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MHRA releases latest final determinations list

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As the May 1 deadline for the removal from sale of unlicensed herbal medicines approaches the MHRA has released its latest batch of product determinations.

The latest Final Determinations list is the result of investigations of 32 products. Four black cohosh products, three milk thistle products and two St John’s Wort products are among those assessed to be a medicine.

Products are considered medicines if they meet either of two criteria set out under EU medicine law: they contain substances presented as having properties for treating or preventing disease; or they contain substances that restore, correct or modify physiological function (by exerting a pharmacological, immunological or metabolic action).

“The MHRA warns brands that ‘erroneous labelling of a herbal medicinal product as a food or dietary supplement is unacceptable and may mislead consumers’ and stresses that ‘mislabeling’ doesn’t alter the legal classification of a product”

An additional consideration –  the “familiarity of the averagely well informed consumer with the current day and long traditional use” of ingredients – is applied under the first criterion, ensnaring many well-used single herb products.

The majority of singe herb products judged to be medicines met both limbs of the definition. Some were considered to have brand names that inferred they acted as a treatment.

The MHRA warns brands that “erroneous labelling of a herbal medicinal product as a food or dietary supplement is unacceptable and may mislead consumers” and stresses that “mislabeling” doesn’t alter the legal classification of a product.

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