Industrial Hemp Enrollment and Oversight (IHEO) Authorization
The California Department of Public Health, Food and Drug Branch (FDB) finalized its Industrial Hemp regulations on July 5, 2022. The FDB is now accepting applications for the manufacture of in-state industrial hemp products and extracts. An industrial “hemp manufacturer” is defined in the regulations as either 1) A processor extracting cannabinoids from hemp biomass and/or 2) A processor purchasing industrial hemp raw extract for the purpose of manufacturing a final form product.
As an industrial hemp manufacturer in California, one must now obtain an “Industrial Hemp Enrollment and Oversight (IHEO) Authorization” in order to legally manufacture, pack, or hold industrial hemp products and extracts. In addition, industrial hemp manufacturers must also register with the FDB for the appropriate processed pet food, food or cosmetic product, if applicable. In addition, companies that manufacture industrial hemp inhalable products need an IHEO Authorization, but can only sell out of state, and non in California as of August 2022.
Our hemp lawyers have been specializing in cannabis and hemp laws since 2009. We have helped numerous clients obtain cannabis and hemp licenses and can help you apply for your Industrial Hemp Enrollment and Oversight Authorization. We can consult with you to explain the hemp laws, including the Sherman Food, Drug and Cosmetic Act with which hemp manufacturers must comply in order to keep their license and avoid fines and/or hemp license forfeiture.
Your industrial hemp business must also be in compliance with the California Health and Safety Code sections 111923.3 and 111923.5, among others. We review these laws with you during your hemp consultation and also review the fees required for the registration and also prepare you for the IHEO inspection process.
In addition to the Industrial Hemp Enrollment and Oversight (IHEO) Authorization, an industrial hemp manufacturer must also pass an inspection conducted by the California Department of Public Health, Food and Drug Branch prior to beginning its industrial hemp manufacturing activities. Once your IHEO application has been processed by the FDB, an FDB inspector will contact you to schedule an IHEO inspection, which is part of the IHEO registration process.
Our Cannabis Law Group attorneys can prepare your application and help you to pass your inspection by advising you of all of the legal requirements that have been put in place following the passage of Assembly Bill 45 last year. The IHEO inspection conducted by the FDB is done to verify that your company is employing the appropriate operational procedures to ensure that regulated industrial hemp products are both safe and suitable for human and pet consumption an use.
As we will explain in detail, the IHEO inspection includes Requirements for Good Manufacturing Practices (GMPs) and labeling. In addition, the inspection will ensure that your company is following the specific requirements for industrial hemp manufacturing.
Here are some helpful hints when preparing for your inspection:
- Labels: Have your Industrial Hemp product label ready to be inspected for AB 45 compliance regarding labeling and advertising.
- Don’t make any “untrue health-related statements”, for example, don’t say that your product is guaranteed to cure cancer. See Health and Safety Code Section 110407(a).
- Do not advertise to children. We advise clients not to use any marketing or advertising that could be construed to be targeting minors. See Health and Safety Code Section 111926(b).
- Raw hemp extract or raw hemp product THC concentration must not exceed 0.3% THC. “THC” is now defined to include any tetrahydrocannabinol, including, but not limited to, Delta-8- tetrahydrocannabinol, Delta-9- tetrahydrocannabinol, and Delta-10- tetrahydrocannabinol.
- “Raw Hemp Extract” means extract that is not intended for consumer use and that contains THC levels less than 0.3%. “Raw Hemp Product” means a product that is derived from industrial hemp that intended to be included in a dietary supplement, food, beverage or cosmetic. “Final Form Product” means a product that is intended for consumer use and is intended to be sold at a retail premise.
- Please note that if you are an industrial hemp cultivator, your company is not presently required to obtain the IHEO registration, unless you plan on manufacturing industrial hemp products. However, you must obtain a license to cultivate form an “established and approved industrial hemp program”, which our cannabis and hemp attorney can help you if you need.
Please call the cannabis and hemp attorneys at Cannabis Law Group to get started with your Industrial Hemp Enrollment and Oversight (IHEO) Authorization. We can help you apply today! Call: 949-375-4734.