Dr. Welch was speaking during a session at SupplySide East recently that addressed a range of issues including good manufacturing practice (GMP) inspections, new dietary ingredient (NDI) responses, enforcement actions, NDI guidance, ingredients of concern and the pending Human Foods Program reorganization.
On the topic of GMPs, when asked if 500 inspections per year is enough, Dr. Welch said: “I'm going to be pretty blunt and say no, I don't think the number we have right now is adequate, and that comes down to just plain limitations in so many ways.
"I don't know what the right number is at this point. I think we have 10,000 facilities that we're aware of, and that's probably a low number. We do about 500 inspections a year, that's not enough. And that's not always new inspections of new facilities, right? That doesn't count the repeat inspections, the ‘for cause’ inspections, but we are part of the Foods Program and so the Foods Program as a whole is dealing with all food facilities and all the different factors that go into that.
"I think dietary supplements has done well in that sense. We have been supported, but what we need to do is we need to be very strategic in what facilities we're inspecting, why we're inspecting, how we can make the most of those resources."
Priorities: Consumer safety, NDIs, GMPs and stakeholder engagement
During her presentation, Dr. Welch announced that FDA/ODSP is reorganizing its priorities, with top priorities to include consumer safety, NDIs, GMPs and stakeholder engagement.
“Protecting consumers is going to be sort of our top activity,” she said, referencing issues with weight loss supplements containing toxic yellow oleander masquerading as tejocote root.
She said the Agency is also very concerned about tianeptine, an unapproved drug that is illegally marketed as a dietary supplement. The ingredient made headlines recently when it was implicated in the death of a 37-year-old Ohio man who reportedly purchased a tianeptine-containing product marketed as a dietary supplement from a gas station.
The Agency has also spent a lot of time strengthening its approach to the regulation of NDIs. With two guidance documents in recent months (one final, one a draft). Dr. Welch said it is all part of “building a framework to get us to the point where we can strengthen that regulation [and] ensure high quality, properly labeled dietary supplements in the marketplace.”
"I really hope people are taking the opportunity to read this draft guidance, putting together comments [because] that's going to be very helpful for us as we prepare for finalizing that guidance," she added. "It's a proposal at this point, but having that feedback is very important."
Dr. Welch stressed that it is important for firms to ‘stay in touch’ when it comes to new dietary ingredient notifications (NDINs), noting that "early and often communication with FDA seems to trend to a good response."
On the GMP front, she said this is where the serious enforcement happens and highlighted this is an where stakeholder engagement is a real priority because it helps with informed decision making internally and ensures that the Agency has the information to direct its priorities and activities.
"This is not just industry relationships," she explained. "It's the relationship with trade groups, it's the relationship with consumer advocates, health care providers, [to ensure] we have open lines of communication and can understand what's important to them to see if that can inform our priorities."
Proprietary information
The presentation was followed by a Q&A with the audience and a panel discussion where Dr. Welch joined industry regulatory experts Russell Michelson, regulatory and safety strategy lead for food supplements at Reckitt, and Larisa Pavlick, regulatory program manager at Informa Markets. The panel was moderated by Jon Benninger, vice president and market leader at Informa Markets. During this Q&A, Dr. Welch was asked how much and what kind of information companies will be allowed to keep private under the new dietary ingredient master files.
“So honestly, the same as what would be part of a new dietary ingredient notification," she said. "A master file program, like what we propose in that draft guidance, carries no special authorities with it. So if the information is trade secret or CCI [confidential commercial information], then FDA is not at liberty to share that. So we would have to redact it, but it doesn't get any special privileges for protective information.
"I would say when a master file submission comes in, as well as the new dietary ingredient notification, it's really important for the notifier who knows the most about that information, to identify what they think is trade secret and for confidential commercial information. We do our review, and we sort of come to a conclusion, and then that information is redacted. I'm hopeful that the master file plays into this broader aspect of building a framework where we can facilitate submission of notifications for a master file for the trademarked ingredient and then the products that are using that ingredient can rely on that master file. Ideally, it all fits together. I understand that it is a long work in progress. I think that we're headed in the right direction."
Ingredient directory
Leaning on an open line of communication with stakeholders, Dr. Welch addressed the Ingredient Directory launched just over a year ago.
"The reaction was admittedly not great, but that's an opportunity for us to learn," she said. "So we heard some of the comments and the constructive criticism and went out with a second shot. I think we're getting there, and we're improving every step of the way. And then continuing… this stakeholder interaction which is really important to us…and all this sort of leads to meaningful engagement. These conferences, these events are great opportunities to engage with the entire breadth of the industry and so I really appreciate being here today."
CBD position remains unchanged
During the Q&A, Dr. Welch was asked if FDA would change its mind about CBD if cannabis were to be fully decriminalized at the federal level.
"No it would not," she said. "Our position on CBD had nothing to do with the criminalization of cannabis. CBD was authorized for investigation and ultimately approved as a new drug before it was ever marketed as a food or dietary supplement."
Enforcement against bad players
As much of the industry continues to self-police, a question that regularly comes up is how to report bad players.
Dr. Welch said that while information provided to FDA is helpful in informing next steps, the Agency cannot take action against unscrupulous sellers based on evidence that was not collected by FDA.
"We love to see the evidence," she said. "We cannot take action based on information that's just handed to us. We would need to replicate it most certainly. But understanding what your assertion might be based on is really helpful to our determination of, do we follow up on this report, this report or that report?”
Unsurprisingly, natural products manufacturer NOW’s supplement policing found its way into the conversation as many call on FDA to take action on NOW's testing results regarding supplements purchased online. South Carolina Congressman Jeff Duncan amplified those calls recently when he wrote FDA Commissioner Dr. Robert Califf to inquire about the perceived lack of a response from the Agency.
“So we're also aware of the reports, right? They're publicly posted," Dr. Welch said. "But we need to understand what's behind it, right? What method was used? Do we understand the methodology? Is it a dosage form question? We internally have been exploring gummies and the challenges that gummy format can have on finished products analysis.
“And so, sometimes we need a bit more information about the methodology. We probably still need to replicate it on our own. And so, you know, do we have data on X or Y products? Is there an inspection coming up? We might flag it for an inspection that is planned for this year or next year.”
Dr. Welch added that the Agency is only allocated so many ‘sampling assignments' per year, so it has to be very selective when choosing what products to follow up on while also considering which will have the greatest impact on public health.
Additives and the Food Program
Another topic that came up is additive bans that states like California are adopting, such as titanium dioxide. Dr. Welch took the opportunity to talk about the reorg and underscore the importance of integrating the supplement program more tightly with the foods program.
"Food additives will continue to be applied to the food additives standard, and food additives of course are used in supplements," she said. "Titanium dioxide as a whitener, is applied to the Food Additives standard. When that ingredient is showing up in supplements, that same science can be applied to the supplement safety standard, and that's absolutely appropriate, and I think that's an area where we'll be able to sort of leverage each other's expertise and overall improve the Agency's activities with food and dietary supplement compounds."
