The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:

"Approved source" means a manufacturer of an industrial hemp extract or food containing an industrial hemp extract edible hemp product that operates (i) under inspection by the responsible food regulatory agency in the location in which such manufacturing occurs and (ii) in compliance with the laws, regulations, or criteria that pertain to the manufacturer of an industrial hemp extract or food containing an industrial hemp extract edible hemp product in the location in which such manufacturing occurs. If the location in which a manufacturer operates does not have a law, regulation, or criteria that pertains to the manufacture of an edible hemp product, then the manufacturer shall not be an "approved source."

"Batch" means a specific quantity of an industrial hemp extract edible hemp product that is uniform and is produced during a specified period of time under similar conditions and identified by a specific code that allows traceability.

"Cannabinoid" means (i) a naturally-occurring, biologically active, chemical constituent of naturally occurring bioactive phytochemical in Cannabis sativa that is or is a derivative of cannabigerolic acid (CAS RN: 25555-57-1) or (ii) any bioactive phytochemical that is both structurally and chemically similar to a derivative of cannabigerolic acid.

"CAS RN" means Chemical Abstracts Service Registry Number.

"Certificate of analysis" means a document issued by an ISO/IEC 17025 accredited laboratory that details the results of an analysis conducted by that laboratory.

"Consumer" means a person who (i) purchases an industrial hemp extract or a food containing an industrial hemp extract edible hemp product for personal use, (ii) is not functioning in the capacity of an operator of a food establishment or food processing plant, and (iii) does not offer the industrial hemp extract or food containing an industrial hemp extract edible hemp product for resale.

"Consumption" means oral ingestion.

"Contaminant" means any substance not intended to be an ingredient in a food and that is potentially harmful to the consumer.

"Department" means the Virginia Department of Agriculture and Consumer Services.

"Dietary supplement" means the same as that term is defined in 21 USC § 321.

"Edible hemp product" means any hemp product that is or includes an industrial hemp extract, as defined in § 3.2-5145.1 of the Code of Virginia, and that is intended to be consumed orally.

"Extract" means a naturally occurring phytochemical produced by the industrial hemp plant that has been removed from the inert structural material of the plant.

"Food" means any article that is intended for human consumption and introduction into commerce, whether the article is simple, mixed, or compound, and all substances or ingredients used in the preparation thereof. "Food" includes a dietary supplement. "Food" does not mean a drug as defined in § 54.1-3401 of the Code of Virginia. "Food" includes a dietary supplement.

"Food and Drink Law" means Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia.

"Industrial hemp" means any part of the plant Cannabis sativa with a concentration of tetrahydrocannabinol that is no greater than that allowed by federal law.

"Industrial hemp extract" means an extract (i) of a Cannabis sativa plant that has a concentration of tetrahydrocannabinol that is no greater than that allowed for hemp by federal law and (ii) that is intended for human consumption the same as that term is defined in § 3.2-5145.1 of the Code of Virginia.

"Manufacturer" means a person that who (i) produces a packaged food or a food intended to be used as an ingredient in a food or packages a food for retail sale and (ii) offers the food or ingredient to be used in a food for sale directly to consumers or for wholesale distribution. "Manufacturer" does not include a person that adds an industrial hemp extract to food for immediate consumption by consumers in a retail food establishment or at a farmers' market, if that person did not produce the industrial hemp extract.

"Phytochemical" means any naturally occurring chemical compound in a plant.

"Processor" means a person registered pursuant to subsection A of § 3.2-4115 of the Code of Virginia to process industrial hemp.

"Production field" means the land or area on which a grower is growing or intends to grow industrial hemp.

"Retail food establishment" means a food business regulated under and operating in compliance with the Retail Food Establishment Regulations (2VAC5-585) and Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia.

"Retail sale" means the sale of a product directly to a consumer, including electronic commerce.

"Sale," "sell," or "offering for sale" means selling, offering to sell, holding, preparing for sale, trading, bartering, offering as a gift as an inducement for sale, or advertising for sale in any media.

