Possible FDA Crackdown Against CBD Products

Possible FDA Crackdown Against CBD Products

December 3, 2019 | Pharmaceutical Litigation

The Food and Drug Administration told over a dozen companies to stop selling cannabidiol-infused food products and stop making inflated health claims about their products.

CBD is a non-psychoactive marijuana ingredient which has medicinal properties. Yet the FDA has only approved one CBD product.

Epidiolex treats some rare forms of childhood epilepsy. Other CBD products, such as health supplements and edibles, have not been reviewed.

Regulators are especially concerned that CBD products, which have not been proven safe, are often marketed to infants and children. 

Companies in Arizona, California, Colorado, Florida, New York, and several other states all received warning letters.

The FDA Review Process

CBD-infused products have been available for quite some time, even before the 2018 Farm Bill legalized cannabidiol, at least to some extent. But for some reason, regulators have not spoken out against such products until now.

For many years, pundits have criticized the FDA for its slow drug and device approval process.

Many of these commentators probably had financial links to drug companies that wanted to sell risky medicines and make lots of money, but that’s the subject of another blog.

Partially in response to such criticism, regulatory wait time has decreased significantly since 1993.

For example, so-called priority review times have decreased from nearly two years to just over six months.

In fact, wait time is almost nonexistent in fast-track reviews. This drug and device review process covers the following four categories:

  • Fast Track: If a new drug or device addresses a serious condition which, as far as the FDA is concerned, there is no effective treatment, regulators quickly approve the product for sale and do not ask too many safety-related questions.
  • Breakthrough Therapy: Many drugs and devices qualify as breakthrough therapy. The FDA expedited approval if the product is a “substantial improvement over available therapy.” Pretty much every new or improved product arguably meets that standard.
  • Priority Review: The FDA promises to approve the product within six months. That guarantee probably means that some issues get overlooked.
  • Accelerated Approval: Congress substantially expanded this program in 2012, If the product treats a serious condition and has an even theoretical advantage over existing treatments, fast approval is all but assured.

The bottom line is that the FDA is no longer the consumer watchdog agency that it was back in the day.

For the most part, these regulators have only one mission: to quickly approve unproven drugs and devices so consumers can have more choices and these companies can increase their profits.

So, FDA approval is no guarantee of product safety. If the drug or device causes injury, the manufacturer may be strictly liable for damages.

These damages normally include compensation for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering. Additional punitive damages are usually available as well.

Procedurally, these claims usually go to Multidistrict Litigation courts. MDL claims are consolidated in one court for pretrial purposes.

So, plaintiffs can pool their resources together. Additionally, once one case settles, the settlement momentum builds and spreads to other cases, sort of like a falling line of dominoes.

Dangerous Food/Drug Products and the Discovery Rule

The statute of limitations is another procedural rule that often comes up in these cases.

Typically, victims have only two years to bring dangerous drug and other tort claims. Otherwise, they lose the chance to obtain fair compensation.

The delayed discovery rule protects victims in these cases.

To see how this rule works, let’s examine a hypothetical case.

Assume Felix takes Drug X for a few months in 2017. In 2018, the company amends the warning label to account for heart problems among people with certain pre-existing conditions.

Felix, who has such a condition, develops a heart problem, and he goes to the doctor in 2019. In 2020, he stumbles upon some information on the Internet discussing the link between Drug X and heart problems.

In 2021, his attorney files legal paperwork.

The drug company would argue that the statute of limitations, which according to them expired in 2019, precludes his claim. 

But according to the delayed discovery rule, the clock does not begin ticking until Feliz discovers the full extent of his injury and he links that injury to the defendant’s misconduct. So, the SOL does not expire until 2022.

Dangerous food and drug products often cause serious injuries, and the FDA is not as vigilant as it used to be.

For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. We handle these claims on a nationwide basis.

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CATEGORY: Pharmaceutical Litigation

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