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.

As part of the settlement, medical regulatory body Medsafe withdrew its prosecution of Promisia Integrative Ltd over Arthrem.

Promisia accepted it breached the Medicines Act, and agreed to stop making, advertising and selling Arthrem.

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Arthrem has been linked to serious cases of liver harm.

Following warnings to the company that its advertising of Arthrem breached the Medicines Act, Medsafe launched its prosecution against Promisia in January 2019.

The companys claims about Arthrems use for arthritis effectively made the product a medicine, which was unapproved, Medsafe said.

A settlement was preferable given how long a court case would take, said Medsafe group manager Chris James.

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.

Despite the warnings, Promisia continued to sell Arthrem in New Zealand and overseas.

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.

Getting regulatory approval for a medicine is expensive. You need to submit evidence of its safety and efficacy, Lai said.

In contrast, dietary supplements do not need regulatory approval. They are regulated within our food safety regime.

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Arthrem, which was sold as a joint mobility supplement, will be taken off the shelves.

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.

There were reports of 46 cases of adverse reactions associated with the use of Arthrem by the end of February, 2020.

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.

Promisia was first warned in 2016 that its advertising of Arthrem breached the Medicines Act.

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Arthrem, linked to liver harm, is pulled from shelves in deal with Medsafe - Stuff.co.nz