"Statement of identity" means the common or usual name of the food or, in the absence thereof, an appropriately descriptive term.

"Tetrahydrocannabinol" means the same as that term is defined in § 3.2-4112 of the Code of Virginia.

"Total delta-9 tetrahydrocannabinol concentration" means the post-decarboxylation delta-9 tetrahydrocannabinol concentration, which can be determined using the following equation: [delta-9 tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid]) same as that term is defined in § 3.2-4112 of the Code of Virginia. "Total tetrahydrocannabinol" is determined using the following equation, which includes the necessary conversion factor: (sum of the weights of all tetrahydrocannabinol and all other isomers of tetrahydrocannabinol) + (0.877 x the weight of tetrahydrocannabinolic acid).

"Wholesale distribution" means the sale of a product to an intermediate entity that intends to further distribute that product for retail sale.

Industrial hemp extracts and foods containing an industrial hemp extract Edible hemp products are subject to the provisions of this chapter.

A. A person that manufactures an industrial hemp extract in Virginia and introduces that industrial hemp extract into commerce shall first be inspected by the department for compliance with the requirements in 2VAC5-595-50.

B. To apply for an inspection to manufacture an industrial hemp extract or to introduce an industrial hemp extract into commerce, a person must:

1. Submit an application on a form provided by the department; and

2. Provide documentation of an unexpired Industrial Hemp Processor Registration issued pursuant to subsection A of § 3.2-4115 of the Code of Virginia.

A person who manufactures, packages, holds in storage, offers for sale, or sells an edible hemp product in Virginia must obtain a food safety permit in accordance with subsection C of § 3.2-5100 of the Code of Virginia for each location where manufacturing, packaging, holding, offering for sale, or selling occurs, unless exempt from a permit pursuant to subdivision (C)(6) of § 3.2-5130 of the Code of Virginia.

A. A manufacturer shall produce an industrial hemp extract edible hemp product in compliance with Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia the Food and Drink Law and Regulations Pertaining to Food for Human Consumption (2VAC5-600), including 21 CFR Part 117.

B. Notwithstanding subsection A of this section, a manufacturer shall produce an industrial hemp extract or food containing an industrial hemp extract edible hemp product in compliance with 21 CFR Part 111 if the industrial hemp extract or food containing an industrial hemp extract product is:

1. Produced in a tablet, capsule, powder, softgel, or gel cap form;

2. Labeled with a panel titled "Supplement Facts" the phrase "Dietary Supplement" or a similar phrase indicating the product is intended to be a dietary supplement; or

3. Labeled with a statement that describes the role of a nutrient or ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or ingredient acts to maintain such structure or function.

C. The manufacture or sale of food that contains an industrial hemp extract wholesale distribution of an edible hemp product is not eligible for the exemption from inspection or permitting requirement provided in § 3.2-5130 of the Code of Virginia.

D. A person offering for sale a food containing an industrial hemp extract shall obtain the industrial hemp extract from an approved source An edible hemp product offered for sale must be manufactured by an approved source.

E. An edible hemp product shall not have distinct components or a physical composition that varies in cannabinoid content.

F. An edible hemp product when offered for retail sale shall (a) contain a total tetrahydrocannabinol concentration of no greater than 0.3 percent and (b) contain either no more than two milligrams of total tetrahydrocannabinol per package or an amount of cannabidiol that is no less than 25 times greater than the amount of total tetrahydrocannabinol per package.

G. An edible hemp product when offered for sale shall be accompanied by a certificate of analysis that:

1. Is produced by an independent laboratory that meets the requirements in subsection D of 2VAC5-595-50;

2. States the laboratory's analysis results for all testing required in 2VAC5-595-50;

3. Is in printed or electronic format and readily accessible to consumers. If provided electronically through a QR code, the QR code must either link directly to the certificate of analysis or provide a simple method to access the certificate of analysis; and

4. Is modified in accordance with ISO/IEC 17025 standards, when modifications are necessary. Any modification to a certificate of analysis not made in accordance with ISO/IEC 17025 standards shall render the certificate of analysis invalid for the purpose of determining compliance with this chapter or the Code of Virginia.

