- 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.)
- 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.
You must apply for and maintain an IHEO Authorization issued by CDPH to manufacture, 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,
cannery license,
pet food registration (PDF), and
cosmetic manufacturing registration. Applications and guidance documents for those programs are included at the links.
You must meet these requirements to sell in California:
-
Possess a license or registration for your specific commodity (such as Processed Food Registration).
- Obtain an IHEO Authorization for each commodity.
- Comply with California law and federal law including but not limited to California Food and Agriculture (CDFA) law; California Department of Public Health (CDPH) law, such as the
Sherman Food, Drug and Cosmetic Law; and the
2018 Farm Bill.
- Currently, inhalable industrial hemp products may not be sold in California.
Yes. Under AB 45, cosmetic manufacturers that include industrial hemp 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 delta-8, delta-9, delta-10 and any other type or cannabinoid that causes intoxication as defined by the department.
āAuthorization Fee Tier
(Gross Annual Sales)
| Extract Producer | Human Food Manufacturer | Processed Pet Food Manufacturer | Cosmetic Manufacturer |
Tier 1
(</=$100,000)
| $2,750 | $1,900 | $1,300 | $1,600 |
Tier 2
($100,001-$500,000)
| $3,500 | $2,800 | $2,000 | $2,400 |
Tier 3
($500,001-$1,500,000)
| $5,000 | $3,700 | $2,500 | $3,000 |
Tier 4
($1,500,001-$3,000,000)
| $7,000 | $4,700 | $3,000 | $3,600 |
Tier 5
($3,000,001-$5,000,000)
| $9,500 | $5,900 | $3,600 | $4,300 |
Tier 6
($5,000,001-$7,500,000)
| $13,500 | $7,100 | $4,300 | $5,200 |
Tier 7
($7,500,001-$12,500,000)
| $18,500 | $8,500 | $5,200 | $6,200 |
Tier 8
($12,500,001-$17,500,000)
| $24,000 | $9,900 | $6,200 | $7,400 |
Tier 9
($17,500,001-$25,000,000)
| $32,000 | $11,500 | $7,400 | $8,800 |
Tier 10
(> $25,000,000)
| $42,000 | $14,000 | $9,000 | $10,500 |
No. IH products must be made at a suitable, commercial location.
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.
Your application will be reviewed, and an inspection may be assigned to field staff. If there are no significant violations of applicable laws and regulations observed, a supervisor will review your file and request that an IHEO Authorization is sent to the mailing address you included on your application.
IHEO Authorizations are valid for one year from the date of issuance.
No. This is not a license to sell cannabis. The Industrial Hemp Enrollment and Oversight Authorization only regulates products derived from industrial hemp.
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.
No. An IHEO Authorization is required for manufacturers of IH products and IH extracts. Retailers, subject to the California Retail Food Code, must ensure they obtain their packaged IH products from CDPH licensed sources.
No. The law requires all IH products to be prepackaged and shelf stable. Manufacturing IH products at retail cafƩs and restaurants is not allowed.
Yes. Extraction of cannabinoids must be done under the regulatory framework established by AB 45. Cannabinoid extraction businesses must obtain an IHEO Authorization.
Yes. Each location where industrial hemp products are manufactured, packed or held must obtain an IHEO Authorization.
Food manufacturers who include industrial hemp in their product must follow all food safety laws and regulations. Some of the applicable statutes include:
-
California Health and Safety Code (HSC) Section 109875 et. Seq. (Sherman Food, Drug and Cosmetic Law).
-
HSC Section 111950 ā 112130 (California Food Sanitation Law)
- Title 21 Code of Federal Regulations (CFR),
Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food).
- Title 21 CFR,
Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements).
- Title 21 CFR,
Part 101 (Food Labeling)
- Title 21 CFR,
Part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers)
- Title 21 CFR,
Part 114 (Acidified Foods)
-
Federal Food, Drug, and Cosmetic Act (FD&C Act)
-
Fair Packaging and Labeling Act (FPLA)
Cosmetics:
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.
Existing labeling requirements applicable to specific commodities must be followed. For example, food product labels must comply with Title 21, CFR Part 101 ā Food Labeling. Required information on food labels include a statement of identity, ingredient list in descending order of predominance by weight, net quantity of product in the package, an address for the responsible party and a nutrition facts panel, when applicable.
New labeling requirements established pursuant to AB 45 for food and cosmetic products which contain industrial hemp (e.g. batch numbering, scannable QR code, cannabinoid concentration, warning statements, etc.) must be in place by January 7, 2022. Please refer to the
text of the law for a list of the new labeling requirements.
Yes. Extract manufacturers of industrial hemp both within California and outside of California must obtain an IHEO Authorization to lawfully ship their product into and out of California in compliance with AB 45. Out-of-state extract manufacturers must comply with federal law to address interstate commerce concerns pursuant to the 2018 Farm Bill.
Currently, AB 45 requires a certificate of analysis from an independent testing laboratory that confirms:
- 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.
Currently, CDPH's Food and Drug Branch (FDB) has guidance documents published on our website related to food safety, cosmetic safety, and other licensing programs. We may publish guidance documents related to the IHEO Authorization (e.g. labeling, registration steps, inspection expectations, etc.) as they are developed.
Since FDB is a regulatory agency and cannot offer consulting services for product development, you may want to contact a private consultant, trade association, or other qualified third-party for assistance with your product development and specific situation.
California only requires an out-of-state industrial hemp extract manufacturer to be licensed and obtain an IHEO Authorization. California does not license or require an IHEO Authorization for out-of-state manufacturers of final form products to be sold in California.
AB 45 requires that all IH products that are sold or distributed in California shall conform with all applicable state laws and regulations. Manufacturers must include a certificate of analysis to confirm approved THC concentration and product content and provide proof that the IH product was from an approved IH growing program.
CDPH may initiate an investigation to determine compliance with AB 45 or other law such as misbranding, adulteration, food manufacturing safety, etc. Enforcement may include:
- regulatory warnings
- public health advisories warnings
- civil penalties
- recall of IH final form products or extracts
- seizure and embargo of IH products
Also see FAQ titled, "Besides the specific requirements of AB 45, what laws apply to my IH food or cosmetic product business?"