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Food and Drug Branch

Industrial Hemp Enrollment and Oversight (IHEO) Authorization

fdbih@cdph.ca.gov

Industrial Hemp Enrollment and Oversight (IHEO) Authorization


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 Preparing for an IHEO Inspection

Once your application and check have been processed by FDB, you will be contacted by an FDB inspector to schedule the registration and IHEO inspection. An inspection ensures that the firm is in compliance with the California Health & Safety Code. These include Good Manufacturing Practices, commodity specific regulations (if applicable), and product labeling requirements. The inspection verifies that appropriate operations are employed to ensure that regulated products are safe and suitable for human consumption and use. Inspections typically include the following areas:

  • Requirements for Good Manufacturing Practices (GMPs) and labeling.

  • Requirements specific to industrial hemp. Please have all applicable items ready for your category of products. This list is a basic guidance and is not all inclusive. The inspector will let you know if there are any additional items required for your product type for permitting purposes. 


☐ Have your IH product label ready to be checked for compliance with AB 45 labeling and advertising requirements.

☐ No untrue health-related statement(s) (HSC 110407(a))
☐ No advertisement to children, or persons who are pregnant or breastfeeding (HSC 111926(b))
☐ No advertisement in places where majority of the audience was 18-years or younger (HSC 111926(c))

☐ Have your Certificate of Analysis (COA) ready to be checked for compliance with AB 45 testing requirements.

☐ Raw hemp extract or raw hemp product THC concentration does not exceed 0.3% (HSC 111921(a)(1), 111925(a)(3), 111925.2(a))
☐ Raw hemp product does not contain contaminants that are unsafe for human or animal consumption (HSC 111925.2(c))
☐ Contaminant levels meet the requirements in B&P Code Section 26100(d)(2). (HSC 111925.4(a))
☐ IH product was tested for any hemp derivatives identified on the product label or in advertising. (HSC 111921(a)(2))
☐ IH final form product does not exceed 0.3% (HSC 111925(a)(3))

☐ IH grown in California was produced in compliance with Food and Agriculture Code (FAC) section 81000 (HSC 111921(b))

☐ IH grown outside of California was produced in compliance with USDA requirements (HSC 111921(b))

☐ IH product does not include cannabinoids produced through chemical synthesis (HSC 111920(f))    

☐ Independent lab does not have direct or indirect interest in testing entity (HSC 111920(e)(1))

☐ Independent lab does not have direct or indirect interest in an IH facility (HSC 111920(e)(2))    

☐ Independent lab does not have a license from DCC, except as a licensed testing lab (HSC 111920(e)(3))  

☐ Independent laboratory is ISO accredited or licensed pursuant to division 10 of B&P Code (HSC 111920(e)(4)(a)) and (HSC 111920(e)(4)(b))

☐ IH is not included in any product in any of the following categories:     

☐ Medical devices (HSC 111921.5(a)(1))
☐ Prescription drugs/non-prescription drugs (HSC 111921.5(a)(2))
☐ A product containing nicotine or tobacco (HSC 111921.5(a)(3))
☐ An alcoholic beverage (HSC 111921.5(a)(4))   

☐ IH comes from an approved source.

☐ IH used is from a state or country with an approved IH program. (HSC 110469(b)(1))           
☐ Cultivator or grower is in good standing and in compliance with governing laws. (HSC 110469(b)(2))    

☐ Food or beverage is prepackaged and shelf stable (HSC 111922(b))                                      

☐ IH human food and processed pet food label, barcode, website, or QC code is linked to the COA and identifies the following:

☐ Product name (HSC 111926.2(a)(1)(A))
☐ Responsible firm name, address, and telephone number (HSC 111926.2(a)(1)(B))
☐ Batch number which matches product batch number (HSC 111926.2(a)(1)(C))
☐ Cannabinoid concentration, including total THC and any marketed cannabinoid or ingredient (HSC 111926.2(a)(1)(D))
☐ Contaminant levels within product batch (HSC 111926.2(a)(1)(E))
☐ Product expiration or best by date (HSC 111926.2(a)(2))
☐ Warning statement for children and those who are pregnant and breastfeeding (HSC 111926.2(a)(3))
☐ Statement that products containing cannabinoids should be kept out of reach of children (HSC 111926.2(a)(3))
☐ FDA Safety Statement (HSC 111926.2(a)(5))  

☐ IH cosmetic product label, barcode, website, or QC code is linked to the COA and identifies the following:                           

☐ Product name (HSC 111926.3(a)(1)(A))
☐ Responsible firm name, address, and telephone number (HSC 111926.3(a)(1)(B))
☐ Batch number which matches product batch number (HSC 111926.3(a)(1)(C))
☐ Cannabinoid concentration, including total THC and any marketed cannabinoid or ingredient (HSC 111926.3(a)(1)(D))
☐ Contaminant levels within product batch (HSC 111926.3(a)(1)(E))
☐ Product expiration or best by date (HSC 111926.3(a)(2))
☐ FDA Safety Statement (HSC 111926.3(a)(3))     

☐ Manufacture of IH inhalable products are for sale in other states only                                                                   

☐ IH inhalable products are not marketed or sold to consumers under 21 years of age (HSC 111929)                   

☐ IH inhalable products do not contain any of the following prohibited ingredients:                           

☐ Flavorings other than natural terpenes (HSC 111929.2(a))
☐ Polyethylene glycol (PEG) (HSC 111929.2(b))
☐ Vitamin E acetate (HSC 111929.2(c))
☐ Medium chain triglycerides (MCT oil) (HSC 111929.2(d))
☐ Squalene or squalane (HSC 111929.2(e))
☐ Any other substance that the department finds to be a danger to public health (HSC 111929.2(f))  

If your firm is found to be in compliance, applicable certificate(s) will usually be issued within two weeks of the inspection. If deficiencies are identified during the inspection process, then issuance of the certificate(s) will be delayed until compliance is achieved.

Any inspection that results in violations or deficiencies being discovered may subject your firm to a re-inspection to verify that corrective actions have occurred.

After the issuance of the certificate(s), routine inspections will be conducted on an annual basis, or as otherwise indicated. These inspections are NOT scheduled in advance.

                                                                  


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