The Port of Miami and Miami International Airport have positioned South Florida as a major global hub for trade and commerce. With so many imports and exports, the South Florida area is one of the largest regions for inspections and enforcement action by the Food and Drug Administration (FDA). Federal lawmakers passed the Food, Drug and Cosmetic Act (FDCA) to extensively regulate the imports, exports, manufacturing, sales, and interstate trading of foods, medical devices, drugs, biologic products, dietary supplements, and cosmetics. Penalties for violating the FDA’s laws can range from administrative penalties (seizures, fines, warning letters, or injunctions) to criminal penalties through the United States Attorney’s Office, with some penalties reaching up to twenty (20) years in federal prison. If combined with fraud charges, violations of the FDCA could lead to even more prison time, fines, and money forfeiture.
If you or your business have been approached by FDA investigators, it is important to seek the advice of an experienced Miami criminal defense attorney. Stroleny Law has extensive experience defending charges in state and federal courts across Florida. Call (305) 615-1285 for a free phone consultation.
What are FDA-Related Crimes?
The FDA enforces laws and regulations intended to ensure that drugs, medical devices, biologic products, dietary supplements, food, and cosmetics are safe and effective for their intended uses, and that they contain accurate and true information on the labeling. As will be explained below, the FDCA prohibits the interstate trade of unapproved new drugs, as well as adulterated or misbranded products. The FDCA also prohibits the counterfeiting of drugs and drug diversion, the distribution of Human Growth Hormone, the refusal to permit access to certain FDA-required records, and the failure to register a manufacturing facility with FDA (among other crimes).
It is important to note that, with some exceptions, most FDCA crimes are strict liability crimes, meaning that the prosecutor does not need to prove that a defendant intended to violate the law, that the defendant knew that the product they were importing or selling was regulated by the FDA, or even that he or she knew that they were violating FDCA. Since the FDCA is a public welfare statute that regulates potentially harmful products, Congress intended that a violation of the FDCA is enough to trigger criminal penalties.
The FDCA applies not only to those that are physically involved with the FDA-regulated products, but also to those that are responsible for “the causing thereof,” meaning that the FDCA can be enforced against those in positions of authority in a company who simply fail to take adequate action to prevent violations of the FDCA.
There are enhanced penalties for those that have a prior conviction for a violation of the FDCA, as well as enhanced penalties for those that intended to mislead or defraud the FDA or the consumer. There are also enhanced penalties for counterfeiting charges, for distributing Human Growth Hormone, as well as for wholesalers and manufacturers involved in drug diversion.
Unapproved New Drugs
The FDA regulates products based on how the manufacturer/seller intends for the consumer to use the product. Therefore, a product is a “drug” if it is intended to be used in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals. The FDCA further clarified that a drug is an article, other than food, that is intended to affect the structure or any function of the body of humans or animals. A “drug” also includes products that are used as components of other drugs. The FDA will look at the labels and labeling of a product to determine the intended use.
The FDCA defines “label” as “a display of written, printed, or graphic matter upon the immediate container of any article,” and “labeling” as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Courts have interpreted “labeling” to include many non-traditional forms, including advertisements by the manufacturer or seller, blog posts, other statements on the manufacturer or seller’s website, and even social media posts.
This means that even if a product is labeled as something else (for example, a dietary supplement), if the product claims to cure or treat or prevent a disease or condition, it will be regulated as a drug.
Generally speaking, all drugs must be FDA-approved (with some exceptions). Therefore, a “new drug” cannot move in interstate commerce unless and until a sponsor submits a new drug application for the drug and the FDA determines that the drug is safe and effective for its intended uses and approves the new drug application. A “new drug” without a new drug application and FDA approval would be an “unapproved new drug” under the FDCA.
In the most general terms, a product is misbranded if the labeling is not truthful or is misleading in any way. This tends to be an issue most often with imported products, since foreign manufacturers do not have the same requirements in other countries as they do with the US.
The following are some common examples (among many others) of misbranding, according to the FDCA:
- False or misleading labeling;
- The product does not have “adequate directions for use;”
- Selling a prescription drug without a valid prescription;
- The product is missing required symbols or words, such as Rx on a prescription product;
- The label is in a foreign language;
- The medical device lacks a required 510(k) premarket notification;
- The label fails to disclose the active pharmaceutical ingredient.
As there are many possible ways that a product could be misbranded, it is important to consult with an experienced criminal FDA criminal defense attorney that is familiar with the FDCA and FDA regulations.
Adulteration generally means “the act of making something poorer in quality.” The FDCA prohibits the sale or exchange of adulterated products to protect consumers from potential harm, and can impose harsh penalties to those that are involved in the adulteration. Adulteration is most often seen in the food or cosmetic industry, but can also be applied to the drug, medical device, and biologic industries. Some common examples of adulteration are the following:
- The product contains any “filthy, putrid, or decomposed substance;”
- If the product has been prepared, packed, or held under insanitary conditions where it may have been contaminated with filth, or may be injurious to health;
- The product or its container is composed, in whole or in part, of any poisonous or banned substance;
- The product was created in a facility that did not follow Current Good Manufacturing Practices (commonly referred to as “CGMPs”);
- The product was processed in a facility that did not follow a Hazard Analysis and Critical Control Point (“HACCP”) plan;
- The product contains an unsafe food or color additive;
- An unapproved new animal drug can be considered adulterated;
- An unapproved new medical device can be considered adulterated;
- The strength, quality, or purity of the product falls below industry standards, or was replaced or mixed with another substance.
These are just some examples of adulteration. As there are many possible ways that a product could be adulterated, it is important to consult with an experienced FDA criminal defense attorney that is familiar with the FDCA and FDA regulations.
Other Crimes Usually Charged with FDA Crimes
When the FDA refers cases to the US Department of Justice for prosecution, criminal investigators also look for other violations of federal law, including conspiracy, mail or wire fraud, health care fraud, obstruction of agency proceedings, false statements to an agency official, controlled substance charges, smuggling, clinical trial fraud, entry of goods by false statement, tampering, money laundering, and/or trafficking in counterfeit goods.
Experienced, Aggressive Defense for Miami FDA Enforcement
The FDA takes violations of the FDCA very seriously, so it is important that anyone that is a target of an FDA investigation hire a skilled Miami criminal defense attorney. Stroleny Law can help protect your constitutional rights and prevent wrongful convictions. Call 305-615-1285 today or contact us online to schedule your free consultation. Don’t delay – the sooner you have an experienced criminal attorney fighting for you, the better protected your legal rights will be.
Stroleny Law, P.A. handles a variety of criminal law cases, so call now if you have any questions.