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Miami FDA Defense Lawyers

FDA Defense Lawyers Representing Importers, Exporters, and Other Clients in Miami

Jared Davis
Jared H. Davis
FDA Team Consultant
Former FDA and HSI Special Agent in Charge

Miami is one of the nation’s epicenters for U.S. Food and Drug Administration (FDA) enforcement in the area of import/export compliance. The Port of Miami is a frequent site of FDA inspections and investigations, and the FDA aggressively targets companies and individuals throughout the Miami Metropolitan Area for suspected violations of the U.S. Food, Drug, and Cosmetic Act and other laws.

Miami address – by appointment only:
2250 Southwest 3rd Ave, 4th Floor
Miami, FL 33129
305-928-8505

FDA enforcement actions can lead to substantial penalties. While FDA penalties are generally administrative and civil in nature, the FDA also works with the U.S. Department of Justice (DOJ) to pursue criminal charges when warranted. Criminal prosecution is particularly likely in cases involving the unlawful import, export, and misbranding of medications, medical devices, materials used to make controlled substances, foods, cosmetics, and other items that have the potential to harm consumers.

Experienced FDA Defense Counsel for U.S. Residents, Foreign Nationals, and Companies Facing Allegations in Miami

At Oberheiden P.C., we serve as experienced FDA defense counsel for U.S. residents, foreign nationals, and companies facing allegations in Miami. This includes allegations involving the unlawful import, export, misbranding, and distribution of contraband and counterfeit goods. All imports and exports to and from the U.S. are subject to stringent federal requirements, and federal laws strictly control the labeling, branding, and distribution of drugs, foods, cosmetics, and other consumer products as well.

Our FDA defense team includes senior-level attorneys who have experience on both sides of FDA inspections and investigations. Our team also includes a former FDA Director of Compliance who relies on more than 30 years of experience working inside the FDA to help guide our clients. We represent clients in all FDA fraud matters, and we assist our clients with establishing and maintaining FDA compliance so that they can mitigate their risk of facing additional scrutiny in the future.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd
Lynette S. Byrd

Former Assistant U.S. Attorney

Partner

Ellen Comley
Ellen Comley

Senior Counsel

Attorney-at-Law

Roger Bach
Roger Bach

Former Special Agent (OIG)

Steven Taylor
Steven Taylor

Healthcare Compliance Consultant

Susan Sage
Susan Sage

Healthcare Auditor

FDA Matters We Handle in Miami

The FDA’s enforcement authority is extremely broad, and the FDA often works with the DOJ and other federal agencies to target companies and individuals with sweeping allegations. We serve as defense counsel for all FDA-related matters in Miami, including (but not limited to):

Import-Export Investigations

As the FDA explains, “All FDA-regulated products imported into the United States are required to meet the same laws and regulations as domestic goods. . . . FDA-regulated products are subject to inspection when offered for import into the United States. Products may be refused entry if they appear, from examination or otherwise, to violate FDA requirements. . . .”

The FDA has oversight of foreign-bound U.S. exports as well—including so-called “import for export” or “IFE” goods. While IFE goods are not subject to the same standards as products imported for domestic distribution, companies and individuals can still face intense scrutiny regarding their IFE operations—particularly when it appears that imported goods are not actually being re-exported.

In addition to IFE goods, the FDA also pays particular attention to goods imported from China and certain other countries. Entities and individuals that import goods from these countries must be especially careful to ensure strict statutory and regulatory compliance.

Along with FDA import-export investigations, we also represent clients facing investigations involving the International Traffic in Arms Regulations (ITAR) conducted by U.S. Customs and Border Protection (CBP) and the Office of Foreign Assets Control (OFAC). We have significant experience in all aspects of federal import-export compliance, and we represent clients in matters involving transactions with specially designated nationals (SDNs) and other OFAC issues as well.

Misbranding

Misbranding is a common issue with imported goods. Foreign manufacturers and distributors often are not familiar with the United States’ marketing and labeling requirements for consumer goods, medications, and other products. Importers must ensure that all products imported for distribution in the U.S. meet all pertinent requirements—as they can face significant penalties if they fail to do so.

