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Industrial Hemp Enrollment and Oversight Email

fdbih@cdph.ca.gov

​​

Industrial Hemp Enrollment and Oversight (IHEO)

Processor and Manufacturer Frequently Asked Questions (FAQs)

​Application​

Licensing​

Fees​​

 Testing and Reporting​

 Human and Pet Food

 Inhalable Products

 Cosmetic Products


​Application​

Which licenses and registrations do I need to manufacture, pack, or hold industrial hemp products in California?​

 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), cannery licensePet Food Registration , and Cosmetic Manufacturing Registration (linked text will direct you to the appropriate applications and guidance documents). The table below provides a quick overview of what is needed for each commodity type.

License/Registration by Commodity Type

CommodityLicense/Registration Needed
Extracts (both in-state and out-of-state manufacturers)PFR and IHEO
Human Food (dietary supplements, food, beverages)PFR and IHEO*
Processed Pet FoodPet Food Registration and IHEO
CosmeticsCosmetics Manufacturing Registration and IHEO
InhalablesIHEO only

*Note: Cannery or other specialty license/registration may also be required (such as for sparkling beverages)

What are the current requirements to manufacture and sell industrial hemp products in California?​

You must meet these requirements to manufacture and 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.

What is "raw extract" or "industrial hemp raw extract"?​

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.

I'm based outside of California and want to manufacture IH raw extracts and export them into California. Do I need to obtain an IHEO Authorization?​

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.

I'm based outside of California and want to manufacture IH products. Do I need to obtain an IHEO Authorization to sell my products in California?​​​​

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.

Do I need an IHEO Authorization to sell IH products at my retail store (e.g. grocery store, market, etc.)?​

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 IHEO. A list of manufactures with valid IHEO authorization can be found here.

Once I submit my application, what is the process for me to receive my registration?​

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. 

I'm registered with the Department of Cannabis Control (DCC) to make cannabis edibles. May I also make industrial hemp products at my facility under the authority granted in AB 45?​

No. At this time, industrial hemp food and cosmetic products may not be made at a facility which also manufactures cannabis products.

I want to grow industrial hemp plants. Will an IHEO Authorization allow me to operate a farm to grow the agricultural commodity?​

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.

​​
Licensing

If I obtain an Industrial Hemp Enrollment and Oversight (IHEO) Authorization from CDPH, will I be exempt from federal requirements regarding industrial hemp?​

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.

If I manufacture industrial hemp products at multiple processing locations, do I need an IHEO Authorization for each location in California?​

Yes. Each location where industrial hemp products are manufactured, packed or held must obtain an IHEO Authorization.

May I make IH products from my home? ​​

No. IH products must be made at a suitable, commercial location.​​

Can I start manufacturing and selling products now?​

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.

​What are the labeling requirements for IH products?​​

The labeling requirements for industrial hemp products may be found in the California Health and Safety Code (HSC) Sections 111926 – 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). 

Will my facility be inspected by CDPH?​

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.

What types of industrial hemp products may I manufacture, pack, distribute or hold in California?​

  • 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.

Will an IHEO Authorization allow me to process or sell recreational or adult-use marijuana?​

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.

What is warehousi​ng or holding IH products or extracts?​

Health and Safety Code Section 111920(h) defines “manufacture" or “manufacturing" to mean compound, blend, extract, infuse, or otherwise make or prepare industrial hemp products. It further defines “manufacturing" to include processing, preparing, holding, or storing hemp components and ingredients.

​Fees

How much does an IHEO Authorization cost?​

IHEO Authorization
Fee Tier


(Gross Annual Revenue)
 Extract
Manufacturer
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

 

IHEO Authorization
Fee Tier


(Gross Annual Revenue )
Human
Food
Manufacturer
Processed
Pet Food
Manufacturer
Cosmetic
Manufacturer
Inhalable
Product

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

 

Is there an option for a payment plan?​

No. Fees must be paid in full with the application.

How long is the IHEO Authorization valid for?​

IHEO Authorizations are valid for one year from the date of issuance.

 

Testing and Reporting

How much CBD may I add to the IH product I intend to manufacture?​

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.

Can you provide me a list of approved testing labs?​

No. CDPH does not approve or recommend testing laboratories for industry. Firms manufacturing industrial hemp products which must be tested by an "independent testing laboratory" must ensure the selected laboratory aligns with the description of an "independent testing laboratory" given under "Chapter 9. Industrial Hemp" in the statute. AB 45 provides that an "independent testing laboratory" 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.

What testing is required for IH products?​

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

I operate a café/restaurant. May I add IH extracts (e.g. CBD) to the food and beverages I advertise on my menu?​

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 cafés and restaurants is not allowed.   

What is the "current good manufacturing practice" (cGMP) for food?​

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

Who can manufacture inhalable industrial hemp products in California?

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.

At this time, how does AB 45 apply to inhalable industrial hemp manufacturers?​

Manufacturers of inhalable industrial hemp are "hemp manufacturers".

Inhalable industrial hemp products meet the definition of "final form products".

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 ("over-the-counter")

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 "hemp manufacturer," 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 ​​​​is voluntary for manufacturers of conventional cosmetics (cosmetics without IH).

Is an IHEO Authorization mandatory for cosmetic manufacturers that include industrial hemp as an ingredient in their products?​

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 chemi​cal synthesis. THC includes delta-8, delta-9, delta-10 and any other type or cannabinoid that causes intoxication as defined by ​the department.​

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