FDA New NDI Draft Guidance


Santa Ana, CA – REJIMUS, a preeminent regulatory management consulting firm to the Food & Beverage, Dietary Supplement, Animal Feed and Cosmetic industries, has submitted an official comment to the FDA on its latest New Dietary Ingredient Notification draft guidance, which provides constructive assessments as well as solutions that industry stakeholders and the Agency can employ.

“We felt it essential to provide commentary in response to the New Dietary Ingredient Notification Draft Guidance because the process of developing this guidance has effectively stalled. The reissuance in 2016 is fundamentally a little different from the effort presented in 2011 with the differences being in expansion of an effort to restrict access. A solution-oriented approach to the impasse is the result,” said Jim Lassiter, COO of REJIMUS. “It is insufficient to only identify flaws and opposition without offering a solution.”

The official commentary addresses early foundational issues of the law, as well as identifying apparent contradictions throughout, and highlights situations of known and acceptable approaches in the regulations. Meeting the needs of all parties involved, including the end consumer who deserves the opportunity to obtain safe, beneficial products based on current and emerging science while meeting the letter and intent of the Law is paramount.

“We sincerely believe that our commentary, coming from a single, independent, and deeply experienced perspective is vital. REJIMUS holds a unique position in the industry in part due to its diverse customer base and breadth of knowledge and experience that allows for both defining the challenges as found in the Draft Guidance and to serve as part of the offered solution described in our commentary,” said Lassiter.


REJIMUS is a highly specialized regulatory management consulting firm supporting companies throughout the respective supply chains of the Food & Beverage, Dietary Supplement, Animal Feed and Cosmetic industries. We support all areas of quality control, quality assurance and regulatory compliance by incorporating Best Compliance Practices, general guidance and strategic planning, Quality System Optimization and the hands-on writing/reviews and documentation to help increase profitability while mitigating legal and regulatory risks.