Another Piece to the CBD Puzzle? FDA Submits Report on CBD Sampling Study to Congress
| Footnotes for this article are available at the end of this page. |
On July 8th, the Food and Drug Administration (FDA) submitted a report to the House and Senate Committees on Appropriations detailing the results of a sampling study of the current cannabidiol (CBD) marketplace.1 FDA conducted the sampling study and submitted its report to Congress pursuant to an ongoing obligation to comply with the Further Consolidated Appropriations Act of 2020 (P.L. 116-94). The purpose of the report was to update Congress on its evaluation regarding the scope of adulterated or misbranded CBD-containing products currently on the market.
The products tested were obtained as far back as 2014 and as recently as 2020. The results reported by FDA include information about products produced both before and after the passage of the Agriculture Improvement Act of 2018 (the ‘2018 Farm Bill’).2 The testing results were broken into three groups: products the Agency obtained from 2014-2018 (N = 78), products obtained in 2019 (N= 34), and products obtained in 2020 (N = 147). The tested products included articles marketed as conventional foods (‘edibles’), pet food, and dietary supplements. Formulations tested included gummies, tinctures, oils, conventional beverages, and capsules (powder).
Of the 78 products obtained from 2014 to 2018:
- 74 products were labeled for human use;
- Four products were labeled for animal use;
- 69 products (88%) were found to contain cannabinoids;
- 67 products (86%) were found to contain CBD;
- 46 products (59%) were found to contain THC; and
- Two products were referred to the Drug Enforcement Agency for containing a controlled substance.
Of the 34 products obtained in 2019, all were tested for the presence of specific elements, 31 were tested for cannabinoids and a quantitative determination of total CBD and total THC was obtained.3 Results of the testing indicated that:
- The level of elements found in any of the 34 products did not raise significant public health concerns; and
- Of the 31 products tested for cannabinoids:
- 21 products specified an amount of CBD on their label, of these only seven products (33%) contained CBD within 20% of the amount indicated on the label;
- 10 products did not specify an amount of CBD on their label, of these six contained CBD and 4 did not; and
- 15 of the products (48%) contained THC.
The samples that were obtained in 2020, tested, and described in the report are part of an ongoing, more extensive CBD sampling effort currently being undertaken by the Agency. The report stated the goal of the current sampling effort was to obtain more comprehensive information the Agency believes is required to determine how to move forward in its efforts to determine a pathway for CBD-containing products to be legally brought to market. The current sampling plan was comprised of two separate phases: a near-term phase and a long-term phase. FDA stated its intention to use the results of the near-term phase, which consisted of testing results of products obtained in 2020 and described in the report, to inform FDA of how to approach and design the long-term phase.
All of the 147 products obtained in 2020 were analyzed for certain cannabinoids and a quantitative analysis was performed for total THC and CBD.4 Also, 133 of the products were quantitatively analyzed for specific elements.5 Results of the testing indicated that:
- 138 (94%) of the 147 products tested contained CBD;
- of the 9 samples that did not contain CBD:
- 7 of the products were not labeled to contain CBD or indicated “zero CBD”;
- 2 products of the products labeled to contain CBD did not;
- 72 (49%) of the 147 products tested contained THC above the LOQ;6
- Of the 102 products labeled to contain a specific amount of CBD:
- 18 products (18%) contained less than 80% of the amount of CBD indicated on the label;
- 46 products (45%) contained CBD within 20% of the amount of CBD indicated on the label;
- 38 products (37%) contained more than 120% of the amount of CBD indicated on the label; and
- Of the 133 products analyzed for specific elements only one contained an amount that may constitute a health hazard. 7
- of the 9 samples that did not contain CBD:
As with everything that has been released by FDA related to CBD, the overarching question still remains: can this report be considered the next glimpse behind the FDA-curtain to inform dietary supplement stakeholders of FDA concerns and where it will ultimately land on further regulations pertaining to CBD-containing products? Maybe, consider these as some of the possible takeaways:
- The report portrays what could be a systematic failure by parties putting CBD-related products in to commerce. It is likely that FDA will now look for and, in turn take, further enforcement action on CBD-containing products that are misbranded or adulterated.
- A significant number of the 200 products FDA bought online were tested this year. Yet, a review of FDA Warning Letters doesn’t seem to indicate a corresponding uptick in FDA enforcing disease claims for these products. Does this mean none of the products purchased by FDA made disease claims that warranted a Warning Letter or the Agency is backing off that approach?
- In the report, FDA says it is conducting the current two-phase sampling plan in order to obtain the useful and comprehensive information it needs going forward. FDA also noted that it plans to start testing the phase-two products sometime in 2020. FDA does not say that results are expected in 2020. Does this mean we should not expect FDA to take definitive steps in the near future regarding a pathway to bring these products to market?
- Those companies introducing CBD-containing products into commerce must be diligent in understanding and having control of the supply chain of the components used to manufacture their CBD-containing products. They must insist that proper specifications are established and adhered to. Then, they must trust, but also verify that they are maintained.
Companies or individuals with legal questions regarding marketing CBD or other hemp and hemp-derived products can contact Kevin M. Bell, Robert Durkin, or Richard J. Oparil.
[2] https://www.govinfo.gov/content/pkg/PLAW-115publ334/pdf/PLAW-115publ334.pdf
[3] Products were analyzed for elements such as arsenic (As), cadmium (Cd), mercury (Hg), lead (Pb,), manganese (Mn), nickel (Ni), copper (Cu), zinc (Zn), selenium (Se), molybdenum (Mo), antimony (Sb), barium (Ba), cobalt (Co), lithium (Li), tin (Sn), and vanadium (V).
[4] These 11 cannabinoids included CBC, CBD, CBDA, cannabidivarin (CBDV), CBG, CBGA, CBN, THC, ∆8-tetrahydrocannabinol (∆8-THC), THC, THCA, tetrahydrocannabivarin (THCV).
[5] Products were analyzed for the elements As, Cd, Hg and Pb.
[6] According to the report, at least one product tested contained THC levels as high as 3.1 milligrams per serving. This is an amount of THC capable of having physical effects.
[7] FDA noted that, at the time of the report, the health hazard evaluation for the specific product is ongoing.