November 21, 2025

The regulation of cannabidiol (CBD) in the United States continues to evolve — creating both challenges and opportunities for manufacturers, distributors, and consumers in the food, dietary supplement, and pharmaceutical sectors. Despite increasing market demand and public acceptance, CBD’s regulatory status remains complex, largely due to its classification as an active ingredient in a drug product.

This article breaks down the FDA’s position on CBD, recent regulatory decisions, and what these developments mean for the future compliance pathway for CBD-containing products.

The Legal and Regulatory Background

Following the passage of the 2018 Farm Bill, hemp and its derivatives were officially removed from the Controlled Substances Act (CSA) a major milestone for the CBD industry. However, this legislative change did not strip the U.S. Food and Drug Administration (FDA) of its authority to regulate cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Section 351 of the Public Health Service Act.

While the public interpreted the Hemp Bill as a green light for CBD-infused foods and dietary supplements, the FDA maintained that CBD cannot legally be marketed as a food ingredient or dietary supplement, since it has been investigated and approved as a drug (Epidiolex). Under U.S. law, any compound first approved as a drug cannot later be legally added to food or supplements without a specific regulatory exemption.

FDA’s Ongoing Enforcement and Public Health Concerns

Since 2015, the FDA has issued numerous warning letters to companies marketing CBD products with unsubstantiated therapeutic or drug claims. These products have often been found misbranded, inaccurately labeled, or containing CBD levels inconsistent with their claims — raising significant safety and consumer protection concerns.

The FDA’s scientific evaluation of Epidiolex data published studies, and internal research has led the Agency to conclude that there is insufficient safety data to support widespread CBD use in foods or supplements. Key safety concerns include:

  • Potential liver toxicity with prolonged use
  • Effects on male reproductive health
  • Unknown risks to children, pregnant women, and vulnerable populations
  • Potential impact of CBD in animal feed, and downstream exposure in milk, meat, and eggs

Citizen Petitions and FDA’s Rejection

Three leading trade associations — the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA) filed citizen petitions requesting that the FDA create a regulatory pathway allowing CBD in dietary supplements.

However, after extensive review, the FDA denied these petitions in early 2023, citing inconclusive safety evidence. According to the Agency, the available data does not establish how much CBD can be safely consumed, or for how long, without causing harm.

The FDA has therefore concluded that the existing dietary supplement and food regulatory frameworks are not appropriate for CBD, and that Congressional action is required to establish a new pathway for safe marketing.

The Path Forward — Collaboration Between FDA and Congress

The FDA has publicly stated that it intends to work with Congress to create a new regulatory pathway for CBD in foods, dietary supplements, and animal feed. This pathway would need to address:

  • Clear safety thresholds and acceptable daily intakes
  • Labeling and dosage standardization
  • Restrictions for vulnerable populations
  • Manufacturing quality and testing requirements
  • Oversight of animal-derived food products containing CBD

Until such regulations are enacted, CBD remains excluded from lawful use in non-prescription food and dietary supplement categories under U.S. federal law.

Preparing for Regulatory Evolution

For companies operating in the CBD and hemp-derived ingredient space, this evolving landscape underscores the need for strategic regulatory planning, toxicology evaluations, and compliance expertise. Proactive engagement with regulatory specialists can help ensure product development aligns with future expectations once the new pathway is formalized.

Partner with Maven Regulatory Solutions

At Maven Regulatory Solutions, we specialize in helping manufacturers navigate evolving U.S. FDA regulations for food ingredients, dietary supplements, and cannabis-derived compounds. Our team of regulatory experts, toxicologists, and compliance strategists provides tailored guidance for product safety assessments, regulatory submissions, and pathway development in alignment with FDA and global standards.

Whether you’re developing a new CBD formulation or planning to expand into the U.S. market, Maven helps you stay compliant, future-ready, and scientifically validated.

Contact us today to discuss how our experts can support your CBD product strategy and ensure alignment with FDA’s evolving regulatory framework.