HerbalGram, the acclaimed quarterly journal of the American Botanical Council, recently published its 2021 \u201cHerb Market Report,\u201d which included data on sales of CBD<\/span> as an herbal ingredient in mainstream and natural retail channels in the United States. The combined total from both channels \u2013 $58,293,034 \u2013 does not include CBD<\/span> sales in licensed cannabis dispensaries or CBD<\/span> products, such as vapes, tinctures, gummies, and other edibles sold online. (E-commerce sales of CBD<\/span> in the U.S.<\/span> in 2021 reached $2 billion, according to Statistica.) The following excerpt analyzes CBD<\/span> marketing trends reported by the American Botanical Council, a membership organization that educates consumers, health care professionals, journalists, and others about the safe and effective use of medicinal plants. Visit this link if you are interested in becoming an ABC<\/span> member, which includes a subscription to <\/em>HerbalGram.<\/em><\/p>\n
A Top Selling Herbal Supplement<\/h2>\n
In 2021, for the fourth year in a row, CBD<\/span> was the top-selling herbal supplement ingredient in natural retail stores. CBD<\/span> first appeared on the natural channel\u2019s top 40 list in 2017, ranking 12th, after sales growth of more than 300% from the previous year. Despite its top rank in 2021, sales of this ingredient have slowed in recent years.<\/p>\n
In 2021, CBD<\/span> sales in the natural channel totaled $38,931,696, a 24% decline. This was somewhat less than the nearly 37% decline seen in 2020. Sales appear to have peaked in 2019, when natural channel consumers spent more than $90.7 million on these products. Still, even after two years of declining sales, natural channel sales of CBD<\/span> in 2021 were still significantly higher than when the ingredient first appeared on the top 40 list. Consumers spent roughly $31.3 million more on CBD<\/span> products in 2021 compared to 2017 \u2014 a 413.4% increase in annual sales.<\/p>\n
The marketing data firm SPINS<\/span> tracks sales of two separate cannabis-derived ingredients: CBD<\/span> and \u201chemp seeds and derivatives.\u201d According to the FDA<\/span>, \u201chemp\u201d is defined as Cannabis sativa with a tetrahydrocannabinol (THC<\/span>) concentration of 0.3% or less. (THC<\/span> is the primary psychoactive compound in cannabis.) Cannabis sativa with more than 0.3% THC<\/span> is considered \u201cmarijuana\u201d or \u201ccannabis.\u201d[1] SPINS<\/span>\u2019 CBD<\/span> category typically includes sales of products that contain hemp-based CBD<\/span> extracts, including CBD<\/span> oils, gummies, and capsules.<\/p>\n
Products in SPINS<\/span>\u2019 hemp seeds and derivatives category, such as hemp seed oil (also written as \u201chempseed\u201d oil), often are marketed for their nutritional content. Hemp seed oil is rich in omega-3 and omega-6 fatty acids and has high levels of provitamin A, vitamin E, and various minerals (e.g., phosphorus, potassium, and calcium).[2] The seeds of C. sativa do not naturally contain cannabinoids, but they can become contaminated with CBD<\/span> from other plant parts during processing.[3] Sales of hemp seeds and derivatives, which ranked 39th in the natural channel in 2021, also decreased from the previous year. Consumers spent $2,782,105 on these products in 2021 \u2014 a 14.1% decline from 2020.<\/p>\n
CBD<\/span> sales declined in 2021 for several possible reasons, including legal confusion, a lack of a clear path for FDA<\/span> regulation, market saturation, and published reports of inaccurate label claims for some CBD<\/span> products.<\/p>\n
FDA<\/span> Intransigence<\/h2>\n
On a federal level, CBD<\/span> is not considered a legal dietary supplement ingredient. Under section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act \u2014 in what some refer to as the \u201cdrug preclusion clause\u201d[4] \u2014 any substance that is an active ingredient in an approved drug product, or that is being publicly investigated as such, is excluded from the definition of a legal dietary supplement ingredient.[5] In June 2018, the FDA<\/span> approved Epidiolex\u00ae (GW<\/span> Pharmaceuticals; Cambridge, UK<\/span>), the first FDA<\/span>-approved pharmaceutical drug to contain a \u201cpurified drug substance [CBD<\/span>] derived from marijuana,\u201d for the treatment of seizures associated with two rare epilepsy disorders.[6] Since then, the FDA<\/span> has maintained that CBD<\/span> is an unapproved drug when sold as a dietary supplement (or in products for external use).[7]<\/p>\n
In 2021, the FDA<\/span> reaffirmed its position on CBD<\/span> in supplements. Early that year, two natural products companies, Charlotte\u2019s Web (Boulder, Colorado) and Irwin Naturals (Los Angeles, California), submitted new dietary ingredient (NDI<\/span>) notifications to the FDA<\/span> in an effort to get CBD<\/span> approved as a supplement ingredient, in accordance with Section 8 of the Dietary Supplement Health and Education Act of 1994. Despite the companies\u2019 submitting the required data demonstrating the \u201creasonable expectation of safety under the recommended conditions of use,\u201d the FDA<\/span> rejected the applications, citing the drug preclusion clause.[4]<\/p>\n