Projected Cannabis & HEMP cGMP Market Requirements
Cannabis Compliance CBD HEMP Industry Marijuana Legislation NEWS 2020
Here are the Facts:
- The FDA through the FD&C Act[1][2] is charged with protecting human health by assuring safety, efficacy and security of products that may impact human health.
- Exclusion: If you are selling FLOWER wholesale, the USDA regulations will take precedent as it is an agricultural crop.
- Cannabis products consumed, ingested, inhaled, applied to skin may impact human health.
- Congress explicitly preserved the FDAs authority to regulate products derived from cannabis w/ <0.3% THC (per Farm Bill 2018[3][4])
- Products currently consumed (food, dietary supplements, drugs), inhaled for medical reasons (medical devices), applied to skin (cosmetics) are required to comply with GMPs[5].
Therefore, products created for human/vet consumption, ingestion, application to body containing cannabis or derived from cannabis must meet GMP requirements as per the FDA and FD&C Act.
Therefore cannabis & hemp related cGMP regulations will require that the cannabis production supply chain complies with the GMP requirements through the controlled documentation of its processes.
There have been numerous instances of the FDA enforcing its authority on cannabis/CBD manufacturers. Several instances and speeches by the FDA pertaining to this matter in 2019 are below:
- Nov 25, 2019 “FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns”
- Oct 22, 2019 “FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease”
- Oct 4, 2019 “Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses”
- Jul 23, 2019 “FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety.”
- CuraLeaf is required to respond within 15 days with a plan to address their unsubstantiated claims of CBD.
- Apr 2, 2019 “Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
- General follow up from December letter, also announcing May 31st public hearing
- The FDA formed “a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
- “Ultimately, we remain committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.“
This reinforces the critical need for cannabis businesses to recognize the importance of the FD&C Act and implement systems that are GMP compliant. Any misstep will result in enforcement action by the FDA which would invariably lead to a seized operation.
[1]https://uscode.house.gov/view.xhtml?path=/prelim@title21/chapter9&edition=prelim
[2]https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/fdas-legal-authority
[3]https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
[4]https://www.ers.usda.gov/agriculture-improvement-act-of-2018-highlights-and-implications
[5] https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/fdas-legal-authority
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