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Cannabis Product Safety: FDA Research and Consumer Protection

By Ryan S. Sultan, MD
Assistant Professor of Clinical Psychiatry, Columbia University
Director, Cannabis Safety and Mental Health Informatics
March 29, 2026

Why the FDA Needed to Hear This

Cannabis is now legal for recreational use in 24 states and the District of Columbia. In New York alone, the legal cannabis industry is growing rapidly following state legalization. But there is a fundamental disconnect at the heart of this expansion: consumers are purchasing products that look regulated, feel regulated, and are marketed as safe -- yet many of these products have never been subjected to anything resembling the safety standards applied to food, pharmaceuticals, or even tobacco.

The FDA has regulatory authority over consumer product safety, but cannabis occupies a peculiar regulatory gap. It remains a Schedule I controlled substance at the federal level while being openly sold in state-legal markets. This means there is no federal agency systematically testing cannabis products for safety, verifying label accuracy, or enforcing marketing restrictions.

That gap is exactly what our CASNY study was designed to investigate.

The CASNY Study: Design and Methodology

The Cannabis Access and Safety in New York (CASNY) study is a research project I direct at Columbia University, conducted in collaboration with Dr. Colin Nuckolls (Professor of Chemistry, Columbia) and Dr. Tim Becker (Child and Adolescent Psychiatry, NewYork-Presbyterian/Columbia). Our multidisciplinary team brings together expertise in child and adolescent psychiatry, epidemiology, and organic chemistry -- including the chemical composition of cannabis and its physical and psychosocial effects on users.

The study was designed in three phases, each building on the last:

Phase 1: Youth Advertising and Access (Secret Shopper Study)

We employed a 22-year-old "secret shopper" who visited 37 randomly selected licensed and unlicensed cannabis stores in New York City. At each store, the shopper systematically observed and documented:

• Marketing and advertising strategies
• Compliance with age-gating regulations (age verification upon store entry and at point of purchase)
• Product presentation and merchandising
• Pricing structures
• Proximity to youth-oriented products and environments

This matters because state legalization was sold to the public on the promise that it would reduce youth access through regulation. Our data suggest that the proliferation of unlicensed retailers -- which in New York have far outnumbered legal shops -- has created conditions where youth access may actually be easier, not harder.

Phase 2: Packaging and Labeling Analysis

We systematically acquired 88 cannabis products (flower and vape pen samples) from both licensed and unlicensed retailers and analyzed their packaging and labeling. We assessed each product for the presence of essential consumer information.

The pattern was consistent and alarming: products from unlicensed retailers systematically lacked the safety information consumers need to make informed decisions, while simultaneously being more likely to feature design elements attractive to children.

Phase 3: Chemical Accuracy and Safety

Product samples acquired during the secret shopper visits were analyzed at Columbia University's mass-spectrometry laboratory under the direction of Dr. Nuckolls. The chemical analysis assessed:

• THC potency: Actual tetrahydrocannabinol concentration compared to labeled content
• Pesticide screening: Presence and concentration of agricultural chemicals
• Chemical composition: Full cannabinoid and terpene profiles
• Concordance: Agreement between retailer-reported metrics and laboratory findings

Why This Matters for Public Health

The findings from our CASNY study are not academic abstractions. They have direct implications for millions of Americans who use cannabis products.

The Youth Access Problem

New York's experience following legalization has garnered national media attention, particularly regarding how illegal cannabis shops have far outnumbered legal ones. Our data quantify what many have suspected: these unlicensed retailers represent a direct pathway for youth to access cannabis with minimal barriers.

As a child and adolescent psychiatrist, this is where my concern is most acute. The developing brain is uniquely vulnerable to cannabis's effects. Early and heavy cannabis use is associated with:

• Increased risk of cannabis use disorder (up to 30% of users develop a use disorder, per national data)
• Cognitive impairments that may persist into adulthood
• Increased risk of psychotic disorders in genetically vulnerable individuals
• Motivational deficits affecting academic and occupational functioning

When unlicensed stores use cartoon signage, sell cannabis next to candy and energy drinks, and fail to check identification, they are effectively targeting the population most vulnerable to harm.

The Labeling Accuracy Problem

If you buy aspirin at a pharmacy, the label tells you exactly what is in the bottle and it is accurate. If you buy cannabis at a store -- even a licensed one -- the label may or may not reflect what is actually in the product.

This is not a minor inconvenience. Inaccurate potency labeling means consumers cannot reliably dose cannabis, increasing the risk of acute adverse effects including severe anxiety, paranoia, vomiting (cannabinoid hyperemesis syndrome), and psychotic episodes. For medical cannabis patients attempting to manage specific conditions, inaccurate labeling undermines the entire therapeutic rationale.

The Contaminant Problem

Previous research -- and our own preliminary findings -- have documented contaminants in cannabis products that pose direct health risks:

• Pesticides exceeding legal limits: Cannabis plants are treated with agricultural chemicals that may not be safe for inhalation
• Fatty acids linked to acute respiratory failure: Particularly concerning in vape products, where vitamin E acetate was linked to the 2019 EVALI outbreak
• Heavy metals: Cannabis plants can bioaccumulate heavy metals from contaminated soil
• Microbial contaminants: Mold and bacteria, especially dangerous for immunocompromised patients

These contaminants have been found even in products from regulated markets, indicating that existing state-level testing requirements are insufficient.

The risk is not hypothetical. The 2019 EVALI (e-cigarette or vaping product use-associated lung injury) outbreak sickened over 2,800 people and killed 68 in the United States, largely traced to vitamin E acetate in unregulated THC vape cartridges. That outbreak was a preview of what can happen when a widely consumed product exists outside a meaningful safety framework.

