November 23, 2016
To hear some corners of the dietary supplement industry these days, the FDA’s newly released NDI guidance spells the end of life as we know it.
I choose to take another view. Five years after the FDA issued its first draft of the guidance, it’s clear to me that the agency has listened to the comments it received. No, the industry didn’t get everything it wanted, but I see signs of a “thawing” at the FDA and an effort to engage with stakeholders to develop a meaningful, but reasonable, framework around new ingredients. Let’s not forget that the requirement that new ingredients must be notified to the FDA 75 days in advance is not a creation of the agency; it is enshrined in DSHEA—a provision the industry’s negotiators agreed to back in 1994 as a trade-off to protect existing ingredients already in the market and allow the FDA to review the safety of novel ingredients and formulations.
In addition, this industry looks nothing like it did back in 1994. After 22 years, we need to work with our regulators. We are a $39 billion dollar industry that wants to continue to attract new consumers with growth rates that are the envy of other consumer goods. With that comes responsibility. Otherwise, we leave ourselves open to the justifiable criticism that dietary supplement producers are a recalcitrant, unmanageable bunch who resist any effort to put guard rails around the industry for the safety of the consumer. That’s a reputation we can’t afford.
So, let’s consider some of the “wins” we already obtained in this latest draft of the guidance:
FDA has agreed to collaborate with industry to create an official “safe harbor” list of grandfathered ingredients—five years ago, it refused.
FDA now acknowledges that its literal reading of what is a chemical alteration of a food ingredient was too broad, and the list in the legislative history was illustrative only, not exhaustive. That’s progress.
The agency listened to the industry’s recommendation that it recognize “master files” and “umbrella notifications” for NDIs that allow ingredient manufacturers to protect their investments in safety research and reduce duplicative filings by each of their customers.
Significant issues of dispute still exist however. The disagreement of whether synthetic copies of botanical constituents should be lawful dietary ingredients persists, and it will likely not be resolved in this forum; the courts or even Congress may eventually dictate the answer. The FDA’s version of when a manufacturing change triggers an old ingredient to become a new one still appears too expansive and would stifle innovation. And the FDA is silent on how the industry might transition to these new interpretations of the statute by offering enforcement discretion while companies identify “new” ingredients already on the market that were previously assumed to be “old.”
So there is still work to be done; but, for me, the larger question is whether the responsible industry enters a constructive dialogue or runs to its corner and refuses to engage. When we declare that the statutory obligations we agreed to 22 years ago will now bankrupt the industry, it hardly looks like we are extending an olive branch. And it plays into our critics' hands.
So I would offer some “truths” that every manufacturer and marketer needs to ponder:
FDA must regulate for the worst as well as the best. For every innovative manufacturing breakthrough that produces purer, more bio-available, more sustainable ingredients, there is a fringe player looking to slip a synthetic stimulant into its products without any assurance of safety and without being noticed. We have to figure out how to allow the FDA to protect against the worst without stifling the innovation of the best.
Not every step toward a workable pre-market notification regime is a march toward pre-market approval. Conspiracy theorists abound who see full-blown, pharma-like, pre-market approval behind every rock. The law expressly gives the FDA the responsibility to protect public safety with a limited review of safety data for new dietary ingredients (and for the finished supplements that contain them). This does not confer the power to review (and to bless) every new formulation to enter the market, but it requires the FDA to insist that new ingredients are reasonably expected to be safe.
As time moves on, it is inescapable that more and more new ingredients will appear and will account for a larger and larger share of the supplement aisle. Old ingredients will become passé. So we need to resolve these issues now before the market is so full of un-notified new ingredients, and the stakes become too high, to ever go back and get this one right.
Dietary supplements are food; the law says so. And food should be assumed to have a wide margin of safety. That means supplement marketers should not be forced into an endless cycle of innovate, file, wait, innovate, file, wait… The solution lies in finding a balance which assures that the FDA can effectively prevent unsafe products from ever reaching consumers. It entails accepting that ingredient change is a continuous cycle, not an easy dichotomy, so the answers may be ingredient-specific.
When one considers what’s at stake, the best course is to meet the FDA at the negotiation table. It calls for moderation and a genuine understanding of the motivations and concerns of both sides. These things can’t occur when we perceive the draft guidance as the precipice that bankrupts the industry. Let’s put down the hyperbole and reach for the middle ground. That would be a remarkably new ingredient for success.
Steve Mister is the president/CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry.
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