Required Registration of Hemp-infused Dosage Form Animal Health Products and Feed Supplements
April 29, 2022 | Montpelier, VT - The Vermont Agency of Agriculture, Food and Markets’ (VAAFM) Hemp and Feed, Seed and Fertilizer Programs want to highlight requirement of Act 41 from the 2021 legislative session. This law clarified what is considered an “feed supplement” and established requirements for registration of “dosage form animal Health” products.
What are these products? Dosage Form Animal Health products are ingestible products formulated for domestic animals that are intended to support the health or well-being of animals without providing nutritional value. Products that fit into this category are tinctures/drops or chews containing hemp CBD, or other cannabinoids marketed to support animal health. Likewise, products that contain CBD or other hemp cannabinoids that also contain nutritional ingredients, aka dog treats, must also be registered as feed products/feed supplements. A retailer does not need a special license to sell these products, but both types of products need to be registered.
When do they need to be registered? The registration period is the same for both products, April 1st through March 31st, annually. The registration fee for dosage form animal health products is $35 per product and the registration fee for feed products/feed supplements is $105 per product. A copy of product labels must be submitted with a registration application for either type of product.
How are they registered? Companies may complete the registrations process online, https://usaplants.vermont.gov/usaplants/ProductRegFSA/BrandSearch.aspx, or by using a paper application, https://agriculture.vermont.gov/public-health-agricultural-resource-management-division/animal-feeds-seed-fertilizer-lime. If using the paper application, please complete and mail along with a copy of the label and the registration fee to VAAFM, Licensing and Registration at 116 State Street, Montpelier, VT 05620-2901
What needs to be on the label? The label requirements are similar for both categories with a few key differences. All labels must include the product name, manufacturer name and contact information, the intended animal species, and for products containing hemp or CBD, a statement such as, “These statements have not been evaluated by the FDA. These products are not intended to treat, cure, or prevent any disease.”
Additional label requirements for dosage form animal health products includes:
- List of active ingredients and the amount of active ingredient per serving in descending order
- List of inactive ingredients in alphabetical order or in descending order by predominance
- Structure/function claim. (This is the purpose of the product. Be sure to avoid mentioning any disease)
- Directions for use
- New weight, net content, or count
- Any precautionary statements and/or warnings
Additional label requirements for feed product/feed supplements includes:
- Guaranteed analysis for protein, fat, and fiber
- List of ingredients in descending order by predominance
- Feeding instructions
- Net weight in avoirdupois and metric
Detailed guidelines for dosage form animal health product labels can be found here: https://agriculture.vermont.gov/sites/agriculture/files/documents/PHARM/DFAH_Products/Dosage%20Form%20Animal%20Health%20Products%20Label%20Registration%20Guidelines%20Feb%202022.pdf
The guidelines for feed product labels can be found here: https://agriculture.vermont.gov/sites/agriculture/files/documents/PHARM/Feed/Feed%20Product%20Label%20Registration%20Guidelines3.24.22.pdf
Labels that do not follow the guidelines will be rejected. Top reasons for rejection include disease claims (e.g., arthritis can’t be mentioned on the label), nutritional claims on dosage form animal health products, and missing contact information. For preapproval of labels, email a copy to firstname.lastname@example.org.
What happened if a product is not registered? If a product is offered for sale in Vermont and is not registered, the company will receive a letter of non-registration from VAAFM. After thirty days, if the product is still not registered, a cease-and-desist order will be issued, and the manufacturer may be fined for non-compliance.
Keep in mind:
- If you aren’t sure if your product is a dosage form animal health product or a feed product, email a copy of your label to email@example.com.
- Each flavor and formulation need to be registered, but different sized packages of the same flavor and formulation do not need be registered.
- All products sold online into Vermont and in retail store shelves in Vermont need to be registered.
- Products used topically do not need to be registered.
- Do not include any feed terminology on a dosage form animal health product label
Visit our website https://agriculture.vermont.gov/public-health-agricultural-resource-management-division/animal-feeds-seed-fertilizer-lime for more information about the feed and dosage form animal health program.