Draft Guidance

All eyes on Dietary Supplement Master Files

11-Jul-2023 By Danielle Masterson

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved...

Special edition: Botanicals

Synthetic botanicals standoff likely to continue despite Georgia ruling

22-Jun-2017 By Hank Schultz

Experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being  the agency’s position is not rooted in science.

Jarrow challenges FDA on probiotics

25-May-2017 By Hank Schultz

Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients.

NDI guidance would over regulate, weaken supplement industry, Jarrow asserts

03-Jan-2017 By Hank Schultz

The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently by finished goods manufacturer Jarrow Formulas.

Bodybuilding.com urges FDA to reinstate GRAS self affirmation exemption in NDI guidance

23-Nov-2016 By Hank Schultz

Dietary supplement retailer bodybuilding.com has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the...

Panel explores issue of how best to live with NDI provisions

11-Oct-2016 By Hank Schultz

The consensus of a recent industry session on NDIs was this: The draft guidance is here to stay. You’d best learn to deal with it.

New Dietary Ingredients (NDI)– A Better Solution

04-Oct-2016 By Jim Lassiter, President/COO, Ingredient Identity

“Antagonistic cooperation is the principle of all markets and many marriages.” - Mason Cooley

NPA asks for NDI comment period extension

26-Aug-2016 By Hank Schultz

The Natural Products Association is asking FDA to add 30 days to the comment period on the updated New Dietary Ingredients draft guidance.

Embracing the future: The dietary supplement industry comes of age

25-Aug-2016 By Duffy MacKay, senior vice president, scientific and regulatory affairs, CRN

Duffy MacKay of CRN argues that there is much in FDA's newly released New Dietary Ingredients draft guidance that represents a step forward for the industry.

Self-affirmed GRAS omitted from new NDI draft guidance

18-Aug-2016 By Stephen Daniells

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

NDIs: The biggest changes may be on the industry side

16-Aug-2016 By Stephen Daniells

The new NDI draft guidance is very similar to the previous version, and yet the howls of outrage heard in 2011 are silent. What’s changed? Well, a lot…

FDA’s new NDI draft guidance: ‘Not much that’s surprising’

15-Aug-2016 By Stephen Daniells

The new draft guidance for new dietary ingredient notifications is “more positive than negative”, says Steve Mister, CEO of the Council for Responsible Nutrition.

It’s here! FDA releases new NDI draft guidance

11-Aug-2016 By Stephen Daniells

Master Files and a grandfathered list are among the highlights in the FDA’s new Draft Guidance for New Dietary Ingredient Notifications, released this morning.

Special Edition: Blood Sugar Management

Medical foods for blood sugar management in limbo more than a year after FDA issued draft guidance

21-Jan-2015 By Hank Schultz

Medical foods formulated for diabetes are still in a state of limbo more than 18 months after the US Food and Drug Administration issued an updated draft guidance on the category in 2013.  After a comment period, the guidance has languished in a draft...

Industry applauds FDA's release of final version of liquid dietary supplements guidance

14-Jan-2014 By Hank Schultz

After a four-year delay, FDA has at last released a final version of its guidance on liquid dietary supplements.  The document doesn’t much change the line of thinking offered in the draft version but does offer more detail and clarification and in general...

Members of Congress ‘concerned’ about speed of progress on NDI draft guidance

09-Jul-2013 By Stephen DANIELLS

Key members of the United States Congress have voiced concern over the speed of progress of revising the controversial draft guidance for new dietary ingredients (NDIs), and called on FDA to produce a revised draft guidance in a 'timely manner'.

House committee admonishes FDA to pick up pace on NDI issue

20-Jun-2013 By Hank Schultz

The US House of Representatives Appropriations Committee has sent a stern message to the Food and Drug Administration on the subject of the draft New Dietary Ingredients guidance.  The message in a nutshell: Get a move on.

FDA: Inflammation and diabetes raising red flags for tainted products

05-Oct-2012 By Stephen Daniells in Laguna Beach

Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of CFSAN at FDA.

Will the FDA revise its stance on synthetic botanical constituents? It’s not looking promising…

30-Jul-2012 By Elaine WATSON

Firms hoping the FDA might change its unpopular stance on synthetic copies of botanical constituents as it rewrites its draft guidance on new dietary ingredients (NDIs) could be disappointed.

