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Unregistered / Non-prescribed CBD Oil now illegal – Legal Challenge Ahead

The TNHA is gearing up to legally challenge the recent scheduling of cannabidiol (CBD) as a prescription-only drug.

Despite a growing body of incontrovertible evidence supporting the extremely low risk profile of non-psychoactive cannabidiol, otherwise known as CBD oil, the expert scheduling committee of the South African Health Products Regulatory Authority (SAHPRA) have arbitrarily declared all CBD-containing products as schedule 4 and schedule 7 drugs respectively. This was done in terms of section 22A(2) of the Medicines and Related substances Act. (Act No. 101 of 1965).

This will severely restrict the public’s access to this beneficial health-promoting substance.

In a growing amount of progressive countries around the world CBD oil is considered to be a safe dietary supplement by their medicine regulatory authorities, and is sold without any restrictions or requirement to be licensed before being sold.

YOUR CURRENT POSSESSION OR SELLING OF CBD OIL IS ILLEGAL

This new CBD scheduling came into effect on the 17th of August last year, three weeks after the MCC arbitrarily changed its earlier decision to schedule CBD from schedule 6 in an earlier scheduling notice published on the 28th of July.

In terms of the new scheduling notice all CBD-containing products are now schedule 4 drugs (sold on prescription, and after being first registered), unless they are intended for industrial purposes including for the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose and/or used for analytical laboratory purposes, in which case they become highly restricted schedule 7 substances requiring special authorisation by the Director-General of the National Department of Health.

This means that all current CBD oil products and common foodstuffs which contain CBD oil (e.g hemp seed protein, flax seeds, cocoa, black pepper, echinacea etc) which are not registered by the SAHPRA, and which are not prescribed by a medical practitioner are now illegal to sell or possess in terms of the Medicines and Related Substances Act (Act No. 101 of 1965).

In terms of the definition of the word ‘sell’ in Section 1 of the Medicines and Related Substances Act, possession and selling have the same corresponding meanings.

sellmeans sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and “sale” and “sold” have corresponding meanings;

Further, contravention of the Medicines and Related Substances Act has serious consequences for those who transgress its provisions and regulations. Section 29 and 30 of the Act makes it a criminal offence to import, manufacture, sell or even possess unregistered medicines without them being duly registered. Offenders may be liable to a hefty fine, or to imprisonment for a period of up to 10 years for each offence.

IRRATIONAL AND UNLAWFUL DECISION MAKING

In the opinion of our regulatory and legal experts it appears the SAHPRA’s so-called expert scheduling committee has not applied any scientific rationale with respect to the current scheduling of CBD.  It also seems apparent that these decisions have been influenced by vested interests in the pharmaceutical industry which are intent on expropriating this naturally occurring substance for their own monopolistic exploits in various patent medicines they are seeking to register.

CBD should not be scheduled as a pharmaceutical drug when sold without a therapeutic purpose, but rather as a food ingredient or as a dietary supplement. The Medicines and Related Substances Act has no jurisdiction over substances which are sold for industrial purposes, or sold without associated health claims.

It can only schedule a substance based on a substantiated risk profile which is comparative to the risk base of other similarly scheduled substances. For example, common over-the-counter substances such as Paracetamol (acetaminophen) and Ibuprofen have a lower schedule than CBD and are sold over the counter in supermarkets and by thousands of street vendors, yet they cause tens of thousands of deaths each year from unsuspecting consumers having adverse drug reactions to them.

We are not aware of any verifiable deaths related to supplemental CBD ingestion at supplemental daily intake levels worldwide.  We want to know exactly how scheduling CDB oil as a prescription product is protecting the public?

The SAHPRA is a state regulatory body which must apply the best current science and international best practices to inform its decision making. If it does not do so, it is in violation of is duties prescribed by the Medicines and Related Substances Act and conferred upon it by our law makers.

There is little evidence to justify the scheduling of all CBD containing products to prescription only status, or worse, making it almost impossible to utilise for any industrial or food preparation purposes.

THE REAL EXPERTS HAVE DECLARED CBD A SAFE SUBSTANCE

CBD has an extremely low risk base when ingested by humans and animals, even at relatively high daily dosages far exceeding the common daily suggested supplemental dosages advised by most manufacturers of CBD oil containing products.

THE WORLD HEALTH ORGANIZATION

The World Health Organization (WHO), the health agency of the United Nations, has officially recommended that cannabidiol (CBD) not be internationally scheduled as a controlled substance. A recent WHO study led to the release of a Pre-Review Report on the 6th of December last year, which found that no public health risks or abuse potential could be attributed to CBD use. According to the report, naturally occurring CBD is safe and well tolerated in humans and animals, and is not associated with any negative public health effects.

The eminent experts who conducted the study and compiled the report further stated that CBD, a non-psychoactive chemical, does not induce physical dependence and is “not associated with abuse potential.” The WHO also wrote that, unlike Tetrahydrocannabinol (THC), people aren’t getting high off of CBD, either. The report was presented by the WHO’s Expert Committee on Drug Dependence, and drafted under the responsibility of the WHO Secretariat, Department of Essential Medicines and Health Products, Teams of Innovation, Access and Use and Policy, Governance and Knowledge.

THE EUROPEAN INDUSTRIAL HEMP ASSOCIATION (EIHA)

In October 2016 the EIHA commissioned an exhaustive review of clinical data and relevant animal studies related to the Safety and Side Effects of Cannabidiol. In their conclusions they also found overwhelming evidence demonstrating the low risk base of CBD for animals and humans alike.

NON-THERAPEUTIC CBD CONTAINING PRODUCTS MUST BE REGULATED AS FOODS

We believe that non-psychoactive, non-addictive and non-toxic naturally occurring CBD sold without health claims up to an agreed daily safe dosage should rightfully fall under the control of the Foodstuffs Cosmetics and Disinfectants Act (Act No. 54 of 1972). If health claims are made for the products, it should be registered as a medicine.

Locking CDB into a pharmaceutical industry product only is not only opportunistic but irrational. It’s the same as trying to lock oranges and vitamin C into pharmaceutical only products. Manufacturers, purveyors and users should be able to make their choices of how they convey and consume their products accordingly.

The aim of the TNHA going forward is to convince the SAHPRA that all the CBD stakeholders could establish a set of rules, guidelines and standards that would enable the industry to comply with its requirements for medicinal CBD products. Our main purpose is to work with industry and government to ensure this market continues to grow, providing safe, effective and tested products for consumers and job security for its workers in the industry.

The TNHA is willing to work with all CBD product producing companies in the industry to advocate the case for a fully regulated market while talking to the South African government to develop a more liberal regulatory framework.

The TNHA would like to adopt a reasonable and pragmatic regulatory framework such as that set out by the European Industrial Hemp Association (EIHA).

LEGAL ACTION

As per our mandate, the TNHA have initiated the legal process of challenging these scheduling decisions within the prescribed six months after the scheduling notice being published. We have served the SAHPRA with an official request for written reasons and supporting documentation related to their scheduling decisions in terms of the Promotion of Administrative Justice Act (Act No. 3 of 2000)

Our request was served by the Sheriff of the Court on the SAHPRA in Pretoria on the 31st of January and they have 90 days in which to either reply or request a two week extension.  We therefore expect the SAHPRA to reply on or before the 30th of April.. Should we not receive either a request for an extension to reply, or cogent written reasons for their scheduling decision, we reserve our rights to approach a competent court to settle the matter.

We will keep you further informed on further progress.