‘A useful regulatory guidepost’: NPA publishes book listing pre-DSHEA ingredients

By Stephen Daniells

- Last updated on GMT

© Getty Images / Pat_Hastings
© Getty Images / Pat_Hastings

Related tags Food and drug administration Npa

The Natural Products Association has released a book compiling a list of pre-DSHEA (old) dietary ingredients to provide a “useful regulatory guidepost” for industry and regulators.

Using original source material predominantly collected from the NPA’s own printed magazines and newsletters, some dating back to the 1950s, Dr Dan Fabricant, PhD and Dr Corey Hilmas, PhD have alphabetically organized a list of more than 1,850 pre-DSHEA or old dietary ingredients (ODIs) that were marketed and sold prior to October 15, 1994.

“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 Dr Fabricant, NPA’s president and CEO. 

“NPA continues to work with the FDA 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 2 years to develop.  We look forward to releasing new editions of the book as we add new independently verified ingredients to this extensive collection.”

FDA’s response

Responding to NPA’s announcement, a spokesperson for the US Food and Drug Administration, told NutraIngredients-USA: “As we said in the revised draft NDI guidance, and in the Federal Register notice announcing our recent public meeting, we are aware that, over the years, several trade associations and industry groups have independently developed their own unofficial lists of ingredients that they believe were marketed before October 15, 1994. We are unable to verify the accuracy of those lists and therefore have never recognized or sanctioned any of them. 

“Our October 3, 2017 public meeting was an important first step toward the goal of developing an authoritative list of pre-DSHEA dietary ingredients in a manner that will be transparent to and will benefit all of our stakeholders.  The comment period on that meeting remains open through December 4, and we hope that NPA will share on the public docket the methods and sources that it used to compile its latest list so that all interested stakeholders can evaluate the quality of its evidence.”

Dr Fabricant told NutraIngredients-USA that discussions have already taken place with FDA regarding the list and NPA would indeed be sharing the methods and sources on the public docket.

“We predicted FDA would go this way two years ago, so the timing has been good, coming so close to the public meeting [on October 3 at the Center for Food Safety and Applied Nutrition campus just outside of Washington, DC],”​ he said.

“FDA isn’t going to come up with their own list and the old ads, which come primarily from the old NNFA retail magazines, support the active moiety and the intended use,” ​he added.

The NPA book, titled Pre-DSHEA List of Old Dietary Ingredients​, is available for pre-sale. It will also be available as a searchable database for NPA members only. The book 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.

Public comments

Speaking at the recent IPA Workshop in DC,​ Dr Cara Welch, Senior Advisor for the Office of Dietary Supplements at the FDA, told attendees that the ODI or pre-DSHEA of “grandfathered” list is “not necessarily a list of safe ingredients. It also doesn’t mean that anything that isn’t on the list is new.”​  The public comment period is open until Dec 4, 2017, and can be accessed at Regulations.gov under Docket No. FDA-2017-N-4625​.

The Agency recently hosted a public meeting​ to discuss what evidence is acceptable to demonstrate an ingredient is old, and what process should be used to develop the list. “We’re only looking at the US for evidence,” said Dr Welch. “It doesn’t matter about other countries and regions.”

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