The American Herbal Products Association hosted its annual Botanical Congress in Las Vegas, NV, on Saturday in conjunction with the SupplySide West trade show. A panel that included Cara Welch, PhD, senior adviser in FDA’s Office of Dietary Supplement Programs, gave its views of what the most immediate concerns for the industry ought to be as it wrestles with how to respond to the concepts contained in the recently updated draft guidance on New Dietary Ingredients. In addition to Welch, the panel included AHPA president Michael McGuffin and attorneys Ashish Talati, Marc Ullman and Andrew Young.
Young, an attorney with the firm Kleinfeld, Kaplan and Becker, said he doubts the guidance will be altered fundamentally from its present form, regardless of how distasteful some its provisions might prove to be. In his view, the task now is to decide how best to operate in the new environment.
“We are at the same place the automobile business was when emissions controls were placed on cars. The US industry hired 10,000 lawyers whereas Japan hired 10,000 engineers. I start with the premise that this is what it is and you have to deal with it,” he said.
Talati, with the firm Amin, Talati & Upadhye, also said firms should start with the assumption that the guidance as it stands represents the lion’s share of its final form. With that being said, he was of the opinion that now was the time for companies to manage their future risk. What in a company’s catalogue is totally new, and really ought to have an NDI Notification on file? How are the older ingredients manufactured, and how has that changed since that ingredient first came on the market? The position of Old Dietary Ingredients is not as secure as it appeared to be before the updated guidance was issued.
“We would be looking to see where is the enforcement coming. True NDIs should be at the top of your priority list for things you need to deal with to manage your risk. For other ingredients, you need to look at manufacturing changes. Not all changes are significant, and not all significant changes alter the identity,” he said.
For McGuffin, one of the key positive points to hold on to is the roadmap provided in the updated guidance that companies can use to have a better chance of a successful NDI filing the first time around. The rate of success for NDI filings has been very low, but some of that can be attributed to industry not understanding the requirements and so submitting substandard dossiers.
“The new guidance provides a roadmap. The No. 1 issue with past filings has been that companies have not properly characterized their ingredient, and FDA responds that they can’t tell what it is that they’re supposed to evaluate,” McGuffin said.
180 degree turn
For Ullman, who is at counsel in the firm Rivkin Radler, the main issue is the emphasis in the updated guidance on the need for filings for every new product that contains an NDI. While he appreciated FDA’s effort to make the process for filing more transparent, he said he believes the guidance does not match the intent of the underlying legislation—DSHEA—which in his view clearly bases this process on the safety of the ingredients, not in vetting every new finished product.
“The concern that I have with this current guidance is that FDA seems to be pretty clearly saying that this process is not just about ingredients. We are talking about lots of notifications. As much as I like the road map that was provided for the process, I am very troubled about the 180 degree turn that FDA took in this guidance,” he said.
Young suggested that allowing companies to submit notifications with a form of disclaimer attached could help lessen the risk of lawsuits that might arise from the whole issue of whether an ingredient has its proper NDI status in place.
“I’d like to propose that we have a disclaimer that allows the submitter to say something along the lines of the submission of this NDI notification does not constitute an admission that this is a New Dietary Ingredient. The greatest fear is by filing a notification there will be some kind of admission that the plaintiffs’ lawyers can pick up on,” Young said.
Goal is to finalize the guidance
Welch emphasized that despite the resignation in the tone of the some members of the panel, the draft guidance is just that, a guidance. It does represent the agency’s current thinking on the statute and thus might figure into coming enforcement actions, since those are based on the statute itself, she said. But she said FDA intends to take industry’s comments into account when putting the guidance into final form.
“We take the comment period seriously. For example, what sort of processes are used in industry to manufacture ingredients that don’t alter the identity of the ingredient? We are looking to industry to provide us with that information. But the goal here is not to end up with another draft guidance,” Welch said.