Arthrem, which has been sold as a joint mobility supplement, will be taken off the shelves after Medsafe reached a settlement with the company that makes it.<\/p>\n
Arthrem has been linked to serious cases of liver harm.<\/p>\n
As part of the settlement, medical regulatory body Medsafe withdrew its prosecution of Promisia Integrative Ltd over Arthrem.<\/p>\n
Promisia accepted it breached the Medicines Act, and agreed to stop making, advertising and selling Arthrem.<\/p>\n
READ MORE:* Kiwi study challenges popular idea on cause of conspiracy theories* Coronavirus: Medsafe to restrict importing and sale of Covid-19 test kits after calls for regulation* Joint supplement Arthrem's makers being prosecuted by Health Ministry<\/p>\n
supplied<\/p>\n
Arthrem has been linked to serious cases of liver harm.<\/p>\n
Following warnings to the company that its advertising of Arthrem breached the Medicines Act, Medsafe launched its prosecution against Promisia in January 2019.<\/p>\n
The companys claims about Arthrems use for arthritis effectively made the product a medicine, which was unapproved, Medsafe said.<\/p>\n
A settlement was preferable given how long a court case would take, said Medsafe group manager Chris James.<\/p>\n
James said the potentially harmful product was illegally marketed to the public as a dietary supplement, with fewer safety controls, when it should have been subjected to the more rigorous controls required for medicines.<\/p>\n
Despite the warnings, Promisia continued to sell Arthrem in New Zealand and overseas.<\/p>\n
Associate Professor Jessica Lai, of Victoria Universitys School of Business and Government, said the Arthrem example showed New Zealand possibly needed stricter regulation of dietary supplements.<\/p>\n
Getting regulatory approval for a medicine is expensive. You need to submit evidence of its safety and efficacy, Lai said.<\/p>\n
In contrast, dietary supplements do not need regulatory approval. They are regulated within our food safety regime.<\/p>\n
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Arthrem, which was sold as a joint mobility supplement, will be taken off the shelves.<\/p>\n
However, the situation with Arthrem highlights the problem that the legal line between a medicine and a dietary supplement is fuzzy. If a product falls within that fuzziness, the temptation is to market the product as a dietary supplement to avoid the process and costs of regulatory review.<\/p>\n
There were reports of 46 cases of adverse reactions associated with the use of Arthrem by the end of February, 2020.<\/p>\n
Medsafe had laid nine charges relating to breaches of section 20 of the Medicines Act 1981. The maximum penalty for a company for a breach of section 20 is a $100,000 fine.<\/p>\n
Promisia was first warned in 2016 that its advertising of Arthrem breached the Medicines Act.<\/p>\n
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See original here: Arthrem, which has been sold as a joint mobility supplement, will be taken off the shelves after Medsafe reached a settlement with the company that makes it. Arthrem has been linked to serious cases of liver harm. Continue reading
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