The most common FDA compliance mistakes first-time supplement founders make on Shopify happen in the copy, not the capsule. A product description that promises to treat a condition, a missing disclaimer, a review widget full of disease claims, or an …
A new supplement brand can open a Shopify store without an FDA lawyer. It cannot lawfully sell a misbranded or adulterated dietary supplement, and the storefront does not change that. The useful question is not whether counsel is legally required …
Food startup founders benefit from FDA consultant review before launch. Ingredient legality, label compliance, and marketing claims each carry separate regulatory risk. Shehadeh Giannamore, PLLC reviews products and marketing materials before market entry, helping companies avoid warning letters, import alerts, …
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. …