The Natural Products Association recently field comments with the Food and Drug Administration regarding its development of a list of pre-DSHEA dietary ingredients. In comments, NPA highlighted their new book titled Pre-DSHEA List of Old Dietary Ingredients, now available for pre-sale for members, non-members, federal agencies and non-governmental organizations (NGOs). It will also be available as a searchable database for NPA members only.
“We are pleased to continue our collaboration with the FDA to develop a list of its pre-DSHEA dietary ingredients,” said Dan Fabricant, Ph.D., President and CEO of NPA. “We are confident this book will serve as a valuable tool for industry regulatory divisions, retailers, industry consultants, as well as state and federal regulators.”
NPA’s comments to the FDA can be viewed here.
NPA’s Pre-DSHEA List of Old Dietary Ingredients
This book, written and compiled by Dr. Daniel Fabricant and Dr. Corey Hilmas, alphabetically organizes a list of pre-DSHEA or old dietary ingredients (ODIs) that were marketed and sold prior to October 15, 1994, the implementation date for the Dietary Supplement Health and Education Act (DSHEA) of 1994. These dietary ingredients would be exempt from filing notifications with FDA as New Dietary Ingredients (NDIs). The ingredient names contain reference citations to the original printed source material, which consists of NPA’s own printed magazines and newsletters over the decades. The ingredient listing also includes ingredients submitted as GRAS notices to FDA with no further comment by the Agency. As there has not yet been an authoritative list of ODIs, this will be the first pre-DSHEA ODI list to be published and available to the public.
For those who are unsure whether a dietary ingredient is ‘grandfathered’ under DSHEA (pre-DSHEA dietary ingredient or ODI) or is a NDI requiring notification under the Federal Food, Drug, and Cosmetic Act, this book will serve as a useful regulatory guidepost. The book contains an index of over 1,850 ingredients to make searching easier. This highly coveted dietary ingredient list is available at $2,000 for members and $10,000 for non-members. There will be an additional upcharge for industry consultants, state and federal regulatory agencies, libraries, and NGOs.
Natural Products Association
The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents over 1,400 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Visit www.NPAinfo.org.