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  4. Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit - 08/13/2019
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Speech

Event Title
Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit
August 13, 2019

Speech by
Lowell Schiller, JD
Leadership Role
Principal Associate Commissioner for Policy - Office of Policy

Thank you for having me here today. It’s a pleasure to join you at this summit, which is focused specifically on issues related to hemp. 

There’s a lot going on these days in the world of hemp, including at the U.S. Food and Drug Administration (FDA). We’ve seen an explosion of interest in hemp and hemp-derived products, as well as some important changes to the legal landscape. And increasingly, we’ve been hearing from a broad range of stakeholders who are eager to better understand where FDA fits into all of this, how our authorities apply to hemp and hemp products, and what the future has in store.

As an agency, we’re trying to be as transparent and informative as possible on these issues, and to resolve open questions quickly, efficiently, but also thoughtfully. So I appreciate this opportunity to talk with you about what we’ve been up to, what our current thinking is, and where we may be headed.

As many of you are keenly aware, things changed considerably for hemp in December of last year, with the passage of the Agriculture Improvement Act of 2018 – or, as we often call it, the “Farm Bill.” 

Up until that time, virtually all cannabis (which includes cannabinoids derived from cannabis) was considered a Schedule I controlled substance under the federal Controlled Substances Act, or the CSA. That’s the most restrictive schedule, and it means significant limitations on research and use, which are generally enforced by the Drug Enforcement Administration, or DEA.

The Farm Bill changed how cannabis is treated under the CSA. Among other things, this law removed a category of cannabis known as hemp from the CSA’s definition of marijuana, which means that hemp (as distinct from marijuana) is no longer an illegal controlled substance under federal law. 

The Farm Bill defines hemp as cannabis and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol, or THC – no more than 0.3 percent on a dry weight basis. So cannabis plants and derivatives with higher THC content remain controlled substances at the federal level, but cannabis plants and derivatives with THC contents below the legal threshold, that meet the definition of hemp, are no longer controlled substances under the CSA.

So what did the Farm Bill change at FDA? In a certain sense, the answer is not much. In the Farm Bill, Congress explicitly preserved FDA’s authorities to regulate products containing cannabis or cannabis-derived compounds, regardless of whether they are classified as marijuana or hemp. These authorities include our responsibilities under the federal Food, Drug, and Cosmetic Act and the Public Health Service Act. 

In preserving these authorities, Congress recognized FDA’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.

In another sense, the Farm Bill has had a very significant impact on FDA. The Farm Bill removed significant restrictions under the CSA on the growth, production, distribution, and use of hemp and hemp products. This has contributed to the recent explosion of interest in such products, including one hemp derivative in particular – a cannabinoid known as cannabidiol, or CBD. And the Farm Bill, by preserving FDA’s authorities while removing other restrictions, made FDA much more practically relevant to many stakeholders.

That includes many stakeholders who may not have much, if any, experience dealing with FDA or our authorities. So this seems like a good time to pause and explain briefly what FDA is, and what we do.

FDA is a federal agency within the Department of Health and Human Services. We’re a consumer protection agency charged with protecting and promoting the public health through our oversight of a broad range of products that account for more than $2.5 trillion of consumer spending, or about 20 cents of every dollar spent by American consumers. These products include: 

  • human and animal drugs; 
  • medical devices; 
  • radiation-emitting products; 
  • vaccines, blood, and other biologics; 
  • human foods, including dietary supplements; 
  • animal foods;
  • cosmetics; and 
  • tobacco products.

We’re also responsible for some other programs and assorted odds and ends. For example, somehow we wound up with responsibility for regulating pet turtles.

Across a portfolio this broad, our authorities and regulatory tools vary considerably depending on the type of product. For example, drugs are regulated differently than medical devices, which are regulated differently than foods. But our overarching mission is to protect American patients and consumers, and the public health overall.

So where does hemp fit into all of this?

On a certain level, the answer is very straightforward: We treat cannabis and cannabis derivatives – regardless of whether they are classified as marijuana or hemp – the same as we do any other substance. 

We don’t approach these substances with any ideological agenda. FDA is a science-based public health agency. Our mission is both to protect and to promote the public health in a science and data-driven manner. 

That means, for one thing, protecting Americans from unsafe products, and from purported medicines that aren’t effective at doing what they’re marketed for. It also means making sure we have viable paths to market for products that can improve Americans’ health and well-being in line with our regulatory standards.

