The folly of the 'Medical Device' loophole for health claims!
The Nutrition and Health Claims Regulation (NHCR) EC 1924/2006 has been considered as being overly restrictive to the sale of foods and related claims due to the complex and expensive process to authorise health claims. As such it has been proposed that Directive 93/42/EE on medical devices (Herein MDD) (The Medical Devices Regulations 2002, under UK law) offers a cheep and effective alternative to escape such rules. But does it? What are the risks?
According to Article 1 of the MDD it states (inter alia) that a medical device intended by the manufacturer to be used for human beings for the purpose of:
1…treatment or alleviation of disease.
2...treatment, alleviation of or compensation for injury of handicap.
Of these functions they must not achieve their principal intended action in/or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
We should start by saying products that have a physical action such as preventing fat being absorbed by the body or act as bulking agents can and have been classified as medical devices. However, other ingredients such as herbs could also be considered as a “medical device” according to the UK regulator according to its own guidance:
“The classification principles relating to medical devices containing medicinal products remain the same irrespective of whether the medicinal product is ‘pharmaceutical’ or an ‘herbal’ medicinal product. It is possible that a product containing herbal substance(s) that have demonstrated a pharmacological action could be classified as a medical device, if the action of the herbal constituent is ancillary to the physical means by which the function of the product is mainly achieved, The notions of pharmacological action and physical means are important elements in reaching classification decisions when considering the borderline between a (traditional) herbal medicinal product and a medical device. Where a products main action is a result of the action herbal ingredient exerting an intended effect by virtue of primarily pharmacological, immunological or metabolic means it may not be considered as a medical device. If such action is ancillary to the main purpose of the medical device then the herbal ingredient may be considered as a medicinal substance…”
*bolding added by us for emphasis
In understanding the MDD definition and the terms such as pharmacological, immunological or metabolic means we have extensive European case law to guide us to the scope of such definitions and their applications to foods and medicines. However, terms such as ‘physical’ and ‘ancillary’ offer additional challenges to the consideration of what are traditional food substances (i.e. herbs, botanicals, vitamins and minerals).
An example limitation of a medical advice put forwards by the European competent authority in this area would be a plaster containing capsaicin from Capsici fructus to deliver a health and pain killing effect.
In this example the Capsaicin would not be considered as wholly delivering an effect by only physical means rather than pharmacological means. As such it would not be considered as a medical device as would say the fat binding effects of dried leaves of prickly pear cactus Opuntia ficus-indica.
We note health claims on traditional food stuffs that are considered medical devices for weight control have been challenged and defended:
And in other cases such challenges have not been defended:
Potential Issues for foods disguised as medical devices
If a product was to achieve a medical device listing they will need to demonstrate conformity with the regulation specifically in relation to clinical data demonstrating its action is by physical rather than pharmacological, immunological or metabolic means. Furthermore, it must be ancillary (support main actions) to the physical action of the herbal device.
As such additional obstacles exist on ingredients they may also be considered as medical devices i.e. do you own the IP rights for said ingredient when making X claim of effect or even in relation to the ingredients composition (method of manufacturer)? Have you enough data to substantiate the effect – data that demonstrates a primary physical and not pharmacological, immunological or metabolic means?
These are also issues that are to be addressed when considering health claims applications for ordinary foodstuffs but in addition for medical devices you have additional obligations such safety assessments of the product during the clinical trials and post market surveillance, manufacturing quality assurance etc.
As such getting a registration alone may require the generation of new study data to confirm the mechanism of action is physical, the ingredient is safe and also ensuring the manufacturing quality is to a very high standard.
Some of the concerns laying further down the line are what happens if said ingredient has a clinical study demonstrating its primary (not ancillary) effect as that stated for the registered medical device is delivered by pharmacological, immunological or metabolic action rather than physical? Can the medical device status be challenged? What would be the effect – loss of claims as they would only be possible under health claims regulation or as a medicine. We already see some products being stripped of Medical device status in light of the health claims regulation http://www.nutraingredients.com/Regulation-Policy/French-cranberry-medical-device-status-stripped and the Commission has given its views that such devices should be registered as ordinary medicines http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2014-002555&language=EN
So despite all the hype over the MDD as being a gap/loophole its one that bears its own risk from an intellectual property standpoint and also its clearly not an area that’s future proofed for business longevity with the EC working towards the removal of products taken orally in all but the rarest of cases.
Similarly, success in one Member State as a medical device does not mean it will achieve similar status in another. The potential issues over mutual recognition are not to be sniffed at, as the category is often borderline between device and food supplement. Unlike the case law related to medicines and food supplements that related to foods and medical devices is less so and may result in less legal certainty and expense during a challenge before the courts. This again can impact any EU wide distribution strategy and potentially damage to the brand.