Safer Solutions: Regulating “Quasi-Medicinal” Substances

At the end of October, a senior adviser for President Donald Trump’s Veterans Health Administration signaled enthusiasm for expanding the U.S. Department of Veterans Affairs (VA)’s capacity to offer mental health treatment using psychedelic drugs. While psychedelics are a promising, emerging treatment for some mental health conditions, none has received Food and Drug Administration (FDA) approval, no treatment protocol has been established outside of research settings, and all remain federally illegal to sell or possess. Although eagerness to “ramp up” capacity doesn’t necessarily mean psychedelics will be offered in VA clinics anytime soon, conversations and policy actions related to the availability of “quasi-medicinal” substances like psychedelics, peptides, and kratom are becoming more common, raising questions about regulation and consumer safety.

Growing Popularity of Quasi-Medicinal Substances

For our purposes, “quasi-medicinal” substances are substances that—while used with therapeutic goals in mind—currently lack sufficient clinical evidence to support formal medical use. 

State laws around psychedelics are changing in response to promising research and public support. Oregon, Colorado, and Washington, D.C. have decriminalized some psychedelics, with both Colorado and Oregon authorizing the operation of licensed “healing” or “service” centers for mental health treatment. First-time use of psychedelic drugs has slightly increased among the general population, with many people using them with therapeutic purposes. Simultaneously, poison control centers have experienced an increase in calls related to use of psilocybin (“magic mushrooms”).

But psychedelics aren’t the only substances with growing consumer support—some influencers also promote peptides and kratom for their possible health-promoting qualities. 

As the building blocks of proteins, peptides have become popular with social media influencers as a biohack for everything from improving athletic performance to slowing aging. Although peptides are found in some FDA-approved medications, unregulated, “research-grade” peptide use continues to proliferate. In July, despite limited clinical evidence, an FDA committee narrowly recommended six peptides for addition to the list of substances compounding pharmacies are allowed to make. The Department of Health and Human Services formally allowed compounding of these peptides in October. (Compounded medications aren’t FDA-approved, meaning the FDA doesn’t verify their safety, effectiveness, or quality before they are sold to consumers.)

Kratom is another substance attracting growing consumer interest. Some people report using it to treat pain, mental health conditions, and opioid use disorder and withdrawal. Per the FDA, kratom can’t legally be marketed as a drug, food, or dietary supplement; however, it is frequently sold at gas stations, in smoke shops, and online. Unlike psychedelics and peptides, which enjoy some policy and regulatory support, kratom has been made a Schedule I substance in several states. Meanwhile, the Drug Enforcement Administration temporarily placed four kratom-related substances on Schedule I, making them illegal to sell or possess.

Regulation and Quasi-Medicinal Substances

Together, psychedelics, peptides, and kratom paint an interesting picture of how politics, public perception, and research can impact how quasi-medicinal substances are regulated and accessed. Despite political and public enthusiasm for psychedelics, their formal medicinal use likely will remain limited until at least one such substance obtains FDA approval as a drug. Peptide regulation seems to be taking a more permissive route: Although consumers currently need a prescription to access them, the proliferation of online pharmacies and prescribers offering fast, inexpensive access to compounded ketamine and GLP-1 medications suggests peptides will follow a similar path. And kratom remains easily accessible despite facing more hostile policy responses in some states.

This inconsistent regulatory and policy environment raises a question: How do we handle substances that are used quasi-medicinally by consumers, present some level of health and/or misuse risk, and lack the evidence or financial backing to receive FDA approval?

Current federal regulatory responses tend to rely on the existing pathway for pharmaceuticals. Although it ensures safety and efficacy, the required clinical testing is time consuming, and the pathway struggles to handle novel therapeutic categories and botanical compounds. Space for a middle-ground regulatory approach exists somewhere between the strict regulation of pharmaceuticals and the less-intense regulation of foods and dietary supplements.

Several key consumer safety elements must be considered when designing such a pathway:

1. Consumers should know what’s in their product. Processed foods must list their ingredients. Over-the-counter pharmaceuticals must list how much of the active ingredient the product contains. Consumers should be informed about what they put into their bodies, and products should contain exactly what they claim to contain.
2. Health claims should be regulated. Advertising and product packaging should not include unsubstantiated claims regarding health benefits. Food and dietary supplements, tobacco products, and pharmaceuticals are all restricted in the type of marketing claims they can make. 
3. Safety reporting and regulatory authority should be built into regulation. Most products are subject to some type of recall authority or regulatory action if their manufacturer doesn’t voluntarily address safety issues when they arise. Ensuring that one agency has authority to ensure product safety is vital to protecting consumers. Safety reporting mechanisms should also ensure that adverse effects can be tracked and action taken if regulators observe concerning patterns or impacts.
4. Appropriate access restrictions should be implemented. Access restrictions—such as age of purchase or places where potentially harmful products (e.g., those including alcohol, cannabis, or tobacco) can be sold—are often intended to prevent minors from accessing these substances. Other examples include purchase limits for over-the-counter drugs or requiring a prescription to access a particular product. 

This is far from an exhaustive list of considerations for the regulatory oversight of quasi-medicinal substances; however, these gaps create space for products to be sold on the grey or illicit market with inconsistent information and contents and/or false claims that could severely compromise consumer safety. Given their quasi-medicinal use, psychedelics, peptides, and kratom highlight the need for deeper conversations about how to regulate products that can either help or harm consumers.