FDA CBD Regulations: What to Know [2019]

We’ve talked and talked about the 2018 Farm Bill and how it has paved the way for CBD sales across the U.S. but, what we haven’t addressed as much is how the FDA really works when it comes to CBD and why many shops across the country have received FDA reprimands in the past few months. First things first, the FDA is the Federal Drug Administration which is set up to regulate and approve drugs and other items that the public will consume to ensure safety, quality, and efficacy of the product itself.

Right now, in the This sounds like a big step for the CBD world but in reality, it makes little headway for small CBD businesses and large alike.

The FDA stated in their recent blog post that their top priority is protecting and promoting public health.  “The Agency is committed to science-based decision making when it comes to CBD, while also taking steps to consider if there are appropriate regulatory pathways for the lawful marketing of CBD, outside of the drug setting.”

In turn, their non-stance on CBD, for the time being, is leaving the CBD industry in a bit of standstill where we only know a few of the rules and they can change at the drop of a hat. Let us lay out what we know, to show just how much we don’t.

What We Do Know about FDA CBD Regs

  • Yes, there are food and beverage finished goods which contain CBD. This is referencing a finished good CBD product being added to a food or beverage after the fact or at the point of sale.)
  • All CBD products sold in the U.S. must fall under 0.3% THC
  • All businesses and consumers must not make any medical claims: i.e. that CBD cures cancer, seizures, anxiety, etc.
  • CBD products must be advertised correctly meaning that the cannabinoid content advertised must match what is in the end product

To read more about the 2018 Farm Bill and the FDA Roundtable meeting and what it means for the industry, read our blog here.

The main concern of the FDA currently is the medical claims issue. Many companies in the past several months received FDA reprimands due to the fact that their website or business itself had one or several medical claims. The reprimands, in simplified terms, said that if the business did not make immediate changes and take down all medical claims they would be shut down until further notice. As a business owner, this can be absolutely terrifying and somewhat jarring if you didn’t know you were doing anything incorrectly. In order to shed a little light on what the FDA is really looking for, we have provided a list of possible ways to change a claim into something the FDA would approve.

FDA Claims Changeover

  • Cures cancer, cures anxiety, cures everything under the sun
    • In talking about CBD you want to make sure you avoid the word “cures” at all costs due to the fact that CBD has not been researched enough to make such a heavy claim. Instead use words and phrases like “helps to relieve”, “works to promote relaxation”, “boosts”, etc.
  • CBD is FDA Approved
    • At this point the FDA has not approved anything in regard to normal CBD sales, they are merely watchers at this point as they work to decide the best course of action. But under no circumstance can CBD companies claim that they have FDA approval. Our company, for example, is FDA compliant, meaning that we follow the FDA guidelines as they have been placed currently and will continue to do so until they are willing to approve CBD companies.

Though we obviously do know some regulations within the CBD industry; we are still missing many of the puzzle pieces. Below is a list of some of the regulations that we are still fuzzy on and things the FDA needs to make decisions on.

  • FDA must decide if CBD can be used in food and beverage products such as infused coffee’s, smoothies, cookies and more
  • Consistent language on CBD products such as warnings, nutrition versus supplement labeling, etc.
  • FDA approval – currently there is no way that any CBD companies can be FDA approved and therefore it leaves many consumers confused as to what is safe and what is not
  • How much leeway do individual states have in making laws and regulations in regard to CBD in their own states? This is a question we get regularly due to the fact that CBD is technically allowed to be sold in all 50 states but individual states have elected to make their own rules and regulations as far as what types of companies and what types of products are allowed as well as having to register individual products with the state for a hefty fee.
  • Is CBD safe for all consumers? Is there a dosing limit or regulation for specific age groups, gender, weight, etc?

To help the FDA in their decision-making process and to help answer some of the questions we stated above; the Hemp Roundtable issued a 29-page report to the FDA in regard to the different concerns and potential solutions that the FDA is facing right now. The report states the following in regard to what the FDA should do as far as regulation of CBD products – it is important to note that this report was compiled by some of the leading companies in the industry that are part of the Hemp Roundtable.

  • “CBD does not appear to pose unreasonable safety risks to consumers and therefore can be regulated by FDA like any other botanical ingredient used in these products. This position is supported by clinical studies conducted at dosages at or above what is commonly used in dietary supplements, food, and cosmetics. Several of these studies are in sensitive populations.”
  • “Appropriate levels of CBD will be much lower in food and dietary ingredients than those used in pharmaceutical products. However, we advise against establishing arbitrary dose limits for these products as the effects of the CBD will vary greatly based on the intended use, formulation, and mode of delivery. Each manufacturer has the burden to establish its specific product formulation is safe for the intended population through FDA’s current regulatory framework.”
  • “Safety concerns that may arise from the lack of data in vulnerable populations such as children, pregnant or lactating women, and patients taking therapeutic levels of CBD can be addressed in the labeling of the product with adequate advisory language and directions for use.”
  • “FDA’s current regulatory system supports incentives for drug development, and clearly and sufficiently distinguishes these products from food and dietary ingredients based on their intended use and labeling.”
  • “The Roundtable urges FDA to use its existing authority under the FD&C Act to enforce the mandatory cGMPs to protect consumers from unsafe products and ensure that all hemp-derived products are produced in a quality, consistent manner and accurately labeled.”

These are just a few of the recommendations provided by the Hemp Roundtable but they help to shed light on what many industry stakeholders are considering when they are presenting information to the FDA. It is the hope that these recommendations will be a major part of the FDA’s decision-making process.

To learn more about their upcoming timeline for decisions go As always, US Hemp Wholesale works to provide the most current news and updates in regard to the CBD oil world as well as break them down for businesses. If you have any questions or would like to talk to a sales representative, fill out our partner form, contact your rep or call us at 844-887-4367.

Sources:

https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-committed-sound-science-based-policy-cbd

https://hempsupporter.com/wp-content/uploads/2019/07/2019.07.16-US-Hemp-Roundtable-FDA-Comments.pdf

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