Product approval; consumable hemp processors; Louisiana Department of Health

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RS 1483 - Product approval; consumable hemp processors; Louisiana Department of Health

A.(1) Each consumable hemp processor shall obtain an annual consumable hemp processor license issued by the department. The department shall charge and collect an annual consumable hemp processor license 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:

(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) Not contain a total delta-9 THC concentration of more than 0.3 percent on a dry weight basis.

(7) Not contain a total THC concentration of more than one percent on a dry weight basis.

(8) Not contain any cannabinoid that is not naturally occuring.

C. All labels shall meet the following criteria in order to receive approval from the department:

(1) Contain no medical claims.

(2) 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.

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

(1) The batch identification number, date received, date of completion, and the method of analysis for each test conducted.

(2) Test results identifying the cannabinoid profile by percentage of weight, solvents, pesticides, microbials, and heavy metals.

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) Is accredited as a testing laboratory approved by the department.

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

G. The department shall 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.

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. The rules shall specify standards for product labels, procedures for label approval, 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.


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