Trust is crucial for consumers when it comes to brain health. The rising awareness of mental health issues and cognitive function, coupled with the unprecedented outbreak of the COVID-19 pandemic, has resulted in consumers becoming more proactive about maintaining their overall health
In fact, according to a FMCG Gurus survey of 23,000 European shoppers, 72% will make greater attempts to eat and drink healthily because of their experience in the pandemic.1 This increased understanding of health and wellness has triggered a requirement in the nutraceuticals industry for supplements that not only promote well-being, but also support healthy ageing.
As research studies indicate growing interest in natural supplements that enhance cognitive function, memory and mental focus — aided by a preference for supplements composed of natural ingredients compared with synthetic ones — users need to know that what they are consuming is safe and legitimate.
Safety and regulation are critical components of the nutraceutical supplement industry. Government-implemented rules serve as checks and balances within the market to ensure that consumers receive high-quality products with the guaranteed identity, purity, strength and composition of the marketed supplement.
Without these regulations, there can be numerous risks, such as the unexpected contamination of products or insufficient/too much active ingredient.
There is an abundance of products on the market that claim to support healthy ageing and well-being. However, it is important that only the ingredients endorsed by a regulatory seal of approval be included in supplements; otherwise, it can be impossible for consumers to distinguish a product’s authenticity, efficacy and safety, and taking it could lead to harmful or even life-threatening consequences.
The EU’s gold standard: novel food
Most countries have established food safety standards and regulations that help to protect public health and well-being, and ensure that consumers receive the product marketed to them. These laws regulate all elements of the food supply chain, including the production, supply and distribution.
In the European Union, according to Regulation (EU) 2015/2283, so-called novel foods require approval before they are made available on the market.
According to the European Commission, a novel food is described as a “newly developed, innovative food” along with the two key underlying principles. It must be
Novel food example: PQQ
One particular ingredient that has been registered as a novel food is pyrroloquinoline quinone disodium salt (PQQ), a naturally occurring antioxidant that’s found in certain fruits, vegetables and meat. Studies have shown that as a compound, PQQ may play a role in preserving and improving cognitive function and delaying ageing.
In addition to providing antioxidant protection to brain cells, research demonstrates that PQQ can also activate mitochondrial biogenesis, a process that results in the growth of mitochondrial clusters in cells, which is critical for healthy ageing.
For a proposed novel food to be approved by the European Commission, petitioners must undergo a rigorous application process, which includes matching criteria outlined by the European Food Safety Authority (EFSA) and submitting scientific data that demonstrates its safety for human use.
The steps required to obtain this permit attest to the high-quality control and safety standards that take place in a product’s manufacturing process. Once confirmed, only the novel foods that have been approved can be marketed — and the original applicant may be granted special protection and the exclusive right to sell the product on the market for 5 years.
Although the Novel Foods Regulation (NFR) makes extensive demands, it is essential for the food or ingredient to go through this approval process to ensure that it’s safe for the consumer. In fact, novel foods without approval are considered to be “unsafe” in the legal sense and must be recalled from the market.3 However, what happens when the novel food special protection and exclusivity period ends?
Five years down the road …
As the NFR focuses exclusively on the novel food and not the applicant, the approval is ultimately bestowed only upon the proposed food or ingredient. That means that although the candidate seeking authorisation conducts the rigorous application process alone, any other food manufacturer can subsequently use the NFR approval and sell their own version of the novel food.
To compensate for this disadvantage, Article 26 and 27 of the NFR protect the scientific data submitted by the applicant for the first 5 years and prohibit third-parties from using the novel food permit within that period.4
After 5 years, however, the original applicant’s data protection and marketing exclusivity rights expire and other manufacturers may also look to place the respective novel food on the market.
Depending on the level of popularity and potential market growth for the novel food, this can lead to a rise of imitation products without the clinical or scientific data to demonstrate their safety or effectiveness. Supplement brands that choose to go with an untested alternative because it may be cheaper put consumers and their reputation at risk.
Case study: MGCPQQ
In 2018, a natural source of PQQ was first introduced to the European market under the brand name MGCPQQ. Developed in Japan by Mitsubishi Gas Chemical, MGCPQQ is produced by harvesting natural PQQ disodium salt from a patented, proprietary bacterial fermentation process using technology that does not include chemical synthesis.
The product is then purified in a process that has been well-studied and validated for quality and safety to ensure that each batch is tested at up to food-grade standards.
Although other forms of PQQ may be available on the market where NFR applies, the vast majority of scientific research has been developed using MGCPQQ specifically and it is currently the only PQQ listed on the European Union’s list of Novel Food Ingredients, attesting to its safety and quality.
To date, MGCPQQ is the only PQQ ingredient permitted to be sold in the EU. Mitsubishi Gas Chemical has also marketed the popular ingredient under the brand name BioPQQ in the United States, Canada and Japan.
However, in the first 4 years of data and marketing exclusivity in the EU, other supplements containing unauthorised PQQ ingredients were illegally sold online through Amazon, eBay and six other EU online marketplaces, not counting individual online pharmacies or small retailers.
As a result, MGC took legal action to prevent the sale of knockoff PQQ supplements in the EU, EEA, UK and Switzerland, all regions where the NFR applies. Germany has proved particularly effective in this regard. The Hamburg Regional Court has also issued several injunctions, which were also enforced in the Netherlands and the US.
Abiding to the Novel Food Regulations, only the protection of the data and the exclusive right of use of the originator will expire in September 2023. Although the approval remains in place and is still required for the commercialisation of PQQ, other food manufacturers can make use of the NFR if they succeed in “replicating” MGC’s authorised PQQ.
To do so, the copycat PQQ ingredient must be covered by the approval. Any PQQ products that deviate from this would require their own approval separately. Marketing without novel food approval remains illegal. And for the consumer, this is critical information.
As natural supplements continue to increase in popularity, so does the need for more stringent monitoring and enforcement of ingredient regulations. For companies to make the claim that their product is safe and effective, they must be able to back it up with scientific proof.
Only hard data from numerous and well-documented clinical studies can provide the level of safety and assurance that customers expect and demand from a brand worthy of their trust. Not only must the scientific evidence be available, it must also stand up to scrutiny by the EU Commission in an approval process. So, although it’s essential for a brand to earn consumer trust, in the world of natural supplements, trust alone is not enough.
MGCPQQ: most tested, most studied, most trusted
Mitsubishi is a pioneer in the PQQ research field, conducting or supporting more than 1000 in vitro, animal and human clinical studies to demonstrate MGCPQQ’s safety and superior quality. Supplementing a daily routine with MGCPQQ may provide a wide range of health benefits.