OAR 845-026-7060: Industrial Hemp-derived Vapor Item Labeling Pre-approval Process

(1) Prior to selling, offering for sale, or transferring an industrial hemp-derived vapor item that is for ultimate sale to a consumer, a hemp vapor item manufacturer must submit a label application to and receive approval from the Commission. The initial submission shall be made electronically if required by the Commission. The hemp vapor item manufacturer must submit a physical prototype upon request by the Commission. (2) Except as provided in sections (5) to (7) of this rule, the packaging and label applications must be accompanied by the following: (a) A fee as specified in OAR 845-025-1060; and (b) Information including but not limited to: (A) A picture of and description of the item to be placed in the package. (B) For label applications for an industrial hemp-derived vapor item that contain non-cannabis additives: (i) The non-cannabis additive’s list of ingredients from the non-cannabis additive’s manufacturer; and (ii) In a form and manner prescribed by the Commission, information regarding the manufacturer of the non-cannabis additive, the additive or additives being used by the hemp vapor item manufacturer, and attestation by the hemp vapor item manufacturer of the accuracy of the information submitted for label pre-approval. (3) If a hemp vapor item manufacturer submits a list of ingredients to the Commission in order to comply with paragraph (2)(b)(A) of this rule, and that the hemp vapor item manufacturer believes the list of ingredients is a trade secret, the hemp vapor item manufacturer must mark the information “confidential - trade secret.” (a) If the Commission receives a public records request for information submitted by a hemp vapor item manufacturer, it will review all documents submitted to determine whether the documents contain trade secrets that would be exempt from disclosure under Oregon’s Public Records Act, ORS 192.345. (b) For purposes of this rule “trade secret” has the meaning given that term in ORS 192.345. (4) The Commission will evaluate the label in order to determine whether the label: (a) Complies with the labeling rules, OAR 845-026-7000 to 845-026-7070, or any additional labeling requirements in ORS 475C, OAR 333, Division 7, or OAR 845, Division 26. (b) Contains any material that is attractive to minors; and (c) Contains untruthful or misleading content. (5) The Commission must review the labeling and notify the hemp vapor item manufacturer whether labeling is approved, and if not approved, a description of the packaging or labeling deficiencies. (6) If the label is deficient, the hemp vapor item manufacturer must correct the deficiencies and resubmit the label for pre-approval, but the hemp vapor item manufacturer is not required to submit an additional fee unless the label is found deficient for a second time in which case the application will be denied and the hemp vapor item manufacturer must resubmit the labeling in accordance with section (1) of this rule. (7) A hemp vapor item manufacturer may submit labeling for approval on the same application for a product that may have different flavors, colors or sizes, if the product is otherwise identical. Applications for approval of labeling under this section are subject to a single application fee. (8) Labels that have been previously approved do not need to be resubmitted if the only changes to the label are: (a) Changes in the: (A) Processing date; (B) Test results; (C) Net weight or volume; or (b) The deletion of any non-mandatory label information. (c) The addition, deletion or change in the: (A) UPC barcodes or 2D mobile barcodes (QR codes); (B) Website address, phone number, fax number, or place of address of the hemp vapor item manufacturer; or (d) The repositioning of any label information on the package, as long as the repositioning of label information is consistent with these rules. (9) Prior to a hemp vapor item manufacturer transferring a label approval from one hemp vapor item manufacturer to another, the hemp vapor item manufacturer requesting to transfer the label must submit a form prescribed by the Commission and pay the applicable fee as described in OAR 845-025-1060. (10) Labels for industrial hemp-derived vapor items do not require pre-approval if they are generic labels as defined in OAR 845-026-7000 and contain only the information required by these rules. (11) Notwithstanding any provisions of this rule, the Commission may permit or require electronic submission of labels for approval. (12) The Commission shall charge the following fees: (a) Labeling preapproval: $100. (b) Change to previously approved package or label: $25. (c) Transferring labeling application to another hemp vapor item manufacturer: $25 per application.