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Food and Beverage Regulatory Lawyer for Brickell

Brickell is the financial capital of Latin American trade — the banks that finance Miami’s imports, the regional headquarters that direct them, and the executives who make product and market-entry decisions for the hemisphere all sit within a few blocks. Garg Law’s Miami office is here, at 1221 Brickell Avenue, in the middle of that corridor. That concentration of regulated commerce is why Garg Law brings its FDA and customs practice to Brickell businesses from a Miami office on Brickell Avenue — close enough to the port, the airport and the agencies to act the day a problem surfaces. The companies steering FDA-regulated product lines from Brickell towers need regulatory answers at deal speed — and the office handling them is on the same street.

Understanding food and beverage regulatory matters

The Food Safety Modernization Act rebuilt food regulation around prevention: registered facilities must maintain hazard analyses and preventive controls, importers must run Foreign Supplier Verification Programs (FSVP) proving their suppliers meet U.S. safety standards, and FDA enforces it all through inspections, records demands and the import screen. Miami’s food importers — perishables through MIA, containers through PortMiami — live under that regime daily.

Labeling is its own discipline: the Nutrition Facts panel, ingredient declarations, the major food allergens, standards of identity, net quantity, and the claims rules that separate lawful nutrient-content and health claims from the ones that turn food into an unapproved drug. Specialty categories — juice and seafood HACCP, acidified and low-acid canned foods, infant formula — add their own layers.

When something goes wrong, the toolkit is enforcement response: import detentions and alerts on flagged commodities, Form 483s and warning letters after inspections, recalls (voluntary and FDA-mandated), and the records and testing that prove a problem fixed.

Acting early vs. waiting: what it costs

Food is FDA’s highest-volume enforcement space, and FSVP violations are now among the most-cited import findings. A single labeling defect can strand a container at the port; a supplier problem can put a commodity on import alert; an inspection finding can spiral into a recall. Prevention costs a fraction of any of them.

The engagement, step by step

  1. Regulatory mapping of your products: applicable rules, registration status, specialty-category obligations
  2. FSVP and supplier-verification program build-out or remediation — the records FDA actually inspects
  3. Full labeling review against FDA requirements, allergen rules and the claims boundaries
  4. Import strategy: entry data, prior notice, and admissibility management for flagged commodities
  5. Enforcement response — inspections, 483s, warning letters, recalls — with corrective actions FDA credits

Five mistakes that sink these matters

  • Importing food with no FSVP importer identified — or an FSVP file that is a folder of certificates
  • Treating allergen labeling as a formatting detail instead of the top recall driver it is
  • Making health claims the evidence and the regulations do not support
  • Assuming the foreign supplier “handles FDA” — the U.S. importer owns the obligations
  • Skipping specialty-category rules (HACCP, LACF, juice) that apply to your exact product

Food and Beverage Regulatory Lawyer services for Brickell

The work around Brickell — international banking and trade finance, multinational regional headquarters, consumer brand offices, legal and professional services, import/export holding companies — is FDA-regulated at nearly every turn, and matters here move on Miami’s financial district, home to the banks, trade finance desks and regional headquarters that fund and direct hemispheric trade. Garg Law's Miami office is at 1221 Brickell Avenue, and the practice was built for exactly this market: founder Shelly Garg spent years counseling importers at the world's largest dedicated international trade law firm before opening her own, and works at the crossroads of FDA and CBP compliance for foreign and domestic companies across the food, beverage, supplement, cosmetics, OTC drug and medical device industries.

Frequently asked questions

What is FSVP and does it apply to my company?

The Foreign Supplier Verification Program rule requires most U.S. food importers to verify their foreign suppliers produce food meeting U.S. safety standards — hazard analysis, supplier approval, verification activities, records. If you are the FSVP importer identified at entry, FDA can inspect you and cite you personally.

Why do food shipments get detained at Miami ports?

The common causes: filth or contamination findings, undeclared allergens, labeling violations, missing facility registration or prior notice, and import-alert matches on the commodity or shipper. Each has a distinct response path — and most are preventable with entry-level compliance work.

Do I need FDA approval before selling a new food product?

Generally no pre-approval — but the ingredients must be lawful (approved additives or GRAS), the facility registered, the label compliant and any specialty-category rules met. “No pre-approval” means FDA checks compliance at the border and in the market instead.

What triggers a food recall?

Most recalls are voluntary, prompted by pathogen findings, undeclared allergens or foreign material — but FDA holds mandatory recall authority for foods under FSMA. Recall execution (strategy, notifications, effectiveness checks) is regulated too, and handled badly it multiplies the damage.

How should a food importer prepare for an FDA inspection?

Have the FSVP records ready — that is what FDA comes to see: hazard analyses, supplier approvals, verification records, corrective actions. Inspections of importers are records inspections; companies fail them on documentation, not on food safety intent.

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★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
Claire P. Client

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