Enforcement Actioncritical
FDA Enforcement Action: Injunction Against Hemp CBD Beverage Manufacturer
Federal court grants injunction halting manufacture and distribution of CBD-infused sodas and sparkling waters
Announced: November 5, 2024
Effective Date: November 5, 2024
CBDBeverage
Summary
In November 2024, a federal district court granted FDA's request for a permanent injunction against a Colorado-based hemp CBD beverage manufacturer, halting the manufacture, distribution, and sale of CBD-infused sodas and sparkling waters. The injunction follows a multi-year enforcement action that began with warning letters in 2022.
Key findings supporting the injunction:
- The company continued manufacturing and distributing CBD beverages after receiving two warning letters and a consent decree
- Products were found to contain CBD levels 40–300% of label claims in FDA testing
- Products were distributed across 28 states through major retail channels
- The company made implied health claims through lifestyle marketing without required disclaimers
- Gross revenue during the enforcement period exceeded $14 million
The injunction requires immediate cessation of manufacturing, recall of all affected products, and payment of FDA's investigative costs. The case represents the first permanent injunction against a hemp CBD food/beverage company and establishes an important enforcement precedent.
Deep-Dive Analysis
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What Operators Should Do Now
Critical lessons from this injunction — act now:
1. If you have received an FDA warning letter, treat it as a legal crisis, not a regulatory inconvenience. Immediate, complete, and documented corrective action is required.
2. Audit label accuracy: third-party batch testing of finished goods for CBD content must match label claims within ±20%. Failures here create enforcement exposure independent of legality questions.
3. Do not continue selling CBD beverages without a written legal assessment from qualified cannabis law counsel. The permanent injunction signals FDA is willing to pursue litigation.
4. Maintain financial reserves for potential recall costs — FDA's cost recovery authority extends to investigation and litigation expenses.
5. If you are in the CBD beverage space, consult counsel immediately to assess your current enforcement risk and develop a compliance roadmap.
