Will CBD Lose its Over-The-Counter Status After FDA Certification?
Future CBD OTC may be a thing of the past after FDA certification.
CBD is currently sold over the counter (OTC) in America. This is true despite the fact that it’s not officially a recognized OTC medication certified by the FDA. And yet, the availability of CBD at grocery stores, pharmacies, recreational retailers, and even pet stores, means it’s easier than ever for consumers to purchase. But, once certification comes down from the authorities, will we see CBD OTC? Or prescription only?
What is the Standard Process for OTC Qualification?
Over-the-counter medications are available without a prescription or the guidance of a health care professional. Patients pick them up at grocery stores, gas stations, and just about everywhere else that sells consumer goods. And according to Drugs.com, “OTC drugs are medications that are safe and effective for use by the general public without seeking treatment by a health professional.”
In the U.S., there are more than eighty different categories of OTC drugs. The most popular varieties are anti-inflammatories, anti-acne formulations, and cold medicines. Some medicines, while technically still classified as OTC, remain behind the counter, as health authorities have deemed them higher risk. This may be because patients need additional information from the pharmacist, or because these are at risk for theft.
Since the Food and Drug Administration (FDA) created the OTC label, many prescriptions have transitioned into OTC status. These drugs have met all the necessary conditions, including the following:
- They have a low potential for misuse and abuse
- They’re suitable for self-diagnosed conditions
- The consumer can use them safely and effectively without a health care provider’s instruction
- Adequate labelling
Based on these standards, CBD should be certified, right? So what’s holding them back?
What’s Holding Back CBD OTC Certification?
The FDA has been studying CBD for years, but as of the last update in March 2020, it still has not released any specific recommendations or guidelines for selling CBD to consumers and patients.
As per the most recent update, the FDA says, “It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” and “some CBD products are being marketed with unproven medical claims and are of unknown quality.”
Until the FDA is satisfied that the drug is safe, suitable for self-diagnosed conditions, and meets all the other OTC criteria, CBD’s status will remain in limbo.
One of the biggest issues holding the FDA back is the question of dosing CBD.
Unlike other OTC medications, dosing CBD can be more complicated. After all, more CBD doesn’t necessarily equate with more relief. All cannabinoids seem to have pharmacological action based on a bell-shaped dose-response curve.
Multiple variables influence the perfect dose for each individual. These include:
- body mass index
- other medications
So therefore, even if the side effects are generally negligible, it’s not as easy to predict a proper CBD dose as other common OTC medications, like acetaminophen or a cold medicine. But what might the side effects of CBD include? And are these worse than other OTC medicines?
What Are the Side Effects of CBD?
All medications, when taken in excess, have the potential to harm.
This includes something as seemingly benign as acetaminophen, but also includes options like CBD. While OTCs are legally designated to be safer than prescriptions, it doesn’t mean these are without side effects or dangers. Even CBD, which is considered to have a great safety profile, may have some side effects worth considering before consumption.
Thankfully, according to “An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies” published in Liebert Publications in 2017, “In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research.”
The authors summarized the potential side effects: “tiredness, diarrhea, and changes of appetite/weight.” Importantly, they also noted that in comparison with the pharmaceutical alternatives, CBD had a significantly better safety profile.
So is CBD more dangerous than other OTC’s? We don’t have enough scientific information to completely seal the case. However, it’s unlikely, especially when you look at the potential dangers of some common OTC medications in comparison to the lauded safety profile of CBD.
The Potential Danger of Other OTCs
Looking at acetaminophen, which is the most common OTC in the US, there can be issues even if patients take it correctly. As described by Jane E. Brody’s piece in The New York Times, if someone takes it too frequently, acetaminophen can cause serious liver damage. Take too much at once, and it can kill you. Many people take this OTC every single day. Brody’s article also describes how some OTC drugs have a risk for abuse, including sleeping pills and laxatives.
Brody’s piece also highlights how non-steroidal anti-inflammatory drugs have dangerous, adverse effects when taken for long periods. These include “bleeding ulcers, kidney or liver damage and an increased risk of a heart attack or stroke.”
Now, both the FDA and the authors of the Liebert scientific review highlighted above suggest that CBD could also affect the liver. Thankfully however, the effects seem less severe than those of acetaminophen, and are from a single reported case. As per the review, there is currently only one report of liver damage during the clinical trial of CBD-based Epidiolex, and it’s not clear whether the drug is responsible for said damage.
A Look at CBD OTC From Around the World
Overall, despite its widespread availability in both the US and Canada, there is no guarantee CBD will stay this way.
Regulations are lax, but times may change as scientists conduct more research. The FDA has remained surprisingly lenient on the sales of CBD across the US, only cracking down on companies selling their products based on medical claims.
The Australian government announced in April that they plan to make CBD an OTC medication. In Australia, CBD is currently sold in a grey market. Official OTC designation will mean CBD is taxable, regulated, and tested. Perhaps in other markets, such as North America, regulators may want to consider the benefits of moving CBD into an official OTC model like that. After all, it would mean better oversight of the industry, and therefore safer products for the consumer.