26 Aug 2016

Some Progress but No Dramatic Changes

On August 11, 2016, the United States Food and Drug Administration (FDA) released revised draft guidance on New Dietary Ingredient Notifications and related issues. This version supersedes FDA's July 2011 draft guidance on the same topic. The agency states that the goal of the guidance is to improve the rate of compliance with the notification requirement, as well as protect consumers from health risks associated with ingredients with unknown safety profiles.

Upon our initial review we find that much of the information contained in the guidance remains unchanged from the previous version; however the agency has attempted to provide additional clarification of certain points.

The agency provides information to help industry stakeholders determine:

  • what qualifies as a dietary ingredient and when a notification is required,
  • the definition of "chemical alteration",
  • what type of evidence that should be included to establish the safety of the new dietary ingredients and finished supplements containing this ingredient (the FDA defines the battery of specific studies it expects based on the exposure to the NDI i.e., daily, intermittent, etc.),
  • the acceptability of synthetic versions of different classes of dietary ingredients (herbal/botanical synthetics still generally not considered dietary ingredients, while synthetic vitamins, minerals, and amino acids are acceptable), and
  • when changes in the manufacturing process to an established dietary ingredient may result in the formation a new dietary ingredient requiring a notification.

One highlight of the updated guidance relates to the FDA's intention to develop an authoritative list of dietary ingredients marketed in dietary supplements prior to the enactment of Dietary Supplement Health Education Act (DSHEA) on October 15, 1994, which are "grandfathered" and thus exempt from notification requirements. While some trade associations have attempted to compile of so-called "old dietary ingredients", the FDA does not consider inclusion on such lists as definitive proof that the ingredient is not an NDI. However, based on substantial input from industry in the forms of adequate and verifiable documentation to support pre-DSHEA marketing, the FDA will compile an authoritative list. This should make it easier to confirm whether a dietary ingredient is new or not when it is ultimately built.

The FDA also defined the use of "NDI master files". Although chemistry and manufacturing information could be submitted confidentially to the FDA in the past, this approach allows for the master file information to be incorporated by reference into NDI notifications, either by the submitting company, or by other firms (i.e., customers) that may leverage this information in their notifications with proper authorization. This approach is already utilized by FDA for pharmaceuticals and for supplements in other jurisdictions (e.g., for Natural Health Products in Canada). Thus these master files may assist downstream customers in submitting their own abridged NDI notifications.

There is currently a 60 day comment period, sometime after which the FDA is expected to release a final version. However, given that there was 5 year wait for this updated version, the timing of finalization is uncertain. As in the past, it is anticipated that the FDA will follow the recommendations contained in the guidance in the interim.

Do you have questions about the new guidance or NDI notification process in general?

Intertek Scientific & Regulatory Consultancy has qualified experts with experience with ingredient safety evaluations and preparation of successful New Dietary Ingredient notifications. For more information, contact us directly food.sci-reg@intertek.com or visit our website for all our service offerings: https://www.intertek.com/food/consulting/

You may be interested in...