§ 3:1483 — Product approval; consumable hemp processors; Louisiana Department of Health
§1483. Product approval; consumable hemp processors; Louisiana Department of Health A.
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§1483. Product approval; consumable hemp processors; Louisiana Department of Health
A.(1) Each consumable hemp processor shall obtain an annual consumable hemp
processor permit issued by the department. The department shall charge and collect an annual
consumable hemp processor permit fee. The fee shall be for each separate processing facility
and shall be based on the annual sales of such facility according to the following schedule:
Annual Sales Annual Fee
Under $500,000 $175.00
$500,001 - $1,000,000 $475.00
$1,000,001 - $2,500,000 $775.00
$2,500,001 - $5,000,000 $1,075.00
Over $5,000,000 $1,375.00
(2) In addition to the qualifications required in R.S. 3:1485, an applicant for a
consumable hemp processor permit shall meet any additional requirements for the physical
consumable hemp processing facility and equipment as required by rules and regulations
promulgated by the department.
(3) A consumable hemp processor shall conduct a potency test of the distillate or
concentrate used to produce a consumable hemp product.
(4) A consumable hemp processor shall conduct a test on each batch of consumable
hemp product that shall indicate all of the following:
(a) Disaggregated THC components by percentage of the total THC contained in the
product.
(b) The serving size of an individual unit of the product.
(c) The total THC milligrams per serving.
(d) The presence and concentration of any solvents, pesticides, microbials, and heavy
metals.
(5) A consumable hemp processor shall retain the records of each test for a minimum
of three years.
(6) A consumable hemp processor shall adhere to any sanitary regulations
promulgated by the department.
(7) A permitted consumable hemp processor may produce consumable hemp
products that exceed the allowable total THC per serving and package size required for
product approval in Paragraph (B)(6) of this Section if all of the following are met:
(a) The permit holder completes a sworn statement in writing attesting to both of the
following:
(i) The product will be delivered or transported beyond the borders of the state.
(ii) The product meets any statutory requirements of the receiving state or territory
for product and label approval, THC concentration, THC per serving, and serving per
package.
(b) The permit holder conducts the same tests required on distillates and concentrates
as provided for in this Subsection.
(c) The permit holder agrees to maintain a copy of the sworn statement and the
distribution records of each product delivered or transported beyond the boundaries of the
state, distinct from those delivered or transported within the state, including the batch
identification number, the name of the product, and the receiving state or territory, for a
minimum of three years.
B. Any consumable hemp product that is manufactured, distributed, imported, or
sold for use in Louisiana shall meet the following criteria:
(1) Be produced from hemp grown by a licensee authorized to grow hemp by the
United States Department of Agriculture or under an approved state plan pursuant to the
Agriculture Improvement Act of 2018, P.L. 115-334, or under an authorized state pilot
program pursuant to the Agriculture Act of 2014, P.L. 113-79.
(2) Be registered with the department in accordance with the provisions of this
Section. The department shall charge and collect a fee of not more than fifty dollars for each
separate and distinct product registered. This charge shall be in lieu of the charge collected
pursuant to R.S. 40:628.
(3) Receive product and label approval from the department.
(4) Not be marketed as dietary.
(5) Not contain any active pharmaceutical ingredient (API) recognized by the United
States Food and Drug Administration other than cannabidiol. The provisions of this
Paragraph shall not apply to products intended for topical application.
(6) Individual servings and packages of consumable hemp products shall meet the
following criteria:
(a)(i) For products other than beverages and tinctures for human consumption, each
serving shall not exceed five milligrams and shall be distinct and separate from other
servings contained in the same package. A package shall not contain more than forty
milligrams of total THC per package.
(ii) A package for products other than beverages shall be child-resistant.
(b)(i) A single serving of a consumable hemp beverage shall not exceed five
milligrams and shall not be less than twelve ounces.
(ii) Each serving shall be in an individual, tamper-evident container and distinct from
other servings contained in the same package.
(iii) A package of beverages shall not contain more than four individual containers.
(c)(i) For tinctures for human consumption, a package shall contain no more than one
ounce of an oil-based consumable hemp liquid.
(ii) A serving shall be one milliliter and shall not exceed one milligram of total THC
per serving.
(iii) Each package shall have a dispensing dropper that is capable of dispensing not
more than one serving of the oil-based consumable hemp liquid.
(iv) A tincture for human consumption shall not include any concentrated
water-soluble liquid containing consumable hemp that can be consumed directly or added
to any food or beverage.
(d) Nonedible consumable hemp products shall not be subject to the individual
serving and package requirements of this Paragraph.
(7) Repealed by Acts 2024, No. 752, §2, eff. Jan. 1, 2025.
(8) Repealed by Acts 2022, No. 498, §3, eff. June 16, 2022.
C.(1) All labels shall meet the following criteria in order to receive approval from
the department:
(a) Contain no medical claims.
(b) Have a scannable bar code, QR code, or web address linked to a document or
website that contains a certificate of analysis as provided in Subsection E of this Section.
(c) Clearly state the amount of total THC per serving.
(d) Provide a warning that consumption of products with THC may result in a failed
drug test.
(e) Accurately reflect the contents of the packaging with a variance of no greater than
fifteen percent.
(2) The department shall not approve any of the following:
(a) Any floral hemp material for retail sale.
