News analysis: Takeaways from ACI-CRN conference

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.”

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.

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’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.

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.