*** Important Update: Please Read Carefully and Pass Along ***
*** Important Update: Please Read Carefully and Pass Along ***
In this update:
- Topic 1 – AAFCO Joint Open Letter of Concern Over the Allowance of Hemp in Animal Feed
- Topic 2 – NASC-sponsored CBD Safety Study in Dogs
Topic 1: AAFCO Joint Open Letter of Concern Over the Allowance of Hemp in Animal Feed
Over the years, the NASC has worked very successfully with FDA-CVM, many states, and AAFCO to help define, develop and implement responsible pathways forward for both food (nutritional) supplements as well as dosage-form products intended for non-nutritional health benefits, similar to human dietary supplements.
On February 9, 2022, this letter regarding hemp in animal feed was sent to agricultural leaders and policy makers in an effort to help them understand the approval process and AAFCO's role in helping to facilitate approval for ingredients to be included in food for animals. NASC, along with 16 other organizations, participated in helping to draft the language of this letter, and in doing so affirm that we do support the approval pathways that help to ensure the nutritional benefits and the evaluation of risk of ingredients in animal food. On February 15, 2022, this document will be made public on the AAFCO website. We wanted to give NASC members a heads-up, along with an explanation of why the NASC is involved.
Our support and this announcement specifically target the use of hemp in animal feed and does not apply to dosage-form animal health products, which are marketed for non-nutritional structure-function benefits. Hemp, hemp by-products, hemp seed oil and other similar products all have great potential for becoming recognized as important sources of protein, fiber, essential fatty acids and for other nutritional benefits. We are also helping to assist several organizations in an advisory capacity that are seeking approval for hemp as a feed ingredient, and we do support the established approval pathways available to achieve the status of hemp being approved for use in animal feed.
Again, we are sharing this information so you will be in the loop and understand our position as this letter is released and circulated. Please reach out if you have questions.
Topic 2: NASC-sponsored CBD Safety Study in Dogs
As most of you are aware, since 2015 the NASC has taken an active leadership role in cannabis and cannabis derivatives for use in dogs, cats and horses. We have previously discussed the initiative of NASC to conduct a safety study in dogs to help answer FDA-CVM questions about the safety of CBD, and more specifically help answer the liver toxicity concerns expressed by the agency.
On behalf of our members and for the good of the industry, the NASC board of directors has approved a clinical study protocol, which we jointly adopted with Nutrasource, an NASC Preferred Supplier and a leading contract research organization (CRO) for natural products as well as pharmaceuticals. (We will post the complete study protocol in the member area of the NASC website.) Key highlights of the study are:
- Study duration: 91 days. This is the timeframe discussed with FDA-CVM and the length of time they wanted the study to monitor
- Study size: the study consists of four groups of dogs, 32 dogs total:
- Control group
- Broad-spectrum CBD
- CBD/CBG combination
- CBD/CBDA combination
- CBD Concentration: 5mg/kg body weight maximum
- Expected time to complete entire project: 10 months
- Start-up - 2 months
- Ethics approval - 1 month
- Study period - 3 months
- Follow-up, query resolution - 1 month
- Draft tables, listings, figures - 1 month
- Draft clinical study report - 1 month
- Total estimated cost of study: $438,695. Yes, you read that correctly.
- This is an NASC-sponsored study. Any products used in the study will be kept confidential and no finished-product company will be highlighted. The study is for the good of the industry, benefits everyone, and supports the philosophy we have always followed as one of our guiding principles, "A rising tide floats all boats."
Note: This is ONLY a well-controlled study for the safety of the cannabinoids listed, which are the most commonly found in the industry. It is NOT a study to demonstrate efficacy. It is also NOT a study supporting the nutritional benefits of hemp, hemp cake, hemp meal, etc., however it may help answer questions from FDA-CVM about cannabinoid post-processing residuals the MAY be helpful for those seeking approval for hemp as a food/feed ingredient.
Why is this study important, and what support do we need?
This study benefits the entire industry. We have well over 100 NASC member companies selling products that contain cannabis and cannabis derivatives, including CBD. Additionally, among the member companies that do not currently have these products in their offering, a large number are considering them. It would be also logical to assume that raw material suppliers in our Preferred Supplier program will be involved; I have already had discussions with a couple of them.
HERE IS THE ASK: We ask that all NASC member companies – Primary Suppliers and Preferred Suppliers – along with retailers, other associations, and even pet owners help to financially support this study.
- We will post a list of those supporting the study on the NASC website, along with a running total amount contributed. However, we will not disclose individual contribution amounts. 100% of all funds contributed will go directly to the study.
- Will non-NASC members benefit? Yes, this study benefits the entire industry. However, we have always said that NASC members contribute to a cause greater than their own individual company's interests. (We do ask our retailer partners to keep this in mind when deciding which products to offer their customers.)
HOW TO CONTRIBUTE: Send an email directly to me (Bill Bookout | b.bookout@nasc.cc) stating the amount you wish to contribute. If you need an invoice for accounting purposes, let us know and we will send you one.
If we all pitch in to help fund the study, we all benefit from the results! Please help support this important initiative by contributing financially, and also by passing this message along to others who may be able to support our collective efforts.
I hope this information was beneficial. Please consider helping with the CBD safety study, and if you have any questions, don't hesitate to reach out. I am happy to answer your questions and provide more information.
Happy Valentine's Day!
—Bill Bookout, NASC President
