Earlier this week, the MED put out an industry bulletin that caught us by surprise. The industry has made some tremendous progress over the course of the last few years, and it’s disappointing to see that there are still unscrupulous industry participants that struggle with compliance and as a result, give the rest of us a bad wrap. Accordingly to MED Industry Bulletin 18-06, there are apparently businesses out there claiming that marijuana and/or marijuana products can provide relief for pregnancy related morning sickness. In today’s post, we’ll dig into the issues surrounding this behavior and the guidance the MED provides.
First, the packaging and labeling rules (specifically, M 1002-1 D 2k iii & R 1002-1 D i iii) require that a warning statement be included on labels: “There may be long term physical or mental health risks from use of marijuana including additional risks for women who are or may become pregnant or are breastfeeding. Use of marijuana may impair your ability to drive a car or operate machinery.” From our perspective, we’d consider it common sense to not provide information or guidance that would conflict with a mandatory MED warning statement.
Furthermore, the packaging and labeling rules (specifically, M 1002-1 B 5 & R 1002-1 B 5) explicitly indicate that “The label(s) on the Container and any Marketing Layer shall not make any claims regarding health or physical benefits to the consumer.” Again, this rule is extremely straightforward and is abundantly clear that absolutely no health claims should be made.
Interestingly, the MED Bulletin went so far so to expand upon these rules: “Licensees (including owners, managers, and employees of medical and retail marijuana businesses) making health or benefit claims to consumers or otherwise communicating information that is prohibited from being advertised or displayed on labels affixed to Containers of Retail and Medical Marijuana, Concentrate and Product may be viewed by the Division as an attempt to evade marketing, advertising, and/or labeling requirements, resulting in recommendation for administrative action.”
For those who thought there might be ambiguity in these regulations prior to the bulletin, it’s now extremely clear that there is no way to wiggle around these rules. Bottom line: Don’t make health or benefit claims on labels, marketing materials, in conversations with patients, or in any other fashion. Let’s hope this guidance becomes common sense!
Yours in Compliance,