Remarks by Lowell Schiller, JD at the Council for Responsible Nutrition Conference - 11/7/2019
November 6, 2019
- Speech by
Lowell Schiller, JD
Principal Associate Commissioner for Policy - Office of Policy
Thank you for having me here with you today.
As we gather to discuss issues relating to dietary supplements, we also have the opportunity to recognize an important milestone. As you know, last month marked twenty-five years since the Dietary Supplement Health and Education Act of 1994, or DSHEA, was signed into law.
The enactment of DSHEA was a landmark event. It established the regulatory framework that governs dietary supplements to this day, and struck an essential balance between two critical, and equally important, objectives:
- The first is preserving consumers’ right to access safe, well-manufactured, and appropriately labeled dietary supplements.
- The second, and every bit as important, is ensuring that FDA has the ability to protect the public from unsafe and otherwise unlawful products.
I think it’s helpful and appropriate to think of DSHEA in terms of this balance. But it can also be a little misleading because it can give rise to the misimpression that these two goals – consumer access on the one hand, and safety and product integrity on the other – are in conflict. In fact, these goals are mutually reinforcing.
You’ll notice that when I just described the goal of consumer access, I didn’t talk about it as a right to access anything marketed as a dietary supplement. A consumer has a right to access supplements that are safe, that contain what the label says they contain, and for which there’s a basis for believing that the product will do what it claims to do.
If a consumer walks into a store, or goes online, and doesn’t have confidence in the safety or integrity of a product, or doesn’t know which products he or she should have confidence in, then that’s not real or meaningful access. Likewise, if a consumer is injured by an unsafe product, or deceived by information on the label, that’s a public health problem, and it’s also a problem that in the long run will undermine confidence in the industry overall. So these goals – safety and access – are linked.
At the same time, one of the most important insights advanced through DSHEA is that these goals do need to be balanced. At FDA, we regulate many different types of products, and we do so using many different frameworks for ensuring safety. The framework that makes sense for one type of product – say, prescription drugs – may not make sense when applied to a different type of product – say, dietary supplements.
Applying a framework that isn’t the right fit for the type of product can impede consumer access, either by imposing unnecessary burdens that result in limited consumer choice, or by providing inadequate protection, which can erode consumer confidence and, even worse, put people in harm’s way.
Under the balance struck 25 years ago in DSHEA, the dietary supplement industry has grown enormously. What was once a $4 billion industry, composed of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 different products available to consumers – and possibly as many as 80,000 or even more.
This growth is a testament to, among other things, the confidence that many consumers have learned to put in this industry. And that confidence is directly attributable to the hard work of many in the dietary supplement industry – including many of you here in this room – to act responsibly and comply with the requirements DSHEA imposes relating to the safety, manufacturing, and labeling of dietary supplements.
But that success, and that hard work, can lead to new risks. The consumer confidence earned through responsible behavior can lead to a certain “halo effect”: It creates an opportunity for bad actors to exploit the reputations built through the quality work of legitimate manufacturers, and instead distribute and sell dangerous products that put consumers at risk.
As the popularity of supplements has grown, so has the number of dangerous or deceptive products. And, as the internet has grown, so have the opportunities for bad actors to reach consumers directly.
The irresponsible marketing of unsafe or deceptive products puts Americans’ health and safety at risk. It also undermines the hard-earned reputations built by more responsible members of industry.
For all these reasons, FDA is strongly committed to upholding our obligation to protect the public from unsafe and unlawful products, and to holding accountable those actors who are unable or unwilling to comply with the requirements of the law.
With this in mind, and as we mark DSHEA’s Silver Anniversary, at FDA we’re asking ourselves two questions:
- First, are we using our existing authorities and resources as effectively and efficiently as possible?
- Second, given all the evolution we’re seeing in the market, are there statutory changes that would help preserve DSHEA’s essential balance in the modern era?
In looking at the first question, we’ve taken a number of steps, including forming an internal agency working group. This group has been tasked with looking at FDA’s organizational structures, processes, and procedures to ensure that we are using our existing resources as efficiently and effectively as possible. And to look for areas where we can do better.
We’ve also begun rolling out some new policies and tools, including a new Dietary Supplement Ingredient Advisory List that is intended to quickly alert the public when FDA identifies ingredients that don’t appear to be lawfully included in products marketed as dietary supplements.
