Minnesota Administrative Rules

9810.1101 PRODUCT RECALL.

Subpart 1.

Factors for recall.

The office must require a license holder to recall any regulated product if the office has evidence that the regulated product:

A.

contains a contaminant level exceeding the acceptance criteria established by the office for foreign material, heavy metals, microbiological contaminants, mycotoxins, pesticide residues, or residual solvents;

B.

contains an undeclared allergen, as defined in the Minnesota Food Law, Minnesota Statutes, chapter 31;

C.

is otherwise unfit for human use, consumption, or application;

D.

was not cultivated or manufactured by a licensed cannabis or hemp business as required by Minnesota Statutes, chapter 342;

E.

has packaging that fails to disclose a known allergen contained in the product;

F.

has packaging that does not comply with the labeling requirements in Minnesota Statutes, section 342.63; or

G.

otherwise poses a risk to public health or safety.

Subp. 2.

Mandatory recall process.

Upon the office's request, a license holder must perform a traceback and trace-forward investigation to identify all affected businesses, markets, and consumers and must respond to all information requests made by the office related to the recall within 24 hours of the office's request. The office may take control of a product recall process at any time.

A.

If the office determines that a recall is necessary under subpart 1, the office must:

(1)

issue the license holder a notice of recall with the specific product subject to the recall and the basis for the recall under subpart 1; and

(2)

post the notice of recall on the office's website.

B.

If the office requires that a license holder recall a regulated product, the business must, within one day of receiving notice from the office:

(1)

notify any other business impacted by the recall;

(2)

notify all individuals who may have purchased the recalled product and reimburse individuals for any returned product; and

(3)

ensure that all products subject to the recall are destroyed in accordance with this chapter and record the destruction in the cannabis business's seed-to-sale tracking system.

C.

A license holder must notify the office of the license holder's compliance with item B, subitems (1) to (3), within three days of receiving the notice of recall.

Subp. 3.

Voluntary recall process.

A license holder may initiate a product recall when the license holder has information that a regulated product is mislabeled, defective, or unsafe for consumption. A license holder initiating a recall must:

A.

provide notice of the recall to the office, including a description of the recalled product and the basis for the recall. Upon receipt, the office must post the notice on the office's website with information that the license holder initiated the product recall; and

B.

comply with subpart 2, item B.

Statutory Authority:

MS s 342.02

History:

49 SR 1143

Published Electronically:

April 25, 2025