With the uptake of consumer CBD (cannabidiol) products rising at record growth rates, the need to assure consumers of product safety and transparency is of elevated importance. Sharing the knowledge and/or point of view on CBD, along with recommendations to the FDA, was the purpose of the FDA’s Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds public hearing on May 31, 2019. Based on the presentations and comments made by manufacturers, Kline, a respected provider of world-class consulting services and high-quality market intelligence, issued the following top three takeaways:
- FDA is empowered to enforce and ensure that CBD manufacturers are compliant with current good manufacturing practices (cGMP).
- FDA should ensure safe concentrations and daily intake levels of CBD and specifically THC.
- FDA guidelines in place should be used for packaging and labeling (for food, dietary supplements, and cosmetics).
“In the CBD market right now, ‘caveat emptor’ is very real. Oversight on consumer-use CBD products is required because there are many producers operating with various levels of standards. Labeling, dosing, and contents of products need to have some minimum requirements quickly in order to protect American consumers,” states Laura Mahecha, Kline’s Healthcare Industry Manager.
The Consumer Healthcare Product Association’s (CHPA) senior vice president, David Spangler, stated that medicines containing CBD should follow the regulatory status quo, while asking that the FDA provide a lawful pathway for makers of dietary supplements that contain CBD this year. Using existing New Dietary Ingredient (NDI) regulations manufacturers would need to prove safety of their CBD products. Spangler stated, “Those NDIs would still need to meet the standard of sufficient information to provide reasonable assurance the ingredient does not present a significant or unreasonable risk.”
Noramco, one of the presenting manufacturers at the hearing, cited a JAMA study that found 69% of 84 cannabidiol products to be mislabeled. This reinforces the need to make sure all manufacturers are GMP- and ideally cGMP-compliant. Noramco further recommended that the FDA work with the USP to formulate manufacturing standards for pharma grade and dietary supplement grade CBD ingredients – with testing to ensure identity, purity, quality, and strength.
Other companies also presented at the FDA hearing. CV Sciences, one of many CBD suppliers analyzed in Kline’s recently published Consumer CBD Products: U.S. Market Analysis and Opportunities report, outlined its view on the scope of regulatory needs for CBD-based dietary supplements.
To read the full article which further covers limits on THC levels as well packaging and labeling insights, visit our blog.
Kline’s Consumer CBD Products: U.S. Market Analysis and Opportunities report is a comprehensive analysis of consumer-use cannabidiol (CBD) health and beauty products, regulatory and legal status, currently available products, marketing channels, and outlook for CBD-based products.
Kline provides management consulting services to current and potential participants in the CBD and cannabis markets covering market strategy, supply chain, and go-to-market strategy (contact email@example.com).