The FDA on CBD is quite complicated. Notably, the 2018 Farm Bill removed hemp-based CBD from the controlled substance list and made it federally legal for consumer sale. It also gave states and local territories the right to determine their own CBD hemp laws pending USDA approval.
Unfortunately, hemp laws are often convoluted because of the plants’ similarity to intoxicating marijuana-type cannabis. What’s more, as a recently descheduled substance, CBD regulations are murky. Currently, the FDA offers minimal guidance regarding the best ways to navigate it. They essentially just tell us what we can’t do, then we adjust our business tactics to accommodate.
Today, we’ll discuss the FDA’s current stance on CBD and try to explain why the FDA on CBD is so complicated anyway.
The FDA on CBD
The CBD market is huge with ample growth opportunity. Consumers want CBD and businesses want to sell it to them. Unfortunately, how companies promote and sell hemp CBD products is somewhat problematic and absolutely covered in sticky red tape.
Importantly, the FDA recently approved the CBD medication Epidiolex. As such, companies cannot label the compound as a dietary supplement. However, Epidiolex is the only FDA-approved CBD medication, so companies cannot promote their products as approved medicines, either. They cannot suggest (or imply) that the CBD within their products cures any diseases or promotes specific health benefits. For example, no one may suggest that CBD improves any diagnosable conditions like anxiety, insomnia, psoriasis, and so on.
Despite current CBD research, the FDA is far from approving CBD as a therapeutic substance. The entity claims that they must better assess risks and standard CBD dosing before they can approve cannabidiol as an OTC medication or therapeutic substance. Importantly, the FDA recently took a new stance stating that no products with CBD can be sold as OTC medications. This is true even if the CBD itself is “nonactive” and other pre-approved OTC ingredients are.
The COVID pandemic likely contributed to the delay, as do the countless variables that make it difficult to standardize CBD consumption. Examples of these variables include different extraction types, consumption methods, product quality, etc.
Inconsistencies in the Hemp Industry
With minimal guidance from both the FDA and USDA, CBD businesses must largely fend for themselves. They must make sense of patchwork regulations as they build their business and source appealing products. Essentially, many hemp companies “roll the dice” with innovative products until a government entity tells them they can’t. When this happens, they must pivot and keep moving forward or fail.
Notably, companies that don’t pivot, or those who ignore existing regulations, face strict fines, banking problems, and potential business collapse if they cannot financially recover from the lost business and lost product.
Successful CBD businesses must remain abreast of American hemp laws and act quickly and accordingly when they change. Those who sell hemp CBD nationally must adhere to changing federal hemp laws as well as regional law in all the areas they serve. As such, the best way to stay aware of changing hemp laws is to hire an experienced consultant and only work with informed CBD product suppliers.
The FDA on CBD; Closing Thoughts
CBD is a relatively new industry with long, tangled roots in the legal system. As such, hemp CBD businesses must manage countless regulatory hurdles, many of which are not yet established. As the FDA slowly establishes hemp CBD protocol, businesses must scramble to make sense of the complicated industry. Unfortunately, they must do all of this while simultaneously attempting to develop new and exciting legal hemp products.
If you have a CBD business, don’t worry! VCM consultants and product specialists are very familiar with changing FDA hemp regulations and always ensure our clients are in the loop. All of our products meet FDA on CBD regulations, and our team of professionals will help ensure yours do too.
Contact us to learn more ways VCM can help your CBD business thrive despite changing FDA regulations. Also, view our cataloge, sign up for our newsletter, and follow us on social media for news, CBD business tips, and product updates.
Abby is a freelance cannabis writer and Founder of Cannabis Content, a marketplace and training platform designed to connect cannabis creatives with businesses that need their services. Learn more at CannabisContent.net