The European Union is considering an amendment to their legal definition of a “novel food” that will have a major impact on the nootropics industry. By placing approval on a case-by-case basis, individual member states will be responsible for determining whether or not nootropics are fit for human consumption or must be seized and destroyed. While this is being done as part of an effort to protect citizens from unsafe, untested products, it could have significant negative consequences for the nootropics industry in Europe.
In the EU, nootropics are currently regulated as novel foods, which means they must go through extensive testing before they’re allowed to be sold to the public. Now the EU is considering an amendment to their legal definition of a “novel food” that will have a major impact on the nootropics industry. Known as the “Nutrasect Case,” the amendment will remove the case-by-case approval required of novel foods and make it all-encompassing.
Nootropics are a class of compounds that act as cognitive enhancers and “neuroprotectants.” By assisting in memory and cognitive function, they can be helpful in a variety of fields: from treating issues with attention and attention control to improving memory retention and performance in daily life. While more research is still being conducted to better understand their efficacy, they’ve been shown to be safe and effective when taken according to the recommendations of a healthcare provider.
During the darkest days of WWII, the US military relied heavily on one thing to revitalize the scientific advancement spirit: LSD. Upon realizing the potential that these compounds had, pharmaceutical companies liked J.W. O’Neil and Eli Lilly flooded the market with them. Unfortunately for the military, these were short-lived effects, as their subjects experienced post- LSD euphoria, paranoia, and memory loss. This led to the importance of long-term studies into these compounds and spurred addiction and abuse of certain nootropic substances.
Thus, while not truly classified as a drug, they still have strict regulatory requirements. Since it’s still being studied and researched, these substances carry a lot of risk for users as well! This is what led to the formation of the UK Natural Products Regulatory Agency (NPRA), which brought about an amendment that aimed to alleviate the harsh reaction of these compounds, as well as requiring stronger studies into their impact.
Modafinil, for example, is one of the most well-known nootropic compounds in the world. Gone are the short-lived effects and dependence and in comes an indistinguishable but mild cognitive enhancer. This compound blocks dopamine re-uptake and inhibits re-acceleration of neural activity caused by adolescent hormone deficiency.
By placing approval on a case-by-case basis, individual member states will be responsible for determining whether or not nootropics are fit for human consumption or must be seized and destroyed.
The Commission’s proposal will allow member states to place approval for nootropics on a case-by-case basis. This is significant because it means individual countries will be responsible for determining whether or not nootropics are fit for human consumption or must be seized and destroyed. This could have a major negative impact on the European market since approval in one country could mean the end of sales in another. In addition, nootropics in all their forms — supplements, specially designed pharmaceuticals or oral gummies — could be highly difficult to export across the continent since approval to sell a particular substance would no longer be centralized across EU borders. The final version of the regulation will be presented in May with a view to getting it voted through at the end of the year.
Notably, the proposal uses vague language and does not explain what exactly an “eligible drug or medicine” consists of. Most experts are against the possibility of opening up this type of approval to countries all over the world, because it would create a significant amount of oversight that could prevent any promising technological developments from taking off in the nootropics market. And while this agreement offers a chance for member states to protect their populations from untested and potentially unapproved products, it could potentially cost millions in lost sales to nootropic companies, like Nootropics Frontline, across the European continent.
Many individuals buy legitimate dietary supplements for themselves and others, whether for sports performance, due to serious medical conditions, or for enhancing mental alertness and focus. Considering an already costly market to navigate and more mental hurdles to establish, it might not be an idea the European Commission is eager to consider. The new legal amendments are currently expected to be voted back into effect in 2021, however, with the opportunity to implement them extended until 2023. Given the unpredictable timeline of when exactly we will receive the final version of these laws, we might see a lower timeline once again.
While this is being done as part of an effort to protect citizens from unsafe, untested products, it could have significant negative consequences for the nootropics industry in Europe.
The European Union (EU) is currently considering a ban on sales of nootropics and supplements. While this is being done as part of an effort to protect citizens from unsafe, untested products, it could have significant negative consequences for the nootropics industry in Europe. Europeans have been consuming supplements for a long time unlike Americans in the US who only began to embrace the supplement and fitness industry in the 2000s. The EU originally banned certain supplements in 2011, but a year later included nutraceuticals and herbal supplements in the same regulations. Just recently, biotech and nootropic companies are getting involved in the fight against these regulations.
According to an article published by Forbes, certain high profile basketball players, are using supplements to improve sports performance. Other companies like BioNTech, UK-based Strand and Nutrapharmac are emerging as competitors to Pfizer and BioNTech.
In comparison to Japan, where athletes like Shinsuke Nakamura and Hisashi Yamanaka are big advocates of takehome supplements like that of Magnesium/Zinc, the EU has been notably slow in adopting regulations. While many attribute this to the mentality of large corporations, it is not too hard to see why. Since high profile nutraceutical companies can afford to take legal action, you can see why they want to ensure that public health regulations do not unnecessarily hinder their ability to make a profit by enforcing regulations deemed more onerous or onerous to manufacturers would certainly go against their vested interests.
For novel foods, a watertight case-by-case approval process is crucial to avoid any mishaps or unsafe products being spread throughout Europe. The plethora of small batch manufacturing in Europe means that legal action is much easier to take than it is in the United States.
What the government of the EU will ultimately decide is not certain.