H. The certificate of accreditation pursuant to standard ISO/IEC 17025 issued by a third-party accrediting body to the independent laboratory conducting the testing required in 2VAC5-595-50 shall be available for review at the location at which the edible hemp product is offered for sale.

A. If an industrial hemp extract is used as an ingredient in a food and that industrial hemp extract was produced by a manufacturer that is an approved source pursuant to § 3.2-5145.3 of the Code of Virginia, that food containing an industrial hemp extract is not subject to the testing requirements prescribed in this section. However, a food containing an industrial hemp extract that contains any contaminant in an amount that exceeds an acceptable criteria or tolerance established in this section is adulterated.

B. A manufacturer of an industrial hemp extract edible hemp product shall submit for laboratory analysis a sample from each batch of industrial hemp extract the manufacturer produces. Such laboratory analysis shall only be performed by a laboratory that meets the requirements prescribed in subsection E of this section edible hemp product for laboratory analysis. However, if each industrial hemp extract used as an ingredient in a batch of food (i) was manufactured by an approved source that maintains and makes available for review documentation of the laboratory analysis conducted on the industrial hemp extract and (ii) does not exceed the acceptable criteria or tolerance for any substance established in this section, the manufacturer of the batch of food that includes this industrial hemp extract is not required to submit a sample of the batch for laboratory analysis of its microbiological content, mycotoxin content, heavy metal content, residual solvent content, or pesticide chemical residue content.

C. B. A batch of edible hemp product whose sample contains any contaminant a microbiological content, mycotoxin content, heavy metal content, residual solvent content, or pesticide chemical residue content in an amount that exceeds an acceptable criteria or tolerance established in this section is adulterated and may not be offered for sale. A manufacturer of an industrial hemp extract may not offer for sale or sell any industrial hemp extract from a batch whose sample contains any contaminant in an amount that exceeds an acceptable criteria or tolerance established in this section.

D. C. A manufacturer of an industrial hemp extract may not offer for sale or sell any industrial hemp extract from a batch of edible hemp product whose sample does not contain the a cannabinoid or other phytochemical concentration claimed declared on the product label for the industrial hemp extract is misbranded and may not be offered for sale.

E. D. The laboratory analysis required in subsection B of this section shall be performed by a laboratory that:

1. Has no direct or indirect financial interest in a manufacturer of an industrial hemp extract edible hemp product or in any other entity that may benefit from the production, manufacture, sale, purchase, or use of an industrial hemp extract or product containing an industrial hemp extract edible hemp product. Additionally, no person with a direct or indirect financial interest in the laboratory shall have a direct or indirect financial interest in a manufacturer of an industrial hemp extract edible hemp product or in any other entity that may benefit from the production, manufacture, sale, purchase, or use of an industrial hemp extract or product containing an industrial hemp extract edible hemp product.

2. Employs at least one person to oversee and be responsible for the laboratory testing who has earned from a college or university accredited by a national or regional certifying authority at least (i) a master's degree in chemical or biological sciences and a minimum of two years of post-degree laboratory experience or (ii) a bachelor's degree in chemical or biological sciences and a minimum of four years of post-degree laboratory experience Is accredited pursuant to standard ISO/IEC 17025 of the International Organization for Standardization by a third-party accrediting body. The scope of the laboratory's accreditation shall include the testing required in this section.

E. A laboratory that performs the laboratory analysis required in this section shall produce a certificate of analysis that:

1. States the identification code of the batch of edible hemp product represented by the sample analyzed;

2. States the laboratory's analysis results for all testing required in this section;

3. Complies with the requirements for laboratory reports as specified in the ISO/IEC 17025 standard; and

4. If modified, is modified in compliance with the ISO/IEC 17025 standard.

F. Laboratory analysis shall determine the content of the following phytochemicals in a sample from a batch of an edible hemp product, by weight and by percentage:

