- Misbranding is a federal offense whereby the product fails to meet all the statutory requirements regarding the reporting of vital product information such as the name, manufacturer, or distributor.
- A product is misbranded if its label is false or misleading as to its quality or branding.
- The Federal Food Drug and Cosmetic Act (“FDCA”) is the federal law that establishes penalties for anyone selling misbranded products in interstate commerce. The FDCA is enforced by the Food and Drug Administration (“FDA”).
- The FDA has the authority to bring civil enforcement actions against parties suspected of engaging in misbranding, including warning letters, recalls, debarments, seizures, injunctions, and civil penalties.
- Serious charges of misbranding could also subject the party to a criminal investigation and result in criminal penalties and jail time.
- Consider hiring on attorney competent in dealing with the many provisions of the FDCA as well as FDA civil and criminal enforcement proceedings.
Experienced Defense Team
If you need advice regarding misbranding charges or are worried about an impending investigation, do not hesitate to contact one of our defense attorneys.
Misbranding lawsuits can present a serious problem for you and your company and result in civil fines, injunctions, criminal penalties, jail time as well as the loss of customer base and extensive reputational damage.
Do not let an aggressive prosecution shut down your life’s hard work without getting a proper defense strategy.
At Oberheiden, P.C., our team of experienced attorneys has experience representing and defending clients on misbranding and other related federal charges.
There are steps that we are trained to pursue to either mitigate procedures in the investigation process or settle the matter quickly under terms most favorable for our clients.
Do not wait to get in touch with a qualified attorney today. Put Oberheiden, P.C. on your side to advise and defend you against allegations of misbranding and fight for your liberty and reputation.
Misbranding or Mislabelling Defined
Misbranding – also referred to as mislabelling in some circumstances – is a term used to describe products that fail to meet certain federal requirements. For instance, common misbranding charges refer to products whose labels do not contain vital information such as the name, manufacturer, or distributor.
In other words, a product is misbranded if the label, brand, or notice under which the product is sold is false or misleading in any particular way as to its quality or branding in violation of statutory requirements.
It is a federal offense that the government aggressively pursues and prosecutes due to the potentially dangerous effects on consumers.
The Federal Food Drug and Cosmetic Act (“FDCA”)
The FDCA governs many products, including food, food additives, color additives, cosmetics, drugs (both prescription and non-prescription drugs), dietary supplements, medical devices, tobacco, etc. It regulates these products for consumer safety.
The provisions of this Act are enforced by utilizing various methods such as administrative actions, civil and criminal penalties, imprisonment, recalls, injunctions, and seizures.
The agency responsible for enforcement of the FDCA is the U.S. Food and Drug Administration (“FDA”). In addition to the FDA, the Drug Enforcement Agency (“DEA”) and the Federal Bureau of Investigation (“FBI”) may also be involved in investigating, enforcing, and prosecuting violations of the federal misbranding provisions.
Examples of Misbranding
Misbranding can occur in a variety of instances. In addition to engaging in misbranding, companies can simultaneously be held liable under additional consumer product laws at the federal or state level.
Below we offer a couple examples of misbranding violations or violations of other consumer product and protection statutes:
- knowingly trafficking misbranded products whether at the manufacturing, distribution, or sales stage
- refusing to allow federal authorities to inspect company records as a part of their investigation
- inadequate or lack of warnings on labels such as directions for children
- reporting unsafe dosages or failing to disclose suggested duration to take drug or other applicable required warnings
- creating and selling false or misleading labels with the intent to mislead consumers
- failing to maintain adequate directions for the use of certain drugs
- selling imitation drugs to consumers
- denying a federal authority its request to inspect a company’s premises in response to allegations of misbranding or failing to maintain such records
- selling a product under the name of another drug
- failing to include all the active ingredients of a drug or other details such as the name of the manufacturer
- making a false or unsubstantiated health claim on the label
This list is only representative of the possible circumstances that could be considered and prosecuted as misbranding.
If you have any worries or concerns regarding a charge or investigation, contact our team of dedicated and experienced attorneys right away.
What Is the Difference Between Misbranded Products and Adulterated Products?
The FDCA governs and provides for liability for both misbranding and adulterating products in violation of federal requirements. Therefore, the difference between the two are often conflated and can be a little confusing.
Simply put, misbranding refers to a defect or false act regarding the product’s composition or makeup. Misbranding, on the other hand, refers to a defect or other problem in the labelling or warnings located on the product.
For example, products are adulterated in instances where the ingredients are fake, there is an unapproved ingredient in the product, the product is manufactured in unsanitary conditions or the formula is decomposed, or the strength of the product is not as potent as the required standards.
Products are misbranded in cases where a drug’s label is false or otherwise promotes a health advantage that is not true, the product is missing a required warning or the label is lacking a required notice (e.g., dosage, quantity, age restrictions), or certain ingredients in the product are deliberately excluded from the product’s label.
Who Can Be Held Liable for Misbranding?
All parties in the distribution line can potentially be held liable for misbranding:
- Manufacturers who created the inadequate label (which can simultaneously constitute a product defect under tort law as a warning label defect)
- Pharmacies or pharmacists who fail to place the required labels on the products
- Retails who know or should have known that certain labels or instructions were required for particular products and not included
Civil Enforcement for Misbranding
The FDCA authorizes federal authorities to initiate various civil enforcement proceedings for misbranding:
- Warning Letters: The FDA sometimes issues warning letters to companies or individuals that provide the company or individual with the opportunity to voluntarily comply with the terms of the letter before the FDA initiates more formal enforcement proceedings.
- Recalls: Certain products may be recalled before or after the distribution process where the FDA determines that the product violates the FDCA or otherwise presents a safety danger to the health and wellbeing of consumers.
- Import Alerts: The FDA is authorized to issue Import Alerts, which is a notice to border officials that certain articles or products should be automatically detained without physical examination and should be refused admission into the United States until further notice.
- Injunctions: In some instances, federal district courts may issue injunctions to prevent future violations of the FDCA.
- Seizures: The FDCA allows certain products such as food, drugs, cosmetics, devices, etc. to be seized where they are found to be misbranded or adulterated.
- Debarment: The FDA is also authorized to prohibit or debar companies or individuals from engaging in certain activities that are otherwise authorized by the FDA based on their allegedly improper conduct.
- Civil Penalties: The FDA may impose civil penalties on companies and individuals for certain violations of the FDCA.
Criminal Investigations for Misbranding
Criminal investigations can be initiated by the FDA in conjunction with the DOJ and local U.S. Attorneys with respect to the more serious misbranding violations. Specifically, the chief responsibility for criminal enforcement is vested initially with the FDA’s Office of Criminal Investigations (“OCI”).
Importantly, criminal violations under the FDCA do not require the defendant to have a guilty mind, though evidence of intent or repeated violations could result in multiple years of prison time and increased criminal fines.
Criminal penalties under the FDCA include fines and imprisonment, though such criminal prosecutions under the FDCA are relatively rare.
Need Advice on Misbranding?
Facing enforcement proceedings or a criminal investigation in connection to misbranding charges can be a worrisome and potentially dangerous situation.
It can result in civil and criminal penalties, jail time, injunctions as well as the loss of customer base and significant reputational damage.
The attorneys at Oberheiden, P.C. have the experience and knowledge needed to combat misbranding charges in settlement proceedings and federal litigation. We can provide advanced and personalized defense strategies to give you and your company the best chance of success.
Call 888-680-1745 or contact us online today for a free consultation to defend your rights, fight for your reputation, and avoid unwarranted misbranding allegations and further complications.