By Dr. Corey Hilmas, Chief Regulatory Officer, KGK Science
FDA made minor headlines last week by publishing a new Import Alert (IA #54-18), titled “Detention Without Physical Examination of Dietary Supplements and Bulk Dietary Ingredients That Are or Contain New Dietary Ingredients.” While to the everyday consumer, this act might go unnoticed, to the regulatory world, this constitutes a major movement on the part of the Agency to cite firms, products, and new dietary ingredients for failing to file a New Dietary Ingredient Notification. This IA is step one from FDA toward enforcing the NDI adulteration provision which has already been in place. It represents a quick and easy solution for FDA, without investing in significant resources, to regulate non-compliant ingredients, products, and companies attempting to enter the various US ports of entry. IA #54-18 will have an immediate impact on ingredient imports coming from China and India, but it will also impact finished dietary supplement products containing dietary ingredients FDA believes are “new”. In IA #54-18, FDA references their “Red List” (let’s call it Scarlet) of companies and ingredients, and products flagged for non-compliance with Federal statute. Higenamine, identified on the new IA’s Red List, is an ingredient identified by FDA several years earlier in their “Dietary Supplement Ingredient Advisory List,” which was started in 2019. Is this a permanent ban on higenamine? No, FDA wants to see it filed as an NDI notification, shown proof that it is an Old Dietary Ingredient (ODI) with independent and verifiable evidence, or provided documentation as to how it is somehow exempt from NDI filing.
This FDA action officially marks the start of NDI enforcement, but many questions remain unanswered. Was there an internal Import Bulletin (not published) in place prior to this Import Alert? If so, when did that occur? Does this action mean we will see a finalized NDI guidance in 2021 for companies? Will the NDI guidance document provide closure on topics it introduced in NDI town hall meetings like NDI master files with mechanisms in place for the NDI holder to update the NDI docket with ingredient suppliers and finished products covered under the NDI? How will 201(ff)(1)(E) be interpreted in the finalized NDI guidance? Will FDA allow for a broad interpretation of the statute, favored by industry to enable future growth, or will the interpretation be narrow, hindering ingredient innovation? What manufacturing processes will constitute chemical alteration of an ingredient, requiring NDI notification to FDA? How will FDA protect the intellectual property of those who have navigated the NDI process already? Will FDA enforce against ingredients produced by non-NDI holding manufacturers or ingredient suppliers, who rely on an FDA-acknowledged NDI produced by a competitor (e.g., copycat or piggy-back riders)? Will FDA use the same NDI adulteration provision to target products already located in the US on store shelves?
While adulteration is quite different than adultery, being placed on an Import Alert “Red List” for adulteration is akin to the shame of wearing the Scarlet Letter. No one wants the stigma associated with either charge. In this case, the charge is over failure to file a New Dietary Ingredient (NDI) notification. Removing oneself from the Import Alert for “A”dulteration will be difficult, requiring nothing short of investment in preclinical safety and filing an NDI notification.
Corey Hilmas, MD, PhD
Chief Regulatory Officer, KGK Science
Dr. Corey Hilmas is a respected scientist, medical doctor, and former U.S. federal food regulator. After having completed his Medical Degree and Doctorate in Toxicology, Dr. Hilmas worked as a Principal Investigator for many years, and served on behalf of the U.S. government at FDA. Dr. Hilmas combines his unique science skillset with extensive U.S. regulatory training. He served as an NDI Notification reviewer and as a branch chief within the Division of Dietary Supplement Programs at the FDA. As a recognized regulatory expert with intimate knowledge of the dietary supplement industry. Dr. Hilmas has made significant contributions to building and shaping the regulatory landscape. As Chief Regulatory Officer, Dr. Hilmas provides clients with novel and informed strategies to generate distinction for branded ingredients in the marketplace.