1. Delta-9 tetrahydrocannabinol (CAS RN: 1972-08-03);

2. Delta-9 tetrahydrocannabinolic acid (CAS RN: 23978-85-0);

3. Delta-8 tetrahydrocannabinol (CAS RN: 5957-75-5);

4. Cannabidiol (CAS RN: 13956-29-1); and

5. Any other cannabinoid or phytochemical declared on the product label.

G. The microbiological content in one gram or one milliliter of a sample from a batch of industrial hemp extract edible hemp product shall meet the standard for the microbiological test established in 18VAC110-60-300 comply with the following limits:

1. Total aerobic microbial count: ≤10,000.

2. Absence of E. Coli.

3. Absence of Salmonella spp.

4. Total combined yeast and mold count: ≤1,000.

G. H. The mycotoxin content in a sample from a batch of industrial hemp extract edible hemp product shall meet the standard for the mycotoxin test established in 18VAC110-60-300. comply with the following limits:

H. I. The heavy metal content in a sample from a batch of industrial hemp extract edible hemp product shall meet the standard for the heavy metal test established in 18VAC110-60-300. comply with the following limits:

I. J. The residual solvent content in a sample from a batch of industrial hemp extract edible hemp product shall not exceed the following acceptable criteria: established in this subsection. If an industrial hemp extract is manufactured by a method that does not utilize solvents, laboratory analysis of the residual solvent content of the batch of this industrial hemp extract is not required. "Residual solvent" does not include a solvent that is (i) a component of the product formulation, (ii) listed as an ingredient, and (iii) generally recognized as safe for use in food.

J. Any pesticide applied to industrial hemp or during the processing of industrial hemp must be done so in accordance with the label of that pesticide and in compliance with the Virginia Pesticide Control Act (§ 3.2-3900 et seq. of the Code of Virginia) and regulations adopted thereunder. For at least three years, the manufacturer of an industrial hemp extract shall maintain pesticide application records for the industrial hemp from which it produces the industrial hemp extract.

K. The pesticide chemical residue content in a sample from a batch of industrial hemp extract an edible hemp product shall meet not exceed the most stringent acceptable standard for the a pesticide chemical residue test established in 18VAC110-60-300 any food item as set forth in subpart C of 40 CFR Part 180. Pesticide chemical residue testing shall include testing for carbamates, organochlorines, and organophosphates.

L. The total delta-9 tetrahydrocannabinol concentration of a sample from a batch of industrial hemp extract shall not exceed 0.3% an edible hemp product when offered for retail sale shall:

1. Not exceed 0.3%, and

2. Not exceed two milligrams per package unless the package contains an amount of cannabidiol that is no less than 25 times greater than the amount of total tetrahydrocannabinol.

M. If a manufacturer labels an industrial hemp extract as having any amount of a cannabinoid, a sample from a batch of the industrial hemp extract shall be tested and shall have the claimed amount of the cannabinoid. If a manufacturer labels an industrial hemp extract as having any amount of phytochemical, including a terpene or flavonoid, a sample from a batch of the industrial hemp extract shall be tested and shall have the claimed amount of the phytochemical.

N. If batch testing of industrial hemp extracts from industrial hemp grown in a specific production field consistently shows that levels of contaminants do not exceed the limits established in this chapter, the frequency of batch testing by the manufacturer may be adjusted after consultation with the department. The manufacturer shall retain documentation of the reasoning for adjustment of batch testing frequency and the recommendation of the department and make such available to the department on request.

O. The manufacturer shall maintain industrial hemp extract edible hemp product testing records for at least three five years.

A. For the purpose of this chapter, label or labeling includes the label on the packaging of an industrial hemp extract or food containing an industrial hemp extract edible hemp product as well as any brochure, advertisement, information on social media or on any website, or any other form of product marketing.

B. An industrial hemp extract or food containing an industrial hemp extract edible hemp product that contains tetrahydrocannabinol, when offered for sale, shall be contained in child-resistant packaging. The packaging shall:

1. Be specially designed or constructed to be significantly difficult for a typical child under five years of age to open and not to be significantly difficult for a typical adult to open and, if required, reseal;

2. Meet the general requirements and effectiveness specifications established in 16 CFR § 1700.15(a) and (b); and

3. For any product intended for more than a single use or that contains multiple servings, resealable.

C. An edible hemp product shall be labeled in accordance with 21 CFR Part 101, and Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia the Food and Drink Law, and this chapter.

