Over the past decade, Cannabidiol (CBD) has emerged as one of the most discussed and debated ingredients in the U.S. wellness and nutrition industries. Despite its increasing popularity and therapeutic potential, the regulatory landscape for CBD remains complex and restrictive.

Under current U.S. law, because CBD is being investigated as a drug, it cannot legally be added to foods, beverages, or dietary supplements. This is due to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the inclusion of active drug ingredients in dietary or food products.

At Maven Regulatory Solutions, our experts continuously monitor FDA regulations, global compliance updates, and legislative initiatives to help companies develop clear strategies for navigating CBD product registration, safety assessments, and labeling compliance across multiple jurisdictions.

The Impact of the 2018 Hemp Bill — A Misunderstood Shift

The Agriculture Improvement Act of 2018 (the “Hemp Bill”) removed hemp from the Controlled Substances Act, leading many to believe that CBD would soon be freely available in food and dietary supplements.

However, this assumption overlooked a critical detail — while hemp was declassified, the FDA retained full authority to regulate products containing cannabis-derived compounds under the FD&C Act and the Public Health Service Act (Section 351).

This means that any CBD-containing product—whether derived from hemp or marijuana—must still comply with FDA regulations regarding safety, labeling, and approved use.

FDA’s Position on CBD in Foods and Dietary Supplements

The FDA has consistently maintained that CBD cannot be lawfully marketed as a food or dietary supplement ingredient. Since 2015, the Agency has issued numerous warning letters to companies selling CBD-infused products that made unverified health or therapeutic claims.

In many cases, these products were found to have inaccurate CBD concentrations or misleading labels, violating both safety and labeling standards. The FDA’s enforcement actions underscore its commitment to ensuring that consumers are protected from unapproved or unsafe CBD products.

Citizen Petitions and the FDA’s Recent Decision

In response to growing market demand, three major trade associations — the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA) filed citizen petitions requesting a regulatory pathway for CBD in dietary supplements.

However, in early 2023, the FDA formally denied these petitions, citing significant safety concerns. After extensive review of:

• Data from Epidiolex (a prescription CBD drug),
• Published scientific studies,
• FDA’s own research findings, and
• Publicly submitted safety data,

The Agency concluded that current evidence does not adequately define safe consumption levels or long-term exposure thresholds for CBD.

Safety Concerns Highlighted by the FDA

The FDA identified several key toxicological risks that require further study before CBD can be approved for general consumption:

• Liver toxicity is associated with prolonged CBD use.
• Potential reproductive system effects, particularly in males.
• Unknown impacts on children, pregnant women, and other vulnerable populations.
• Unclear safety data for CBD use in animal feed, which could affect products like meat, milk, and eggs.

These unresolved issues underscore the need for a science-driven, transparent regulatory framework — one that balances innovation with consumer safety.

A New Regulatory Pathway Ahead

Recognizing these challenges, the FDA announced plans to collaborate with Congress to establish a new regulatory framework for CBD. This future pathway aims to:

• Define acceptable daily intake limits and toxicological reference values.
• Establish manufacturing quality standards (GMPs) specific to CBD.
• Set clear labeling and marketing requirements.
• Create monitoring systems for adverse event reporting and post-market surveillance.

Until Congress finalizes this pathway, CBD remains unauthorized for use in foods, beverages, dietary supplements, or animal feed.

At Maven Regulatory Solutions, we assist clients in staying ahead of evolving CBD regulations, developing regulatory submission strategies, and maintaining compliance documentation that aligns with future FDA expectations.

Conclusion: A Pathway Built on Science, Safety, and Compliance

The FDA’s recent decisions make it clear — the road to CBD market approval will be driven by safety data and regulatory rigor.

While the journey toward a clear pathway has been long, the collaboration between the FDA and Congress marks a turning point. This presents an opportunity for companies to prepare proactively through robust toxicology studies, risk assessments, and global compliance strategies.

At Maven Regulatory Solutions, we help businesses navigate complex U.S. and international regulations, manage regulatory submissions, and design evidence-based safety frameworks to bring compliant CBD products to market responsibly.