Under Section 502 of the Food, Drug, and Cosmetic Act, a product can be considered “misbranded” under the following circumstances (among many others):

  • “Its labeling is false or misleading in any particular;”
  • “It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;”
  • “Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;”
  • “The device is subject to a performance standard and it does not bear the labeling prescribed in that standard;” or,
  • “There is any representation that creates an impression of official approval because of the possession by the firm of an FDA registration number.”

The FDA takes misbranding cases very seriously—particularly when the product in question is a medication or medical device. When facing misbranding allegations, companies and individuals must work closely with defense counsel to ensure that they have a clear understanding of their potential exposure—as well as any options they may have for mitigating this exposure during the FDA’s inquiry.

Counterfeiting

FDA import-export inspections and investigations in Miami also frequently involve allegations of counterfeiting. Counterfeiting is another major focus area for the FDA, particularly with regard to medications and medical devices. Importers must implement adequate safeguards to prevent the importation of counterfeit products and the distribution of counterfeit products that they import unintentionally.

Counterfeiting investigations often involve other federal agencies as well. This includes CBP, the FBI, and the DOJ—among others. Companies and individuals accused of importing counterfeit goods (or counterfeiting themselves) can face substantial penalties, and criminal prosecution will be a very real risk in many cases.

Distribution of Material Used to Manufacture Controlled Substances

Federal law specifically prohibits the importing, exporting, and distribution of materials used to manufacture controlled substances. Under 21 U.S.C. Section 843(a)(7), it is a federal offense to:

“[D]istribute, export, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe, that it will be used to manufacture a controlled substance or listed chemical . . . .”

With Miami’s reputation as one of the drug capitals of the world, FDA enforcement activity under Section 843(a)(7) is particularly prevalent in the area. Here too, the FDA frequently works with the FBI, DOJ, DEA, and other agencies to execute large-scale takedowns involving a broad array of federal charges.

Health Fraud Scams

Combatting “health fraud scams” is another top FDA enforcement priority. The FDA defines this term broadly to include virtually all unlawful practices that result in either: (i) illegally imported, misbranded,, counterfeit, or unapproved medications or medical devices reaching consumers; or, (ii) consumers or other payors being charged excessive prices. Individuals and organizations implicated in alleged health care fraud scams can face a wide range of charges, from violations of the Food, Drug, and Cosmetic Act to criminal health care fraud and conspiracy.

FAQs: Defending Against FDA Inspections, Investigations, and Charges in Miami

Why Am I Under Investigation By the FDA?

 

If you are under investigation by the FDA in Miami, there could potentially be several reasons why. For example, the FDA may have received a tip from an anonymous source or another federal agency, or the FDA may have found something that raised questions during a routine inspection. Determining why you are being targeted will be one of the first steps toward building an effective defense strategy.

What are the Risks of Facing an FDA Inspection or Investigation in Miami?

 

FDA inspections and investigations can have substantial consequences for companies and individuals. The FDA can impose administrative and civil penalties, and it can work with the DOJ to pursue criminal charges when warranted. It is not unusual for FDA investigations to carry the potential for six or seven-figure fines and years of federal imprisonment.

Can I Be Prosecuted for Unknowingly Importing Contraband, Counterfeit, or Misbranded Goods?

 

Generally, unknowingly is not a complete defense to unlawfully importing contraband, counterfeit, or misbranded goods. If you are facing an FDA investigation related to your importing operations in Miami, you will need to engage experienced legal counsel to determine what defenses you have available.

What are the Penalties for Importing in Violation of 21 U.S.C. Section 843(a)(7)?

 

Importing, exporting, and distributing materials used to manufacture controlled substances in violation of 21 U.S.C. Section 843(a)(7) is a felony-level federal offense. First-time offenses carry statutory fines and up to four years of federal imprisonment in most cases.

Why Should I Choose Oberheiden P.C. for FDA Defense in Miami?

 

Oberheiden P.C. is a federal defense firm that represents individuals and companies in high-stakes federal cases in Miami and other major cities across the country. Our lawyers and consultants have extensive experience on both sides of FDA inspections and investigations, and we have resolved the substantial majority of our clients’ federal inquiries without charges being filed.


Arrange a Confidential Consultation with a Miami FDA Defense Lawyer at Oberheiden P.C.

If you are facing scrutiny from the FDA in Miami, we encourage you to contact us promptly for a complimentary case assessment. Call 305-928-8505 or inquire online to speak with a senior defense lawyer in confidence.

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