An analysis conducted in 2024 and published in Frontiers in Pharmacology examined 202 CBD products and discovered that 74% of them did not meet their claimed potency by at least 10%. This discrepancy occurred in both directions. Additionally, 26% of the products in the sample did not even meet the basic definition of the product type indicated on the packaging. These findings highlight a market where the label often fails to accurately predict the actual dose provided.
The sample included 100 tinctures, 48 gummies, 34 vape products, and 20 topicals. Potency errors varied among the different product formats, as did the contamination profile.
Discoveries on Contaminants and Potency
The analysis also screened for contaminants and found heavy metals present in 44 out of the 202 products. Residual solvents were detected in 181 samples. Pesticide screening revealed 26 different compounds across 30 products, indicating that cultivation inputs play a significant role in contamination.
Hemp has a tendency to draw metals and other residues from the soil into its tissue efficiently. Therefore, cultivation practices largely determine the purity of the final product. The extraction process also introduces a second point of exposure. Inadequate purging or maintenance of equipment in solvent-based methods can lead to traces of contaminants in the distillate used for tinctures or gummies.
It is important to note that finished-products testing is crucial as it can identify issues that may have been missed during raw material testing. Brands that only test the incoming biomass are essentially verifying the cheapest input in the production chain, while leaving the actual product unverified.
Previous studies have shown similar issues with CBD products. An earlier analysis of 84 over-the-counter CBD products revealed that only 31% were accurately labeled within 10% of the advertised content. The inconsistency in potency has been a persistent problem in the industry for nearly a decade, prompting regulators to place more emphasis on current certificates as a minimum requirement rather than a courtesy.
The type of product can influence the margin of error. Tinctures, for example, rely on consistent suspension in the carrier oil. If a batch separates during storage, the amount delivered at the top of the bottle may differ from the bottom. Similarly, gummies require even distribution in the mixture before setting, making it possible for individual units to vary significantly from the batch average even if the batch as a whole tests correctly. Testing a composite of 10 gummies may mask the variation that customers would encounter.
Potency errors are significant because CBD is an active compound. A FDA-funded trial administering CBD to healthy adults twice daily for 28 days revealed elevated hepatic aminotransferase levels in some participants. Reported adverse events included hepatic enzyme increase in 11% of participants, eosinophilia in 9%, somnolence in 8%, and diarrhea in 8%. These effects reversed once dosing ceased, with no serious adverse events reported. However, the findings were strong enough to warrant publication.
CBD also has an impact on several cytochrome P450 enzymes, altering the rate at which the liver metabolizes common medications. If someone is unknowingly consuming a product with 40% more CBD than indicated on the label while taking other medications, it could lead to unintended changes in dosage that the prescribing physician may not detect.
Accurate labeling is crucial for ensuring consumer safety. Relying on the printed serving size means trusting a number that can only be supported by laboratory testing.
Federal Enforcement and Labeling Regulations
Since 2019, the FDA has issued over 200 warning letters to cannabinoid companies. In April 2025, the agency’s Center for Veterinary Medicine addressed Bailey’s Wellness, Holista, and House of Alchemy regarding unapproved cannabis-derived products marketed for uses that had not been evaluated by the agency. These letters often cite both marketing language and manufacturing practices.
The inclusion of therapeutic claims in marketing can categorize a supplement as an unapproved drug under the Food, Drug, and Cosmetic Act. Once a product falls into this classification, the regulatory standards applied by the agency change accordingly. Companies that avoid making disease claims position themselves within a regulatory category that aligns with the capabilities of their quality systems.
Secondary Audiences for Test Results
Certificates of analysis extend beyond the factory setting. Underwriters evaluating new accounts often request these certificates alongside licenses and product catalogs. Companies processing CBD payments view these documents as indicators of operational discipline. Organized lab records streamline the review process for underwriters and other stakeholders.
Retailers and insurers also conduct similar checks before engaging with a product. Both parties seek evidence that the product contents match the label claims. The presence of proper documentation from a functional lab program can instill confidence in the product’s quality.
Establishing a Testing Program for Regulatory Compliance
Each production lot should have its own certificate of analysis, linked to a specific lot number printed on the packaging and issued by a laboratory accredited to ISO 17025 standards. Composite testing across multiple lots can conceal the variations that the tests are designed to reveal.
The analysis should cover various aspects including cannabinoid potency, residual solvents, heavy metals, pesticides, microbials, and mycotoxins. Retention samples from each lot enable re-testing in case of complaints received up to 8 months after the sale. By publishing the certificates with a lot-number index, customers can verify the contents of the product they have purchased.
An effective testing program relies on qualified suppliers. Purchasing distillate from reputable sources ensures better control over cultivation practices. Independent tests commissioned by the brand carry more weight than certificates provided by sellers. Qualified suppliers undergo periodic audits and adhere to contractual specifications with the right to reject substandard batches.
Documenting complaints and associating them with lot numbers allows a brand to quickly identify and address any issues that arise. Swift action is crucial in limiting the impact on inventory and customers in case of a problem.
The Consequences of a Failed Batch
A contaminated or mislabeled batch typically has repercussions beyond the immediate product. Product recalls entail destroying inventory and conducting extensive lab work to determine the extent of the issue. Subsequent costs include reviews by acquiring banks, product suspensions by retailers pending re-qualification, and potential repricing of product liability policies by insurers. These parties all rely on the same documentation to make informed decisions, which are not easily reversed.
The FDA has emphasized that it has not reviewed the manufacturing processes of unapproved CBD drug products and the effects of consuming products with unsafe levels of contaminants remain unknown. This information is not only highlighted in consumer-focused materials by the agency but also influences risk assessments conducted by financial institutions and insurers.
While full-panel testing for every lot may incur additional costs for most operations, the consequences of overlooking quality control measures can have severe repercussions for businesses.
