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NPA: Setting safety limit on CBD key part of regulatory process


Many industry critics are calling on Congress to give FDA additional regulatory powers, including mandatory product listing. Some even call for “DSHEA 2.0”. This is despite the fact that FDA has failed to fulfill its existing responsibilities and have ample authority.

The regulatory status for cannabidiol is a prime example of FDA’s lack of will. All of us want FDA to make CBD an acceptable ingredient in food and dietary supplements. This is despite the fact that CBD products are used by 1/5 Americans.

Mixed message from FDA To say that the FDA messages have been misinterpreted is an exaggeration. While the former commissioner claimed it would be foolish to take CBD products off the market, FDA has stated that CBD is not legal in any form. But, there are still thousands of CBD products flooding the market and FDA has not sent any warning letters to the companies that make the most outrageous claims.

As an sector, it is important to be scientifically and responsibly accurate about CBD. Some industry leaders claim that CBD is not a safety concern. It would be irresponsible. Our critics have been energetic in trying to obtain new FDA premarket authority.

I’m certain FDA enjoys the constant coverage of the mandatory product labeling discussion, but FDA must address CBD before anyone in the industry can entertain the idea of new authorities. It seems to be common sense, but some industry leaders get caught up in the “politics of the moment” instead of staying true to the mission.

Legislation will have to be based on safety assessment

Assuming we in industry still want to pursue CBD legislation — which may be necessary if FDA continues to sit on its hands — it can and will only move forward based on safety. Some people are upset by this fact and want to amend DSHEA so that Members of Congress can look into which chemicals are food, drugs, and which you have access to. Are we really asking Congress to do this?

Interestingly, we know that FDA has provided technical assistance on some legislative proposals on CBD, in which FDA pointedly stated safety would need to be addressed. Knowing that CBD must be regulated in both drug and food/dietary supplements pathways in the future, having been involved in regulatory work in the past, I would like to see FDA follow precedent and set a CBD intake limit. When they have the same molecules, claims and dosage are what distinguish our drugs from foods.

For new ingredients, setting a safe limit has been part of our DNA as a component of the NDI process. Our organization has conducted surveys and other research that have revealed that the majority of consumers expect safe levels to be addressed.

The DSHEA Act was adopted in 1994, and gave FDA regulatory authority for finished dietary supplements products as well as dietary ingredients. Federal Food, Drug, and Cosmetic Act requires manufacturers and distributors to disclose safety data that will show the FDA why the ingredient is safe to use for suggested or recommended uses. The FDA’s May 2019 meeting focused on CBD safety and health risks. The stakeholders identified the ways FDA could have the staff and resources to determine a CBD daily exposure limit.

The former chief of FDA suggested that dosage levels

This is not the first suggestion from an ex-official at FDA. Scott Gottlieb (former FDA commissioner) suggested that the best path to CBD was determined by the intended usage. When discussing intended use for CBD, Dr. Gottlieb stated the right approach should be “one concentration where the product is a drug and another concentration where the product is a food and or dietary supplement.”

And yes, Red Yeast Rice/Monacolin K is the most obvious example of how the FDA reconciles natural products that appear in the marketplace that have some level of an active pharmaceutical ingredient (API) present in the dietary supplement or food. Although some may not be able to understand the FDA and court decisions regarding Red Yeast Rice’s use, they generally establish a daily level or a threshold via a Health Hazard Evaluation (HHE). The agency hasn’t conducted an HHE to date. However, 2019, Congress passed legislation dedicating funds to the agency for an HHE.

Although the submissions are based on drug and food law, they must submit safety studies such as a 90-day toxology study for their product. Also include the CBD levels. This data would be used by FDA to determine an initial exposure limit that allows FDA to enforce enforcement actions against products that exceed this level. The FDA would be able to balance consumer access with enforcement discretion, by knowing the dosage at which a natural product is considered a drug. It has side effects similar to drugs, and as such it is not available in food or supplements. This would be in line with our legal framework which gives us access to the most safest foods and drug supplies in the world, and the principles of science.

Two separate NDI notification for full-spectrum cannabis extract were rejected by the FDA in recent weeks. This shows that the NDI system works. DSHEA regulations and their application work in the industry’s best interests. If DSHEA is properly enforced, our industry can provide safest dietary supplement in the world. Because of our safety record, more than three quarters (or four) Americans are willing to take dietary supplements from us.

Regardless if a submission contains CBD or another ingredient, science submitted must meet the standards set by the NDI. FDA cannot issue an AKL if the submitted safety data exceeds the FDA threshold.

Some executives of trade associations have incorrectly claimed that the FDA doesn’t have the power to establish a CBD safe consumption level.

New authorities unlikely to benefit consumers

New authorities unlikely to benefit consumers

It’s disturbing that some of these executives are collaborating with fierce industry critics to give FDA new authorities that are unlikely to benefit either the industry or our consumer. Why would we require new premarket authorities such as product registration when FDA already has the ability to obtain labels from manufacturers or from the NIH database? FDA is unable to get these labels upon request. Is it possible that they have forgotten the NIH databank? Before we advocate for changes in regulations, it is important to have the right answers.

It is possible that those who are trying to create new authorities do not understand existing ones. It is puzzling that those who claim the FDA can’t decide on safe daily consumption levels have also submitted a petition to the FDA asking them to do so. They stated that “based on its own evaluation of all available scientific literature, it proposed an acceptable daily intake of up to 40mg CBD per day .”. It is strange that these same people are against the FDA establishing a maximum daily allowance for food and supplements.

CBD regulations are in need of action. There is momentum on Capitol Hill to address a framework for food and supplements. CBD has a lot of potential and is promising. If the status quo is maintained, some bad actors could ruin both the CBD and dietary supplement markets.

We have done everything we can to make sure consumers get the best and safest products. Industry association leaders who are concerned about the integrity and efficacy of DSHEA should reread the laws, their regulations, as well as how they are applied. You might be surprised to learn that DSHEA is a working law and FDA was able to establish a safe consumption level for a brand new ingredient such as CBD.

Editor’s Note: Daniel Fabricant is the president and chief executive officer of Natural Products Association.

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