In a 17-page submission to the FDA, Loren Israelsen, UNPA’s executive director, states that until industry and the Food and Drug Administration (FDA) can ‘work together through a guidance or rulemaking process’ the NDI draft guidance should not be implemented and should be withdrawn.
“This draft guidance misinterprets the plain language of DSHEA and imposes needlessly burdensome and expensive requirements on dietary supplement producers and marketers without advancing the overall safety of dietary supplements,” writes Israelsen.
“This would lead to higher consumer prices, reduced variety of product choices, contraction of jobs and innovation and would foster an inequitable competitive environment between manufacturers.”
Echoing calls from all around the industry, UNPA calls for FDA to withdraw the document and “re-propose further guidance”.
The deadline for comments on the NDI draft guidance passed on Friday, December 2 following a 60 day comment period extension by the FDA.
The vast majority of the industry has called for FDA to withdraw the draft guidance and to refrain from adopting or enforcing the ‘current thinking’ outlined in the document.
UNPA’s comments address seven key topics: The definition of an NDI as an ingredient and not a finished dietary supplement product; who must file an NDI Notification; the need for an authoritative list of grandfathered ingredients; why synthetic botanicals should be considered dietary ingredients; how the agency deals with probiotics and other microbial dietary ingredients; why food additive safety requirements are inconsistent with DSHEA; and why the agency should assess ingredients themselves “rather than applying a restricted list of illustrative processes to determine whether chemical alteration has occurred resulting in a new dietary ingredient”.
In terms of the list of old dietary ingredients, the UNPA comment submission also includes a review by the alliance’s NDI Working Group of existing lists from the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and UNPA itself.
Let’s work together
The way forward is to withdraw the current NDI guidance, “until the FDA and the dietary supplement industry have an opportunity to work together through a guidance or rulemaking process that achieves a balance between FDA’s consumer protection mandate, industry’s ability to innovate new products and consumers’ need for unhindered access to safe dietary supplements and ingredients”.