When it comes to hemp, we see exciting potential opportunities, but also potential risks. The same is true for a lot of things we regulate. As an agency, we have well-established frameworks and regulatory tools for evaluating the products under our jurisdiction. We apply those same frameworks and tools when we think about hemp.

That brings me back to something I said a moment ago, and if you take one thing away from these remarks, it should be this: We treat cannabis and cannabis derivatives, including cannabinoids like CBD, the same as we do any other substance. 

We don’t hold a grudge against them, but we also don’t hold them to a lower standard of safety or absolve them of other requirements. Consumers have a right to expect the same level of FDA protection with respect to hemp and derivatives like CBD as they would expect with respect to any other substance. 

So what does this mean in practice? Which specific rules and authorities are relevant to hemp, and how do they apply? 

The answer depends on what type of product you’re talking about. As I said earlier, FDA regulates a lot of different types of products, and the rules vary by product type. For example, if you have a product containing hemp, or a hemp derivative like hemp seeds or CBD, and you market it as a human drug, then it’s subject to different rules than if you market it as a food, or a cosmetic, or a veterinary product – product types that all have their own rules. And if the hemp is developed into a product that FDA doesn’t regulate, like biodiesel or clothes or jewelry, then there may not be a role for FDA anywhere in the life cycle of the product, all the way from the farm to the ultimate end user.

We recognize the need to provide clear answers regarding how specifically our authorities apply to different types of hemp products, particularly given the incredible amount of interest in these products. 

This is especially true when it comes to CBD. Recently, we’ve seen an enormous surge of interest in this substance, and the level of excitement is palpable. At FDA, we’re excited too. We see significant potential in this substance, including potential clinical uses. 

For example, last summer we approved a CBD product for marketing as a drug to treat two pediatric seizure disorders. And we know that CBD is being studied for other potential medical uses as well, which could have very significant public health benefits.

CBD has a different risk profile compared to some other cannabinoids, such as THC. For example, it does not provide the same sort of “high” or intoxicating effects as THC and is therefore not expected to be an abused substance.

At the same time, we also know that CBD is not a risk-free substance. As with many drugs, there are potential adverse effects – including, in the case of CBD, potential liver toxicity, drug interactions, and drowsiness. Other adverse effects also have been identified. And there may be other risks that emerge with further study. 

For example, we have not seen much data yet on the long-term effects of sustained use. And there are a number of other unanswered questions about the safety profile of this substance when it’s used outside its approved drug indications – that is, for uses other than treatment of the two pediatric seizure disorders for which a CBD product has been approved.

So we have a substance with significant potential, some safety risks as well as open safety questions, and an incredible amount of public interest. And we have a crop – the hemp plant – that can be used to produce CBD and many other things as well, and for which there is an enormous amount of agricultural interest. 

Given all that, let’s talk about what it means in practice to say that FDA regulates hemp and hemp-derived products applying the same standards, and the same authorities, as we do for any other substance.

It’s helpful to break it down by the type of product.

Let’s start with drugs. For those who may not be familiar with how FDA regulates drugs, it’s important to understand that any given product may or may not be a drug depending on its intended use. For example, if a product is marketed with a claim that it will diagnose, cure, mitigate, treat, or prevent a disease, then it generally will meet the definition of a drug, and it will be subject to FDA’s drug authorities.

Let me give a more concrete example. Let’s say I sell you a jelly bean and claim it will cure your cancer or relieve your pain. That jelly bean is a drug, and it’s subject to FDA’s drug authorities. But if the jelly bean is intended just as a tasty snack, and it’s not marketed with any drug claims, and there’s no other evidence that it’s intended for a drug use, then it’s not a drug. 

A new drug must be approved by FDA for its intended use before it may be introduced into interstate commerce. This requirement, which applies both to human and animal drugs, is one of the cornerstones of FDA’s public health mission. 

American patients and consumers can have confidence that an FDA-approved drug has undergone a rigorous scientific and medical review to ensure that it works correctly and that its health benefits outweigh its known and potential risks for each approved use. The approval process protects patents against quackery and fraud, and it provides doctors and patients the information they need to use medicines wisely and appropriately.
This requirement applies to hemp products, including CBD, just like any others.

