Katherine Giannamore in the Shehadeh Giannamore, PLLC office
Katherine GiannamoreFounder & FDA Regulatory Attorney — Shehadeh Giannamore, PLLC
FDA • FTC • USDA Regulatory Counsel

Katherine Giannamore — FDA Regulatory Attorney

Helping food, beverage, dietary supplement, cosmetic, medical device, and OTC drug companies achieve FDA compliance nationwide and internationally — since 2012.

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    We may be reached seven days a week by phone at (305) 507-9843 or by email at contact@giannamore-law.com and strive to respond to all inquiries within 24 hours.

    2012Practicing FDA & food-drug law since
    19Dedicated FDA legal service areas
    24 hrsResponse to every inquiry — reachable 7 days a week
    GlobalClients served nationwide & internationally
    What We Handle

    FDA Compliance Services

    Regulatory counsel across every FDA-regulated product category, from pre-market review to enforcement defense.

    Food & Beverage

    Ingredient reviews, label reviews, nutrient content claims, organic & natural claims, allergen compliance, and FSMA guidance.

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    Dietary Supplements

    Supplement facts panels, structure/function claims, 30-day NDI notifications, and health claim substantiation.

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    Cosmetics

    Label reviews, marketing and website compliance, and MoCRA regulatory guidance.

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    Medical Devices

    510(k) premarket clearance, premarket approval (PMA) support, and device classification guidance.

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    Drugs & OTC

    FDA registrations, premarket notifications, and compliance review for over-the-counter drug products.

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    Enforcement & Import Defense

    Warning letter responses, import alert removals, reconditioning requests, and FDA inspection preparation — across every industry above.

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    Katherine Giannamore, FDA regulatory attorney and founder of Shehadeh Giannamore, PLLC
    Meet Your Attorney

    About Katherine Giannamore

    Katherine Giannamore has led the firm's Food & Drug Law practice since founding it in 2012, after beginning her career in the FDA practice group of a mid-sized Miami law firm. She has been a featured speaker on gluten-free labeling and major food allergen labeling under the Food Allergen Labeling and Consumer Protection Act (FALCPA), and works with clients in every FDA-regulated product category — foods, beverages, dietary supplements, cosmetics, medical devices, and OTC drugs.

    Licensed to practice law in Florida; admitted before the U.S. Courts of Appeals for the Third and Eleventh Circuits; rated by Super Lawyers.

    Featured Speaker — Gluten-Free Labeling Featured Speaker — FALCPA Allergen Labeling Practicing FDA Law Since 2012

    All FDA Legal Services

    FDA Compliance, Explained

    FDA Regulatory Compliance: What Businesses Need to Know

    What an FDA Regulatory Attorney Does

    An FDA regulatory attorney advises companies on compliance with the laws enforced by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the U.S. Department of Agriculture (USDA). This includes reviewing product labels and ingredients before launch, filing required registrations and notifications, responding to enforcement actions such as warning letters and import alerts, and advising on marketing claims. Katherine Giannamore has practiced FDA regulatory law since 2012 and represents clients nationwide and internationally.

    Who FDA Regulation Applies To

    Any company that manufactures, imports, distributes, or markets food or beverages, dietary supplements, cosmetics, medical devices, or OTC drugs in the United States is subject to FDA regulation — regardless of where the company itself is based. Shehadeh Giannamore, PLLC represents both domestic and international clients across each of these categories.

    Common FDA Compliance Issues We Handle

    Ingredient and label review before market launch; structure/function and health claim substantiation; FDA facility registration and premarket notifications; 510(k) submissions and premarket approval (PMA) for medical devices; responses to FDA warning letters; and removal from FDA import alerts, including reconditioning requests.

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    Stay Current

    Latest FDA Regulatory Alerts

    [Month Year]

    Cosmetic Fragrance Allergen Labeling

    FDA has signaled intent to propose fragrance allergen disclosure rules under MoCRA. Cosmetic marketers should review formulations ahead of a final rule.

    [Month Year]

    New Dietary Ingredient (NDI) Notifications

    Enforcement continues to focus on NDI compliance for supplement ingredients not marketed in the U.S. before October 15, 1994.

    [Month Year]

    cGMP & Label-Claim Substantiation

    Current enforcement focus includes cGMP compliance and substantiation of structure/function and health claims.

    Read the Food & Drug Blog →
    How It Works

    How We Work With You

    We offer a free initial consultation and respond to all inquiries within 24 hours. Whether you need a one-time label review or ongoing regulatory counsel, we'll provide a clear scope and fee estimate before any work begins.

    1

    Request a Consultation

    Free initial call to discuss your issue — seven days a week.

    2

    Get a Clear Scope & Fee Estimate

    No work begins without an agreed scope.

    3

    Resolve Your FDA Matter

    Ongoing counsel or a one-time deliverable — your call.

    Frequently Asked Questions

    FDA Regulatory Questions, Answered

    What does an FDA regulatory attorney do?
    An FDA regulatory attorney advises companies on compliance with FDA, FTC, and USDA law — including label and ingredient review, product registrations, and responses to enforcement actions like warning letters and import alerts — so products can be marketed lawfully in the United States.
    Do I need an FDA attorney or a regulatory consultant?
    A regulatory consultant can assist with technical compliance tasks, but only an attorney can represent you in FDA enforcement matters, provide advice protected by attorney-client privilege, and represent your company in proceedings against a federal agency.
    What is an NDI notification and when do I need one?
    A New Dietary Ingredient (NDI) notification is generally required before marketing a dietary supplement containing an ingredient not sold in the U.S. before October 15, 1994, and must typically be filed with FDA at least 75 days before the product is marketed.
    How should a company respond to an FDA warning letter?
    A warning letter response should address each violation cited, describe corrective actions taken or planned with specific timelines, and be submitted by the deadline stated in the letter — typically 15 working days.
    What triggers an FDA import alert, and how can it be removed?
    Import alerts are typically triggered by a pattern of violative shipments, adulterated or misbranded products, or failed inspections. Removal generally requires demonstrating, through testing data or corrective action documentation, that shipments comply with FDA requirements.
    Does my product need a 510(k) or premarket approval (PMA)?
    Most moderate-risk (Class II) medical devices require a 510(k) premarket notification showing substantial equivalence to a legally marketed device, while higher-risk (Class III) devices generally require the more extensive premarket approval (PMA) process.
    Does Shehadeh Giannamore, PLLC work with clients outside Florida?
    Yes. The firm represents food, beverage, dietary supplement, cosmetic, medical device, and OTC drug companies nationwide and internationally, since FDA jurisdiction applies regardless of where a company is physically located.
    How quickly does the firm respond to inquiries?
    We may be reached seven days a week by phone at (305) 507-9843 or by email at contact@giannamore-law.com, and we strive to respond to all inquiries within 24 hours.

    Ready to Talk Through Your FDA Matter?

    Request a free consultation — we respond to all inquiries within 24 hours, seven days a week.

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