Chapter 595. Regulations Governing the Manufacturing and Sale of Products That Contain Industrial Hemp Extracts Intended for Human Consumption
2VAC5-595-10. Definitions.
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 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 in the location in which such manufacturing occurs.
"Batch" means a specific quantity of an industrial hemp extract 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 a naturally-occurring, biologically active, chemical constituent of Cannabis sativa .
"Consumer" means a person who (i) purchases an industrial hemp extract or a food containing an industrial hemp extract 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 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.
"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" does not mean a drug as defined in § 54.1-3401 of the Code of Virginia. "Food" includes a dietary supplement.
"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.
"Manufacturer" means a person that (i) produces a packaged food or a food intended to be used as an ingredient in a food and (ii) offers the 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.
"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]).
"Wholesale distribution" means the sale of a product to an intermediate entity that intends to further distribute that product for retail sale.
Statutory Authority
§ 3.2-5145.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 38, Issue 26, eff. August 15, 2022.
2VAC5-595-20. Regulated articles.
Industrial hemp extracts and foods containing an industrial hemp extract are subject to the provisions of this chapter.
Statutory Authority
§ 3.2-5145.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 38, Issue 26, eff. August 15, 2022.
2VAC5-595-30. Inspection required.
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.
Statutory Authority
§ 3.2-5145.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 38, Issue 26, eff. August 15, 2022.
2VAC5-595-40. General requirements.
A. A manufacturer shall produce an industrial hemp extract in compliance with Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia 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 in compliance with 21 CFR Part 111 if the industrial hemp extract or food containing an industrial hemp extract is:
1. Produced in a tablet, capsule, powder, softgel, or gel cap form;
2. Labeled with a panel titled "Supplement Facts"; 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 is not eligible for the exemption from inspection 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.
Statutory Authority
§ 3.2-5145.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 38, Issue 26, eff. August 15, 2022.
2VAC5-595-50. Laboratory testing required for contaminants and phytochemicals of an industrial hemp extract or a food containing an industrial hemp extract.
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 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.
C. A batch whose sample contains any contaminant in an amount that exceeds an acceptable criteria or tolerance established in this section is adulterated. 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. A manufacturer of an industrial hemp extract may not offer for sale or sell any industrial hemp extract from a batch whose sample does not contain the cannabinoid or phytochemical concentration claimed on the label for the industrial hemp extract.
E. 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 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. 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 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.
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.
F. The microbiological content in a sample from a batch of industrial hemp extract shall meet the standard for the microbiological test established in 18VAC110-60-300.
G. The mycotoxin content in a sample from a batch of industrial hemp extract shall meet the standard for the mycotoxin test established in 18VAC110-60-300.
H. The heavy metal content in a sample from a batch of industrial hemp extract shall meet the standard for the heavy metal test established in 18VAC110-60-300.
I. The residual solvent content in a sample from a batch of industrial hemp extract shall not exceed the following acceptable criteria:
Residual solvent | Acceptable criteria |
1,2-Dichloroethene | 5 ppm |
1,1-Dichloroethene | 8 ppm |
Acetone | 5,000 ppm |
Acetonitrile | 410 ppm |
Benzene | 2 ppm |
Butane | 2,000 ppm |
Chloroform | 60 ppm |
Ethanol | 5,000 ppm |
Ethyl Acetate | 5,000 ppm |
Ethyl Ether | 5,000 ppm |
Ethylene Oxide | 5 ppm |
Heptane | 5,000 ppm |
Hexane | 290 ppm |
Isopropyl Alcohol | 500 ppm |
Methanol | 3,000 ppm |
Methylene Chloride | 600 ppm |
Pentane | 5,000 ppm |
Propane | 2,100 ppm |
Toluene | 890 ppm |
Trichloroethylene (1,1,2-Trichloroethene) | 80 ppm |
Xylenes, Total (ortho-, meta-, para-) | 2,170 ppm |
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 shall meet the standard for the pesticide chemical residue test established in 18VAC110-60-300. 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%.
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 testing records for at least three years.
Statutory Authority
§ 3.2-5145.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 38, Issue 26, eff. August 15, 2022.
2VAC5-595-60. Labeling of industrial hemp extracts and foods containing an industrial hemp extract.
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 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 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.
C. Notwithstanding subsection B of this section, a manufacturer shall label an industrial hemp extract or food containing an industrial hemp extract 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 if the industrial hemp extract or food containing an industrial hemp extract is:
1. Produced in a tablet, capsule, powder, softgel, or gel cap form;
2. Labeled with a panel titled "Supplement Facts"; 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. If a manufacturer labels an industrial hemp extract or food containing an industrial hemp extract as containing a specific cannabinoid or concentration thereof, the number of milligrams of such cannabinoid must be declared on the product label. The manufacturer must make and maintain records verifying the declared amount of cannabinoid. Such records may include a recipes, formulation, or batch record.
E. The label of an industrial hemp extract or food containing an industrial hemp extract 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 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. A manufacturer shall identify each batch of an industrial hemp extract or a food containing an industrial hemp extract 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 label.
G. The label of an industrial hemp extract that contains tetrahydrocannabinol or a food containing an industrial hemp extract that contains tetrahydrocannabinol 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;
2. All ingredients contained in the industrial hemp extract or food containing an industrial hemp extract;
3. The amount of such industrial hemp extract or food containing an industrial hemp extract that constitutes a single serving; and
4. The total percentage and milligrams of tetrahydrocannabinol included in the industrial hemp extract or food containing an industrial hemp extract and the number of milligrams of tetrahydrocannabinol that are contained in each serving.
Statutory Authority
§ 3.2-5145.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 38, Issue 26, eff. August 15, 2022.
Forms (2VAC5-595)