THE STATE SERIES: New York

Labeling & Testing for Medical Cannabis

It is really interesting...watching the world as we know it transform from a "Reefer Madness" mentality to one of promise and hope for cannabis.  Governor Cuomo is no stranger to this transformation.  Actually, he has undergone his own.  A few years back, Governor Cuomo considered marijuana a "gateway drug" that would cause more harm than good.  Now, he believes that it should be fully legalized and that the facts on the drug have changed.  I don't know if the transformation is politically motivated, driven by greed, or if it is a genuine change of heart, but New Yorkers will benefit from it.

In 2018, Cuomo called for the New York State Department of Health to conduct an investigation into the benefits and risks of legalizing cannabis for recreational use.  The study concluded,

"The positive effects of a regulated marijuana market in NYS outweigh the potential negative impacts. Areas that may be a cause for concern can be mitigated with regulation and proper use of public education that is tailored to address key populations. Incorporating proper metrics and indicators will ensure rigorous and ongoing evaluation."

In the meantime, here is a summary of how medical marijuana products are labeled and tested in New York State.

What is on the label?

  • Name, address, & registration # of organization
  • Product form and brand designation
  • Single dose THC & CBD content for the product set forth in “mg”
  • Lot #
  • Quantity in package
  • Date packaged
  • Expiration date
  • Storage conditions
  • A patient specific dispensing label must be affixed to the package and additionally include: dosage & administration instructions, date dispensed, and other pertinent information
  • A package safety insert must additionally include: any excipients (additional inactive ingredients in the product) used, contraindications (when the product should not be used), instructions for reporting adverse effects and other warnings
  • Warning statements

How is product quality ensured?

  • Every batch is tested for cannabinoid profile (THC, THCA, THCV, CBD, CBDA, CBDV, CBN, CBG, & CBC), microbials, mycotoxins, heavy metals, and pesticides
  • Batches are destroyed if testing fails
  • State performs periodic inspections

Strengths

  • Stability testing is required to confirm expiration dates
  • Labs must be approved by the state and DEA
  • A package insert is required in addition to the label
  • Patients have a way to report adverse effects
  • Significant oversight and control of labeling and testing

Flaws

  • Testing does not include water activity (which can lead to bacteria and/or mold growth)

 

Source: https://regs.health.ny.gov/content/part-1004-medical-use-marihuana