And we’ve continued to send warning letters and bring enforcement actions as needed to protect the public against violative products that can harm or deceive consumers.
In addition to the work we’re doing inside the Agency, we also are engaging our external stakeholders. We want to make sure that as we think about the future, we’re having a broad conversation and hearing the full range of perspectives.
To this end, we held a public meeting this past spring on the topic of responsible innovation in dietary supplements. At the core of this meeting was the question: How can we better allow for innovation and growth in the dietary supplement marketplace while maintaining and even strengthening our ability to evaluate product safety?
When DSHEA passed 25 years ago, I don’t think anyone assumed the dietary supplement market would freeze as it was in 1994. Rather, DSHEA clearly envisions a dynamic dietary supplement market, governed by a regulatory framework that provides adequate space for appropriate innovation and advancements, but that’s also sufficiently robust to protect the public health and provide consumers with adequate assurances of safety.
In terms of providing the space for innovation and growth, DSHEA has been incredibly successful. As I said a few moments ago, we’ve seen extraordinary growth in the size of the industry. We’ve also seen the market grow in other ways – technological advances, increased sophistication of many manufacturers, and so on.
As the market continues to evolve along these lines and others, we need to ask how DSHEA’s statutory construct should apply to this innovative market, and to what extent changes might be needed. The public meeting FDA held this past spring was intended to help us move forward in our thinking about these issues.
For example, DSHEA articulates specific categories of “dietary ingredients” that may be included in a dietary supplement. In fact, it lists them directly in the definition of “dietary supplement.” The law also requires manufacturers in many cases to notify FDA before marketing a dietary supplement that contains a “new dietary ingredient,” or NDI. But when is an ingredient new? For example, as technology advances, when (if ever) do changes to manufacturing processes alter the character of an ingredient so much that it is a new ingredient?
We don’t want to impose regulatory requirements needlessly, where there isn’t a corresponding public health benefit. But at the same time, if an ingredient is developed or altered in such a way that it might raise new or different questions of public health, and a dietary supplement containing such an ingredient is introduced to the market without FDA ever hearing about it, then that undermines the integrity of the entire system. It also undermines the essential balance struck in DSHEA. And ultimately it erodes consumer confidence in the industry.
So we need to think carefully about how to make sure the statutory framework can keep working for a market that continues to evolve. So that we are set up for success over the next 25 years and beyond.
We had a great response to the May public meeting and thank you, again, to everyone here who participated, including to the leadership of the Council for Responsible Nutrition. But the meeting was just the beginning of the discussion, and we want to have a continued dialogue. Among other things, we also opened a public docket (it closed mid-July) and had a good response with over 70 comments received.
- Some of the comments discussed prioritizing FDA’s efforts to enforce the current NDI requirements or establishing new systems, such as master files for NDIs, aimed at protecting ingredient manufacturers’ investment in generating safety data but which could also promote overall compliance with the premarket notification requirement.
- We also received comments that discussed potential new authorities that would strengthen FDA’s oversight of dietary supplements.
So the next steps on this front: We didn’t hold the public meeting expecting to have all of the answers resolved then and there. Our goal was to articulate questions and to start a conversation. We’re currently reviewing the comments and other information at hand to try to identify areas of consensus about what we should do and how, to make sure we have a framework that can foster innovation, and ensure the twin goals of consumer access and safety, for the next 25 years and beyond.
On that note, I want to turn back to the second question I asked earlier – whether there are statutory changes that would help us keep pace with changes in the market. We’ve already publicly identified certain areas where we think legislation is needed.
In FDA’s budget request for fiscal year 2020, we included a proposal for mandatory product listing. Under this proposal, the statute would be amended to require all products marketed as “dietary supplements” to be listed with FDA, and it would give FDA authority to act against non-compliant products and their manufacturers or distributors.
Today, without mandatory product listing, we lack basic, fundamental information about the dietary supplement market:
- We don’t know how many dietary supplements are on the market, and we have no systematic way of knowing when a new product is introduced.
- We don’t know how many products contain any given ingredient. And if it turns out that there’s a safety problem with a particular ingredient, or a particular ingredient supplier, we don’t have the basic information to quickly identify which products are affected.
- We don’t have a reliable way to capture trends in the market so we can anticipate and adapt to new areas of risk.
- And we don’t have the visibility we need to be able to effectively prioritize our resources.
