CBD Medicalization: Analysis of the Regulatory Trend
An analysis of the systematic strategy of the authorities to classify any CBD product as a medicine, blocking its trade outside the pharmacy channel.
The Trend: All towards Pharma
We observe a convergent regulatory trend of Spanish and European authorities to classify any product containing CBD as "medicinal product by function", regardless of:
Result:
Significant restriction of non-pharmaceutical CBD trade (hemp flower, food, cosmetics, supplements), channeling distribution exclusively through the pharmaceutical channel.
The Four Fronts of Medicalization
1. RD 903/2025: Medical Cannabis
Regulatory Implications
The Problem Definition (Art. 2.d)
CBD is defined as a "chemical substance responsible for different pharmacological effects" without specifying dosage or form of administration.
This all-encompassing definition allows the AEMPS to classify virtually any CBD product as a medicinal product.
The "Spillover Effect
Although the RD is titled "Medical Cannabis," its broad definition of CBD taints the ENTIRE market:
- →Industrial hemp flower (even with 0.2% legal THC)
- →Novel Food with CBD (oils, gummies)
- →Cosmetics with hemp extracts
- →Dietary supplements
Current status: AECANI DEFENDS that products with ≤1% THC are NOT narcotic drugs (CN61).
2. SCCS: Restrictions on CBD Cosmetics
Scientific Committee on Consumer Safety (EU)
Restrictive Approach
The SCCS has issued restrictive opinions on the use of CBD in cosmetics, citing "lack of safety data" and possible systemic effects.
The problem: An impossible standard of evidence is demanded for natural extracts with centuries of traditional use.
Meanwhile, synthetic ingredients from the chemical industry obtain approvals with much less rigorous studies.
Consequence
De facto blocking the inclusion of CBD in the COSING (Cosmetic Ingredients Allowed in the EU) Catalogue, forcing manufacturers to:
- • Recall products from the market
- • Reformulate without CBD (losing the added value)
- • Operating in a gray zone with legal uncertainty
📖 Full analysis available
We have published a comprehensive technical analysis examining the SCCS methodology in light of scientific studies (Hess, Junaid, PSEUDOMA).
Read SCCS and Cosmetics → Analysis3. AEMPS and the Public Prosecutor's Office: Administrative Pressure
Spanish Agency of Medicines and Health Products
AEMPS Doctrine: Everything is Medicines
The AEMPS has developed a maximalist interpretation of the "drug by function" concept:
AEMPS Doctrine: Everything is Medicines
Criterion applied: If a product can (theoretically, potentially) have some effect on the human organism → It is a drug → Prohibited outside of pharmacy.
Consideration: Under this criterion, chamomile, coffee, valerian or any herb with a relaxing effect could be classified as medicines.
Coordination with the Public Prosecutor's Office
Coordination between the AEMPS and the Public Prosecutor's Office has been observed in relation to the marketing of CBD products:
- AEMPS reports used as a basis for criminal complaints
- Allegations of "illegal sale of medicines" without authorization
- Administrative store closings and product seizures
Practical effect
The result of this administrative dynamic creates pressure on the sector to: reconsider its market presence, medicalize its products, or channel distribution through pharmaceutical channels with reduced margins.
4. Novel Food: Deliberate Regulatory Limbo
EFSA - AESAN - Systematic blockage
The Regulatory Dilemma
To sell CBD as food in the EU, Novel Food authorization is required. However:
Problem 1: The costs of the authorization dossier are prohibitive (500.000€ - 2.000.000€). Only affordable for large pharmaceutical companies.
Problem 2: EFSA requires toxicology data that are impossible to obtain for a complex natural extract.
Problem 3: If the product has "health claims" → It is drug → Rejected as Novel Food.
The Result
After years of applications and thousands of pages of documentation, NO CBD product has obtained Novel Food authorization in the EU.
Regulatory Convergence
We observe a multi-level regulatory convergence that merits detailed analysis:
At the legislative level (RD 903/2025)
Deliberately ambiguous definitions that allow for maximalist interpretations.
Scientific level (SCCS, EFSA)
Impossible standards of evidence for natural products.
Administrative level (AEMPS)
Extensive interpretation of the concept of "drug by function".
At the judicial level (Public Prosecutor's Office)
Criminal proceedings that create uncertainty in the business sector.
Key question:
why so much administrative and legislative effort to block a product with zero documented cases of serious toxicity and which is already freely marketed in other countries?
🚨 LATEST ALERT: ECHA/ANSES (Feb 2025)
France has proposed to classify CBD as a reproductive toxicant based on studies with doses 350x higher than human use.
Read complete analysis →Jurisprudence in Our Defense
ECJ Judgment C-88/07 (Commission v. Spain)
The "Melatonin Case
The CJEU determined that Spain had applied the definition of "medicinal product by function" in an excessively broad manner in relation to herbal products.
Established doctrine:
It is not enough that a product "may have" effects on the body. It must be demonstrated that its pharmacological effects are significant under normal conditions of use.
Application: This ruling is a direct precedent for challenging RD 903/2025's attempt to define CBD so broadly.
Kanavape Judgment (CJEU C-663/18)
The CJEU affirmed that a Member State cannot prohibit the marketing of CBD legally produced in another State if it does not demonstrate a real risk to public health.
Inverted burden of proof:
It is not up to the operator to prove that CBD is safe. It is up to the State to demonstrate that it is dangerous with solid scientific evidence.
Our Position: RD 903/2025
AECANI defends that products with ≤1% THC are NOT narcotics and enjoy free circulation in Europe (Kanavape Judgment).
Fundamentals of Our Position
- • Infringement of the principle of proportionality
- • Extensive application of the "drug by function" concept
- • Incompatibility with TPD and Novel Food Directive
- • Precedent Ruling C-88/07 (Melatonin)
Modification Proposals
- • Modify Art. 2.d (to limit pharmacological dosage)
- • Exclude products ≤1% THC from the scope of the RD
- • Recognize the 3 chemotypes of the Pharmacopoeia
- • Ensuring free movement of EU goods
Our Position: Proportionality and Science
We do not deny that CBD has effects on the body. We defend that:
1. The dose makes the poison
A product with traces of CBD cannot be equated to a drug with pharmacological doses. The classification should be based on the concentration and form of administration.
2. Traditional use matters
Hemp has been consumed for millennia without being classified as a medicine. The mere presence of an active compound does not convert a traditional food into a drug.
3. Consumer intent counts
A consumer who buys a CBD cream is looking for hydration and wellness, not to cure a disease. This does not make them a patient.
4. The evidence must be proportional
If a prohibitive dossier is required to prove that CBD is not dangerous, we should demand the same for coffee or green tea.
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