10 CRR-NY 1004.16NY-CRR
10 CRR-NY 1004.16
10 CRR-NY 1004.16
1004.16 Medical marihuana marketing and advertising by registered organizations.
(a) All physical structures owned, leased or otherwise utilized by a registered organization, including any dispensing facility, shall:
(1) not advertise medical marihuana brand names or utilize graphics related to marihuana or paraphernalia on the exterior of the physical structures; and
(2) not display medical marihuana products and paraphernalia so as to be clearly visible from the exterior of a physical structure.
(b) All restrictions listed in subdivision (a) of this section shall apply to any item located on any real property on which a registered organization’s physical structures is located.
(c) All restrictions listed in subdivision (a) of this section shall apply to all vehicles owned, leased or utilized by a registered organization.
(d) All advertisements, regardless of form, for approved medical marihuana products that make a statement relating to effectiveness, side effects, consequences or contraindications shall present a true and accurate statement of such information.
(e) An advertisement does not satisfy the requirement that it presents a “true and accurate statement” of information relating to effectiveness, side effects, consequences, and contraindications if it fails to present a fair balance between information relating to effectiveness, side effects, consequences, and contraindications in that the information relating to effectiveness is presented in greater scope, depth, or detail than is the information relating to side effects, consequences and contraindications, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.
(f) An advertisement is false, lacking in fair balance, or otherwise misleading if it:
(1) contains a representation or suggestion that one marihuana brand or form is better, more effective, useful in a broader range of conditions or patients or safer than other drugs or treatments including other marihuana brands or forms, unless such a claim has been demonstrated by substantial scientific or clinical experience;
(2) contains favorable information or opinions about a marihuana product previously regarded as valid but which have been rendered invalid by contrary and more credible recent information;
(3) uses a quote or paraphrase out of context or without citing conflicting information from the same source, to convey a false or misleading idea;
(4) uses a study on persons without a debilitating medical condition without disclosing that the subjects were not suffering from a debilitating medical condition;
(5) uses data favorable to a marihuana product derived from patients treated with a different product or dosages different from those recommended in New York State;
(6) contains favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions; or
(7) fails to provide adequate emphasis for the fact that two or more facing pages are part of the same advertisement when only one page contains information relating to side effects, consequences and contraindications.
(g) False or misleading information in any part of the advertisement shall not be corrected by the inclusion of a true statement in another distinct part of the advertisement.
(h) An advertisement for any approved medical marihuana product shall not contain:
(1) any statement that is false or misleading;
(2) any statement that falsely disparages a competitor’s products;
(3) any statement, design, or representation, picture or illustration that is obscene or indecent;
(4) any statement, design, representation, picture or illustration that encourages or represents the use of marihuana for a condition other than a serious condition as defined in subdivision 7 of section 3360 of the Public Health Law;
(5) any statement, design, representation, picture or illustration that encourages or represents the recreational use of marihuana;
(6) any statement, design, representation, picture or illustration related to the safety or efficacy of marihuana, unless supported by substantial evidence or substantial clinical data;
(7) any statement, design, representation, picture or illustration portraying anyone under the age of 18, objects suggestive of the presence of anyone under the age of 18, or containing the use of a figure, symbol or language that is customarily associated with anyone under the age of 18;
(8) any offer of a prize, award or inducement to a certified patient, designated caregiver or practitioner related to the purchase of marihuana or a certification for the use of marihuana; or
(9) any statement that indicates or implies that the product or entity in the advertisement has been approved or endorsed by the commissioner, department, New York State or any person or entity associated with New York State provided that this shall not preclude a factual statement that an entity is a registered organization.
(i) Any advertisement for an approved medical marihuana product, which makes any claims or statements regarding efficacy, shall be submitted to the department at least 10 business days prior to the public dissemination of the advertisement.
(j) The submitter of the advertisement shall provide the following information to the department in addition to the advertisement itself:
(1) a cover letter that:
(i) provides the following subject line: Medical marihuana advertisement review package for a proposed advertisement;
(ii) provides a brief description of the format and expected distribution of the proposed advertisement; and
(iii) provides the submitter’s name, title, address, telephone number, fax number, and email address;
(2) an annotated summary of the proposed advertisement showing every claim being made in the advertisement and which references support for each claim;
(3) verification that a person identified in an advertisement as an actual patient or health care practitioner is an actual patient or health care practitioner and not a model or actor;
(4) verification that a spokesperson who is represented as an actual patient is indeed an actual patient;
(5) verification that an official translation of a foreign language advertisement is accurate;
(6) annotated references to support disease or epidemiology information, cross-referenced to the advertisement summary; and
(7) a final copy of the advertisement, including a video where applicable, in a format acceptable to the department.
(k) Advertising packages that are missing any of the elements in subdivision (j) of this section, or that fail to follow the specific instructions for submissions, shall be considered incomplete. If the department receives an incomplete package, it shall so notify the submitter.
(l) No advertisement may be disseminated if the submitter of the advertisement has received information that has not been widely publicized in medical literature that the use of any approved medical marihuana product may cause fatalities or serious damage to a patient.
(m) A registered organization, its officers, managers and employees shall not cooperate, directly or indirectly, in any advertising if such advertising has the purpose or effect of steering or influencing patient or caregiver choice with regard to the selection of a practitioner. Nothing contained within this section prevents a registered organization from educating practitioners about approved medical marihuana products offered by the registered organization.
(n) The department may:
(1) require a specific disclosure be made in the advertisement in a clear and conspicuous manner if the department determines that the advertisement would be false or misleading without such a disclosure; or
(2) require that changes be made to the advertisement that are:
(i) necessary to protect the public health, safety and welfare; or
(ii) consistent with dispensing information for the product under review.
10 CRR-NY 1004.16
Current through March 15, 2020
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