Smart Regulation For Smart Drugs

Editor’s note: Geoffrey Woo and Michael Brandt are co-founders of Nootrobox, an e-commerce nootropic company.

“For the modern mad men and wolves of Wall Street, gone are the days of widespread day drinking and functional cocaine use. Instead, in this age of efficiency above all else, corporate climbers sometimes seek a simple brain boost, something to help them to get the job done without manic jitters or a nasty crash. For that, they are turning to nootropics,” writes Jack Smith IV on the cover story for an April 2015 edition of the New York Observer.

Nootropics, smart drugs and other biohacks are now drawing mainstream scrutiny and controversy as more and more people are using legal, off-label, and unscheduled “research chemicals” as nootropics to enhance their academic or work performance.

The controversy stems from the fact that many nootropics currently sit in a regulatory void, skirting around the edges of powerful lobbyist and interest groups. While daunting for startups at first glance, operating within regulatory haze among powerful entrenched interests is really just par for the course in Silicon Valley.

For example, Uber is currently warring with dozens of taxi and transportation commissions across the globe; Zenefits had to face shutdown threats in Utah; and 23andMe recently earned FDA authorization for performing genetic tests for Bloom Syndrome after several years of being outright prohibited from offering genetic health analysis.

The nootropics and biohacking industries together with regulators need to build a framework that fully legitimizes the field and allows end users to safely utilize enhancement products.

Industry Ahead of Regulation

The purview of the FDA can be divided into two broad categories: scheduled (i.e. prescription or over-the-counter) drugs approved for treatment for a specific disease or condition, or 2.) supplements and foods which are generally regarded as safe (GRAS) and allowed limited health claims.

In addition to compounds found in the first two categories, nootropic hobbyists and biohackers often dabble and experiment with substances in an emerging third category — chemical compounds taken for performance enhancement (and not therapy) without formal FDA approval or scheduling. Nootropics in this class are sold on the open market as “research chemicals” and cannot be labeled for human consumption.

Even with this risk, people still buy and use these compounds because there’s preliminary but promising data showing that nootropics can increase working memory capacity and endurance, and mitigate risks of neurodegeneration and Alzheimer’s.

Productizing from an industry perspective is a challenge as many of these promising nootropic research chemicals are public domain and cannot be patentable. Therefore, pouring private R&D dollars into large-scale trials that definitely classify substances doesn’t make sense from a conventional intellectual property standpoint.

On the other hand, the FDA is understandably hesitant to classify these research chemicals under the umbrella of supplements, available freely in the Targets and GNCs of the world; especially as events like the massive supplements investigation by the NY State Attorney General earlier this year underline the supplement industry’s tendency to play fast and loose with regulation. There should be a middle road. We propose a path uniting both industry and government to create a new regulatory framework to push the nootropics industry forward.

A Path Forward

The Orphan Drug Act of 1983 sets precedent to loosen heavy regulatory burdens for public good. The premise for this legislation is to lessen clinical statistical burden and offer subsidies to encourage industry to produce therapeutics for rare diseases that might not otherwise be profitable.

Thus, for nootropics, if the public would benefit from government-scale research which the market is not reaching on its own, there’s a good case to be made for government investment in this common good.

From an industry involvement, consortiums have historically played a major role in establishing broader public safety and awareness. In 1973, 54 farmers in California came together to define new methodologies and new procedures for growing and tending produce in an ‘organic’ way. Over the course of years of lobbying and effort, the organic movement was able to push the Organic Foods Production Act (OFPA) through the U.S. Congress in 1990, creating the National Organic Program (NOP) under the USDA, which defined “certified organic” at the national level.
We view this as a historical roadmap for the nootropics and biohacking industry, and we advocate for the formation of a “Certified Nootropics Program” consortium that would pool members’ expertise and resources to drive broader regulatory reform.

We propose the following framework to regulate, tax, and legitimize nootropics:

Step 1: Allow companies to sell new technologies (e.g. research chemicals) for human consumption. These new research chemicals must have a baseline pilot study that shows a baseline of safety and potential efficacy. Require labeling of research chemicals which discloses that preliminary data suggests safety and effectiveness, but that there is a lack of longitudinal data.
Step 2: Tax all products containing research chemicals.
Step 3: Use tax money to fund clinical research as research grants or fund a government-run enterprise to engage in research and development on promising / popular research chemicals.

Step 4: For chemicals that are shown to have benefit but minimal harms, classify the compound as a supplement. For beneficial chemicals that may have harmful side effects, schedule them per normal procedures as prescription-only or over-the-counter. Enforce misleading trade and marketing practices on mislabeled claims with sanctions and fines.

This framework treats people like adults. We should allow people to do their own research and make their own decisions and risk assessments around exploratory enhancement products while achieving the goal of providing tax revenue and resources to advance research that otherwise would not be done.

Challenges

Regulation is tied to politics, and politics is tied to lobbying. There are major lobbying forces in this hemisphere. Senator Orrin Hatch from Utah, current President pro tempore of the U.S. Senate, a well-known stalwart for the supplements industry has maintained the status quo for keeping the regulatory and enforcement arms minimal.

Big pharma has deep pockets, as well. The nootropics and biohacking movement has potential to add massive value to the world, and the regulatory framework around it should enable two key ideas:

1. giving people freedom of choice and make decisions around enhancement, and
2. providing the structure to generate tax revenue to further push the cutting edge of research that would not happen otherwise

The regulatory and lobbying landscape is complex with deep relationships. But just as the transportation, human resource brokerage, and genetic testing industry were at first recalcitrant to change, significant progress has now been made in fewer than five years. For the nootropics and biohacking industries, let’s start the dialogue now.