June 29, 2022
Today, I virtually attended day one of the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements co-hosted by the American Conference Institute (ACI) and the Council for Responsible Nutrition (CRN).
Having covered this industry now for over a decade—with a focus on regulatory and legal issues—here are five of my takeaways from the conference so far.
Companies would like to avoid another battle royale with FDA over an “article” marketed in a dietary supplement that the agency later asserts was first approved or studied as a drug. If this isn’t ringing a bell, please read our coverage on NAC (N-acetyl-L-cysteine), including FDA’s denial of citizen petitions requesting the agency reverse its position that NAC is excluded from the definition of a dietary supplement. Andrew Shao, Ph.D., senior vice president of global scientific and regulatory affairs with ChromaDex, and Xin Tao, counsel with the law firm Hogan Lovells LLP, discussed NAC, other drug ingredients and provided tips in a session aptly titled, “NAC Case Study: How to Prevent Your Supplement from Becoming the Next Target of Drug Preclusion.”
Among Tao’s advice, he recommended firms marketing a dietary ingredient should focus on three key dates—when the ingredient was first:
• approved as a drug
• authorized for substantial clinical investigation
• marketed in a dietary supplement or food.
Shao suggested that following FDA regulatory pathways for an ingredient—such as a new dietary ingredient notification (NDIN)—could help establish its legitimacy in the marketplace prior to it being studied or approved as a drug. He cited a warning letter where FDA asserted an NDI had not gone through the required premarket notification to the agency and consequently was not “legally marketed as a dietary supplement” before it was investigated as a drug.
Due to the Covid-19 pandemic that emerged in the spring of 2020, FDA conducted fewer than 300 cGMP (current good manufacturing practice) inspections in each of fiscal years 2020 and 2021. The public health agency now must play catch-up to address a backlog of inspections. Speaking at the ACI-CRN conference, FDA’s Office of Dietary Supplement Programs (ODSP) Director Cara Welch, Ph.D., suggested the agency wasn’t necessarily capturing an accurate picture of industry’s compliance with cGMPs even before the pandemic broke. In the years immediately prior to 2020, FDA was inspecting annually about 5% of the roughly 10,000 registered facilities, according to her remarks and slide deck.
FDA is considering industry proposals to increase its oversight of facilities, such as whether to integrate into its inspectional program external third-party audits. While the agency hasn’t decided on anything, FDA wants to make the best use of its resources and get a better sense of the overall cGMP compliance picture.
Welch reiterated the agency’s desire for gaining greater insight into NDIs on the market. She said FDA has reviewed and responded to 1,164 notifications since 1994 and is receiving about 30 to 50 NDINs annually. FDA has estimated for years that the U.S. market contains between 50,000 and 80,000 dietary supplement products. Welch highlighted positive news for industry, namely the recent rate of so-called AKL letters to notifications. These are letters in which FDA acknowledges a notification without an objection. The AKL rate has risen from 35% in FY18 to 46% in FY19, 47% in FY20 and 60% in FY21, FDA data show, based on Welch’s presentation. More good news? FDA has found the AKL rate is even higher when there are pre-NDI meetings with FDA. These are conversations with FDA staff prior to submitting a notification.
Welch discussed FDA’s plans—as articulated in a recently published draft guidance—to exercise “enforcement discretion” to give firms an opportunity to submit an NDIN without fear of being penalized for failing to timely comply with the premarket notification requirement. In some respects, her remarks echoed comments she made to me in a recent interview. Provided a guidance is finalized, FDA is hoping to shrink the pool of noncompliant NDIs. During the ACI-CRN conference, Welch suggested the smaller pool would help FDA target its enforcement to firms that continue to resist compliance, even when given another chance to do so. Bottom line: FDA seems to be conveying the message that the proposed amnesty period represents companies’ FINAL CHANCE to comply with the NDIN requirement, or they will face adverse consequences.
Welch’s remarks, questions posed to her at the conference, and a separate panel discussion underscored complexities tied to the NDIN requirement. Those nuances include an exemption to the notification requirement for ingredients in the conventional food supply in a non-chemically-altered form. In a session entitled, “Sound Strategies to Employ While Waiting for Updated New Dietary Ingredient (NDI) Guidance,” three regulatory and legal experts discussed ingredient strategies, including whether a GRAS (generally recognized as safe) evaluation is proper to establish compliant use and safety.
This topic is convoluted, and according to FDA itself—as documented in an FDA letter I reported on last year—presents challenges in determining which ingredients are actually subject to the NDIN requirement. And it remains to be seen how FDA will enforce against noncompliant firms in cases in which they are claiming their NDI is exempt from the notification requirement due to being present in the food supply.
Mandatory product listing (MPL) remains a very timely topic of conversation. This issue was discussed at the ACI-CRN conference. Unfortunately, a session entitled “Preparing the Way for Mandatory Product Listings” was not open to me as a member of the press. If you are interested in the particulars of the session and couldn’t attend the conference, perhaps reach out to the speakers: Jessica O’Connell, partner with Covington & Burling LLP; Will Woodlee, partner with Kleinfeld, Kaplan & Becker LLP; and Julia Gustafson, vice president of government relations with CRN.
MPL will continue to be in the news over the next several weeks as Congress moves forward in passing a bill to fund FDA user-fee programs. For those unfamiliar with the latest developments on this issue, a key committee in the U.S. Senate recently voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act. That same committee, however, narrowly rejected an amendment supported by dietary supplement interests.
There’s a lot at stake with MPL legislation and much uncertainty on Capitol Hill.
Got feedback on this column and/or story ideas? Drop me a line at [email protected].
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