As I mentioned earlier, last summer FDA for the first time approved a drug containing CBD, Epidiolex. It is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. Epidiolex is not risk-free, but FDA determined that when the drug is used for these intended uses, it provides benefits that outweigh its known and potential risks for the intended population, particularly because those risks are managed by a health care professional who prescribes the drug and monitors patient care.

We know there’s also interest in other potential therapeutic uses of CBD. FDA encourages research into such uses. If there were evidence demonstrating that a CBD product meets the drug approval standard for a new indication, and an application were submitted and approved, that would be a big win for public health.

At the same time, we have seen too many hemp products – including many CBD products – being marketed with claims of therapeutic benefit, or other drug claims, without having gone through the drug approval process. These include CBD products that are marketed for serious diseases and conditions like cancer, Alzheimer’s disease, opioid use disorder, and pain. These products are unapproved new drugs, and they are illegal. 

FDA has sent warning letters to companies marketing such unlawful products, and we will continue to monitor the marketplace and take action as needed when we encounter violations that deceive consumers and put them at risk. 

Unlike drugs approved by FDA, the manufacturing processes of these products have not been subject to FDA review as part of the drug approval process, and FDA has not evaluated whether these products are effective for their intended use, what the proper dosages are, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Unsubstantiated claims associated with CBD products may also lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care.

For these reasons, addressing unapproved drug products making therapeutic or disease claims is an important priority for FDA. But that’s not our only focus. Outside the drug space, we’ve seen rapidly growing interest in marketing hemp products in other FDA-regulated products, including human and animal foods, as well as dietary supplements and cosmetics.

The regulatory frameworks for foods, dietary supplements, and cosmetics differ considerably from the framework for drugs. But we approach these products with the same science-based, data-driven focus on keeping Americans safe and protecting and promoting the public health.

Unlike drugs, foods, dietary supplements, and cosmetics generally don’t need to be approved by FDA before they can be marketed in interstate commerce. One exception is food additives, which FDA must determine to be safe for specified conditions before they can be added to foods, unless the use of the substance is generally recognized as safe (or GRAS) by qualified experts. For dietary supplements, if the product contains a new dietary ingredient – meaning a dietary ingredient that wasn’t marketed in the United States before October 1994 – the manufacturer generally must notify FDA before coming to market.

In addition, there are other requirements that apply to foods, dietary supplements, and cosmetics. For example, like drugs, they can’t be contaminated or otherwise adulterated, and they can’t be labeled with false or misleading information. And, like drugs, there are regulations that govern how particular types of products can be produced, such as good manufacturing practices and preventive controls for conventional food.

We apply these requirements to hemp products the same as we do to other products that may be marketed in foods, including supplements. And there are hemp products that can lawfully be put in foods.

For example, FDA recently evaluated three GRAS notices related to the use of hemp seed-derived ingredients in human food and had no objection to the submitter’s conclusion that the ingredients are generally recognized as safe. That means that hulled hemp seeds, hemp seed protein, and hemp seed oil can be legally marketed in human food without the need for any further approval, provided they comply with all other requirements and don’t make drug claims.

Bear in mind that this is limited to human food. The use of hemp ingredients in animal food, including pet food, needs to be evaluated separately. Animals process foods differently than humans, and even from one species to another. They also have less varied diets, which means that introducing a new ingredient to their food can have a larger impact compared to humans. And, when it comes to food-producing animals, we also need to think about how the ingredient might be passed through to meat, dairy, or eggs that humans might consume. 

The legal framework I just described also governs the use of CBD in foods, including dietary supplements. But there are two statutory provisions that have particular relevance for CBD products:

  • First, it’s a prohibited act under the federal Food, Drug & Cosmetic Act to add a substance into food if that substance has been approved as a drug, or if that substance has been the subject of substantial clinical investigations, the existence of which has been made public. 
  • Second, a product that includes such a substance is excluded from the definition of a dietary supplement.

Both of these provisions apply to CBD, not only because CBD has been approved as a drug, but also because CBD was studied clinically for a number of years before that. 

These provisions do have an exception for substances that were in foods (including supplements) before they were ever approved or studied as drugs. So, for example, substances like caffeine and baking soda don’t have to come out of the food supply because they’ve been approved in drugs. But if a substance was studied as a drug first, it can’t subsequently be added to a food or supplement. 

