Takeaways from the First FDA Cannabis Hearing (May 2019)

The SōRSE team recently attended the FDA cannabis hearing at the end of May. The hearing resulted in a recognition that the FDA needs to catch up with the present consumer demand. In order to do this, guidelines and pathways for regulation are needed. A timeline for this progress has not been provided. Below are takeaways from our team in key categories:

GENERAL TAKEAWAYS

• 120 testimonies were heard – each ranging 2-5 minutes. The majority advocated for CBD to be allowed in food and supplements. Some advocated for pharmaceutical pathway only, some advocated for a pathway for animal products and feed, and a small fraction advocated for a complete ban of all cannabis products.
• Most testimony was anecdotal. Many indicated they will submit more specific data via written comments due 7/2.
• Lack of data: The FDA maintains there is a lack of scientific data to determine safety, however commenters were split. Some viewed there is adequate credible scientific research including:
  • 2018 WHO CBD report
  • In vivo studies in Humans (between 1973-2010 there were 8 studies cited)
  • Epidiolex Safety Trials
  • A critique of Ewing et al, 2019 (liver toxicity in mice).

  However, many commenters when pressed by FDA panelists to provide specific recommendations agreed that more research and data was needed.

   

  CONSUMER DEMAND

  CONSUMER DEMAND IS STRONG FOR FOOD AND SUPPLEMENT CHANNELS.

  • 26% of American adults have tried CBD in the past two years according to the Jan 2019 Consumer Reports nationally representative survey.
  • Consumers believe CBD is effective to treat the condition for which they were taking it (top conditions: anxiety, relaxation and joint pain).
  • Consumers assume the CBD they are taking is safe.

  ECONOMIC IMPACT

  THE US IS MISSING MARKET SHARE TO OTHER COUNTRIES.

  • In North Carolina, hemp farmers get $30-60K per acre for CBD market versus $700/acre for fiber.
  • China already has 50% of global market share, but issues with low quality and harmful contaminants.
  • There are conflicting laws allowing import, but not domestic production.

  FDA CONCERNS

  AN FDA WORKING GROUP HAS BEEN CREATED TO STUDY SAFETY.

  • Labeling – accuracy & what is required on labels
  • Purity/Contaminants (microbial, toxins, solvents, pesticides, heavy metals, synthetic compounds, THC>0.3%)
  • Manufacturing Quality
  • Dosage/Daily Intake
    • “A dose is not a dose” – Ingestion vs inhalation
  • Potential for harm with Chronic Use
  • Appropriateness for General Population (>2 years old)
  • Appropriateness for Pregnant Women
  • Quantification/measures of effectiveness.