Is it a PARNUT? Is it a Medicinal Product? Is it a Food for a Specific Group?

The PARNUTs regime which regulates specialist foods has not changed much since it was created in 1977. However, since the 1970s the market for specialist foods has grown astronomically and the boundary between specialist foods and general food has become much less clear. Mainstream consumers increasingly understand terms like “gluten free”, “dairy free” etc. Mainstream brands have now launched “free from” variants. In response to these changes the EU has decided to replace the general PARNUTs regime and instead focus on specific consumer groups that have very specialist needs that require additional regulatory protection. Those products that were formerly regulated by PARNUTs but will not fall under the new FSG regime will now be regulated as general foods.

The new FSG Regulation was adopted in 2013. However, Article 3 gives the Commission the power to decide which consumer groups fall within the FSG Regulation. As a consequence there has been ongoing debate about which groups should (and should not) be in scope. As recently as June 2016 groups were still being added and removed. For example on 15 June 2016 the commission decided that sports people should not be one of the specific groups. For more information click here.

Whether to include toddler cereals as food for a specific group has also been a contentious and political matter. Toddler cereals were originally included but in January 2016 a European Parliament opposition was passed which removed them from the FSG Regulation. This was because the proposed Commission implementing regulations for toddler cereals contained maximum sugar levels three times the World Health Organisation’s recommended limit. Manufacturers can maintain the current sugar levels under the EU general food regulatory regime as there are no limits on sugar in toddler cereals. However, not being covered by the FSG Regulation means these sugar levels do not benefit from an implicit official sanction. We have already seen challenges to sugar levels in products aimed at toddlers in countries outside the EU. For example the Australian Competition and Consumer Commission has started legal proceedings against Heinz in relation to sugar levels in snacks for toddlers. With increasing focus on sugar, the practical impact of toddler cereals losing their “specific group” status is that manufacturers are going to be under political and consumer pressure to defend their products or reformulate.

PARNUTS and the new FSG regime also present an opportunity to derogate from the restrictions in the general EU food regulations. The benefits of being outside the general EU food regulations have been important for a long time in relation to claims, in some cases so important that some manufacturers have been prepared to go to court over the issue. For example in R v (Nutricia) v The Secretary of State for Health [2015] EWHC 2285 (Admin) Nutricia asked for a judicial review of the decision by the Secretary of State that their product Souvenaid (a food marketed “for the dietary management of early Alzheimer’s Disease”) was not a PARNUT. The Court concluded that a ruling was required by the ECJ however the questions were withdrawn before the ruling was made.

The general EU rules on health and nutrition claims for foods (contained in EC Regulation 1924/2006) are very strict, and constitute an approved restrictive list of health claims that can be used for products. Claims that suggest or imply that a food has properties to prevent, treat or cure human disease are prohibited and any new health claim must first be approved by the European Food Safety Authority. To get a claim approved the manufacturer must submit scientific evidence to prove the new claim. By comparison under both the old PARNUTS regime and new FSG Regulation a manufacturer is instead required to explain the “purpose” of the product. This “purpose” can make reference to diseases provided the product does not claim to prevent, treat or cure human disease. This gives manufacturers greater freedom to promote their products. For example Nutricia had marketed its PARNUT, Souvenaid, “for the dietary management of early Alzheimer’s Disease”.

Manufacturers whose products used to be PARNUTs but which will now fall outside of the FSG Regulation, should urgently review the viability of continuing their current claims. One option will be to assess if their existing claims can be rewritten to fit within the restrictions of the general EU food regime on health claims. However, this could mean abandoning old style PARNUTs explanations based upon “purpose”.

A radical but significantly more onerous alternative, would be to consider registration as a “medicinal product”. Products regulated as medicinal products either have “active substances” or are presented as having medicinal properties, which mean they have to be regulated as medicinal products. The definition of medicinal product (in Directive 2001/83) includes: “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings”. MHRA determinations on borderline cases have found that products that are marketed as having a medicinal function are “medicinal products” for the purposes of the Directive and are therefore subject to the requirements for authorisation of medicines.

Former PARNUTs whose “purposes” make reference to disease like Souvenaid might in theory be regulated as a “medicinal product” subject to adequate supporting data. The product and its manufacturer would then be regulated under the Human Medicines Regulations 2012. Claims, as well as safety, quality and efficacy, for medicinal products would, of course, need to be supported by clinical and other relevant data and the requirements for this are significantly more burdensome than the requirements for food health claims or marketing of foods. It would, however, potentially allow manufacturers to write their own claims provided they can substantiate these in terms of clinical data.

A decision to register a product as a medicinal product should not be taken lightly because registration as a medicinal product, would subject the product and its manufacturer/marketing authorisation holder to all the requirements of the Human Medicines Regulations 2012. This would include the requirement for marketing authorisation and strict controls over development, manufacturing and post-market safety, as well as pharmaceutical pricing in the event the product were to qualify as a prescription only product. Nonetheless, as was made clear in the recent UK appeal case (concerning the obligations of the UK medicines regulator to assess food supplement products which shared the same active ingredient) of R (Blue Bio Pharmaceuticals Ltd and Abba Pharma Ltd) v Secretary of State for Health (2016) [2016] EWCA Civ 554 if a product is regulated as a medicinal product then products which share several significant characteristics with the medicinal product may also have to be regulated this way unless they have another significant characteristic which takes them outside the legal definition of a medicinal product. Therefore the registration of one food product as a medicinal product could in some cases force an entire category of significantly similar products into regulation under the medicinal products regime.