Patiently waiting for its official assignment, the FDA is monitoring cannabis regulation and markets preparing – while already involved in some aspects –to regulate the industry. What can be expected is a complete realignment and enhancement of the industry with improved products meeting a set standard, lawsuits and consultant hassles, and higher costs to enter the market.

The FDA is always on call when it comes to regulating products such as medical devices, tobacco, genetic testing, foods, etc. Purified extracts of marijuana with real medical claims are already being regulated as new drugs under 21 CFR 201. It can be expected that they will be distributed for retail sale in pharmacies, supermarkets, etc. pending clinical trials.

The overall schematics that will likely occur are that cannabis buds/leaves for smoking will have their own standards like tobacco [21 CFR 1140], and that backyard marijuana growing will be allowed –like beer– for personal use only. Edibles will be considered a ‘medical food’ and handled in that regard. Marijuana oil can be regulated as an OTC drug [21CFR 300] under a new monograph. The United States Pharmacopeia is already considering a USP monograph to set that standard.

The FDA is expected to–as always–impose strict lab test regulations, standards, etc. Thanks to the seed-to-sale system, the FDA’s work is made easier. They merely have to download the data from lab tests, perform audits of lab sites, and follow data back to the producer, if products do not meet uniform requirements, to shut them down or fine them. Ensuring product excellency and setting standards for over 100 years, the FDA will soon oversee cannabis markets, only time will tell when.

MAPH Enterprises, LLC | (305) 414-0128 | 1501 Venera Ave, Coral Gables, FL 33146 |
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