FDA silent on calls from Sen Hatch and Harkin to withdraw NDI draft guidance

06-Jan-2012 By Stephen Daniells

Staff for Senators Harkin and Hatch are still waiting for a response from the Food and Drug Administration (FDA) following calls from the Senators for FDA to withdraw its NDI draft guidance and for January meetings to discuss concerns.

Fabricant on NDI draft guidance: Thanks for your 146,000 pages of comments. We’ll get back to you…

22-Dec-2011 By Elaine Watson

Those hoping the Food and Drug Administration (FDA) is preparing for a major climb down on its draft guidance on new dietary ingredients (NDIs) will draw little comfort from comments made by the agency's supplements chief yesterday.

Ullman: NDI draft guidance withdrawal unlikely, but industry deserves timely response

20-Dec-2011 By Elaine Watson

While it is possible that the FDA could withdraw its draft guidance on new dietary ingredients (NDIs), such a move would be “highly unusual”, according to one leading food law attorney.

NDI comments review: Industry urges FDA back to the drawing board

09-Dec-2011 By Stephen Daniells & Claire Videau

One week on from the deadline for submission of comments on the FDA’s new dietary ingredients (NDI) draft guidance, we review the comments.

NDI Draft Guidance Comments in brief

Atrium Innovations on NDIs: The system isn’t broken, so why fix it?

07-Dec-2011 By Stephen Daniells

The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says Atrium Innovations.

NDI draft guidance comments

CRN on NDI draft guidance: ‘A choir has many voices but we’re all singing the same song ‘

02-Dec-2011 By Elaine Watson

There will be differences in emphasis in comments submitted to the FDA on its draft guidance on new dietary ingredients (NDIs), but the overall message from the supplements industry is clear - and consistent - says the Council for Responsible Nutrition...

Trade to FDA: Don’t leave us in limbo on NDI guidance

29-Nov-2011 By Elaine Watson

While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...

Special Edition: SupplySide West

01-Nov-2011 By Stephen Daniells

NDI draft guidance, market opportunities, adulteration, a perceived lack of innovation, and the specter of ‘dry labbing’ all got people talking at this year’s SupplySide West show in Las Vegas.

Ullman: NDI guidance creates ‘new dietary supplement’ notification process

11-Aug-2011 By Stephen Daniells

The New Dietary Ingredient (NDI) draft guidance represents ‘rulemaking by guidance’ and should immediately be ‘withdrawn and revised’, says New York-based law firm Ullman, Shapiro & Ullman, LLP.

Special edition: NDI draft guidance reaction

The wait is over: FDA releases NDI draft guidance

01-Jul-2011 By Stephen Daniells

The Food and Drug Administration (FDA) has released the much anticipated New Dietary Ingredient (NDI) draft guidance, meeting its statutory deadline for the release of the document.

Quality of nano toxicity data is ‘not great’, says expert

22-Jun-2011 By Elaine Watson

The limited nature of many toxicity studies into engineered nanoparticles used in the food and dietary supplements industry makes it very difficult to draw firm conclusions about their safety, according to one expert in the field.

FDA: Foods vs supplement feedback raises ‘complex legal questions’

13-May-2011 By Elaine Watson

The Food and Drug Administration (FDA) says feedback it has received about its December 2009 draft guidance clarifying where a liquid dietary supplement ends and a conventional beverage begins has raised “complex legal questions”.

FDA recommends greater conflict of interest transparency

22-Apr-2010 By staff reporter

The Food and Drug Administration (FDA) has called for more transparency regarding conflict of interest statements when the agency waives them to allow experts to participate in scientific advisory meetings.

Stay on top of supplement labeling changes, says NPA

09-Oct-2008 By Lorraine Heller

Dietary supplement manufacturers in the US should inform the nation’s regulator of the cost burden they are likely to incur if proposed labeling regulations are passed, an industry association said yesterday.

AHPA opposes FDA's CAM guidance

30-Apr-2007 By Clarisse Douaud

In a case that furthers the polemic surrounding regulatory
structure of the dietary industry, the American Herbal Products
Association (AHPA) has issued comments to the US Food & Drug
Administration (FDA) urging the agency to...