About FDA Consultant Attorney Katherine Giannamore and Shehadeh Giannamore, PLLC
Katherine L. Giannamore is an FDA compliance attorney and the founder of Shehadeh Giannamore, PLLC. She advises companies that make, import, or sell food, dietary supplements, cosmetics, and over-the-counter drugs on whether a product, a label, or a marketing claim will hold up before it reaches the market, and on what to do when the FDA says it does not.
She is Board Certified in Health Law by The Florida Bar, and she holds an LL.M. in Food and Drug Law from the University of Maryland Francis King Carey School of Law. Before law school she earned a B.S. in Food Science and Human Nutrition from the University of Florida and an M.P.H. from the University of Miami, so ingredient questions, labeling, and regulatory strategy are handled by the same person.9
An FDA compliance attorney for Coral Gables, Brickell, and Doral
The firm is based in Miami and works with businesses in Coral Gables, Brickell, and Doral, along with clients elsewhere in Florida and nationwide. Most FDA compliance work happens on documents rather than in a courtroom, so where a company sits rarely decides whether she can take a matter. It does decide how quickly a label, a formula, or an import hold gets reviewed.
For a company searching for an FDA compliance attorney in Coral Gables, Brickell, or Doral, or for a dietary supplement compliance attorney in Coral Gables, the engagement looks the same: a written review of the product and its claims before packaging is printed or advertising spend starts.
What she reviews
The practice concentrates on the points where a product most often runs into the FDA.
- Ingredient reviews, including whether a substance belongs in a food, a supplement, or a cosmetic, and whether a new dietary ingredient needs a 30-day notification.
- Label reviews: Supplement Facts and Nutrition Facts panels, outer packaging, allergen labeling, and required statements.
- Claim reviews, covering structure/function claims, health claims, nutrient content claims, and wording that crosses into a disease claim.
- Marketing reviews for websites, brochures, video ads, and social content, including claims that a customer review can create.
- Import matters: detention, import alert removal, and reconditioning.
- Warning letter responses.
- Registration and listing, plus premarket questions for devices, including 510(k) clearance and premarket approval.
Dietary supplement compliance is the largest share of the work. A supplement does not need FDA approval before it is sold, and that is precisely what gets founders into trouble. The claims, the ingredients, and the labeling still have rules, and the firm reviews all three before a launch.
Background
She has led the firm’s FDA practice since it opened in 2012. She earned her J.D. from the University of Miami School of Law the same year, after working on FDA matters as a student at a mid-size Miami firm. She is licensed in Florida and admitted in the United States Court of Appeals for the Third Circuit and the Eleventh Circuit.
Her speaking has covered gluten-free food labeling and major food allergen labeling under the Food Allergen Labeling and Consumer Protection Act. Both talks were given as those rules took shape, and the labeling framework she spoke on is the one she still applies to client packaging.
Companies also hire her to review an entire store before it opens. For supplement brands selling through Shopify, that review covers the product pages, the ad copy, and the claims a review section can make by accident.
Talk to the firm
Send the label, the formula, or the FDA letter. She reads it herself and responds within one business day, seven days a week. Call (866) 785-0873 or write to contact@giannamore-law.com.