C. D. Notwithstanding subsection B C of this section, a manufacturer shall label an industrial hemp extract or food containing an industrial hemp extract edible hemp product in compliance with the labeling provisions for dietary supplements in 21 CFR Part 101, and Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia the Food and Drink Law, and this chapter if the industrial hemp extract or food containing an industrial hemp extract edible hemp product is:

1. Produced in a tablet, capsule, powder, softgel, or gel cap form;

2. Labeled with a panel titled "Supplement Facts" the phrase "Dietary Supplement" or a similar phrase indicating the product is intended to be a dietary supplement; or

3. Labeled with a statement that describes the role of a nutrient or ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or ingredient acts to maintain such structure or function.

D. E. If a manufacturer labels an industrial hemp extract or food containing an industrial hemp extract edible hemp product as containing a specific cannabinoid or concentration thereof other phytochemical, the number of milligrams of such each cannabinoid or phytochemical must be declared on the product label. The manufacturer must make and maintain records verifying the declared amount of cannabinoid. Such records may shall include a recipes, formulation, or formulations, batch record records, and certificates of analysis.

E. F. The label of an industrial hemp extract or food containing an industrial hemp extract edible hemp product shall not contain a claim indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease, which shall render the product a drug, as that term is defined in 21 USC § 321(g)(1). An industrial hemp extract or food containing an industrial hemp extract edible hemp product with a label that contains a claim indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease is not a food and shall be considered misbranded.

F. G. A manufacturer shall identify each batch of an industrial hemp extract or a food containing an industrial hemp extract edible hemp product with a unique code for traceability. Julian date coding or any other system developed and documented by the manufacturer for assigning a unique code to a batch may be used. The batch identification shall appear and be legible on the industrial hemp extract edible hemp product label.

G. The label of an industrial hemp extract that contains tetrahydrocannabinol or a food containing an industrial hemp extract that contains tetrahydrocannabinol H. An edible hemp product must be equipped with a label that states:

1. That the industrial hemp extract or food containing an industrial hemp extract contains tetrahydrocannabinol and may not be sold to a person younger than 21 years of age The product's statement of identity;

2. All ingredients contained in the industrial hemp extract or food containing an industrial hemp extract; product listed by the common or usual name for the ingredient. The ingredients list shall include:

a. The sub-ingredients for any ingredient that consists of two or more substances; and

b. The name of the food source for each major food allergen contained in the product unless the food source is already stated in the common or usual name of the ingredient.

3. The amount of such industrial hemp extract or food containing an industrial hemp extract edible hemp product that constitutes a single serving, stated in terms of weight or volume in either metric or U.S. customary measures; and

4. If the product contains tetrahydrocannabinol:

a. The total percentage of total tetrahydrocannabinol included in the package;

b. and The milligrams of total tetrahydrocannabinol included in the industrial hemp extract or food containing an industrial hemp extract and the number of package;

c. The milligrams of total tetrahydrocannabinol that are contained in each a single serving; and

d. That the product contains tetrahydrocannabinol and may not be sold to a person younger than 21 years of age.

Application for Manufacturer of an Industrial Hemp-Derived Extract Intended for Human Consumption, VDACS-FSP-APPIH (rev. 6/2022)

Application for Manufacturer of an Industrial Hemp-Derived Extract Intended for Human Consumption, VDACS-FSP-APPIH (rev. 08/22)

Permit Application for Manufacturing/Warehouse Food Establishment, VDACS-FSP-APPMW (rev. 06/22)

Permit Application for Retail Food Establishment, VDACS-FSP-APPRE (rev. 06/23)

General Requirements for the Competence of Testing and Calibration Laboratories, ISO/IEC 17025, Third edition, 2017, International Organization for Standardization