Dietary supplement Arthrem will be taken off shelves in exchange for Medsafe withdrawing its prosecution against the manufacturer.
Medsafe says Arthrem’s manufacturer Promisia was in breach of the law by effectively promoting the supplement as a medicine. The settlement means Promisia accepts it breached the Medicines Act and will now stop producing, advertising, and selling the supplement, which Medsafe says has been linked to serious cases of liver harm.
The SMC asked experts to comment on this announcement.
Associate Professor Jessica Lai, Wellington School of Business and Government, Victoria University of Wellington, comments:
“The Medicines Act 1981 states that no one can sell, distribute or advertise a medicine without regulatory approval. Medsafe is the Authority that grants this approval. It assesses the likely therapeutic value of a medicine, weighed against any potential risk.
“Getting regulatory approval for a medicine is expensive. You need to submit evidence of its safety and efficacy.
“In contrast, dietary supplements do not need regulatory approval. They are regulated within our food safety regime.
“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.
“The Arthrem example also shows that we possibly need stricter regulation of dietary supplements.”
No conflict of interest.