Minnesota Administrative Rules

9810.1003 PETITIONING THE OFFICE.

Subpart 1.

Petitions for approval.

Any person may petition the office to:

A.

approve a new medical cannabinoid product;

B.

approve the use of a cannabinoid in lower-potency hemp edibles;

C.

approve a new product category;

D.

declare a cannabinoid nonintoxicating;

E.

approve the use of a new medical delivery method for a cannabinoid product; or

F.

approve the manufacture and use of an artificially derived cannabinoid.

Subp. 2.

Petition process.

A.

To file a petition for approval with the office, an applicant must provide:

(1)

the name and a description of the cannabinoid product, product category, or delivery method;

(2)

if applicable, evidence supporting the ability of the cannabinoid product to be manufactured, packaged, labeled, and sold in compliance with this chapter;

(3)

if applicable, proposed testing protocols for the product, including:

(a)

identification of the applicable categories listed in part 9810.3100, subpart 5, item B, which are appropriate for testing;

(b)

proposed acceptance criteria for contamination levels in each identified category in part 9810.3100, subpart 5, item B; and

(c)

scientific research from peer-reviewed sources that supports the proposed testing protocols; and

(4)

if applicable, scientific research from peer-reviewed sources demonstrating that the cannabinoid product is safe for human use.

B.

Beginning January 1, 2026, the office may consider petitions for approvals that are received by the office between the first and last business day in July.

C.

No later than December 1 of the year in which the office receives the petition, the office must notify the petitioner of the office's decision regarding the petition and publish the office's decision on the office's website.

Statutory Authority:

MS s 342.02

History:

49 SR 1143

Published Electronically:

April 25, 2025