Carlsbad, CA—The Council for Responsible Nutrition (CRN) held its Annual Symposium for the Dietary Supplement Industry in Carlsbad, CA earlier in November. A highlight of the event: In a session titled “Perspectives from FDA,” Lowell Schiller, JD, Principal Associate Commissioner for Policy – Office of Policy at the Food and Drug Administration, discussed the history—and future—of DSHEA. He also discussed the FDA’s current thinking on cannabidiol (CBD).
In terms of DSHEA, Schiller spoke of two goals. “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.
“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,” Schiller said. He added that these goals are linked, and need to be balanced. “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, Schiller said, is a testament to the confidence many consumers put in the dietary supplements industry—and that confidence is directly attributable to the hard work of many in the dietary supplement industry who act responsibly and comply with DSHEA. But, he continued, “The consumer confidence earned through responsible behavior can lead to a certain ‘halo effect.’ It creates an opportunity for bad actors to exploit the reputation 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.”
As we mark DSHEA’s silver anniversary, Schiller said, those at FDA are asking two questions:
- Are we using our existing authorities and resources as effectively and efficiently as possible?
- 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?
Turning his attention to CBD, Schiller discussed the “explosion” in interest, and noted that while CBD does not have the same euphoric effects of THC, “it is not a risk-free substance”—he pointed to potential liver toxicity, drug interactions and animal studies indicating potential risk to the male reproductive system.
Regarding the legality, he said, “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.”
There are a variety of pathways for products containing cannabis-derived ingredients to come to market lawfully, he said. His example: the approval of the Rx drug Epidiolex.
Regarding CBD in foods and supplements, he said there are challenges. “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.” He added that these provisions apply to CBD because CBD has been approved as a drug and 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 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.”
Related: NPA Poll: 51% of Americans Don’t Know CBD is Illegal
Industry Associations Ask Congress: “Take Quick Action to Clarify the Legal Status of CBD”
Where that leaves us: FDA has been considering the avenue of notice-and-comment rulemaking to issue a regulation excluding CBD from either or both of these provisions—Schiller said the agency plans to report on its 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.”
Schiller said FDA is working “to learn as much as we can about CBD, as quickly as we can” in terms of the consequences of long-term use, the risks to vulnerable populations “and lots more.” “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.” Among the concerns he noted:
- “Many” of the manufacturers entering this space lack experience with FDA or DSHEA.
- Issues like harmful contaminants such as pesticides, heavy metals, or other drugs like THC.
- “Egregiously irresponsible behavior” like marketing CBD products for use by infants, or promoting them to treat serious conditions like cancer or opioid use disorder.
Summing up, Schiller said, “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.”
Related: CBD: Proof that DSHEA Works?
Schiller’s speech can be accessed here.