From a packaging perspective, the legalization of marijuana — or more appropriately, taking it from prescription-only use to recreational — isn’t unusually complicated. Protect the product from moisture and oxygen. What about light? I’m not sure, but I guess there are those who will know.
How many forms will it take? That’s a good question. Liquid, vape, ground, etc.
Who will regulate the packaging and labeling? Today in the U.S. it is still a DEA Schedule I drug, i.e., illegal as far as the federal government is concerned for recreational use, but most states already allow and regulate medical use. Does it then fall under Schedule II? Colorado, California, Massachusetts and six other states allow recreational use. Have we leapt past FDA’s auspices now? Recreational use does not imply any medical benefit as is typical for branded drugs that make the OTC switch at patent expiration. They still have the same medical benefit but are now available without a prescription. Marijuana for recreational use has no medical claims, so it is not an OTC drug. Therefore, it still falls under Schedule I according to DEA and federal legislation use despite some states covering its recreational use. Will there be regulated levels of intoxication, like what is done with alcohol, to limit vehicle use after taking the drug?
Let’s say we get to nationally recognized recreational use. The states are taxing it, maybe the federal government is taxing it, too. Who has control then? Does it fall under ATF (Alcohol, Tobacco and Firearms)? Better yet, what then happens to illegal dealers, who will then be termed “black market?” Today each state has its own penalties for possession and quantities that pass the threshold of use vs. selling. If we get to national acceptance, these black market dealers will be guilty of tax evasion — both on the sale of the product and failure to collect appropriate taxes and on the income itself. Ask Al Capone, the IRS has very little sense of humor about avoiding collecting and paying your share. Suddenly, the people involved in selling outside accepted channels have another enemy.
All of this requires some forethought, but in our world we are concerned about packaging. This whole segment presents some very interesting questions and challenges for packaging and packagers. For instance, if this were a drug the labeling has very clear guidelines dictated by 21CFR 208, which is prefaced by:
This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. It applies primarily to human prescription drug products used on an outpatient basis without direct supervision by a health professional. This part shall apply to new prescriptions and refill prescriptions.
So that covers prescription drugs and refills for in-home use. But recreational marijuana use may not fall into that category. In fact, I doubt it will. Will it be handled by ATF?
The Alcoholic Beverage Labeling Act (ABLA) is a U.S. federal law requiring (among other provisions) the labels of alcoholic beverages to carry a government warning, which reads:
According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects.
Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.
Should we expect similar guidance on marijuana labeling? What about the products sold in and through pharmacy? If so, federal guidelines may come in conflict with state pharmacy regulation.
There seems to be a supply of state guidance. However, maybe there cannot be any federal guidance yet because we have a product on two fences instead of one since medical and recreational will have different oversight and requirements.
We aren’t exactly sure where the next months and years will take us, but the final regulation and guidance around marijuana packaging and labeling will be interesting to watch.
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