FDA consultants and food and drug attorneys both guide product compliance, but their scope, authority, and legal protection differ sharply. A food and drug attorney provides privileged legal representation before the FDA, including enforcement defense, while an FDA consultant offers …
FDA food consultant costs vary depending on expertise and project scope. Shehadeh Giannamore, PLLC offers tailored consulting rates for small businesses and start-ups navigating FDA compliance, product development, and marketing requirements, ensuring cost-effective guidance suited to each client’s regulatory needs. …
An FDA consultant for food services conducts ingredient reviews, label reviews, marketing reviews, and FDA registration support to confirm products meet federal law. We evaluate formulations, review advertising claims, and guide manufacturers through compliance issues, including warning letter responses, import …
Food facility registration renewal under Section 415 of the FD&C Act closes December 31, 2026, ending the biennial window that opens October 1, 2026. Facilities missing this deadline face registration cancellation and lose authorization to manufacture, process, pack, or store …
Foreign device manufacturers must designate one U.S. agent through FDA’s Unified Registration and Listing System as part of annual establishment registration under 21 CFR Part 807. This agent serves as FDA’s official point of contact, receiving communications and, when designated, …
Missed FDA registration or U.S. Agent deadlines expose foreign manufacturers to import detention, listing suspension, and removal from FDA’s registered facility database. Food facilities that skip the biennial October 1–December 31 renewal lose registration status entirely, halting shipments to U.S. …
Facility registration renewal is due biennially, with the first renewal deadline set for July 1, 2026, following initial registration by July 1, 2024. FDA charges no government fee for registration or listing, though foreign facilities must maintain a designated U.S. …
FDA warning letters in 2026 continue targeting compounding pharmacies. Telehealth operators, with a notable wave issued June 18, 2026, alongside sustained enforcement against online GLP-1 marketing—facilities. Products must maintain accurate FDA registration and listing to avoid triggering these actions. Foreign …
FDA import alerts can stop shipments at the border and disrupt your operations. These alerts indicate potential violations that may lead to detention of goods, lost revenue, and added logistics costs. This article walks through why import alerts happen, how …
Navigating FDA labeling rules can feel overwhelming for manufacturers and brand teams in the food and dietary supplement space. Because misbranding carries legal exposure and risks to consumer safety, companies need clear, practical guidance to get labels right. This article …