Processor and Manufacturer Frequently Asked Questions (FAQs)
āApplicationā
Licensingā
Feesāā
Testing and Reportingā
Human and Pet Food
Inhalable Products
Cosmetic Products
āApplicationā
You must apply for and maintain an IHEO Authorization issued by CDPH to manufacture, distribute, pack, or hold IH products in California.
You must also maintain and comply with laws for all other applicable registrations for your specific commodity. Other common licenses and registrations include the Processed Food Registration (PFR), Pet Food Registration,
Cosmetic Manufacturing Registration and
cannery license (linked text will direct you to the appropriate applications and guidance documents). If you believe your products fall under the Cannery Program or you are producing sealed, shelf-stable products, please see our
Cannery Program websiteā. In order to determine if your products fall under the Cannery program, you will need to submit your products to our contracted lab for testing.ā The table below provides a quick overview of what is needed for each commodity type.āāā
License/Registration by Commodity Type
Extracts (both in-state and out-of-state manufacturers)
|
PFR and IHEO |
| Human Food (dietary supplements, food, beverages) |
PFR and IHEO* |
| Processed Pet Food |
Pet Food Registration and IHEO |
| Cosmetics |
Cosmetics Manufacturing Registration and IHEO |
| Inhalables |
IHEO only |
*Note: Cannery or other specialty license/registration may also be required (such as for sparkling beverages)
You must meet these requirements to manufacture and sell in California:
It is an extract from industrial hemp not intended for consumer use and that contains a THC concentration of not more than an amount determined by the CDPH in regulation.
Yes. Manufacturers and distributors of industrial hemp extract both within California and outside of California must obtain an IHEO Authorization and a food processor registration to lawfully ship their extract into and out of California in compliance with AB 45.
No. California only requires an out-of-state industrial hemp extract manufacturers or distributors to be licensed and obtain an IHEO Authorization. Currently, California does not license or require an IHEO Authorization for out-of-state manufacturers of final form products to be sold in California. However, if you have a facility that warehouses or holds your product in California, you will need to obtain IHEO authorization.
At this time, food facilities subject to the California Retail Food Code must ensure they obtain their pre-packaged and shelf stable IH food products from AB 45 compliant sources in-state or out-of-state. For in-state IH food products, the retailer must ensure that the prepackaged and shelf-stable IH food products come from CDPH approved manufacturers with a valid IHEOā (PDF).
Your application will be reviewed and inspected for compliance with law. Upon review your file and approval, an IHEO Authorization and any applicable registration or license for the IH commodity (e.g. Processed Food Registration for IH beverage) are sent to the mailing address you included on your application.
No. At this time, industrial hemp food and cosmetic products may not be made at a facility which also manufactures cannabis products.
No. Industrial hemp cultivation is under the regulatory authority of the California Department of Food and Agriculture (CDFA). Please contact CDFA directly for information about their registration process.
āā
Licensing
No. Federal agencies who have jurisdiction over the cultivation of industrial hemp, and/or the manufacturing of food, drugs, inhalables, and cosmetics may take regulatory and enforcement action independent of your status with the California Industrial Hemp Compliance Program.
Yes. Each location where industrial hemp products are manufactured, packed or held must obtain an IHEO Authorization.
No. IH products must be made at a suitable, commercial location.āā
You may manufacture and sell industrial hemp products or raw hemp extract only after obtaining an IHEO Authorization. In order to learn the process of applying, please visit the
IHEO Process page.
The labeling requirements for industrial hemp products may be found in the California Health and Safety Code (HSC) Sections 111926 ā 111926.3. Additionally, food, processed pet food, cosmetics and inhalable industrial hemp products must follow all applicable labeling requirements for the underlying commodity (see Division 104, Part 5, Chapter 4 of the California Health and Safety Code).
