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.
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.
Learn moreDietary Supplements
Supplement facts panels, structure/function claims, 30-day NDI notifications, and health claim substantiation.
Learn moreCosmetics
Label reviews, marketing and website compliance, and MoCRA regulatory guidance.
Learn moreMedical Devices
510(k) premarket clearance, premarket approval (PMA) support, and device classification guidance.
Learn moreDrugs & OTC
FDA registrations, premarket notifications, and compliance review for over-the-counter drug products.
Learn moreEnforcement & Import Defense
Warning letter responses, import alert removals, reconditioning requests, and FDA inspection preparation — across every industry above.
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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.
All FDA Legal Services
- FDA Consultant Services
- Ingredient Reviews
- FDA Label Reviews
- Label & Marketing Reviews
- FDA Imports
- Supplement Facts Panels
- Outer Packaging Requirements
- Website Reviews
- FDA Food Services
- Nutrient Content Claims
- Organic & Natural Claims
- Dietary Supplement Services
- Structure/Function Claims
- Disease Claims
- Health Claims
- FDA Warning Letter Responses
- 30-Day Notification — Dietary Supplements
- Premarket Approval (PMA)
- 510(k) / Premarket Clearance
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.
Rated on Google
The firm’s legal analysis is exceptionally thorough, and every matter is approached with meticulous attention to detail. Their briefs are thoughtfully researched, strategically crafted, and supported by comprehensive legal authority, reflecting a deep command of both substantive and procedural law. It is evident that no issue is addressed superficially; every argument is carefully developed and backed by extensive research and sound legal reasoning.
Equally impressive is the firm’s responsiveness and communication. Questions are answered promptly, deadlines are consistently met, and clients are kept informed throughout the process. They remain current on evolving statutes, regulations, and case law, ensuring that every strategy is informed by the most up-to-date legal developments.
What distinguishes this practice is its combination of intellectual rigor, strategic advocacy, and unwavering professionalism. The level of preparation, precision, and diligence brought to every matter inspires confidence and demonstrates a genuine commitment to achieving the best possible outcome for clients.
I would highly recommend this firm to anyone seeking knowledgeable, responsive, and exceptionally well-prepared legal counsel.
Latest FDA Regulatory Alerts
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.
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.
cGMP & Label-Claim Substantiation
Current enforcement focus includes cGMP compliance and substantiation of structure/function and health claims.
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.
Request a Consultation
Free initial call to discuss your issue — seven days a week.
Get a Clear Scope & Fee Estimate
No work begins without an agreed scope.
Resolve Your FDA Matter
Ongoing counsel or a one-time deliverable — your call.
FDA Regulatory Questions, Answered
What does an FDA regulatory attorney do?
Do I need an FDA attorney or a regulatory consultant?
What is an NDI notification and when do I need one?
How should a company respond to an FDA warning letter?
What triggers an FDA import alert, and how can it be removed?
Does my product need a 510(k) or premarket approval (PMA)?
Does Shehadeh Giannamore, PLLC work with clients outside Florida?
How quickly does the firm respond to inquiries?
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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