(b) Any inhalable consumable hemp product, including but not limited to vapes.
Placement of "not for inhalation", "do not inhale", or similar language on the label,
packaging, or display area shall not prohibit a determination by the department that the
product is designed or intended for inhalation.
(c) Any alcoholic beverage regulated by the office of alcohol and tobacco control that
contains consumable hemp.
(d) Any other consumable hemp product packaged in a manner that makes the
product more appealing to children, including the name of the product or any logo or mascot
of the product that appears similar to that of a nonconsumable hemp candy or beverage
product.
(e) Any other consumable hemp product that does not comply with Subsection B of
this Section.
(3) The department shall extend existing approval of the label of products that are
prohibited by this Part through December 31, 2024, provided that no additional fee shall
apply.
(D) Repealed by Acts 2024, No. 752, §2, eff. Jan. 1, 2025.
E.(1) The application for approval and registration of a consumable hemp product
shall include a certificate of analysis certifying the following information:
(a) The batch identification number, name of the product, date received, date of
completion, and the method of analysis for each test conducted.
(b) Test results identifying:
(i) Solvents, pesticides, microbials, and heavy metals.
(ii) The cannabinoid profile by percentage of weight.
(c) A potency test of the final product indicating the serving size, total THC per
serving, total number of servings, and total THC per package, identified as milligrams per
grams.
(2) The application for registration shall include a sworn verification that the product
was produced from hemp in compliance with this Part. Acceptable forms of verification shall
be determined by the department and may include a copy of the hemp grower or processor's
license and a copy of the independent laboratory's license and certificate of accreditation.
(3) Repealed by Acts 2023, No. 752, §2, eff. Jan. 1, 2025.
F.(1) The certificate of analysis required by this Section shall be completed by an
independent laboratory accredited by the International Organization for Standardization or
other accrediting entity approved by the department. A laboratory testing consumable hemp
products shall be approved by the department. The department shall not approve a laboratory
that has a direct or indirect interest in a grower, processor, wholesaler, or retailer of hemp or
hemp products.
(2) Notwithstanding any provision of this Part to the contrary, the testing laboratory
affiliated with the University of Louisiana at Monroe shall be the preferred laboratory for
completing the certificates of analysis required by this Section once it meets all applicable
requirements of this Section and of any rules promulgated thereunder and commences
operations for such testing. Processors may utilize any other testing laboratory meeting all
applicable requirements of this Section and of any rules promulgated thereunder.
G. The department shall:
(1) Conduct an initial review of any product submitted pursuant to this Section and
notify the submitting party of any deficiencies existing which prevent the approval of the
product within sixty business days of the date of submission. If the department fails to notify
the submitting party within sixty business days of the date of submission, the product may
be sold by a wholesaler or retailer permitted pursuant to R.S. 3:1484 from the day following
the sixtieth business day until the submitting party receives final approval or denial from the
department for the product.
(2) Provide a list of registered products to the office of alcohol and tobacco control,
law enforcement, and other necessary entities as determined by the department.
(3) Provide a mechanism to allow the office of alcohol and tobacco control to scan
products to determine if the product is registered with the department.
(4) Employ a minimum of two full-time employees to review and approve products.
The positions shall be filled utilizing existing department vacancies and associated funding.
(5) Develop a process to register any consumable hemp product that is grown and
processed in the state of Louisiana as a "Louisiana Hemp Product". The department may
adopt a logo to be used for products registered pursuant to this Paragraph. No consumable
hemp product may hold itself out as being a "Louisiana Hemp Product" unless such product
has been registered by the department pursuant to this Paragraph and rules promulgated by
the department.
(6) Promulgate rules in accordance with the Administrative Procedure Act
concerning the requirements for independent laboratories that prepare certificates of analysis
in accordance with Subsection F of this Section. The rules may address aspects of testing
including but not limited to all of the following:
(a) The preference for laboratories in this state.
(b) The procedure for an on-site facility inspection.
(c) The requirements and prerequisites for third-party entities that audit independent
laboratories for compliance with ISO Standard 17025 or equivalent.
H. The provisions of this Section do not authorize any person to manufacture,
distribute, import, or sell any cannabinoid product derived from any source other than hemp.
I. Any facility processing industrial hemp products intended for human consumption
that do not meet the definition of consumable hemp product provided in this Part shall be
regulated in accordance with the State Food, Drug, and Cosmetic Law.
J. Whoever processes consumable hemp products without a license shall be subject
to imprisonment at hard labor for not less than one year nor more than twenty years and shall
be fined not more than fifty thousand dollars.
K. The provisions of this Part shall not apply to any cannabinoid product approved
by the United States Food and Drug Administration or produced in accordance with R.S.
40:1046.
L. The department shall promulgate rules and regulations in accordance with the
Administrative Procedure Act to implement the provisions of this Section. In order to
expedite implementation, the department shall utilize emergency rulemaking. The rules shall
specify standards for product labels; procedures for label approval; definitions for product
types provided for in Subsection B of this Section; limits for solvents, pesticides, microbials,
and heavy metals; requirements for accreditation for laboratories; any prohibited dosage
vehicles as determined by the department; and sanitary requirements specific to consumable
hemp processors.
Louisiana § 3:1483 (Product approval; consumable hemp processors; Louisiana Department of Health) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.