What is misbranding?
Misbranding is an offense where a product or service doesn’t meet all the statutory requirements when it comes to reporting important information like the manufacturer, name, or distributor.
A product can also be considered misbranded if it has a misleading or false label. In the United States, the Federal Food Drug and Cosmetic Act (FDCA) is the one responsible for formulating laws and penalizing anybody found selling misbranded products.
FDCA laws are implemented by the Food and Drug Administration. The agency has the mandate to institute charges against anyone suspected of engaging in misbranding activities. FDA can issue warning letters, civil penalties, injunctions, debarments, and recalls.
As mentioned earlier, sometimes you could find yourself being accused or misbranding without your own knowledge. Or the charges may have arisen because of a mistake on the side of an employee.
If that is the case, it is important to involve a good misbranding defense lawyer right from the start.
An experienced defense team
Not every lawyer can handle a misbranding case. You need to hire an attorney who has the experience and specializes in misbranding defense.
This is simply because misbranding lawsuits can be tricky to handle especially if you are being represented by an inexperienced lawyer.
Weak legal representation can cause a lot of problems to your company such as injunctions civil fines and even jail term. At the end of the day, your business will definitely suffer financial losses as well as a damaged reputation.
It is up to you to ensure that the prosecution doesn’t bring your business operation to a crashing halt with an indictment.
At Spodek Law Group, we ensure that the rights of our clients are protected. We have a vibrant team of experienced lawyers who have represented different people across the country accused of misbranding.
Our attorneys are trained on different steps and techniques aimed at either mitigating the procedures at the investigation stage or reach a settlement with the prosecution side as soon as possible.
All this is only possible if you reach out to our lawyers as soon as you become aware of the charges leveled against you. Allowing the case to advance can give defense lawyers a hard time to represent you come out with a favorable outcome.
Examples of misbranding
Misbranding can happen in a variety of ways. Other than engaging in misbranding, businesses can also be charged under other consumer product laws at the state or federal level.
Here are examples of misbranding violations:
• Denying federal authorities a chance to inspect business records during an investigation
• Intentionally selling misbranded products either at the sales, distribution, or manufacturing stage.
• Insufficient or lack of clear warning labels
• Creation and sale of false labels
• Sale of pirated drugs to the public
• Failure to maintain or provide proper directions on the use of certain drugs
• Selling a drug or product under the name of another
• Making an untrue health claim on a label
What is the difference between adulterated products and misbranded products?
The FDCA is the one that controls and gives liability for adulterated and misbranded products from the violations of their stipulated requirements. As such, the difference between the two can sometimes be confusing.
In other words, companies and businesses have to be very careful when it comes to differentiating between misbranding and adulterated products.
Who is liable for misbranding?
All parties involved in the distribution chain can be held accountable for misbranding:
• A manufacturer who makes an inadequate label
• A pharmaceutical company that distributes drugs with clear labels
• Retailers who understand that certain labels are necessary on packages or bottles but fail to provide them
Misbranding criminal investigations
Criminal investigations are usually pursued by FDA in collaboration with the Department of Justice and other local enforcement agencies. The nature of the violation will also determine the seriousness at which the case will be pursued.
Penalties for misbranding under the FDA laws comprise of fines and imprisonment. Although FDA prosecutions as rare, it is important to liaise with misbranding lawyers to ensure that you are always compliant.