Misbranding Products Attorney

misbranding products defense attorney

Mislabeling or misbranding a product is a crime that the federal government takes seriously. The reason being is the potentially devastating effect it can have on the well-being of everyday consumers. The root of the 2010 salmonella outbreak was tracked by to an Iowa egg company operating under the name Quality Egg, LLC. The company was caught selling products with labels that made the eggs appear fresher than they were.

Federal prosecutors ultimately charged the company and its two executives with violating federal food and drug safety laws. As a result, the company was charged with a felony for fraud by way of misbranding products and the two executives were charged with misdemeanors for distributing expired food.

This is only one example of how the federal government can impose themselves on companies violating federal laws. If you find yourself facing charges for mislabeling or misbranding products, be sure to seek legal counsel from a knowledgeable criminal defense attorney. The misbranding products attorneys at The Umansky Law Firm have experience representing clients facing a range of federal charges and can help settle your legal matter on the most favorable terms.

Federal Laws Governing Misbranding Products

The federal government established penalties for those who engage in interstate commerce of misbranded products via The Federal Food Drug and Cosmetic Act (FDCA). This act governs over commerce regarding cosmetics, food, drugs, medical devices, and tobacco. Penalties for violating the FDCA include everything from a fine to imprisonment, but they are not the only entity policing these violations. The Food and Drug Administration (FDA) will also respond to reports of misbranding with injunctions, civil sanctions, fines, and seizures.

The FDCA is a part of the U.S. code as 21 U.S.C. § 331, making it a crime for those who misbrand products, but that isn’t all. Knowingly trafficking misbranded products is also a federal offense. Examples of trafficking include:

  • Manufacturing
  • Receiving
  • Delivering
  • Introducing for sale

While the actual misbranding or adultering of a product is a punishable federal offense, there are other consumer product and interstate commerce laws that constitute a federal offense if broken. These include:

  • Failing to maintain records as required by federal laws
  • Refusing to permit the inspection of suspected misbranded products
  • Refusing to permit access to records after an investigation

Criminal Penalties for Misbranding Food, Drugs & Devices

The FDA prefers companies to self-correct after being notified of an FDCA violation rather than immediately imposing criminal penalties. The FDA typically hosts a Section 305 hearing for alleged violators; however, that does not disrupt the possibility of federal penalties being handed down. That is at the sole discretion of the U.S. Secretary of Health and Human Services.

The penalties violators face depends on the number of times they’ve violated the FDCA. The initial violation of mislabeling consumer products (except for particular drugs) is a misdemeanor offense punishable by:

  • Up to 1 year in federal prison
  • Up to $1,000 in fines

A subsequent violation is a felony and punishable by:

  • Up to 3 years in federal prison
  • Up to $10,000 in fines

Penalties become even more severe if the misbranded product is a prescription drug as defined by federal law. The penalties for misbranding a prescription drug are as follows:

  • Up to 10 years in federal prison
  • Up to $250,000 in fines

Federal Regulations for Branding Drugs and Medical Devices

Drug and medical device manufacturers must abide by strict federal regulations when branding their products. Following the provided branding instructions is all the more crucial when manufacturing products for international commerce. Medical devices made for use in the U.S. must at least  have the following brandished per FDA’s 21 CFR 801:

  • Name and place of the business
  • Intended use
  • Adequate directions for use

Any false or misleading language on the medical device subjects the manufacturer to federal penalties. One of the few exemptions to criminal charges is if the product itself lacks sufficient space for the necessary labeling.  The FDA has further labeling requirements specifically for medical devices.

Orlando Attorneys Defending Against Federal Charges

Misbranding lawsuits are aggressively prosecuted, but that does not mean that there is no way to defend yourself. The primary concern in misbranding cases is consumer safety. Therefore, a simple recall is enough to remedy the situation, and any other penalties are usually to make an example out of the violators. Our team can negotiate a voluntary correction of the violation to help steer clear of criminal prosecution. In the event the case is prosecuted, we can implement proven effective criminal defense strategies to have charges lessened or even dismissed if possible.

Facing prosecution for a federal offense is no laughing matter. The U.S. government will have their best prosecutors on the case to help ensure that you are held responsible for misbranding products. Combat their efforts by securing the legal counsel of an attorney with experience combatting federal charges.

Board Certified Criminal Trial Lawyer Brice Aikens is a seasoned criminal defense attorney with numerous years of experience representing those facing federal charges. Recognized as one of Florida’s Legal Elite by Florida Trend Magazine, Brice has the legal know-how and commitment to help bring your legal issues to a favorable conclusion. Contact us today at 407-228-3838 for a free case evaluation.