Mandatory product listing would address these problems and help us to more effectively weed out irresponsible actors in the market who threaten to tarnish the reputations of those who work hard to try to comply with the law.
I believe we can achieve these benefits without upending DSHEA’s framework or adding hugely burdensome new requirements. We’re not talking about imposing a new pre-market approval requirement. If manufacturers and distributors were just to provide us with certain basic information – information that in many cases already appears on product labels – it would be a big win for public health and legitimate industry, while imposing only minimal new costs.
As part of this proposed legislative change, we also need to consider whether other updates would help us to address products unlawfully marketed as dietary supplements. This includes looking at potential updates to the provision that excludes certain drug ingredients from the definition of “dietary supplement.”
The way the law is currently structured, a product is excluded from the definition of “dietary supplement” if (subject to certain exceptions) it contains a substance that has been approved as a drug or licensed as a biologic, or a substance that has been the subject of substantial clinical investigations for such uses, if the existence of such investigations has been made public.
There is a similar prohibition on putting certain drug substances in conventional foods, but with a critical difference: whereas there’s a prohibited act associated with putting certain substances in conventional foods, it’s just an exclusion from the definition of “dietary supplement.”
This distinction can lead to anomalous results. In contrast to the automatic prohibited act that follows from putting certain approved drugs in food, if a product is labeled as a dietary supplement, but it contains one of those same drug substances, it may not actually be a dietary supplement at all. In such situations, there might be other violations of the FD&C Act that provide a clear path to removing the product from the market. But establishing those violations can be tricky, depending on the circumstances.
For example, sometimes we see products that are marketed as dietary supplements with express claims about treating impotence, but it turns out that the secret ingredient is undisclosed sildenafil (i.e., Viagra). In such cases, the claims about impotence establish that the product is intended for use as a drug, and classifying the product as an unapproved new drug will be a fairly straightforward determination for us to make.
But other cases may be more complicated. For example, if a drug substance is mislabeled as a dietary supplement, but there are no express claims, then depending on the facts, it could be resource-intensive or otherwise challenging to determine the best path forward.
One way to help address this issue would be to move the drug substance exclusion out of the definition of “dietary supplement,” and make it clear that the presence of such substances in a dietary supplement renders the product an adulterated dietary supplement – which would be in addition to any other potential violations. The universe of what could be a lawful supplement wouldn’t change, but FDA would have a clear and direct way to use our authorities over adulterated dietary supplements to move against these unlawful and potentially dangerous products containing drug ingredients.
One common thread that runs through these potential legislative updates is that they may be able to offer significant public health benefits without imposing significant – or in some cases any – new burdens. As we continue to consider possible legislation in this space, we should be looking for more opportunities like these – updates that can preserve the essential balance of DSHEA while at the same time advancing FDA’s ability to detect and address violations that put the public health and safety at risk.
Improving FDA’s capacity in this regard will be particularly important as more novel products and ingredients enter the market and call themselves dietary supplements. And that brings me to CBD.
We’re seeing an explosion of interest in CBD, and the last year has brought some important changes to the legal landscape outside of FDA. I think it’s worth addressing, not just in terms of what this all means for CBD, but in terms of the potential implications that may be broader than just cannabis.
By way of background, CBD, or cannabidiol, is one of the many compounds that can be derived from the cannabis plant. CBD doesn’t have the same euphoric effects as another cannabinoid you’ve probably heard of – THC – but it’s also not a risk-free substance. In fact, there are a number of known health risks, including (among other things) potential liver toxicity and drug interactions. We’ve also seen animal studies indicating potential risk to the male reproductive system.
The growing public interest in CBD picked up even more rapidly last December with the passage of the Agriculture Improvement Act of 2018 – or, as it’s often called, the “Farm Bill.” Among other things, the Farm Bill defined a category of cannabis known as “hemp,” meaning cannabis and cannabis derivatives with extremely low concentrations of THC – no more than 0.3 percent on a dry weight basis.
Whereas cannabis and cannabis-derivatives with higher THC content remain Schedule I controlled substances under federal law, products defined as hemp are carved out of these restrictions. And that has spurred even more interest in hemp-derived CBD.
At the same time, the Farm Bill expressly preserved FDA’s authorities. Congress didn’t put CBD in a special new class of products, subject to a special set of rules. Under the framework recognized and preserved in the Farm Bill, we look at an FDA-regulated product containing CBD the same way as we would look at an FDA-regulated product containing any other substance. We apply the same tools and authorities and statutory provisions.
