Tave was speaking at the recent Council for Responsible Nutrition Conference in Dana Point, CA. He did not address CBD during his prepared remarks, but when asked about it by an audience member, he said that CBD falls within exclusion clause. In other words, it was the subject of an investigational new drug authorization, and therefore cannot be used in dietary supplement products.
The FDA has been very clear about the legality (or lack thereof) for CBD in dietary supplements. “FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act,” states the Agency’s website. A similar exclusion clause exists for food.
“I’m not sure why it’s out there,” said Tave. “Just because we haven’t taken enforcement action people seem to think it’s OK.”
Three pillars
During his prepared remarks, Tave discussed the FDA’s current approach to dietary supplements, which is based on three main pillars:
- Consumer safety
- Product integrity
- Improved decision-making
Consumer safety
Concerning consumer safety, Tave noted the Agency’s actions against caffeine, including its April guidance that stated that highly concentrated caffeine are adulterated because they pose a risk. This was followed up with warning letters.
“One important note about this guidance is that we issued it directly as a final guidance – we didn’t put out a draft version first,” said Tave. “And that is something that we’re able to do only when the circumstances allow it, and I think it speaks to the seriousness of the public health problem in this case.
“But another essential aspect of the guidance was that we addressed this public health problem as precisely as we could. We didn’t sweep too broadly and declare that all caffeine was hazardous – rather, we recognized expressly that caffeine, when it is formulated and marketed appropriately, can be an ingredient in a safe dietary supplement.”
On the NDI notification process, Tave noted that it represents the Agency’s only opportunity to evaluate the safety of a new ingredient before it hits the market. A revised draft guidance was issued in August 2016, and since then stakeholders ask what is next and when.
“The answer to “when” is a little complicated – the revised draft guidance is a long document, it covers a number of issues, and we’ve received hundreds of substantive comments on it,” said Tave. “Many of these issues don’t necessarily lend themselves to easy solutions. But we don’t intend to allow challenges answering all of the questions to stop us from answering some of the questions.
“So our approach has been to try to make progress, where we can, on discrete topics.”
On the issue of pre-DSHEA dietary ingredients, he said the Agency is committed to being transparent, but there is a diverse range of opinions on how the list should be compiled, with some suggestions including the broadening scope. However, he said that the benefits of a list would have to justify the resources put into it.
FDA has also been working on the issue of NDI master files in order to reduce the burden of submission associated with NDI notifications. “But we want to make sure that it is consistent with stakeholder needs – we don’t want to spend our time developing a process that won’t be used,” he noted. .
NDI Notifications allow FDA to meaningfully review the safety of an ingredient before it is released to the market, and these notifications need to be well-prepared and contain what they’re supposed to, said Tave. “We’re open to a dialogue,” he said. “and one thing that we’ve observed is that notifications tend to have a higher success rate when the submitter has met with our staff before submitting the notification.
“So we want to do a better job of publicizing that option, and we also recognize the opportunity to do more in terms of training and education around new dietary ingredient notifications.
“A robust NDI is an integral part of the DSHEA framework,” he added. “But we also recognize that developments in this space over time have created a disconnect between economic incentives and regulatory objectives, leading some firms to pursue GRAS status instead or not to notify at all. So, premised on the assumption that responsible firms want to comply, we are thinking actively about what we can do to help firms see the value in a good NDI notification.
“And hopefully you all saw a letter we issued in February of this year to a firm that tried to misrepresent a facially complete notification as a substantively compliant product, notwithstanding our objections to their assertion of safety.
“That should be a clear signal that we take the NDI process seriously, and that we don’t intend to stand idly by when we see firms abusing it.”
Product integrity
On this issue, Tave explained that this covers tainted products and current Good Manufacturing Practices (cGMPs).
Tainted products are back in the news, he noted, and the Agency moves quickly to remove these products from the market. Such products put consumers at risk and they damage the reputation of responsible companies, he said.
“The reality is we’re spending a lot of time and resources on these,” added Tave. “We’re long overdue for a candid dialogue on a solution.”
Regarding cGMPs, he said that, “the state of affairs has to improve. This will only become more challenging as various FSMA requirements take effect.”
“At the same time – and I always make it a point to say this – many firms are getting it right, and are committed to ensuring that they deliver a quality product to their customers. That’s attributable, in many ways, to industry-led efforts to promote compliance, including through education and training,” he added.
Tave did note a shift in FDA’s approach to this, noting that field activities have moved to a commodity-based assignment structure, meaning inspectors are assigned based on their expertise, and not on where they are stationed.
Improved decision-making
The third of the pillars concerns decision-making, and the Agency’s actions to ensure consumers are not exposed to companies making unfounded disease claims. These could include, for example, products making opiate-related claims and sunscreen claims.
More recently, the Agency recently released a draft guidance that would allow for labeling of live microbial ingredients (probiotics) as colony forming units (CFUs) in addition to weight on the supplement facts label.
“CFUs are a much more meaningful measure of live microbial activity than metric weight, which is what the regulation requires. So this guidance provides space for firms to include that information without worrying about getting in trouble,” he noted. “This is a draft guidance and the comment period is still open. If you think we missed the mark – or if you want to tell us what a great job we did – please submit comments to the docket.”
To conclude, Tave noted that we all know that dietary supplements are regulated, regulations on the books are not enough: The goal should be a market that is effectively regulated.
“I spend a lot of time thinking about this question, and when I do, I always come back to the consumer’s perspective,” he said. “In my mind, a well-regulated dietary supplement market means that a consumer who decides to purchase, use, or recommend a specific dietary supplement product can reasonably have confidence in three things: first, that the product won’t cause them harm; second, that the product contains only what the label says, in the right amounts; and third, that there is a basis for believing that the product will do what it claims to do.”