Yes. CDPH will evaluate your application and determine if a pre-registration, onsite inspection is necessary to protect public health and ensure compliance with applicable statutes. The California Health and Safety Code grants the CDPH the authority to enter and inspect any establishment engaged in any covered activity, such as manufacturing, packing, or holding foods, drugs, medical devices, or cosmetics. Additionally, AB 45 specifies that CDPH may inspect financial data, sales data, and personnel data.
- Shelf-stable food (e.g. baked goods, candy, confections, dried mixes, etc.)
- Dietary supplements taken by mouth (e.g. botanicals, herbs, powders, amino acids, etc.)
- Cosmetics (e.g. lotions, balms, makeup, salves, cleansers, etc.)
- Processed pet food (e.g. food for animals NOT including livestock)
- Beverages
- Inhalables ONLY for out-of-state sales
- Raw hemp extract
IH products which require refrigeration for safety are NOT allowed. You may NOT include industrial hemp in an alcoholic beverage, a product containing nicotine or tobacco, medical devices, or prescription or nonprescription drugs.
No. This is not a license to sell cannabis. The Industrial Hemp Enrollment and Oversight Authorization only regulates products derived from industrial hemp. Please contact the California Department of Cannabis Control (DCC) directly for information about their registration process.
Health and Safety Code Section 111920(h) defines āmanufactureā or āmanufacturingā to mean compound, blend, extract, infuse, or otherwise make or prepare industrial hemp products. It further defines āmanufacturingā to include processing, preparing, holding, or storing hemp components, ingredients and industrial hemp productsāāā.
āFees
Tier 1
(</=$100,000)
|
$2,750
|
Tier 2
($100,001-$500,000) |
$3,500 |
Tier 3
($500,001-$1,500,000) |
$5,000 |
Tier 4
($1,500,001-$3,000,000) |
$7,000 |
Tier 5
($3,000,001-$5,000,000) |
$9,500 |
Tier 6
($5,000,001-$10,000,000) |
$13,500 |
Tier 7
($10,000,001-$20,000,000) |
$18,500 |
Tier 8
($20,000,001-$30,000,000) |
$24,000 |
Tier 9
($30,000,001-$50,000,000) |
$32,000 |
Tier 10
(More than $50,000,000) |
$42,000 |
Tier 1
(</=$100,000) |
$1,900 |
$1,300 |
$1,600 |
$1,700 |
Tier 2
($100,001-$500,000) |
$2,800 |
$2,000 |
$2,400 |
$2,600 |
Tier 3
($500,001-$1,500,000) |
$3,700 |
$2,500 |
$3,000 |
$3,300 |
Tier 4
($1,500,001-$3,000,000) |
$4,700 |
$3,000 |
$3,600 |
$4,000 |
Tier 5
($3,000,001-$5,000,000) |
$5,900 |
$3,600 |
$4,300 |
$4,800 |
Tier 6
($5,000,001-$7,500,000) |
$7,100 |
$4,300 |
$5,200 |
$5,700 |
Tier 7
($7,500,001-$12,500,000) |
$8,500 |
$5,200 |
$6,200 |
$6,800 |
Tier 8
($12,500,001-$17,500,000) |
$9,900 |
$6,200 |
$7,400 |
$8,100 |
Tier 9
($17,500,001-$25,000,000) |
$11,500 |
$7,400 |
$8,800 |
$9,700 |
Tier 10
(> $25,000,000) |
$14,000 |
$9,000 |
$10,500 |
$12,000 |
No. Fees must be paid in full with the application.
IHEO Authorizations are valid for one year from the date of issuance.
Testing and Reporting
IH products may contain up to 0.3% (dry weight basis) THC in the final form. There is no specific limit on how much CBD may be present in the final form of the product. However, CDPH has the authority to limit the amount of CBD in allowable products through regulation, if needed.
