Hemp from US farms now legal, But caution on Cannabis prevails, rightly so

CEO Communique
Date:  2019-02-01
Author:   Dr. Sean Hall
Medlab Cannabis in a beaker

The US Farm Bill amended in December 2018 makes hemp production legal under certain conditions, so will this change the world of medical cannabis?

In short, not immediately, nor should it but it’s a positive direction and logical to restore the status of a crop whose production history dates back several thousand years.

So what is the US Farm Bill?

It is renewed every five years and has been in place since the Great Depression to offer financial assistance to farmers.

What the recent Farm Bill amendment does is overturn a 1937 prohibition on hemp production and so long as hemp, defined in the legislation as the cannabis plant, contains less than 0.3 per cent of THC, the mind-altering compound, it and derivative products can be sold nationally.

Production will be regulated by Federal and State Governments and it opens up new hemp-derived vegetable oil and fibre markets but any hemp above 0.3 per cent THC would be classified as marijuana and subject to quite different restrictions.

Some industry enthusiasts have jumped to the conclusion that the hemp amendments make the CBD component of hemp legal but that is not the case – it remains a Schedule 1 drug and subject to those restrictions.

And it remains the case that any health or medical claims made by cannabis-based products still fall under the jurisdiction of the Food and Drug Administration (FDA).

At this stage, there is only one FDA approved cannabis-derived medicine, Epidiolex, used for treating infant seizures.

There are varying implications from all this for Australia.

Regarding product claims, Australia’s Therapeutic Goods Administration (TGA) operates similarly to the FDA.

But cannabis and marijuana are still illegal substances, although low THC hemp production is allowed.

A big question for Australia, especially with the prospect of a Federal election in May, is whether we might follow our US counterparts in semi or full legalisation of cannabis.

In some quarters there is political and business support for legalisation but my view is that it needs caution.

I have a biased belief – I support whole-hearted research into cannabis and the development of new medicines from that research.

I strongly believe that cannabis has significant therapeutic opportunities but research and the clinical trial route is what is required to improve understanding and develop drugs backed by a scientific process.

Some issues that have surfaced from US cannabis legalisation are criticisms that health policy is dictated by potential tax revenue and that effects of wider use of cannabis are not as benign as one would think.

In Colorado, where cannabis has been legal since 2014, the state’s Department of Public Safety has issued an impact analysis of cannabis use, with results not all positive.

There have been increases in crime, illegal cultivation, interstate diversion and hospitalisations as well as negative impacts in relation to road safety and school attendance.

In California, expectations for a big lift in taxation revenue have fallen well short of forecast.

By contrast, in Australia we manage the humane response well.

The TGA’s Special Access Scheme helps patients in need and over 2018 I witnessed Federal and State co-operation to streamline and significantly improve approvals and turnaround times, which was a commendable and positive initiative.

As election fever hots up in Australia no doubt there will be more debate around cannabis legalisation.

The US precedents are influential and many call for them to be introduced here.

But in my view, it’s a complex topic and one where medical research is beginning to shed some light.

What we really need to do is remove the hype and understand the facts, not blindly follow popular rhetoric.


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Dr. Sean Hall, Chief Executive Officer of Medlab
Chief Executive Officer
Dr. Sean Hall

Sean founded Medlab in August 2012; he has over 20 years' experience in nutraceutical sales and development, as well as early drug discovery in Australia, Asia and the US. Sean has led and inspired his teams to author multiple patents, write peer-reviewed articles and deliver lectures at scientific conferences. His passion is leading his researchers into novel areas and strong commercialisation opportunities.

Prior Sean was a founder of FIT-BioCeuticals. Under his management and guidance, BioCeuticals became the most innovative, research-driven, practitioner brand in Australia. For his sale of FIT-BioCeuticals to Blackmores in 2012, Sean was nominated as a finalist in the inaugural Australian Exit CEO of the Year Award. Sean is a Medical Doctor with an MBA in clinical pharmaceutical management and focuses on the research to pioneer innovation and commercialisation. Sean is an active member of Medicines Australia, the European Medical Association, the American Federation for Medical Researcher, The World Medical Association, A4M and Special Operations Medical Association.