The FDA (Food and Drug Administration) is the federal agency that is in charge of regulating food products and medications that are marketed and sold in the United States. Before a food product or a medication can be made or sold in the U.S., it must comply with the myriad regulations set forth by the FDA.

The FDA has requirements as to labeling of food products and as to which ingredients must be specifically listed. The FDA also promulgates rules for the manufacture of food products, intended to promote food safety and the avoidance of contamination.

For the manufacture and sale of medications, the FDA’s requirements are stringent and complex. For the purposes of the FDA, any product that is meant to be ingested and claims to produce a specific health benefit, is considered a drug. Every step of the process is subject to detailed regulation, from the initial manufacture and safety and effectiveness testing process, through the marketing and packaging of the finished medication.

Norman Spencer Law Group PC offer representation to business clients at every level of the food and drug development, production, distribution, and packaging industries. Our team of knowledgeable and skilled attorneys have extensive experience advising and representing food and drug producers, cosmetics and medical device manufacturers, and packaging manufacturers, converters and designers nationwide on issues concerning:

• FDA Requirements
• Food Contact Notifications; GRAS Notices and Analyses
• USDA Requirements
• Labeling Requirements
• Defense Against Allegations of FDA Violations
• Preparation For Government Inspections

This is one of the major federal criminal statutes which address the misbranding and harmful adulteration of food. The Federal Food, Drug, and Cosmetics Act provides for criminal penalties for violation of its prohibitions, which currently include a number of offenses such as:

• Adulterating or misbranding foods or drugs in interstate commerce;
• Introducing or receiving adulterated or misbranded foods or drugs in interstate commerce;
• Refusing to permit access to records;
• Refusing to permit inspection;
• Giving a false guarantee;
• Forging or counterfeiting;
• Unauthorized use of trade secrets;
• Falsely labeling or advertising drugs or devices;
• Adulterating or mutilating labels while the articles are held for sale;
• Sale or offering of colored oleomargarine;
• Use of F.D.A. report in advertising;
• Failure to register or furnish notification in compliance with the Act;
• Improper importation of a drug;
• Making a knowingly false statement in records or reports; and
• Submission of a report or recommendation that is false or misleading in any material respect.

The Food, Drug, and Cosmetic Act gives the government a broad sweep in prosecuting FDA violations.

Most FDA criminal cases start when the FDA agents discover violations during inspections. The FDA has authority to conduct reasonable searches and inspections of the premises of businesses and establishments regulated by law, and to collect samples for testing and examination. The Act also makes it a crime to refuse to permit such inspections. There has been a great degree of discussion whether the FDA searches require a warrant and it is generally established today that they do.

The Federal Food, Drug, and Cosmetic Act applies to corporations and corporate officers alike. The Supreme Court addressed criminal liability of corporate officers in US v. United States v. Dotterweich. In that case, the president of a small pharmaceutical company was convicted for shipping adulterated and misbranded drugs. He was not personally involved in shipping but he was the president of the corporation and as such he was in charge of the corporation’s day-to-day business. The Supreme Court upheld his conviction. After this decision, the law holds corporate executives to a high standard of care with respect to compliance with FDA regulations. In essence, the law creates a strict liability offense in not requiring any specific criminal intent. A corporate officer may be found guilty just by nature of his position.

One available defense against FDA violations charges is the guarantee defense which means that the defendant was guaranteed by his vendors that the goods were not adulterated or misbranded or if he otherwise acted in good faith.

Another potential defense may be the defendant was not under the obligation to comply with the Act. If the defendant had no responsibility or authority to comply, he cannot be prosecuted.

Our firm is there to provide advice and guidance on compliance with FDA regulations, including developing plans for compliance, implementation of compliance strategies, evaluation of current plans, and identification of weaknesses in current processes. Our attorneys will work closely with you to help you achieve complete adherence to FDA requirements.

Our FDA defense attorneys have a broad range of knowledge and experience in analyzing and evaluating products and components to determine whether a given product falls under FDA jurisdiction and to guide you through the FDA approval process. If you have already been accused of FDA violations, we offer a proactive and strong defense that will obtain the best possible outcome in your case.

Norman Spencer Law Group PC have particular expertise in working internationally with overseas companies which seek to market their product in the United States.

Whether you need to obtain FDA approval for your product, ensure compliance with FDA regulations, or you are facing accusations of FDA violations, Norman Spencer Law Group PC will be there for you. Call us at (212) 577-6677 for a thorough and straightforward discussion of your case.