No. CDPH does not approve or recommend testing laboratories for industry. Firms manufacturing industrial hemp products which must be tested by an āindependent testing laboratoryā must ensure the selected laboratory aligns with the description of an āindependent testing laboratoryā given under āChapter 9. Industrial Hempā in the statute. AB 45 provides that an āindependent testing laboratoryā means one that:
- Does not have a direct or indirect interest in the entity for which testing is being done.
- Does not have a direct or indirect interest in a facility that cultivates, processes, distributes, dispenses, or sells raw hemp products.
- Does not have a license issued by the Department of Cannabis Control, except as a licensed testing laboratory.
- Is either a testing laboratory licensed pursuant to Division 10 of the Business and Professions Code, or is accredited by a third-party accrediting body as a competent testing laboratory pursuant to ISO/IEC 17025 of the International Organization of Standardization.
Currently, AB 45 requires a certificate of analysis from an independent testing laboratory that confirms the following:
- The industrial hemp raw extract, in its final form, does not exceed THC concentration of an amount determined allowable by the Department in regulation, or the mass of the industrial hemp extract used in the final form product does not exceed a THC concentration of 0.3 percent.
- The industrial hemp product was tested for any hemp derivatives identified on the product label or in associated advertising following Section 111926.2.
- The industrial hemp product was produced from industrial hemp grown in compliance with Division 24 (commencing with Section 81000) of the Food and Agricultural Code if sourced from within California, or licensed in accordance with United States Department of Agriculture (USDA) requirements if sourced from outside the state.
- The industrial hemp product was tested for contaminant levels as required by Health and Safety Code Section 111925.4(a).
Human and Pet Food
No. The law requires all IH products to be prepackaged and shelf stable. The preparation, manufacture or making of IH products at any food facility such as retail cafƩs and restaurants is not allowed.
The cGMPs for food are the foundational requirements for most businesses who manufacture, pack, or hold food in the United States. They are outlined in Title 21, Code of Federal Regulations, Part 117, subpart B and apply to IHEO Authorization participants who manufacture food products for human consumption.
Inhalable Products
Industrial hemp inhalables may be manufactured by California manufacturers. However, California-based manufacturers can only manufacture for sales outside California, as it is currently prohibited for sale in the state. To manufacture inhalables in California, you shall obtain an Industrial Hemp Enrollment and Oversight (IHEO) Authorization from CDPH annually.
Manufacturers of inhalable industrial hemp are āhemp manufacturers.ā
Inhalable industrial hemp products meet the definition of āfinal form products.ā
Unless later approved by the FDA or other controlling law, industrial hemp inhalable products cannot contain any of the following:
- Alcohol
- Nicotine
- Tobacco
- Any drug whether prescription or non-prescription (āover-the-counterā)
Note that the law also authorizes CDPH to restrict, via future regulation, any other substance that the department finds to be a danger to public health.
At this time, manufacturers of inhalable industrial hemp must follow all requirements for a āhemp manufacturer,ā such as testing requirements under applicable portions of the Sherman Food, Drug, and Cosmetic Law and restrictions on advertising or marketing to children or persons who are pregnant or breastfeeding.
Cosmetic Products
Currently, registration āāāāis voluntary for manufacturers of conventional cosmetics (cosmetics without IH).
Yes. Under AB 45, cosmetic manufacturers that include industrial hemp in their products must obtain an IHEO Authorization from the CDPH, as well as a mandatory cosmetic manufacturing registration that is referenced above.
However, cosmetic manufacturers registration is voluntary and does not require an IHEO Authorization under the following conditions:
- Cosmetics that do not contain any industrial hemp.
- Cosmetics that only contain industrial hemp that have received FDA GRAS designation for human food products.
- Cosmetics that only contain industrial hemp derivatives, substances, or compounds derived from the seed of industrial hemp.
The product cannot include tetrahydrocannabinol (THC) isolate as an added ingredient and cannot include cannabinoids produced through chemical synthesis. THC includes deltaā-8, delta-9, delta-10 and any other type or cannabinoid that causes intoxication as defined by āthe department.āāā