Regulatory Focus™ > News Articles > Manufacturer Seeks to Avoid MHRA Regulation by Registering as Confectionary

Manufacturer Seeks to Avoid MHRA Regulation by Registering as Confectionary

Posted 07 August 2012 | By Alexander Gaffney, RAC 

British heroine Mary Poppins and her "spoonful of sugar" would very likely approve. In response to increased pressure from UK regulators, homeopaths marketing unlicensed medicines are reportedly considering an unlikely source as the cure to their woes: candy.

The Guardian reports the Medicines and Healthcare Products Regulatory Authority (MHRA) is in the midst of cracking down on unlicensed homeopathic products, many of which lack proper registration with regulators. The products had apparently been on the market for years with little supervision before scientific advocacy groups began a push to remove them from the market by forcing MHRA to take regulatory action against unlicensed products.

The Guardian notes MHRA is "obliged to enforce the law if they receive complaints," including those about homeopathy. The products are characterized by extraordinarily diluted substances-some of which beyond one-part-in-1030 per solution-and critics have derided the products as being little more than sugar water.

Sweet Revenge

Both the impact of the additional enforcement actions and the criticism from scientific advocacy groups don't seem to be lost on homeopaths, with at least one of the groups considering re-defining its product as "confectionary" to avoid MHRA regulators.

"If necessary we could revise the manufacturing method, the labeling of the bottles and kit box to present them as non-medicines and non-homeopathic and market them as 'confectionery,'" wrote Helios Homeopathy in a letter to MHRA condemning the agency's crackdown on homeopathic products.

This would represent a challenge to MHRA while leaving its traditional customer relatively unaffected, wrote Helios. "Customers who have an interest in homeopathy would still know how to use them and would continue to purchase them despite limited labeling," Helios explained. "There would of course be media repercussions and uncontrolled sources appearing and confusion among the public and MPs who would demand a full explanation for the change."

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