With respect to CBD, FDA has concluded, based on the evidence available to us, that this exception does not apply. This means that under current law, it’s unlawful to sell a food or dietary supplement with CBD in interstate commerce. 

I’ll repeat that: Under current law, it’s unlawful to sell a food or a dietary supplement with CBD in interstate commerce.

At FDA, we recognize that there’s substantial interest in marketing or accessing CBD in these forms. And we’ve heard calls for FDA to allow CBD to be sold in foods or supplements based on another exception in the statute.

Specifically, the provisions that exclude drugs from foods and supplements both allow FDA to go through notice-and-comment rulemaking to issue regulations that, in effect, create exceptions to these provisions for particular substances. Given the substantial public interest in the possibility of CBD in foods and/or supplements, FDA is actively evaluating whether such rulemaking might be appropriate for CBD.

Let me say a few words about how we’re approaching that question.

First, safety considerations are front of mind. If we don’t think we’ll have the data to say that some level of CBD can be safely added to a food or dietary supplement, then we wouldn’t want to create an exception for CBD. If, for example, we wouldn’t allow a new food preservative or flavoring substance to be added to foods if it had the same safety data as CBD, then why would we apply a different rule for CBD? For that reason, we are focused on reviewing the data and trying to fill the data gaps.

Remember, the rule about putting drugs in the food supply is just one of many rules that apply to foods and dietary supplements under the federal Food, Drug & Cosmetic Act. As I just said, there are other rules about (among other things) food additives, new dietary ingredients, adulteration, and false labeling. 

Even if we were to issue a regulation for CBD creating an exception to the general rule about putting drugs in the food supply, these other rules would still apply. And if a CBD product were to violate one of these other rules, it would still be unlawful – exception or no exception.

For these reasons, better understanding the potential safety implications of putting CBD in foods or dietary supplements is critical to our process. As I said earlier, we know that CBD is not a risk-free substance. If you read the labeling for Epidiolex, you’ll find information about risks including, among other things:

  • Liver injury;
  • Somnolence and sedation;
  • Suicidal behavior and ideation; and
  • Interactions with other drugs

The labeling also notes that there were inadequate data to support a determination that the drug could be used safely in certain populations, including pregnant and lactating women, children under 2, and persons over the age of 55. 

In identifying these risks, I don’t mean to suggest that they are dispositive. There are many substances that present risks at one level of exposure but that may not present those risks at a different, lower level of exposure. 

Identifying whether a substance has a safe level of exposure – and, if so, what that level might be – is something we do for many substances, across a range of product areas. When we approach that same question with respect to CBD, we do so in the same science-based, data-driven way that we would approach our review of any substance.

I should add that the rules against putting drugs in the food supply aren’t just technicalities. There are important reasons why, as a general matter, maintaining these rules is a good idea. 

For example, if someone were to start selling foods containing blood pressure medication, or chemotherapeutic drugs, it would raise some pretty obvious public health concerns. More generally, prescription drugs are approved in specific formulations and doses, and for specific populations, and they require medical supervision to ensure they are used safely. It’s not possible to ensure this kind of safe use when a substance is added to foods or dietary supplements.

That’s not to say there can’t be exceptions. But as we evaluate whether there should be an exception for CBD, or any other substance, we need to think about how these general concerns might apply.

Another important consideration is making sure we don’t discourage important research. Another reason for the general rules against putting drugs in the food supply is that when a substance is widely available in foods or dietary supplements, it can potentially diminish the incentives to conduct clinical research on that substance. 

There’s still a lot we don’t know about the potential therapeutic benefits of CBD, but we’re excited about the possibility that new therapeutic uses of CBD might be demonstrated to be safe and effective. The last thing we want to do is to discourage that research, and potentially stunt our knowledge of potential uses of CBD. So we need to be thoughtful in our approach.

One thing we realized very early on in evaluating these questions is that there was still far too much we didn’t know about CBD, and about the implications of putting CBD in foods, dietary supplements, and cosmetics. This is part of the legacy of almost all CBD being a Schedule I controlled substance until late last year. It was difficult to research, and it hasn’t been studied nearly as much as we would like. 

