Comprehensive Experience In Food & Drug Law Matters

Our comprehensive food and drug practice involves advising and representing companies involved in the development, manufacture, production, packaging, and distribution of products regulated by the Food and Drug Administration (FDA), including food, food additives, dietary supplements, drugs, cosmetics, and medical devices. Our Chicago law firm provides a complete range of advisory, compliance, and enforcement defense services.

Our assistance for clients in the food and drug industries includes:

Food, drug, dietary supplement, medical device, cosmetic regulatory requirements
Labeling issues
Preparation & Filing of Food Contact Notifications & Food Additive Petitions
Evaluating “Generally Recognized as Safe” Status of Packaging Components and Food Ingredients
Developing & Implementing FDA Compliance Procedures
Preparation for & Response to Government Inspections
USDA Compliance for Meat & Poultry Producers & Packagers
Enforcement Defense, Litigation
Product Crisis Management ( Recalls and similar actions)
Packaging & Labeling Compliance

We work with you and your product from initial development, through pre-approval and approval, and entrance into the market. Our assistance extends beyond entrance into the market, as we can work with you on any inspection or violation issues you may encounter. Our experience in product crisis management means if you face a sudden product problem or potential recall of your product, you will have an experienced product crisis management team to help you evaluate the legal and practical issues you confront and to help guide your company through them effectively.

Thorough preparation and experienced guidance are your best defense against violation allegations, government interference, and litigation. Our goal is always to keep you a step ahead by planning, preparing, evaluating, analyzing, and executing comprehensive product plans.

If you would like to learn more about how we can serve you and your company, contact us anytime.

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GRAS Goes to Congress

By Eric F. Greenberg, Attorney-at-law

Remember that whole business involving NGOs and other folks objecting to the legal system that allows companies to self-determine that their uses of substances are Generally Recognized As Safe (“GRAS”)? And remember how some groups had gone to court to get the system declared unlawful, but late last year the court ruled against them? Well, there’s a new chapter to this story. Now, some members of Congress have proposed a bill that would make changes to the law to address those very same objections.

The GRAS pathway to clearance of the use of substances in packaging and in food is crucially important, and this proposed law has the potential to make enormous changes in various legal obligations. For that reason, packagers should keep a close eye on this latest chapter in the ongoing debate over the policy issues surrounding the GRAS system.

In my view, addressing the complaints we’ve heard for years about the GRAS program required changes in the law, so at least the objectors are in the correct forum. There’s been so much criticism of the Food and Drug Administration lately, what with its slow reaction to the infant formula contamination problem, on top of its handling of issues relating to heavy metals in baby food and various complaints about its handling of COVID and other drug approvals, for some examples. But when it comes to the GRAS program, it’s always seemed that most of the objectors’ objections were better directed at Congress than at FDA.

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