At FDA, we don’t have one set of rules for cannabis-derived substances, and another set of rules for other substances. We don’t approach CBD or other cannabis-derived substances with any sort of animus or impose unique burdens. At the same time, we don’t absolve them of having to meet the relevant safety standards and other requirements for whatever type of FDA-regulated product they’re found in. Consumers have a right to expect as much.
There are a variety of pathways for products containing cannabis-derived ingredients to come to market lawfully. For example, last summer we approved a prescription drug, Epidiolex, that contains CBD. It’s indicated for two pediatric seizure disorders.
But some of the interest in CBD involves putting it in foods or dietary supplements. And that raises challenges. As I mentioned earlier, it’s a prohibited act to put certain drug ingredients into foods, and products containing certain drug ingredients are excluded from the definition of “dietary supplement.”
Both of these provisions apply to CBD, not only because CBD has been approved as a drug, but also because CBD was the subject of substantial clinical investigations for a number of years before that, and the existence of those investigations was made public.
These provisions do have an exception for substances that were marketed in (or as) foods or supplements before they were ever approved or studied as drugs. But FDA has concluded, based on the evidence available to us, that this this exception doesn’t apply to CBD. This means that under current law, it’s unlawful to sell a food or dietary supplement with CBD in interstate commerce.
So we’ve been getting requests to look at another exception, which allows FDA to go through notice-and-comment rulemaking to issue a regulation excluding CBD from either or both of these provisions. FDA has been considering carefully whether such rulemaking might be appropriate for CBD, and we plan to report on our progress soon.
As we consider this issue, safety is 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? The same goes for new dietary ingredients.
This comes back to CBD being subject to the same rules as any other substance. If we are unable to conclude that CBD is safe for use in foods or dietary supplements, and yet we were to make an exception to allow for such uses, what would that mean for the next substance to come along with similar known safety risks?
At FDA, we’re trying to learn as much as we can about CBD, as quickly as we can. But there’s still much we don’t know – about the consequences of long-term use, about the risks to vulnerable populations, and lots more. As we continue to work as rapidly as possible to figure out how to address this popular ingredient that until very recently was a controlled substance, it’s important to remember that there are no special rules for CBD.
We also need to think hard about what it might mean in practical terms to create an exception for CBD in foods or supplements. The CBD market is growing rapidly, and I’m concerned that in many cases the excitement is outpacing capability. Many of the manufacturers entering this space lack experience with FDA or DSHEA, and we have serious concerns about issues like harmful contaminants such as pesticides, heavy metals, or other drugs like THC. We’re also seeing some egregiously irresponsible behavior, like marketing CBD products for use by infants, or promoting them to treat serious conditions like cancer or opioid use disorder.
This kind of misconduct puts the public at risk, and we are making it a significant enforcement priority for FDA.
So we have to ask: If we were to create some kind of exception for CBD, what would that do to our ability to identify and address these kinds of violations?
By some estimates, the CBD market has already grown to roughly half the size of the entire dietary supplement market at the time DSHEA was passed. Think about that.
And think about this: If we were to create some kind of exception for CBD, how many new products would come on the market from manufacturers without a history of complying with basic requirements like good manufacturing practices, or truthful labeling?
Do we at FDA have the tools and resources we would need to identify all the potential violations we might see, let alone address them? And what would that mean for our existing work?
This brings me back to something I discussed a few minutes ago – whether there are new authorities and resources that our dietary supplements program might need, leaving CBD aside, to effectively address dangerous or otherwise unlawful products.
As I noted, we believe there are legislative updates that are critical to the future success of our dietary supplement program. And that’s without adding CBD into the mix.
Simply put, we can’t talk about updating dietary supplement authorities without also thinking about what’s happening in the world of CBD, and what it tells us about our ability to deal with novel products exploding in the marketplace. And in thinking about CBD, we can’t ignore broader questions about whether FDA’s dietary supplements program has all the tools it needs. We need to do both.
In closing, I’ll leave you with this thought: We wouldn’t be where we are today, having the conversations we’re having, were it not for a statute that provided for a lot of responsible growth in the dietary supplement industry, and an industry with many members committed to getting it right.
Working together, I’m excited to see what the next 25 years will bring.