The U.S. Food and Drug Administration (FDA) has a long and complicated history with cannabidiol (CBD). Some proponents of the cannabinoid want CBD to become an FDA approved drug, regulated similarly to over-the-counter medications like Tylenol. However, the Food and Drug Administration – responsible for regulating prescription drugs and non-prescription drugs – has only just begun its drug approval process. The latest FDA CBD report to Congress, published on July 8, 2020, shows that we are in the early stages of governmental CBD approval. So what do you need to know about this report?
Section I: Introduction
The latest FDA CBD report studies the CBD marketplace. The title reads: Sampling Study of the Current Cannabidiol Marketplace to Determine the Extent that Products are Mislabeled or Adulterated. The FDA created the report after an approximately 180-day study into CBD brands and products, mandated by the Further Consolidated Appropriations Act, 2020, signed on December 20, 2019. That Act required the FDA to gather information about CBD products to determine the current safety ramifications of an unregulated marketplace. Some of the first lines state:
This report fulfills the above requirement by providing an update on the Agency’s [the FDA refers to themselves as the “Agency” throughout their report] sampling study of the current CBD marketplace and efforts to determine the extent to which products are mislabeled or adulterated.
Stephen M. Hahn, M.D., the Commissioner of Food and Drugs, signed the FDA CBD report, signaling its conclusion. Furthermore, the FDA divided the July report into five categories (excluding introduction and conclusion). Let’s take a look at the vital information from each of these five categories.
Section II: Background
The FDA’s drug approval process often requires an abundance of information-gathering. This section of their report outlines some of that process, stating that the Food and Drug Administration is aware of the public’s interest in CBD products but has many questions surrounding the characteristics of the marketplace. In fact, the FDA worries that CBD manufacturers withhold important data from consumers. Why?
Prior to the Further Consolidated Appropriations Act, 2020, which required the FDA to develop their July report, the Administration’s CBD-related studies “yielded useful information and raised concerns about the characteristics of currently marketed CBD products.” Apparently, some companies:
- Advertised false CBD content within their products, including some products that contained no CBD at all
- Sold products that contained unsafe quantities of contaminants
- Sold products that contained high concentrations of THC, the cannabinoid that induces intoxicating side effects
However, prior to this FDA CBD report, data was limited and somewhat random. In the Background section of this report, the FDA admits that more research into the CBD marketplace was needed to better understand the cannabinoid industry. In addition, the FDA outlined that the July report:
- Discusses CBD product testing conducted by the FDA before and after the 2018 Farm Bill, the Act that legalized CBD products at the federal level.
- Outlines the FDA’s plans for more comprehensive product sampling.
Comprehensive product sampling is a process compliant with the Administration’s drug approval process. In addition, all FDA approved drugs undergo near-constant sampling. It only makes sense that they would begin to treat CBD in a similar manner.
Section III: Historical (2014-2018) Testing Results
This short section covers the Food and Drug Administration’s testing results before the 2018 Farm Bill (and CBD legalization). Before the Farm Bill, the FDA only tested products of concern. These products had to meet one of four criteria:
- Made a serious disease claim (such as claiming CBD could cure a specific ailment).
- Sold in several states to reflect interstate variations (illegal for most non-prescription drugs without prior approval).
- Available for online purchase and readily available to consumers (illegal prior to the 2018 Farm Bill).
- Subject to customer complaints or adverse reports.
Because of this, the FDA limited testing to only products that, in short, broke the law. However, their results did yield some interesting results. Of the 78 CBD products tested between 2014 and 2018, 67 products (about 86 percent) actually contained CBD. Only one contained high doses of THC, and only one contained synthetic cannabinoids. The recent FDA CBD report admits that, because of this, further study into the CBD industry was needed.
Section IV: 2019 Testing Results
Through this point, the July FDA CBD report discusses only past examinations of the CBD industry. However, in section IV, we begin to see how skewed the FDA’s CBD industry data really is.
In 2019, the FDA tested 34 CBD products, but they (yet again) only tested products of concern. Here’s what they had to say:
Because the FDA’s decision to test particular products was based on particular risk factors, the Agency does not know the extent to which the body of this testing work is representative of the overall market during this time period.
This section later states: “The results obtained for these 34 products is from a limited sample size and cannot be used to draw definitive conclusions.” So if testing was limited, why did the FDA continually overshadow the legal CBD industry in 2019 and install a variety of regulations that limited the sale of CBD products?
Near-Term & Long-Term Sampling
Given the skewed testing results from past CBD product sampling, the FDA developed a plan for CBD testing during 2020 and beyond. “To obtain useful and comprehensive information going forward, [the] FDA has developed a sampling plan divided into two phases: near- and long-term. Near-term results will inform the long-term sampling plan.”
Section V: Near-Term Sampling in 2020
Instead of examining only products of concern, the FDA instead chose 500 products at random. These products had to both:
- Advertise CBD or hemp.
- Be available online.
These 500 products were then separated into seven categories. 147 products were chosen randomly from these seven categories, proportionate to the popularity of the product category: the more popular a product, the more randomly-selected products entered the final 147. Here are the CBD products that were tested:
- Tincture/oil: 82 products
- Capsule/powder: 1 product
- Gummy: 17 products
- Edible: 17 products
- Beverage: 8 products
- Pet: 22 products
The Administration omitted one unknown, unpopular category. These 147 products were examined and tested for 11 cannabinoids, most importantly, CBD and THC. What did the FDA discover about the CBD marketplace from these products?
- 102 products indicated that they contained CBD:
- 18 products contained less than 80 percent of the amount indicated.
- 46 products contained within 20 percent of the amount indicated.
- 38 products contained more than 120 percent of the amount indicated.
- Nine products didn’t contain CBD at all: seven did not advertise for CBD or clearly indicated “zero CBD” on the label and two products labeled CBD but didn’t contain any.
- 72 products contained THC at the lowest detectable amount or higher. However, this could simply indicate that these products contained the legal amount of THC allowed in CBD products (0.3 percent), so the results are inconclusive.
Section VI: Long-Term Sampling Plan
Given the results from Section V, the Food and Drug Administration developed a longer-term sampling plan for the CBD industry. With this plan, CBD products take another step in the drug approval process, getting closer to other FDA approved drugs. How does the FDA CBD report handle long-term sampling?
- The FDA will purchase data on brands, product categories, and distribution channels for CBD products.
- The FDA will develop its own comprehensive list of brands operating in the CBD marketplace using targeted internet searches and analytics.
By leveraging these two data sets, the FDA will begin to sample and test random CBD products on a continual basis. This is one of the first steps in regulating a new, non-prescription drug: understand what’s in it and what consumers are currently taking.
The FDA believes this long-term study will begin in 2020, but the Administration has yet to make an official announcement. We hope that, through this study, the FDA will learn how to better regulate the CBD industry.
What Does the July Report Mean?
For the future of the CBD industry, it’s vital that CBD become an FDA approved drug. The July FDA CBD report shows that the Food and Drug Administration is finally beginning to take the CBD industry seriously, understanding that a large portion of the U.S. population believes in the power of this cannabinoid.
Time will tell what the FDA will learn from their long-term study of the CBD marketplace. However, we know that they also need to examine CBD’s effects instead of focusing entirely on the market itself. As the FDA takes more steps in the drug approval process, we’re confident that clinical trials studying the efficacy of CBD will become more commonplace. If you want to make your own choice and try CBD for yourself, CBD Choice has everything you need! Our selection is personally vetted by our CBD experts so you don’t have to worry about what’s in your products.