02.01.18
Nearly four of five new dietary ingredient (NDI) notifications recently submitted to the Food and Drug Administration (FDA) had technical issues that prevented FDA from being able to determine safety, according to the American Herbal Products Association’s NDI Database.
AHPA recently received information on 50 NDI notifications submitted to FDA between February 2017 and June 2017, but FDA was only able to evaluate 11 of these notifications because the other 39 had significant technical issues.
Among these 50 notifications most recently released by FDA and added to the NDI Database, 18 were identified as not technically compliant with the requirements for what a notification must include. FDA could not complete its assessment of another 21 notifications because the agency was unable to identify the dietary ingredient being submitted. The remaining 11 notifications were both technically compliant and discussed an NDI FDA was able to identify as a dietary ingredient. Nearly half (five) of these were filed by FDA without substantive comment.
The recent rate of technical noncompliance is a dramatic change from what AHPA observed between 1995 and 2016, approaching a rate of incomplete notifications not seen since 2006, AHPA noted. This appears to reflect a growing interest in filing notifications by organizations that lack the knowledge and experience needed to file a complete notification.
"The fact that roughly four of five recent NDI notifications were submitted without a description of a dietary ingredient or in a condition not technically compliant with NDI requirements underscores the importance of industry resources like AHPA's NDI Database," said AHPA Chief Information Analyst Merle Zimmermann, PhD. "AHPA's NDI resources help companies avoid common pitfalls and effectively and efficiently navigate the sometimes time-consuming NDI notification process in order to meet the growing consumer demand for safe, innovative products."
AHPA's NDI Database provides written summaries of FDA's responses to NDI notifications (when available) and information on the dates of notifications. The database enables users to browse by report number or search notifications by company and ingredient, including common or Latin names for botanicals. An "Outcome Statement" is also provided to help users quickly understand FDA responses, including issues that resulted in FDA comments.
Companies that want to use a dietary ingredient not marketed in the U.S. before Oct. 15, 1994 are required to submit an NDI notification explaining why the ingredient is reasonably expected to be safe. This notification must be submitted at least 75 days before the dietary ingredient is introduced into interstate commerce.
FDA does not "approve" or "disapprove" NDI notifications. Instead, the agency generally provides one of several responses, including but not limited to: 1) letter of acknowledgement without objection; 2) letter listing deficiencies that make the notification incomplete; 3) objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; and 4) letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI is not a dietary ingredient as defined by regulation or the product is excluded from the definition of "dietary supplement" under current regulations because it is not intended for ingestion).
AHPA NDI Resources
AHPA NDI Database
NDI Notification Practical: How to Submit an NDI Notification Without Objection (May 2017 webinar)
Summary of 20 years of NDI data
AHPA recently received information on 50 NDI notifications submitted to FDA between February 2017 and June 2017, but FDA was only able to evaluate 11 of these notifications because the other 39 had significant technical issues.
Among these 50 notifications most recently released by FDA and added to the NDI Database, 18 were identified as not technically compliant with the requirements for what a notification must include. FDA could not complete its assessment of another 21 notifications because the agency was unable to identify the dietary ingredient being submitted. The remaining 11 notifications were both technically compliant and discussed an NDI FDA was able to identify as a dietary ingredient. Nearly half (five) of these were filed by FDA without substantive comment.
The recent rate of technical noncompliance is a dramatic change from what AHPA observed between 1995 and 2016, approaching a rate of incomplete notifications not seen since 2006, AHPA noted. This appears to reflect a growing interest in filing notifications by organizations that lack the knowledge and experience needed to file a complete notification.
"The fact that roughly four of five recent NDI notifications were submitted without a description of a dietary ingredient or in a condition not technically compliant with NDI requirements underscores the importance of industry resources like AHPA's NDI Database," said AHPA Chief Information Analyst Merle Zimmermann, PhD. "AHPA's NDI resources help companies avoid common pitfalls and effectively and efficiently navigate the sometimes time-consuming NDI notification process in order to meet the growing consumer demand for safe, innovative products."
AHPA's NDI Database provides written summaries of FDA's responses to NDI notifications (when available) and information on the dates of notifications. The database enables users to browse by report number or search notifications by company and ingredient, including common or Latin names for botanicals. An "Outcome Statement" is also provided to help users quickly understand FDA responses, including issues that resulted in FDA comments.
Companies that want to use a dietary ingredient not marketed in the U.S. before Oct. 15, 1994 are required to submit an NDI notification explaining why the ingredient is reasonably expected to be safe. This notification must be submitted at least 75 days before the dietary ingredient is introduced into interstate commerce.
FDA does not "approve" or "disapprove" NDI notifications. Instead, the agency generally provides one of several responses, including but not limited to: 1) letter of acknowledgement without objection; 2) letter listing deficiencies that make the notification incomplete; 3) objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; and 4) letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI is not a dietary ingredient as defined by regulation or the product is excluded from the definition of "dietary supplement" under current regulations because it is not intended for ingestion).
AHPA NDI Resources
AHPA NDI Database
NDI Notification Practical: How to Submit an NDI Notification Without Objection (May 2017 webinar)
Summary of 20 years of NDI data
