§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) A consumable hemp processor shall adhere to any sanitary regulations promulgated by the department.

            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 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)(a) For consumable hemp products, a product shall not exceed a total delta-9 THC concentration of more than 0.3 percent or a total THC concentration of more than one percent. The total THC in a product shall not exceed eight milligrams per serving. The provisions of this Subparagraph shall not apply to floral hemp material.

            (b) For floral hemp material, a product shall not exceed a total delta-9 THC concentration of more than 0.3 percent on a dry weight basis or a total THC concentration of more than one percent on a dry weight basis.

            (c) Any consumable hemp product that exceeds the THC limits provided in this Paragraph that was registered with the department prior to June 16, 2022, may be sold in Louisiana until January 1, 2023.

            (7) A serving shall be clearly identified by one of the following means:

            (a) The package contains a measuring device that measures single servings of the product.

            (b) The packaging clearly enables a consumer to determine when a single serving has been consumed.

            (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 THC per serving, serving size, and servings per package.

            (2) Any adult-use consumable hemp product shall be identified as such on the label.

            (3) Any label that does not meet the criteria provided in this Subsection that was approved by the department prior to June 16, 2022, may be used in Louisiana until July 1, 2023.

            D. In addition to the requirements provided in Subsections B and C of this Section, floral hemp material shall:

            (1) Be contained in tamper-evident packaging. A package shall be deemed tamper-evident if it clearly indicates prior access to the container.

            (2) Not be labeled or marketed for inhalation.

            E.(1) The application for registration shall include a certificate of analysis containing the following information:

            (a) The batch identification number, 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 verification that the product was produced from hemp. Acceptable forms of verification shall be determined by the department and may include a copy of the hemp grower or processor's license.

            (3) Any application for registration that does not meet the criteria provided in this Subsection that was approved by the department prior to June 16, 2022, may be used in Louisiana until July 1, 2023.

            F. The certificate of analysis required by Subsection E of this Section shall be completed by an independent laboratory that meets the following criteria:

            (1)(a) If the laboratory is located outside of Louisiana, it is accredited by the International Organization for Standardization or other accrediting entity approved by the department.

            (b) If the laboratory is located in Louisiana, it shall:

            (i) Pass an on-site facility inspection conducted by the department.

            (ii) Provide documentation that the owner has operated a state-approved, active medical marijuana or hemp laboratory in another state for at least the past twelve months.

            (iii) Be accredited by the International Organization for Standardization or other accrediting entity approved by the department or have an application pending for International Organization for Standardization accreditation. If the accreditation is not achieved within nine months of the department's inspection, the department shall not accept any additional certificates of analysis from the laboratory until such accreditation is received.

            (2) Has no direct or indirect interest in a grower, processor, or distributor of hemp or hemp products.

            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 fifteen business days of the date of submission. If the department fails to notify the submitting party within fifteen 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 fifteenth 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.

            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.

            Acts 2019, No. 164, §1, eff. June 6, 2019; Acts 2020, No. 344, §1; Acts 2021, No. 336, §1; Acts 2022, No. 498, §§1, 3, eff. June 16, 2022.