Top Critiques of FDA’s NDI Draft Guidance in Industry Comments

It’s been almost exactly four months since FDA released its revised new dietary ingredient (NDI) draft guidance, and in that time the dietary supplements industry has found plenty of provisions in the new draft guidance to take issue with. From concerns about the future of probiotics and synthetic botanicals, to anxiety about the sheer number of NDI notifications FDA could be calling for, the revised draft guidance has encountered plenty of resistance, to say the least.

Yesterday, the comment period ended for the public to submit responses to FDA on the revised NDI draft guidance. Industry stakeholders did find some improvements in the revised draft guidance over its previous iteration, which was published in July of 2011. That includes the proposal for “master files” that would allow companies to create a single NDI notification for a wide range of product formulations, as well as FDA’s statement that it is prepared to create an “authoritative list of pre-DSHEA ingredients.”

But despite the “steps forward,” as the Council for Responsible Nutrition (CRN; Washington, DC) described the improvements in the draft guidance, the consensus in comments submitted by industry trade associations is that more work needs to be done. By and large, industry comments reaffirm the objections Nutritional Outlook has reported on over the past few months. Here are some of the top critiques:

• In requiring new NDI notifications be submitted for different ingredient combinations, among other provisions, FDA may effectively be calling for product-specific NDI submissions. Instead, “FDA must refrain from declaring or implying that each dietary supplement that contains an NDI requires a separate NDI notification, and should instead encourage manufacturers and distributors of new dietary ingredients to include in notifications very broad descriptions of the many dietary supplements that are expected to contain the subject NDI,” according to the American Herbal Products Association (AHPA; Silver Spring, MD).
• FDA is acting outside the provisions of DSHEA in applying the food safety standards used for food additives and GRAS substances to NDIs. “FDA continues to blur the distinction between dietary supplements and conventional food ingredients in their testing recommendations,” according to the Natural Products Association (NPA; Washington, DC).
• Some synthetic copies of herbal or botanical constituents may not fit FDA’s latest definition of what can be NDIs, forcing such ingredients to pursue GRAS affirmations instead of NDIs. If a synthetic or semi-synthetic compound is “chemically identical to the natural compound and has the same level of safety as the natural compound,” the synthetic version should be considered a legitimate dietary ingredient, according to the American Botanical Council (ABC; Austin, TX).
• FDA is taking a perilously narrow view of what constitutes a manufacturing change, suggesting even small changes inherent in traditional food manufacturing will require new NDI submissions.
• FDA should clarify what constitutes a chemical alteration to an ingredient that would require a new NDI be submitted. Minor processing changes, such as switching between similar extraction solvents, should not be considered chemical alterations.
• FDA should perform an economic-impact analysis of the cost to both agency and industry that would result if the revised draft guidance became accepted as final guidance.
• FDA should accept industry lists of pre-DSHEA ingredients and create its own authoritative grandfathered list of old dietary ingredients.
• FDA should clarify the status of live microbial ingredients, such as probiotics.

These are just a few of the critiques and suggestions proposed by industry associations. For a more comprehensive look at industry’s key objections to the NDI draft guidance, check out Nutritional Outlook’s recent eBook on the topic here.

Difference in Tone

The industry responses to the NDI draft guidance also reveal some notable differences in tone from the various trade associations. CRN took the relatively accommodating view that the guidance represented “progress” over the 2011 guidance, although “lingering industry concerns” remain that FDA needs to address. NPA, on the other hand, raised alarms that the revised draft guidance “might encourage more skirting of regulations,” “could harm small business,” and “create a chilling effect on innovation.”

Meanwhile, ABC requested FDA “continue to revise” the NDI guidance, as FDA has “exceeded its statutory authority and the intent of Congress with respect to its provisions in the 2016 draft guidance. ABC encourages FDA to continue to prioritize enforcement against adulteration and cGMP violations, as these are a have a greater likelihood of positive impact on product quality and public health.”

AHPA also raised concerns that FDA was going beyond the bounds of its authority and the intent of DSHEA in the revised NDI draft guidance. As did several of the other trade associations, AHPA urged FDA to work more closely with industry experts, and “turn the page on the decades of discord and misunderstanding between FDA and the dietary supplements industry,” said Michael McGuffin, president of AHPA.

In the coming days and weeks, Nutritional Outlook will cover public comments about the revised NDI draft guidance in greater depth.

Read more:

How FDA’s NDI Guidance Could Paralyze Industry

2 Big Wins for Supplement Industry in FDA’s New NDI Draft Guidance

NDI Draft Guidance: Just When You Thought You Were Safe

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com