The HFC Board wants to provide a comprehensive update on recent interactions with the FDA concerning our proposed feed ingredient definition for Hemp Seed Meal (HSM) as a pivotal source of protein for laying hens.
In-depth Analysis of FDA’s Feedback:
- Utility and Target Animal Safety (TAS): It brings immense satisfaction to share that after meticulous review, FDA-CVM has expressed no further reservations regarding the utility of HSM as a protein source for laying hens. This acknowledgment is not just a procedural step but a significant validation of our relentless efforts and the robustness of our research.
- Human Food Safety: FDA-CVM has not expressed concern but has requested additional information around cannabinoid analysis in the egg product. They have outlined specific guidelines for the Coalition and Eurofins Scientific, our long-standing partner in this quest, to answer these questions. These encompass detailed feeding protocols, stringent egg collection, storage, and shipment measures, and a comprehensive review of analytical methods utilized.
- Chemistry, Manufacturing, and Controls: Subsequent follow up answers to the original application have satisfied FDA-CVM’s questions. Complete descriptions around HSM chemistries, manufacturing and controls establish industry standards that create confidence with regulators as to the robustness of the industrial hemp supply chain and its potential as a feed stock.
Our Resolute Path Forward:
The FDA’s acknowledgment on the Utility and TAS of HSM is more than just a nod of approval. It’s a testament to our rigorous research, unwavering commitment, and the veracity of our claims. This validation reinforces what we’ve been championing all along, and it’s a moment of pride for all of us.
In addition to our efforts, other promising developments have been in the hemp feed sector. Sarah Stephens of Midwest Hemp Technology shared:
“Local quail aviary owners initially approached Midwest Hemp Tech about buying hemp grains for their birds early in our company’s development. They’ve been consistently reporting impressive results. Intrigued by these observations, we collaborated with Kansas State University, known for its esteemed veterinary medicine school, to scientifically validate these claims. Their analysis of the quail meat was both promising and encouraging, highlighting the vast potential of high-protein hemp grains in global food production. This data not only confirms what our farming community has always believed but also paves the way for further AAFCO approvals.”
Projected Timeline for Approval:
In our unwavering commitment to transparency and keeping our valued members informed, I’d like to share our anticipated timeline for the next crucial steps:
- Data Collection: Both the Hemp Feed Coalition and The Wenger Group are diligently working to gather the necessary samples and data. We are on track to complete this data-collection phase by the close of this year.
- Method Validation: Our great partners, Eurofins Scientific Laboratories, has been diligent in their work to answer FDA-CVM’s questions around cannabinoid quantification in eggs. They have received word from FDA-CVM that their proprietary method meets all requirements and is adequate to analyze egg samples.
- Submission to Regulatory Bodies: Armed with our findings, we plan to present our comprehensive data to AAFCO/FDA at the outset of 2023.
- Anticipated Approval: Should our data align with our steadfast belief in the safety and benefits of Hemp Seed Meal, we are optimistic about receiving approval even as early as the end of 2023 from FDA-CVM which subsequently will be up on the table at the next annual AAFCO meeting as an approved ingredient definition.
While the journey has been long and, at times, challenging, it’s essential to see the silver lining. Yes, we haven’t received the greenlight in its entirety, but we are on the cusp of achieving our goal. Though resource-intensive, the need for further studies is a challenge we are ready to embrace. Our steadfast commitment to this cause will shine through as we provide data that not only reiterates the safety of HSM but also underscores its health benefits for human consumption.
In wrapping up, we want to emphasize that our collective journey toward securing federal approval for hemp as a transformative animal feed ingredient is making significant headway. With each step, we are drawing closer to our vision, and it is your unwavering support and belief in our mission that fuels this progress.
Thank you for your continued dedication, trust, and commitment to the Hemp Feed Coalition. Rest assured; we will keep you abreast of every development as we march forward.