The Regulatory Gap

The core problem is structural. Cannabis is legal in the majority of states but remains federally prohibited. This creates a situation where:

• No federal safety standards exist for cannabis products -- unlike food, drugs, tobacco, or alcohol
• State regulations vary enormously in what they require for testing, labeling, and marketing
• Enforcement is inconsistent even within states that have robust regulations on paper
• Research is hampered by cannabis's Schedule I classification, limiting the federal funding and infrastructure available for comprehensive safety studies
• Interstate commerce is prohibited, preventing the development of national quality standards

Our CASNY study is one of the first to systematically examine how retail practices differ between licensed and unlicensed cannabis retailers. The findings underscore that state-level legalization without robust enforcement and federal coordination creates conditions where consumer safety is compromised -- precisely the consumers that legalization was supposed to protect.

Furthermore, cannabis undergoes chemical transformations during combustion and vaping, potentially producing additional carcinogens and respiratory irritants beyond the compounds present in the raw plant material. The chemical composition of cannabis smoke and vapor has not been adequately studied, leaving a fundamental gap in our understanding of what consumers are actually inhaling. This knowledge deficit is not merely academic -- it is a critical failing that perpetuates consumer risks and hampers the ability of any regulatory body to set meaningful safety standards.

The FDA Presentation

In October 2024, our team presented these findings to FDA staff in a formal listening session. The presentation team included:

• Ryan Sultan, MD -- Principal Investigator, study introduction, background, and future directions
• Tim Becker, MD -- Secret Shopper Study and Packaging and Labeling Study findings
• Colin Nuckolls, PhD -- Chemical Analysis Study methodology and results

We requested the session with specific FDA staff with expertise in drug safety and cannabinoid science. The FDA's role as a listening body in this context reflects the evolving regulatory posture toward cannabis -- an acknowledgment that the safety questions are real and that academic research has a role in informing future regulatory action.

What We Recommended

Our presentation concluded with recommendations for federal consideration:

• Standardized testing requirements for all cannabis products sold in legal markets
• Mandatory labeling accuracy standards with enforcement mechanisms
• Federal investment in research on the chemical composition and safety profile of cannabis products, including transformation products created during combustion and vaping
• Enhanced monitoring and enforcement against unlicensed retailers, particularly those employing youth-oriented marketing
• Development of a federal framework that coordinates with state regulatory agencies

How This Connects to CASNY's Broader Mission

The FDA presentation represents one component of a larger research program. The CASNY study is designed to provide the foundational data that policymakers need to make evidence-based decisions about cannabis regulation. This includes:

• Ongoing monitoring of retail practices as New York's legal market matures
• Expanded chemical analysis of cannabis products across multiple product categories
• Investigation of how effectively modifiable health risks are being managed in the cannabis industry
• Assessment of the public health impact of the current regulatory framework

Our position is not anti-cannabis. It is pro-safety. Legalization happened. The question now is whether we will regulate this industry with the rigor it demands, or continue to allow a patchwork of inconsistent standards that put consumers -- especially young consumers -- at unnecessary risk.

What Consumers Should Know Now

Until comprehensive federal regulation is established, consumers can take practical steps to reduce their risk:

Frequently Asked Questions

What is the CASNY study?

The Cannabis Access and Safety in New York (CASNY) study is a three-phase research project I direct at Columbia University. It examines cannabis retail practices, product labeling, and chemical safety in New York City's legal and illegal cannabis market. Phase 1 studied youth advertising and access using a secret shopper method, Phase 2 analyzed packaging and labeling compliance, and Phase 3 tested the chemical accuracy and safety of cannabis products using Columbia's mass-spectrometry laboratory.

What did the CASNY study find about unlicensed cannabis retailers?

We found that unlicensed cannabis retailers in New York City were significantly less likely to verify customer age, sold cannabis at lower prices, and were more likely to use youth-friendly marketing techniques such as cartoon signage. They also sold cannabis alongside youth-oriented products like energy drinks and candy. Their products were less likely to include essential consumer information such as THC potency, standard dose, and expiration date.

Are cannabis product labels accurate?

Our analysis of 88 cannabis products from licensed and unlicensed retailers in NYC found significant labeling discrepancies. Products from unlicensed retailers were particularly deficient. Chemical analysis by Columbia's mass-spectrometry lab assessed concordance between labeled and actual THC content, revealing inconsistencies between retailer-reported metrics and laboratory findings. This problem is not limited to New York -- multiple published studies have documented inaccurate labeling in regulated cannabis markets across the country.

Why is the FDA involved in cannabis safety research?

While cannabis remains federally controlled, state-level legalization has created a rapidly growing consumer market with inconsistent safety standards. The FDA has regulatory interest in consumer product safety, including concerns about labeling accuracy, contaminant exposure, and youth access. Our team presented CASNY findings to FDA staff in a formal listening session to inform potential regulatory action on cannabis product safety.

What contaminants have been found in cannabis products?

Research on cannabis products, including our CASNY study and other published studies, has identified multiple categories of contaminants: pesticides exceeding legal limits, heavy metals, fatty acids linked to acute respiratory failure (particularly in vape products), and microbial contaminants. These have been documented in products from both regulated and unregulated markets, underscoring the need for standardized federal testing requirements.

Further Reading

• Cannabis Research Hub
• The CASNY Study: Full Overview
• Cannabis Labeling in NYC: What We Found
• Cannabis Vaping and Edibles: Safety Considerations
• Publications