- - Tuesday, May 14, 2019

ANALYSIS/OPINION:

On May 31, the Food and Drug Administration (FDA) will hold a meeting to discuss “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” Specifically, this means CBD (cannabidiol). In short, the FDA has realized that it’s time to face reality.

Reality is more complicated than sound bites. The absence — to date — of advanced regulatory thinking relative to CBD has resulted in a maelstrom of false claims and shoddy quality standards. Nature abhors a vacuum.

The FDA has made it clear that hemp-derived CBD is not a legal dietary supplement.

According to the FDA, “Our first priority for dietary supplements is ensuring safety. Above all else, the FDA’s duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: We want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision-making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.”

Bravo, but what’s the relevant messages for the nascent but swiftly growing CBD industry and the American consumer? First, that aggressive and misleading marketing campaigns need to be put on pause now that the FDA has stepped up to the plate. Next, as with all FDA-regulated products, manufacturing quality and labeling integrity are joined at the hip, inseparable condiciones sine quibus non. Complying with FDA regulations isn’t easy or inexpensive and is certainly not a mom-and-pop proposition.



Many in the CBD community think this issue is one of regulatory creep on the part of the FDA, but that doesn’t change the law or the facts on the ground. Waving away as “Big Brotherism” the important public health role of the FDA doesn’t make the agency’s position or authority any less real or relevant.

It’s time for the proponents of CBD — including many highly vocal patients, physicians, pharmacists, manufacturers and distributors — to become part of the solution. If you’re not at the table, you’re on the menu.

Some key issues include:

• No current standard in quality of production

We mustn’t repeat the tragic flaws of limiting the FDA’s hand via outdated DSHEA (the legislation that requires dietary supplements to be regulated as foods). Quality must always trump corporate convenience.

• No dosing standard

When patients are prescribed any other type of medication, they are given a dosing schedule by the doctor telling them how much to take, how to take it and how often. When people are told to use CBD by physicians, pharmacists or friends, they are not given any peer-reviewed guidelines about how they should take it or in what amounts — something that would never happen with any other medication.

• Potential for help and harm through chronic use

What does serious research tell us? Hardly anything and the plural of anecdote isn’t data. We mustn’t repeat the mistakes that led to the opioid epidemic.

• Legalization changes public opinion of harm potential

If you can’t measure it, then it doesn’t count. Quantifying CBD’s therapeutic and manufacturing bona fides for pain treatment isn’t the end of the debate; it is only the beginning. Now we must develop ways to measure its effectiveness and develop ways to capture the real-world evidence that must drive evolving best medical practice and reimbursement policies.

It’s time for the FDA to assume the mantle of leadership and work with the CBD community to develop solid standards and practices for manufacturing and labeling quality, sound science and practical consumer education. As President Kennedy said, “Leadership and learning are indispensable to each other.”

• Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris Descartes Medical School.

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