A new book from the Natural Products Association (NPA) compiles the first ever list of pre-DSHEA (Dietary Supplement Health and Education Act of 1994) dietary ingredients. The NPA book, titled Pre-DSHEA List of Old Dietary Ingredients, is available for pre-sale starting until the end of the year for members, non-members, federal agencies and non-governmental organizations (NGOs). It will also be available as a searchable database for NPA members only.
“This book is the first of its kind and should serve as a valuable tool for industry regulatory divisions, retailers, industry consultants, as well as state and federal regulators,” said Dan Fabricant, PhD, president and CEO of NPA and one of the book’s authors. “NPA continues to work with the FDA (U.S. Food and Drug Administration) in their quest to develop a list of its pre-DSHEA dietary ingredients that are exempt from notification. This book represents a considerable investment of NPA’s resources and took over two years to develop. We look forward to releasing new editions of the book as we add new independently verified ingredients to this extensive collection.”
This book, written and compiled by 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 DSHEA. 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 (generally recognized as safe) 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 more than 1,850 ingredients to make searching easier. This 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.
Please visit www.npainfo.org.