As consumer interest in mind health supplements grows, the regulatory landscape surrounding key ingredients like Ayurvedic herbs, probiotics, CBD, and mushroom-derived compounds remains a complex challenge.
During the NutraIngredients editorial webinar on Mind Health Modulation broadcast on Nov.21, Katia Merten-Lentz, food law expert and partner at Food Law Science & Partners, highlighted the hurdles brands face, including proving safety, obtaining novel food status, and navigating fragmented national regulations and health claim restrictions.
Challenges and opportunities for Ayurvedic herbs
Ayurveda, the ancient Indian system of medicine, has long utilized botanicals to promote mind health, enhance cognitive function, and reduce stress.
Popular ayurvedic ingredients are: Ashwagandha, found to help manage stress and improve cognitive performance; Turmeric, containing curcumin, which has anti-inflammatory and antioxidant properties beneficial for brain health; and Brahmi, which has been found to improve memory, concentration, and learning capacity.
These ayurvedic herbs face challenges related to their classification as novel foods, explained Katia Merten-Lentz.
A streamlined authorization process exists for traditional foods with over 25 years of documented safe use in non-EU countries, potentially reducing approval times from over two years to approximately nine months.
However, variations in national regulations can create additional hurdles; for instance, Italy requires further approvals for concentrated turmeric extracts despite EU authorization.
Using health claims to promote Ayurvedic herbs remains restricted, as botanical health claims have been on hold since 2010, however as Merten-Lentz noted, there is no clear timeline for resolution.
Probiotic claims for mind health
Probiotics can be beneficial for mind health because of their role in maintaining gut health, which is closely linked to brain function through the gut-brain axis.
Key probiotic strains for mind health include: Lactobacillus rhamnosus, which has been found to reduce anxiety and stress; Bifidobacterium longum, shown to improve mood and reduce symptoms of depression; and Bifidobacterium bifidum which may be effective in improving mood and reducing psychological distress.
Probiotics face unique challenges due to restrictions on health claims, said Merten-Lentz. Under EU regulations, the term “probiotics” is classified as a health claim, making its use on product labels difficult: Despite a broad recognition of probiotics' benefits, only one health claim (related to yogurt) has been approved.
However, national regulations vary, with over 10 EU member states allowing the term “probiotics” on packaging, leading to inconsistencies across the EU and raising questions about the European Commission’s authority and respect in regulatory matters.
According to Merten-Lentz, it is a glaring systemic issue that only one probiotic health claim has been authorized in over 20 years, revealing inefficiencies in the approval process and reflecting broader problems in the healthcare approach to probiotics.
She called on the European Commission to revise or remove outdated guidance and address the regulatory gap, noting that efforts are ongoing to push for change. A complaint on this matter is currently pending before the Ombudsman in Brussels.
CBD regulation challenges
Cannabidiol (CBD), a non-psychoactive compound derived from the cannabis plant, has shown potential in anxiety and stress reduction, sleep support, and cognitive function.
However, it presents a fragmented legal landscape, said Merten-Lentz. While it is no longer classified as a narcotic, its regulatory status depends on the specific part of the plant used. For example, hemp seed oil is not novel, but leaf extracts are.
Most CBD products are considered novel foods and require authorization, however, EFSA has not ruled on CBD’s safety due to insufficient data.
This complication in regulation is potentially hindering innovation in the CBD supplement space, said Merten-Lentz, noting that it’s much easier to innovate when the regulatory framework is clear.
And despite CBD no longer being classified as a narcotic product, the industry still faces caution and regulatory delays. This creates risks for CBD operators, many of whom place products on the market despite unclear legality.
As a result, many CBD products sold today are technically illegal, leaving businesses vulnerable to recalls, fines, and other consequences.
Mushrooms for mind health
Mushroom-derived ingredients, particularly from medicinal fungi, have gained popularity for their potential to support mind health.
Lion’s Mane has shown cognitive function benefits, Cordyceps may enhance energy levels, and Chaga may have an indirect effect on mood and mind health.
Due to the complexities of CBD regulations, some brands are shifting from CBD supplements to mushroom-derived ingredients.
Mushrooms are increasingly popular as health-promoting ingredients but determining their regulatory status requires analyzing both the ingredient and its production process, said Merten-Lentz.
This dual evaluation adds complexity and requires FBOs to be diligent in ensuring compliance with EU regulations.
Regulation for mushrooms, according to Merten-Lentz, will remain highly case-specific. Authorities will assess the type of mushroom, the part used, and the processes involved in its preparation.
Each case will require detailed evaluation to determine whether it falls under novel food regulations.