Why the FDA Warns Against Off-Label Claims

As you are probably aware, a drug must receive FDA approval in order to be prescribed for a specific use. This is to ensure the drug does, in fact, treat the condition, disease, or ailment for which it is being prescribed, but also to ensure there are acceptable adverse side effects, and that the benefits outweigh the risks.

However, sometimes, medications intended for one use may be prescribed to treat something else. This is called “off-label use,” and the FDA warns against this. However, doctors are free to prescribe medications as they wish as long as its in accordance with good medical practice. Doctors are actually not constrained to prescribing medications for only FDA-approved indications.

Is Off-Label Use of a Drug Really a Danger?

off label prescribingThe short answer is – it can be. Take COVID-19, for example. Early on during the pandemic, there was talk of using a drug used to treat malaria, hydroxychloroquine, as a potential treatment option for coronavirus. Doing so would be considered an off-label use, and in this particular case, it could have life-threatening consequences.

Hydroxychloroquine and its sister drug, chloroquine, reportedly can cause serious heart issues. As a result, the FDA issued a press release stressing the need to closely monitor patients if using the off-label drug to treat COVID-19 because it has yet to be approved for that specific use.

It’s not uncommon for doctors to prescribe or administer a medication approved by the FDA for off-label use. Oftentimes, they’ll do so in a clinical trial capacity, and they do so after understanding the risks and the possible benefits the drug has for which it was initially prescribed. That’s not to say misuse doesn’t exist.

Enter the False Claims Act.

What is the False Claims Act?

In its earliest incarnation, the False Claims Act, also known as the Lincoln Act, was signed into law in 1863 by President Lincoln in an attempt to increase the quality of goods provided to troops during the Civil War. The False Claims Act considers it a punishable violation to make false claims about a drug in order to make money.

One common penalty for violating the federal False Claims Act is paying a fine that can be in the hundreds of millions of dollars. That’s enough to do some serious damage to a corporation, let alone to a small Mom-and-Pop shop. Making off label claims about a product like CBD, for instance, could easily put a small company out of business for good.

Why Take the Risk?

As a rule, it is not wise for doctors to engage in off-label prescribing. Not only could this put them at risk for making false claims, but you could be endangering your patients or clients. Doctors will prescribe a drug for off-label use under very specific circumstances and typically under their watchful eye.

Examples of off-label use include:

  • Prescribing anti-depressants for pain
  • Prescribing antipsychotics for insomnia and dementia
  • Prescribing a dose that is different, typically higher, than the dosage for which the FDA gave initial approval
  • Using topical analgesics as a vapor rub or migraine treatment (if the label does not indicate alternative uses). 

Curious about CBD topicals?


FDA Stamp of Approval

false claimAfter undergoing clinical trials and accumulating scads of data to support a drug’s efficacy, the FDA will determine whether or not the benefits of taking a drug outweigh the side effects and risks. Getting an FDA stamp of approval means that a product or drug has undergone extensive scientific research.

Only one drug that contains CBD has FDA approval, Epidiolex, indicated for severe seizures. As research continues and As the CBD market continues to grow, the FDA has started to take notice. In an attempt to reign in what has become known as a “Wild West” industry, a hearing was held in May 2019 and the FDA began to conduct a CBD review. Despite no clear-cut FDA regulations put in place to date, the administration is beginning to recognize CBD is a product that has a lot to offer and one that is here to stay.

Why the FDA’s CBD reviews matter to clinicians

It is important to take the FDA’s incentives for CBD clinical research seriously for the following reasons: 

  • Protects patients and health practitioners: By standardizing the market, the products with genuine health benefits will stand out against the products without value on your shelves. 
  • Helps give the CBD industry credibility: CBD products that are backed up by science and data will support the claims that you as a clinician and CBD companies can and cannot make about the products. 
  • Gives clinicians alternative therapies they can offer their patients for safe, natural, non-addictive relief: Clinicians can help patients decrease or stop using medication that carry serious side effects and/or the risk of addiction. 
  • Offers an incentive for research and drug development: It gives clinicians and pharmaceutical developers incentive for research and drug development that is safe, natural, and non-addictive. 
  • Helps clinicians advance their training and clinical toolkit: Clinicians can maintain their licenses with mandatory continuing education units (CEUs) by studying the endocannabinoid system, phytocannabinoids, and other relevant topics in the medical cannabis industry—which they can add to their clinical offerings. 
  • Helps clinicians diversify their income: Clinicians can sell a new class on products or use them for their treatments (and charge more for those sessions). 

Labeling is Key

Something else that occurs when a drug receives FDA approval is proper labeling. When the FDA approves a product or drug, manufacturers and healthcare providers are explicitly instructed as to how a product or drug can be administered properly. FDA-approved labeling will detail exactly what the product or drug is intended for and approved to treat, as well as detailed instructions for use. Additionally, risks and side effects are listed, as is the appropriate dosage.

Labeling a product for the relevant conditions it treats limits false claims and off-label use. That, in turn, makes for a more effective product, allowing you to buy exactly what you need and treat your condition or ailment without any guesswork as to whether or not it will work.

For business owners, steering clear of off-label claims is just good business. Establishing yourself as a retailer who is trust-worthy and offers transparency in terms of what solutions your products have to offer will keep customers coming back again and again.

Get ongoing professional tips and offers

Facebook group- CBD CLINIC ad

Skip to content