How to assess evidence about CBD
Reviewed by executive management. September 16, 2026. Scientific review pending.
Two questions are often confused: whether a specific product is FDA approved for a specific use, and how certain the scientific evidence is. They are not the same question.
Important evidence context. Micelle 60 and FDA-approved prescription cannabidiol are separate products. No clinical, pharmacokinetic, exposure, efficacy, safety or comparability bridge has been established between them. Micelle 60 is not FDA approved, and no clinical benefit or product-specific safety profile has been established for it.
How we review this information
These pages are reviewed and approved by executive management and have been submitted to our Chief Scientific Officer for scientific review. Each page will show her name and the date once she has signed it. Each claim-bearing page identifies its sources, evidence limitations and the date the evidence was last checked. Draft or incomplete pages remain unpublished.
Regulatory status
FDA approval applies to a specific drug product, labeled indication, route, dosing regimen and patient population. It does not extend to another CBD product or another use. [1]Source: U.S. Food and Drug Administration. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). Last checked: .
Evidence domain
We distinguish among controlled human studies, observational human studies and preclinical or mechanistic research. Findings in cells or animals can inform research, but they do not establish clinical benefit in people. Small, uncontrolled or single-dose human studies answer narrower questions and are more vulnerable to chance and bias than adequately powered randomized trials.
A questionnaire can be a valid clinical outcome when it is prespecified, validated and appropriate to the question. It measures something different from outcomes such as hospitalization, relapse or survival.
Clinical certainty
Where a formal assessment has been completed, we report certainty separately as high, moderate, low or very low. “Not assessed” means no completed assessment is available. “No eligible human evidence identified” is used only after a documented search; it does not prove that an effect is impossible.
Relevance to a particular product
Check the exact product, formulation, dose, route, population, condition and outcome studied. A result from another CBD product does not establish the benefits or risks of Micelle 60.
Prescription-dose context
FDA-approved prescription cannabidiol is dosed by body weight. Recommended maintenance doses are 10–20 mg/kg/day for Lennox–Gastaut or Dravet syndrome and 25 mg/kg/day for tuberous sclerosis complex—about 700–1,750 mg/day for a 70 kg adult. These doses, the prescription formulation and the studied populations differ from Micelle 60. Prescription-product evidence does not establish Micelle 60’s exposure, benefits, risks or interaction profile. [2]Source: Jazz Pharmaceuticals, Inc. EPIDIOLEX® (cannabidiol) oral solution: Full Prescribing Information. Revised May 2026. DailyMed, U.S. National Library of Medicine. Last checked: .
What every clinical claim should identify
Each claim identifies the exact question, regulatory status, evidence domain, clinical certainty, product, formulation, dose, route, population, outcome, source and search or review date. It also states whether the evidence applies directly to Micelle 60.
Sources: [1–2]. Evidence last checked September 16, 2026.Source: U.S. Food and Drug Administration. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD).; Jazz Pharmaceuticals, Inc. EPIDIOLEX® (cannabidiol) oral solution: Full Prescribing Information. Revised May 2026. DailyMed, U.S. National Library of Medicine. Last checked: .