UK turns the screw on ‘unlicensed medicines’

The MHRA (Medicines and Healthcare products Regulatory Agency) Medicines Borderline Section (MBS) has been busy writing to retailers and manufacturers and has made no secret of the fact it is engaged in a campaign against unauthorised products, especially in the light of new EU herbal medicine laws and existing UK and EU medicines law.

An MHRA letter seen by NutraIngredients highlights some of the agency’s concerns.

“It is an offence to sell or supply or to advertise a medicinal product which does not have a marketing authorisation,”​ a member of the MBS Inspection, Enforcement and Standards Division wrote to a UK manufacturer.

He wrote that a medicinal product could be defined as per EU Directive 2001/83/EC as:

• “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings.”​
• “Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”​

Presentation matters​

The agency noted that it was more than just ingredients that informed its medical product classifications.

“In practice, in coming to a view about any product, the Agency considers all the characteristics of the individual product and any information which may have a bearing on the product’s status. A product may be viewed as a medicinal product because of the way in which it is presented.”​

“The Agency also considers the effect the product has on human physiology. If it satisfies one or both of the criteria, it is classified as a medicine. A product presented as a nutritional substance or cosmetic may still be a medicinal product if it contains ingredients which have a significant pharmacological effect.”​

Guidelines like ‘significant pharmacological effect’ have been criticised by elements of the food supplements industry which view them as ultimately meaningless because all ingredients could theoretically be deemed to have such an effect, and therefore be subject to medicines law such as the EU Traditional Herbal Medicinal Product Directive (THMPD).  

But Simon Mills, the chief of the Herbal Quality Campaign and the British Herbal Medicines Association, welcomed any increase in enforcement stringency. “It’s what we have been asking for. We have been asking for consistency and clarity and so this is a good sign.”​

Mills’ groups, which represent herbal medicine manufacturers like Schwabe, have criticised the MHRA for not adequately policing the supplements market to ensure products hold THMPD registrations.

But pro-supplement groups like the Alliance for Natural Health (ANH) say the THMPD is over-reaching and are set to challenge its legality in court in 2012.

ANH scientific and executive director, Dr Robert Verkerk has said: “The EU herbal directive is an optional scheme that only applies to those products that meet its restrictive requirements. Many are not, and will never be, eligible to the THMPD scheme without a major change to the rules.”​

“The BHMA must accept that one size does not fit all when it comes to regulating herbal products, and that there are several different regulatory regimes that allow legal sale of herbal products in the EU, including food supplement legislation.”​

The MHRA was not available for comment.

The warning letter highlighted that, “the following forms of marketing are unacceptable”:​

• References to medical conditions.
• Comparison with licensed medicines.
• References to interference with the normal operation of a physical function.
• Product names which refer to adverse medical conditions.
• References to medical and/or clinical research and testing.
• References to the health risks of not taking a particular product.
• Editorial medicinal claims.
• Testimonials that include/imply medicinal claims.
• Graphics that imply medicinal uses.
• References to, or reproduction of “generic” information.
• Juxtaposing with any example of the above.

It gave the company in question 21 days to provide information about the product’s formulation, dosage, labelling, marketing (including online), trade association approval, and certificate of analysis.

In the case of dry extracts, information about, “the strength of each dry extract and the solvent which would have been used in the extraction”​ is required.