product that is being recalled? Who will hold it? How will it be secured?
    The Authority is requiring all recalled product to be destroyed in accordance with the recall order.If there are concerns a supplier is not acting in accordance with the recall requirements of the Act the Police have powers to seize and remove any product which has been recalled. This product then becomes the property of the Crown.The Act also provides for penalties for importers, manufacturers or sellers who do not comply with disposal requirements.
  12. Will any suppliers be prosecuted?
    Not unless they fail to comply with notices under the Act.
  13. How many packets of these products have been sold in the last six months?
    This information is commercial in confidence and not able to be released.
  14. How many people have taken these products in the last six months?
    Sales information collected by the Authority is commercial in confidence and therefore not able to be released.  This information is however made available for clinical assessments and ongoing monitoring of interim approved products and contributes to the Authority’s decision-making.
  15. How do we know other interim approved products are safe?
    The overriding purpose of the Act is to minimise harm to members of the public who have chosen to use interim approved psychoactive products. . The close monitoring of possible adverse side-effects through the risk assessment framework means that the Authority can act on evidence to withdraw products, and the public can have confidence that this will occur where warranted.The Act has put in place requirements on manufacturers around clear packaging including phone details for reporting any adverse effect.As well, the Authority has in January 2014 introduced a Code of Manufacturing Practice to ensure all psychoactive products on the market in New Zealand are made to a consistently high standard in clean, controlled environments. It details the quality control requirements for psychoactive substances and products.
  16. Is this the first time the Authority has revoked approvals under the Act?
    Yes this is the first time the Authority has revoked interim product approvals since the Act came into effect on 18 July 2013.
  17. Under what powers is the Authority acting?
    This action follows publication of a notice in The Gazette revoking the approvals for the products under Part 2 section 40 of the Psychoactive Substances Act. The recall action is being taken in accordance with Part 3 section 88 Recall orders of the Psychoactive Substances Act.
  18. What is a psychoactive product?
    As defined by the Act, a psychoactive product or product means a finished product packaged and ready for retail sale that is a psychoactive substance or that contains one or more psychoactive substances
  19. What’s the difference between a psychoactive product and a psychoactive substance?
    As defined by the Act, psychoactive substance means a substance, mixture, preparation, article, device, or thing that is capable of inducing a psychoactive effect (by any means) in an individual who uses the psychoactive substance. Read more in the Act.

Page last updated: 27 January 2014

Please visit the most recent version on the Official Ministry of Health website;
http://www.health.govt.nz/our-work/regulation-health-and-disability-system/psychoactive-substances/revoked-interim-product-approvals

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