Gottlieb’s statements on the NDI issue were part of a broader outline of new initiatives for the regulation of dietary supplements. He made the statement public on Monday.
In that statement, Gottlieb said FDA has three priorities. They are safety, product integrity and fostering an environment in which consumers and health care professionals can make informed decisions about the use of dietary supplements.
Rapidly evolving marketplace
Gottlieb said one of the reasons for the new policy initiative is that the dietary supplement market is rapidly evolving. When the Dietary Supplement Health and Education Act was signed into law in 1994, the marketplace consisted of somewhere around 5,000 products. Today there are anywhere from 10 to 15 times that amount or more on the market.
“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” Gottlieb said.
One of the aspects of DSHEA was an outline of a process by which new ingredients could lawfully come onto the market. The original law was remarkably concise as federal regulations go and the portion that applies to these ingredients was shorter still, consisting of only a few paragraphs.
That brief mention has spawned many hundreds of pages of documents in the form of two draft guidances on New Dietary Ingredients. Additionally, reams of comments from companies, trade organizations and other interested parties have been submitted on both iterations of the draft guidance.
Many sticking points on NDI issue
There are many sticking points between industry and the agency concerning this issue. These include whether the process applies only to ingredients or also applies to finished products that contain those new ingredients.
Also at issue is whether manufacturing changes to old ingredients change them sufficiently to make them ‘new.’ And whether synthetically manufactured ingredients—be it via chemical synthesis or one of the newer ‘synbio’ fermentation technologies—qualify as dietary ingredients remains a bone of contention, too.
Gottlieb left these issues aside in his statement on Monday, which after all was more a broad policy overview and therefore short on specifics. But he did touch on one of the NDI sore points, that being how the scientific data and manufacturing information that forms part of a notification might be protected so that it benefits that company specifically and cannot be used to underpin ingredients produced by competitors.
As matters stand, some stakeholders are of the opinion that it is too easy for manufacturers of knockoff ingredients to piggyback on the work that original NDI filers have done. This is a rigorous (read: expensive) process, and if it could end up benefiting a competitor, that could prove to be a big disincentive to file a notification in the first place.
Gottlieb said FDA has not turned a blind eye to the issue.
“The key to this effort will be important steps to foster the submission of new dietary ingredient (NDI) notifications,” he said in his statement.
“We’ll look to address other challenges that may act as barriers to dietary supplement innovation and safety including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients,” he added.
Possible IP protection on NDIs
That world ‘exclusivity’ has jumped out to industry stakeholders who have reviewed Gottlieb’s comments.
“When I saw the reference to NDIs and a passing reference to a protection for IP, I sat up immediately,” Kevin Bell, a patent law expert at the law firm Porzio, Bromberg & Newman, told NutraIngredients-USA. “I think that comment is consistent with the way you would enforce IP such as patent rights. A patent gives you the right to exclude others. So if you’ve got this (the NDI Notification) and other manufactures of the same ingredient don’t, then the rest would be adulterated,” he said.
Attorney Mark Ullman, of counsel with the firm Rivkin Radler, has represented several companies that believe the work they have done on NDIs ended up getting appropriated by others. He said it’s nice to hear the agency acknowledge the problem, but he’s withholding judgement until he hears more about FDA intends to do about it.
“I’m encouraged just in that it is good to hear the commissioner acknowledge the issue. This is an important issue. Companies that take the initiative to pioneer new ingredients into the trade deserve something better than to simply be knocked off and have their science used by other companies to get regulatory blessing,” he said.
“But in theory this protection is already there. We have complained about this before; it has been a significant issue with astaxanthin, with PQQ. We have specifically requested that FDA police the marketplace. And nothing has been done,” Ullman added.
Bell said a protection for NDI filings might look similar to how trademarks are enforced.
“You can register trademarks with Customs and Borders and if someone tries to bring something in using your trademark you can have the containers stopped at the border. I think this kind of right on NDIs could eventually evolve into something like that,” he said.
Balancing act
Bethany Kennedy, a partner in the law firm Emord and Associates, said there could be some benefits to some kind of exclusivity around NDIs. If more companies are encouraged to develop new ingredients, that could benefit the marketplace as a whole. But there are potential pitfalls, too.
“I do think some sort of exclusivity could benefit manufacturers, distributors and ultimately consumers, too,” she said.
“But I think you’d need to balance that exclusivity with consumer access. What would that look like if only one company was making a new ingredient? What’s a fair amount of time for that exclusivity, and how much might it raise the price?” she added.