La. Admin. Code tit. 49 § I-517

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-517 - Registration of Consumable Hemp Products

A. In accordance with the provisions of R.S. 3:1482 as promulgated by the 2021 legislature, manufacturers or distributors of consumable hemp products must register each separate and distinct product with the department-annually and initially within 90 days of the effective date of these regulations or prior to marketing the products in the state of Louisiana, whichever comes first.

B. The manufacturer of any product that is not registered within the specified timeframe will be deemed to be in violation of these rules with respect to such product(s).

C. In lieu of the annual examination and administration charge normally collected under R.S. 40:628(B), the applicant for a consumable hemp product registration must provide (both initially and on or before July 1 of each year) the department with a packet that includes:

1. a completed application form;

2. a cashier's check, money order, or electronic payment made payable to the department in the amount of $50 per each separate and distinct product;

3. specimen copies of labeling for each separate and distinct product in electronic format;

4. laboratory accreditation verification documentation;

5. laboratory certificate of analysis (COA) for each separate and distinct product;

6. attestation that the product was produced from hemp. However, the department reserves the right to request a copy of the current grower or processor's license issued by the authority of competent jurisdiction for the firm responsible for the hemp crop from which the products are derived;

7. for each separate and distinct product, photographs or renderings of the product that accurately depict the entirety of the product, including all accessories or physical items included or sold with the product, whether attached or not. The department may require the submission of a specimen of the actual product and all included accessories if it determines in its sole discretion that submitted renderings or photographs do not allow a sufficient determination that the product meets all applicable requirements of this Chapter; and

8. for each separate and distinct product, a detailed written description of how individual servings will be packaged and marketed for sale. A product whose label fails to comply with the requirements of §533 of this Chapter will not be registered. A product packaged, labeled, or marketed in a manner that physically or functionally combines individual servings, resulting in a functional or suggested product serving size that exceeds eight milligrams of total THC per serving, shall not be registered and shall be subject to revocation of registration pursuant to §518 of this Chapter.

D. If all required packet contents, as set forth in Subsection C of this Section, are submitted and a product meets the applicable requirements of this Chapter and R.S. 3:1483, the department shall register the product by entering the application information into the consumable hemp products database. In instances of an annual renewal of a product, the department may allow for the applicant to attest/certify that the required information has not changed since the last application in lieu of repeat submission.

E. No person is authorized to distribute any consumable hemp product in the state of Louisiana unless such product is currently registered and entered into the consumable hemp products database by the department, except that if a firm submits product labeling and supporting documentation for review to the department and does not receive a written response within 15 business days of that initial submission, the product may be sold after the fifteenth business day by any permitted wholesaler or retailer until the submitting party receives notice in writing from the department that the product in question is accepted or rejected for registration. Upon the expiration of the 15 business days, the department will send written notice, via electronic mail only, confirming the "pending" status of any application and, if known, a date by which a final determination will be made.

F. Any firm may apply to the department for the designation of its products as "Louisiana Hemp Products," provided that those products are produced from hemp grown in Louisiana and are processed at a Louisiana-based manufacturer. These items shall be designated with a special mark on the department's list of registered products once they have been registered with the department.

G. No consumable hemp product shall be registered if one or more of the following conditions concerning dosage vehicles apply:

1. it is explicitly or clearly intended or characterized as being for inhalation, or to facilitate same; this prohibition shall not apply to hemp rolling papers;

2. it is explicitly or clearly intended or characterized as being for subcutaneous or transdermal use, or to facilitate same; this prohibition shall not apply to transdermal patches that are not designed for or capable of piercing the skin;

3. it is explicitly or clearly intended or characterized as being for intravenous or intramuscular infusion or injection, or to facilitate same;

4. it is explicitly or clearly intended or characterized as being for rectal or vaginal insertion, including, but not limited to, vaginal or anal suppositories; this prohibition shall not apply to products that are topical personal lubricants; or

5. it includes, is contained within, or constitutes a vape cartridge, vape pen, e-cigarette or a substantially similar item designed to facilitate inhalation.

H. Notice of final denial of a requested product registration shall state the specific reason(s) for the denial and shall include notice of right to an administrative hearing concerning same, which right shall expire unless the applicant files, in the manner specified therein, a written request for an administrative hearing with the department within 20 calendar days of receipt of the notice. Any such request timely received shall be forwarded by the department to the Louisiana Division of Administrative Law. In addition to any method of service authorized by this Title, service of the notice on the applicant may be effected through any means authorized by LAC 51:I.109. Additionally, service may be made by electronic mail sent to any email address provided by the registrant to the department as part of or subsequent to the permitting or registration process, and shall be deemed effective even if returned as undeliverable.

La. Admin. Code tit. 49, § I-517

Promulgated by the Department of Health, Office of Public Health, LR 46359 (3/1/2020), Amended LR 47479 (4/1/2021), Amended LR 481290 (5/1/2022), Amended LR 482982 (12/1/2022), Amended LR 49(EMERGENCY), Amended LR 491940 (11/1/2023).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:4(A)(13), R.S. 3:1483(L) and R.S. 40:604.