by Steve Goldner, Regulatory Affairs Associates

The Food and Drug Administration (FDA) has learned the hard way, over decades, that there is a moving ‘thin blue line’ for it to take legal action. On one side, the last thing FDA wants is to see thousands of seriously ill people demonstrating at the gates, as happened during the AIDS crisis when FDA stood between horrendously ill and dying patients and potentially life-saving drugs. FDA has become a much more savvy political organization since then and knows that any action it takes is always subject to second guessing by the courts, by Congress, and by political pundits on all sides. On the other side, FDA must act when there is clear evidence of people being harmed by products that fall within its jurisdiction.

There is no question that marijuana, whether in smokable, edible, or any other form, creates drug-like effects in people and animals. This medical fact is acknowledged by everyone and everyone admits that FDA could have jurisdiction to act, if it chooses to act. So why hasn’t FDA acted, and can we read the tea-leaves to foresee when it will act, and how it will act?

The key issue for FDA is always safety to people and especially ‘at risk’ patients such as children, people who might mistakenly take cannabis, or people who are medically compromised. Since no one can smoke cannabis by mistake, and FDA physicians can assure themselves that smoking cannabis has remarkably few toxicity issues, the only remaining safety concern is ingestion. Since it is possible to keep ingesting cannabis-containing food materials until a person reaches levels of medical concern, the question moves to: let’s take a look at the data.

While there may be some overdosed patients who have not been reported into the hospital reporting networks, we do have a couple of years with consumers and consumables in Colorado and Washington State. While there have been some reports of regrettable overdoses that created harm, in general, epidemiologists are surprised by the remarkable absence of medical problems. Frankly, we were expecting significant reports of mortality and morbidity, and the reports are nowhere near the level of concern that FDA sees in field reports when action is necessary to save lives. Certainly there have been isolated problems, but far less than were expected and the trend seems to be towards better labeling, better quality control, and better information at point-of-sale.

So if past action was not necessary by FDA, and current action doesn’t appear necessary, what about future action? Does it look like the marijuana movement is working towards higher standards, more scientific analysis, and greater transparency with medical and scientific collaboration? Or is this movement trying to hide problems and deny that critical self-examination issues need to be addressed?

Clearly the industry is making itself safer on a weekly basis through self-regulation and multiple state regulations. Can we do better? Absolutely! So what are the primary opportunities to make huge leaps forward toward better service and better products for our patients and customers?

We suggest these are the top 5 for you to consider. See if you can answer YES to each of these:

1. Do I use a test lab regularly, with suitable sampling, and have they performed ‘FDA validation’ for their analysis procedures so I know they are giving true values?

2. Is the cannabis product produced regularly in the same way so that the product is predictable and do I follow Good Agricultural Practices (GAP)?

3. Am I always honest about having safe and clean product for my customers?

4. Do I know all the state rules and regulations and am I and my workers following them in all parts of my operations?

5. Have I protected myself and my workers from adverse working conditions?

If you can say YES to all 5, then give yourself a hand, and keep looking ahead, so you can stay ahead.

Steve Goldner was Supervisor Forensic Toxicologist at Office of the Chief Medical Examiner, New York City while working on the team that developed the first commercial laboratory chromatography tests for drugs, which helped launch the drug screening industry in the 1970s. He then formulated the drug methadone with his mentor John Broich from Brookhaven Labs., got FDA approval and managed the drug company for several years. After earning his law degree at Quinnipiac University Law School and practicing law in Connecticut, he specialized in gaining FDA approval for new medical technologies, foods, drugs and medical devices. His consulting firm, Regulatory Affairs Associates, became members of NCIA in June 2015, and has helped get over 240 products approved by FDA which launched many new companies. He also has served as FDA Expert Consultant to the National Institutes of Health and advises testing labs, food and drug companies on FDA, State and International compliance.