For the importers, brands, and manufacturers moving food, supplements, and cosmetics through Florida’s ports — practical help meeting FDA requirements and responding quickly when a shipment is held.
South Florida is one of the country’s busiest gateways for food, dietary supplements, and cosmetics, and every product that crosses the border enters a web of federal rules. A label that overstates a claim, a shipment held at the port, or a cosmetics line that missed a registration deadline can stall a business overnight.
FDA regulatory work is federal administrative practice, which means we can advise clients across the country on their obligations under the federal Food, Drug, and Cosmetic Act, not only in Florida. When a question turns on a specific state’s law, we bring in local counsel so you are always properly advised. We do not promise a particular outcome with FDA; the stakes here can be a recall or a seizure, so our approach is careful and deliberate.
We work with importers, brand owners, contract manufacturers, and distributors, and we deliver much of this work in Spanish as well as English — useful when supplier records and agreements originate abroad, even though FDA itself requires records in English. Most matters are handled on flat-fee or retainer terms.
From port detentions to labeling and manufacturing contracts.
When FDA detains a shipment, or holds it under an Import Alert or detention without physical examination, the clock starts immediately. We help you respond to detention notices, prepare the documentation and testimony needed to release a shipment, and petition for removal from an Import Alert.
The federal cosmetics law was significantly expanded, adding facility registration, product listing, a designated “responsible person,” adverse-event reporting, and safety substantiation. We handle these obligations and, importantly, draft the contracts that allocate them between brand owners and the labs that manufacture their products.
Labels carry legal risk. We review ingredient and allergen statements, evaluate structure/function claims and their required disclaimers, and assess claim substantiation to reduce your exposure under FDA rules and to deceptive-practice claims from the FTC and under Florida law.
Food importers must maintain a Foreign Supplier Verification Program, one of FDA’s fastest-growing enforcement areas. We help you build and document an FSVP, draft supplier agreements, and respond when FDA audits your program.
An FDA Warning Letter or Form 483 demands a timely, well-documented written response. We prepare these responses on tight deadlines and coordinate the matter through counsel, which helps preserve the attorney-client privilege that non-lawyer consultants cannot offer.
Supply, co-manufacturing, and distribution contracts should say clearly who carries each regulatory obligation and who bears the risk if something goes wrong. We draft and negotiate these agreements so responsibility for quality and compliance is spelled out, not assumed.
Federal reach, port-side practicality, and clear pricing.
We learn your product, your supply chain, and what is in front of you — a detention, a deadline, or a new launch — and quote the work before we begin.
We assess where you stand against FDA requirements and, when enforcement is involved, map the response and the deadlines that control it.
We prepare registrations, labels, programs, contracts, or written responses, and explain each one in plain language before it is submitted.
We stay available for audits, renewals, and the next shipment, and keep your compliance current as the rules and your product line change.