When an agency implements policies and procedures that are beyond the true scope of its authority, we are prepared to take the federal government to court and zealously defend our clients. Our lawyers understand how to investigate charges, build a case, and muster facts that support our clients, whether before the federal courts or the agencies' administrative law judges. Trust our experience: these are serious charges that require active and immediate attention. Call us at 713.622.8333 today.

The U.S. Food and Drug Administration (FDA) regulates more than 25% of the gross domestic product (GDP) of the United States.

The U.S. Department of Agriculture (USDA) governs a substantial percentage as well. Whether companies under FDA or USDA jurisdiction are bringing a new product to market, responding to an agency enforcement action, improving or responding to food safety and drug safety practices and needs, or attempting to challenge a new regulatory initiative, businesses regulated by FDA or USDA must know how to navigate the regulatory process. They must also clearly understand the legislative process and how new legislation can impact their businesses.

Individuals and companies under FDA, USDA, and DEA jurisdiction are subject to stringent public health statutes. Violation of these statutes carries the risk of civil liability, as well as criminal liability.

An increase of federal FDA investigators has led to an elevated level of inspections across the United States and abroad. Consequently, there has been an array of new violations as well as repeat violations. Repeat violations result in the formation of industry trends and can be quite alarming when you consider that different areas of the country and world are making the same mistakes.

In 2010, the U.S. Food & Drug Administration (FDA) has made nine additions to Import Alert #95-04, “Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements” (IA 95-04) updated on June 3, 2010.

The FDA has regulatory jurisdiction over any and all electronic products capable of emitting radiation: both domestic and of foreign build. As reported by Benjamin L. England, of FDA Imports.com, LLC, “Enforcement on laser pointers was big in the mid 90’s when I worked at the FDA; it appears as though this isn’t something they are going to ‘lighten up on’”. Any shipment may be subject to detention upon first attempt of entry without proper certification that a Laser product has met the Performance Standards (21 CFR 1010.2, 1010.3, 1040.10 and 1040.11) and will be subject to all future entries as well.

More than 60 firms have been placed on the Import Alert #95-04 Red List for importing a range of laser products that do not comply with FDA labeling and safety data. Violations have included failure to provide the required certifications and warnings, submitting false entry documents, or not submitting the correct safety documentation to the FDA’s Center for Devices and Radiological Health (CDRH). Any firm placed on IA #95-04 will have their products Detained Without Physical Examination (DWPE) at Customs.

If you believe you may be under federal investigation for a Healthcare Fraud Case, it is critical that you hire a qualified criminal defense attorney right away. Do not risk having your rights violated by neglecting to retain a skilled, experienced criminal defense attorney.
The Houston, Texas law office of Kuniansky & Associates will work diligently to ensure your rights are protected.

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