Home Opinion How the FDA Will Regulate Cannabis, From an FDA Insider

How the FDA Will Regulate Cannabis, From an FDA Insider

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Flickr @ David Gach

The FDA is going to end up Chief Regulator of all things cannabis. Take a deep breath, feel the conflict, move through it. You’ll be OK. Now, let’s talk about when and how this will happen, and take notice that it has already started; just because you didn’t see it happening doesn’t mean it isn’t. Maybe it’s all for the better, we’ll see.

I really believe that federal officials exist to protect our society and get better products into the marketplace. This has helped make America the safest place to live and our products are trusted throughout the world. But, policies need to change as the times change, and most people recognize the DEA’s policy of seizure, arrest and incarceration has been a disaster. So we need different policies, managed by people who aren’t invested in 50 years of failure.

The FDA is closely following this state-by-state social experiment with cannabis. The end-game arrives when something happens to prod Congress into action. This is how the FDA has operated for decades, always waiting until politicians and the general public demanded action; insisting the FDA reluctantly make something work. Cannabis regulation will be the same.  

There will be a process allowing for public input. It is stage-managed by the FDA and industry lawyers/consultants, with rule-making that extends over 6 years. Dissatisfied parties often file lawsuits during and after the process and they almost always lose. Dramatic realignment of the industry and consolidation of the marketplace with improved products meeting uniform, enforced standards is generally the outcome. And the cost of entry into the marketplace goes up dramatically, to the benefit of early market entrants.

When it comes to creating new federal regulations affecting American’s health and wellness – it’s the FDA that has “stepped up”, usually reluctantly, to regulate medical devices, tobacco, home pregnancy test kits, genetic lab testing, etc.  And the process has already started for cannabis. Here is how it could play out:

Cannabis buds/leaves for smoking will have their own regulatory scheme, like the one recently created for tobacco [21 CFR 1140]. Heirloom or backyard cannabis growing will probably be allowed, just like making beer or wine for craft purposes – for personal use or gifts, but not selling it.

Purified extracts of cannabis with real medical claims are already regulated as new drugs under 21 CFR 201. These special formulations could be distributed for retail sale in pharmacies, supermarkets and food stores via a well-established FDA process called ‘Rx to OTC switch’. All that’s needed are larger clinical trials, and the FDA is constantly working to make those easier to be managed via social media.

Cannabis edibles will have a revised ‘medical food’ category [21CFR 101] that merges with foods making health claims. Cannabis oil can be regulated as an OTC drug  [21CFR 300] under a new cannabis monograph and the United States Pharmacopeia is already considering a USP monograph to set that standard.

Another important issue is to identify the upcoming ‘pinch-point’, since that is where extra value can be obtained. There are multiple ‘constriction points’ in every product stream, but for cannabis, they all converge at one place – laboratory testing.

Lab tests, where nothing can be hidden. Lab tests have to be reproducible or the lab gets shut down. And lab tests are the FDA’s sweet spot. The Agency knows how to inspect lab results, track it back to products, forcing recalls and shutting down producers who don’t meet the standards and regulations. It’s an easy way to ensure honesty and integrity.  

The FDA’s work is simplified by the seed-to-sale system mandated by the states. All the FDA has to do is simply download the data from lab testing, perform spot audits of the labs – just like it does with other industries – and follow the data back to the grower or producer to shut down businesses making bad product or product that doesn’t meet potency and safety requirements.

We know one laboratory that has already offered its test methods to the FDA, and their own labs will develop improved methods. The process is inevitable, and opens the cannabis market in new ways for the best-prepared businesses.

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Steve began his forensic toxicology career at the Chief Medical Examiner’s Office in New York, developing the first reliable screening tests for many drugs, and launching the world-wide Drug Screening industry through his first laboratory start-up, Spectrum Labs. He then developed the drug methadone when he was 24 years old, gaining FDA approval and managing that start-up company, Mifflin Pharma. With both companies successfully exited, he earned his law degree and has served as FDA attorney and advisor to medical device, pharmaceutical, food and nutritional supplement companies in 40 countries. As CEO of Regulatory Affairs Associates, his firm obtained more than 240 FDA approvals for new products, resulting in the start-up of more than 200 new companies. Steve opened Pinnacle Lab in Michigan in 2015, as the only FDA-caliber cannabis test lab. He is about to launch a cannabis-based pharma company and serves FOCUS as the Chairman of Cannabis Testing Standards. Mr. Goldner also represented world-wide cannabis interests at the United Nations UNGASS2016 convocation. In addition, he continues to serve as Chairman of the Board of Directors for his inventive clinical trials company, Curelauncher.

1 COMMENT

  1. Dear sir,
    Cannibas should be regulated as any other pharmaceutical. You must file for your own formulation with the agency regardless of its equivalence to others. You must have a batch record of its production as well as stability data indicating that levels of impurities are below threshold and therefore are safe. You must also have validated all methods, techniques and processes involved in its production. You must include cleaning assessment of equipment used in its production to show that no contamination occurred. You must have training records to show people are qualified to perform their duties. Now the money involved in all of this would gives these pot houses a taste for what I have done for the last 25 years to produce pure, safe and effective pharmaceuticals to the populace so yes take a deep breath. All it will take is a death or any serious injury from any form of cannibas produced and I ask you would there be a recall? Would a pot house be sued? Finally, Because of the food, drug and cosmetic act the FDA exists and therefore cannibas is not excluded. I do not use the junk in any way and only hope people will wake up and understand they have no way of knowing the consequences of using it when no controls are in place.

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