When shopping for a hemp product, you may have realized the packaging bares the words “serving size” rather than “dosage”. While this seems like such a small choice to make, it actually is an important indicator of a brand’s compliance when it comes to laws and regulations. It also is a good indication of the transparency the brand offers to the consumer. But why does a small thing like this mean so much? The devil is in the details.
According to Collins Dictionary, the word dosage is defined as “the amount of a medicine or drug that someone takes or should take.” On the other hand, serving size is defined as “The recommended portion of food to be eaten.”
These two terms may seem similar but can be the fine line between compliant and non-compliant in the hemp industry. According to the Federal Drug Administration, “Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than food) that is intended to affect the structure or function of the body of humans or animals, is a drug. New human and animal drugs must be approved by the FDA or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review, before they can be legally marketed as drugs.”
In December 2020, the FDA published a press release announcing the issuance of five warning letters to hemp brands that used improper marketing tactics, such as using terms like “dose”, “treats”, and “cures”. While these were not the first letters sent to brands violating FDA regulation, these five were highlighted as part of the FDA’s dedication to cracking down on such offenders.
According to the press release, “The products that are the subject of the letters issued today have not gone through the FDA drug approval process and therefore are considered unapproved new drugs. It is not known whether they are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.”
The term dosage has a strong tie to the medical community, whereas serving size does not. In order to remain compliant with FDA regulation, hemp brands avoid using the term dose or dosage in educational material, labeling, or marketing content. However, there is one CBD derived medication that has met FDA standards.
According to the Journal of Pediatric Pharmacology and Therapeutics, “On June 25, 2018, the first plant-derived, purified pharmaceutical-grade cannabidiol (CBD) medication, Epidiolex (Greenwich Biosciences Inc, Carlsbad, CA), was approved in the United States by the US Food and Drug Administration (FDA).”
The anti-seizure medication is a CBD only component with no Delta-9 THC. This allows those prescribed Epidiolex the benefits of CBD without experiencing the psychoactive properties of THC cannabinoids. At this time, the long term side effects of Epidolex are unknown.
Terminology for hemp brands is vital, especially when it comes to print on packaging and educational materials. Brands who use the proper terminology are oftentimes more dedicated to transparency and consumer education than those who opt to use other words, like “dose” or “dosage”. This can be a helpful tool for consumers to use when searching for a quality product to purchase.
While this may sound like a trivial detail for many individuals shopping for hemp products, the small details are part of what separates high quality brands from fly-by-night ones. There are thousands of products on the market, and high quality brands will do anything they can to help make sure their products shine when compared to the rest.