- FDA’s primary goal is public health safety and protection.
- Vast public and stakeholder interest allow “exceptions” to current FDA regulations prohibiting CBD marketed as a food or dietary supplement.
- FDA is actively seeking regulation framework allowing CBD to be marketed outside of the drug context.
Rigorous science is the primary method the FDA utilizes in forming public safety decisions – on what should be allowed into our bodies.
Even though there’s a lot of recent interest in cannabis extracts, cannabis, and CBD in therapeutic applications, the FDA aims to answer pertinent questions about quality standards, safety, and we’ll researched science.
Like every other drug, the FDA claims they will treat cannabis derivatives the same.
Some starts have eliminated cannabis prohibition.
While the federal 2018 Farm Bill removed low THC Cannabis from schedule 1 control definitions associated with marijuana.
However, the very same 2018 Farm Bill left the FDA in charge and tasked them with the responsibility of ensuring public safety and consistent quality standards across the board.
As the FDA continues to get more hard data on low dose THC Cannabis and cannabis extracts, they’re determined to add clarity to stakeholders and provide transparency for forward motion.
Where CBD currently stands with the FDA
CBD can “not” be marketed as a drug without being regulated as a drug and therefore “generally” can’t be sold without FDA approval.
- Interesting choice of wording. What constitutes the ability to be sold without FDA approval?
Drugs make claims to have specific therapeutic effects on diseases and requires rigorous science to support claims.
Food and dietary supplements are regulated differently than drugs, yet, the FDA has the same goal of public safety.
As of now, it’s illegal to add CBD into food while shipping the CBD products in-between states.
These prohibition stand due to clinical investigation being the first ones to seek medicinal value in potentially creating therapeutic CBD drugs. And because CBD is already the main ingredient in an FDA approved CBD isolate drug, Epidiolex.
Due to the VAST public and stakeholders interest in CBD and other cannabinoids, the FDA states there’s a specific regulation that creates an exception, even though there are current statutory provisions prohibiting marketing CBD as a food or dietary supplement.
Various stakeholders are asking the FDA to allow them to put CBD in food and market as a dietary supplement.
Science based decisions and protecting public health is the primary mission of the FDA and are taking active steps into finding appropriate regulatory solutions that will allow the marketing if CBD outside the definition of a drug.
Exidiolex, a CBD isolate containing ONLY the CBD molecule found risk of potential lover injury.
Over the years, the FDA has issued Warning Letters to CBD companies who are making specific medical claims of treating diseases.
In the process of sending Warning Letters, the FDAhad been performing their own tests on various CBD products.
These FDA chemical tests are finding a handful of inconsistencies, including not having the levels of CBD the label is claiming.
As of now, the FDA is making an effort to collaborate on discovering a fair pathway allowing CBD to be marketed in a lawful manner.
Current evaluations are taking public questions and concerns into consideration while evaluating public health and safety concerns.
On May 31, the FDA hosted a 10 hour long hearing, allowing CBD stakeholders (and others) the chance to voice their safety concerns.
Regulatory insights for the public hearing included a desire for:
- Clear safety standards.
- Strong enforcement.
- Supporting research evaluating the therapeutic effects of CBD.
- Consistent terminology related to these products; and, the need for
- Industry standards to address the potentially dangerous manufacturing quality issues with some cannabis-derived products on the market today.
The public has until July 16, 2019 to submit additional safety comments including concerns about:
- Appropriate cannabinoid limits requires safety in food and dietary supplements.
- And more.
The goal of receiving public comments are to allow for an appropriate amount of time to use tidy information gaps.
In order for the FDA to allow CBD to be more available (outside of drug context), the following questions require appropriate answers including:
- How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken?
- Are there drug interactions that need to be monitored?
- What are the impacts to special populations, like children, the elderly, and pregnant or lactating women?
- What are the risks of long-term exposure?
The FDA is concerned that making CBD widely available as in food and as a dietary supplement, could reduce financial incentives for using CBD as a drug – quote, “which would be a loss for patients.”
Overall, even though the FDA believes the drug approval process is the best way to ensure public safety.
The FDA interested in finding a regulator pathway for non drug uses as a food and as a dietary supplement.