As we approach these questions today, we need to better understand things like cumulative exposure. For example, how much CBD is safe to consume in a day? What if someone has a CBD coffee in the morning, applies a topical CBD lotion, consumes some CBD oil, eats a CBD snack, and maybe has a CBD beer? How much is too much, and how is a person to know? How will the CBD interact with other drugs the person might be taking? What if she’s pregnant or nursing? What if children access CBD products like gummy edibles? What are the long-term effects of regular use and consumption?

These are important questions, and the answers will help to inform our path forward. That’s why early on at FDA, we recognized that if we were going to make wise and informed scientific decisions about cannabidiol, we would have to start focusing on a different CBD:

Collect Better Data.

We want to learn as much as we can, as quickly as we can, to support informed and efficient decision making. If there are data or studies that are relevant to the safety of particular uses of CBD, we want to see them. And if there are gaps in our knowledge, we want to understand how big those gaps are and what can be done – by us and by others – to start filling them.

If there’s an interest in exploring whether CBD can be allowed in additional products, consistent with FDA’s authorities, then we need the same kind of data that we would need to perform the same evaluation for any other substance. We need to Collect Better Data.

We recognize that the market is moving quickly, and not always in accordance with federal law. And we know that interested parties want to know the future of CBD regulation at FDA, and they want that information yesterday. 

At FDA, we’ve been taking steps to move our process forward efficiently. First, this past spring we formed an internal agency working group to drive our evaluation of CBD policy questions. This CBD policy working group, which I co-chair along with our Principal Deputy Commissioner, Dr. Amy Abernethy, draws on resources and expertise from across the agency, and we’ve been busy. 

FDA also has a Marijuana Working Group that addresses broader issues related to the regulation of cannabis products, including issues related to policy development, surveillance, and enforcement. That group has been busy, too.

In May, FDA held a public hearing on cannabis issues, including but not limited to CBD. We wanted to hear perspectives and information from the full range of stakeholders, and the public response was tremendous. The hearing was attended by more than 600 people in person, with over 2,300 joining remotely, and included presentations from over 100 speakers, representing a broad and diverse array of stakeholders. We heard a lot of excitement for hemp and hemp-derived products, including CBD, but also a lot of concern about products on the market, including concerns about potential contamination and false labeling.

In connection with this public hearing, we also opened a public docket for anyone to submit comments or data for us to review. The docket was open until July 16, and we received nearly 4,500 comments, which we are in the process of sorting through.

So where are we now? 

The CBD working group is evaluating all the data available to us, including data we received through the public hearing and the public docket, and evaluating our policy options. We’re asking not just “What should we do?” but also “What can we do within our existing authorities and resources?” And if we conclude that we need additional authorities or resources, we’ll need to think about going back to Congress.

As we go through this process, we are talking with other federal regulators who have responsibility relating to marijuana and hemp, and we are trying to learn from the experiences of other regulators – including state and local regulators in the United States, as well as foreign regulators.

Hopefully anyone with relevant data provided them to us through the hearing or the docket. If you have new data that become available, we urge you to come and talk with us right away. And if you’re sitting on data, waiting for the right time to bring it to us, don’t wait any longer. Bring it in. The time to talk with us is now.

We’re looking to report on our progress by early fall. In the meantime, we will be as transparent as possible about our process, and we will continue to take actions to protect the public health. As I said earlier, we’ve sent warning letters to companies that market unapproved CBD products with drug claims. This is a big concern for us: Selling products with unsubstantiated therapeutic claims can put patients at risk, such as by influencing them not to use proven, approved therapies to treat serious and even fatal diseases. 

But that’s not our only concern. We’re also concerned about products that put the health and safety of consumers at risk in other ways. We’ve tested the chemical content of CBD in some products, and many were found not to contain the levels of CBD they claimed to contain. We’ve also heard reports of CBD potentially containing contaminants, such as pesticides and heavy metals. We’re looking into this, and you can expect to hear more from us soon.

In closing, I want to reiterate how excited we are about the potential uses of CBD and other hemp and hemp-derived products. The hemp industry has come an incredible distance in an incredibly short period of time. And in some cases, the enthusiasm and the commercial appeal have outpaced the scientific research. The science needs to catch up.

We’re working hard to do our part at FDA. But we need your help. As this industry matures, it needs to start taking on more responsibilities – for the safety of consumers, and for the future development of an industry that can meet the same requirements as apply to other industries we regulate. 
We look forward to working together as this industry continues to mature.