| Who it’s for | Food and beverage brands, manufacturers, co-packers, importers, restaurants and meal kit companies, startups launching a first product, and retailers building private label lines |
| What’s covered | Label reviews, ingredient and GRAS reviews, FSMA compliance, food facility registration, allergen compliance, import and FSVP support, FDA inspection and warning letter responses |
| Legal basis | Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), food labeling rules at 21 CFR Part 101, FSMA preventive controls at 21 CFR Part 117 |
| Who reviews it | A licensed FDA regulatory attorney, not a general consultant |
| Timely note | FDA food facility registration renewal runs October 1 to December 31, 2026 |
What Are FDA Consultant Food Services?
FDA consultant food services help food and beverage companies meet the rules FDA enforces before a product is made, labeled, imported or sold. That covers what goes into the product, how the facility operates, what the label says, and how the product enters the U.S. supply chain.
Most food businesses do not have in-house regulatory staff. Guidance often comes from a co-packer, a label designer, or a template copied from a competitor, and none of those sources carry any legal responsibility for the outcome. When FDA finds a problem, it holds the brand owner accountable.
Our firm provides these services through a licensed attorney. You get the practical, product-level review a consultant offers, plus legal analysis of your risk and privileged advice if FDA, a competitor, or a class action plaintiff ever questions your product.
Why FDA Food Compliance Matters
FDA treats a food as adulterated or misbranded when it fails to meet federal requirements. Either finding can lead to:
- Warning Letters posted publicly on FDA’s website
- Import refusals and detentions, including placement on an Import Alert
- Mandatory or voluntary recalls that pull product from shelves
- Facility registration suspension, which stops a facility from distributing food
- Retailer delistings, since major retailers increasingly require compliance documentation
- Consumer class actions over labeling claims such as “natural,” “healthy,” or “no preservatives”
A compliance review before launch usually costs a fraction of relabeling, a recall, or litigation.
Launching a new food product or updating an existing one? Talk with an FDA attorney before you print labels or place a production order.
Schedule a ConsultationWhat We Review, by Food Business Type
| Business Type | Key Regulations | What We Focus On |
|---|---|---|
| Packaged food and snack brands | 21 CFR Part 101; FALCPA; FASTER Act | Nutrition Facts, ingredient statements, allergen declarations, nutrient content and health claims |
| Beverage companies | 21 CFR Parts 101, 102, 120 | Juice HACCP, beverage vs. supplement classification, caffeine and functional ingredient claims |
| Manufacturers and co-packers | 21 CFR Part 117 (FSMA) | Food safety plans, preventive controls, supplier programs, recordkeeping |
| Importers | 21 CFR Part 1, Subpart L (FSVP); Prior Notice | Foreign supplier verification, entry documentation, import detentions and alerts |
| Restaurants and food service | 21 CFR 101.11; FDA Food Code (state adopted) | Menu calorie labeling for chains, allergen disclosures, retail food safety alignment |
| Startups and private label | FFDCA; 21 CFR Parts 101 and 170 | Ingredient legality, GRAS status, first-label review, launch readiness |
What’s Included in Our FDA Consultant Food Services
- Label and packaging review for principal display panel, net quantity, statement of identity, Nutrition Facts formatting, ingredient order, and manufacturer information
- Ingredient and formula review to confirm each ingredient is an approved food additive, GRAS, or otherwise lawful for its intended use
- Allergen compliance covering all nine major food allergens, including sesame, which became a major allergen on January 1, 2023
- Claims review of nutrient content claims, health claims, structure/function claims and marketing terms across packaging, websites and social media
- FSMA compliance support for Preventive Controls for Human Food, food safety plan review, and qualified facility exemptions
- Food facility registration including new registrations, biennial renewals and Unique Facility Identifier requirements
- Import and FSVP support for importers, foreign suppliers and U.S. agents
- Inspection and enforcement response to Form 483 observations, Warning Letters, and import detentions
- A written compliance memo explaining each issue, why it matters, and the specific fix
Core Service Areas
Food Label Reviews
Food labels have required placement, type size, order and wording. We check your label against 21 CFR Part 101 and give you marked corrections your designer can implement directly. That includes the Nutrition Facts panel, serving sizes based on Reference Amounts Customarily Consumed, the ingredient list in descending order of predominance, and required allergen statements. Learn more about our label reviews.
Ingredient and GRAS Reviews
A food ingredient must be an approved food additive, a color additive listed for food use, or Generally Recognized as Safe (GRAS) for its intended use. Botanicals, novel proteins, functional ingredients and imported ingredients often fall into gray areas. We review your formula, identify ingredients with regulatory risk, and advise whether an ingredient can be used as is, needs supporting documentation, or should be reformulated. GRAS policy, including self-affirmed GRAS and synthetic color additives, is under active FDA review, and we track those changes for our clients.
Food Claims and Marketing
Claims such as “high protein,” “low sodium,” “heart healthy,” or “supports immunity” each have their own rules. FDA’s updated definition of the “healthy” nutrient content claim now applies, with a compliance date of February 25, 2028. We review claims wherever they appear, since FDA and the FTC look at websites, Amazon listings, and influencer posts as well as the package.
FSMA Compliance
The Food Safety Modernization Act shifted FDA’s focus from responding to contamination to preventing it. Most facilities that manufacture, process, pack or hold food must maintain a written food safety plan prepared or overseen by a Preventive Controls Qualified Individual. We review plans, help determine exemptions for qualified facilities, and prepare companies for the Food Traceability Rule, which FDA has extended to a July 20, 2028 compliance date.
Food Facility Registration
Domestic and foreign facilities that manufacture, process, pack or hold food for U.S. consumption must register with FDA and renew every two years. The current renewal period runs from October 1 through December 31, 2026. A lapsed registration is treated as expired, and food from an unregistered facility can be refused or detained. We handle new registrations, renewals, and U.S. agent questions for foreign facilities.
Food Imports and FSVP
Importers are responsible for verifying that their foreign suppliers meet U.S. safety standards under the Foreign Supplier Verification Program. We help importers build FSVP files, respond to detentions, and petition for removal from Import Alerts.
Our FDA Food Compliance Process
- Submit your materials: labels, formulas, specifications, website links, or FDA correspondence
- Attorney review: analysis against the FFDCA, FDA regulations, and current guidance
- Findings report: a clear written memo listing each issue by risk level with the required correction
- Revision support: we review updated labels or documents until they are compliant
- Ongoing counsel: available for new SKUs, reformulations, and FDA inquiries as your business grows
Most label and ingredient reviews are completed within five to seven business days. Rush timelines are available.
Why Work With an FDA Attorney Instead of a Food Consultant
Many companies search for an FDA consultant for food and never consider a lawyer. The difference shows up when something goes wrong.
- Attorney-client privilege. Your communications with an attorney are generally privileged. A consultant’s notes and emails can be requested in litigation or an FDA investigation.
- Legal risk analysis. We assess regulatory exposure alongside litigation risk from competitors and consumer class actions.
- Enforcement experience. When FDA issues a Form 483 or Warning Letter, your attorney is already familiar with your products and can respond immediately.
- One point of contact. Label review, contract questions with co-packers, and enforcement defense are handled by the same counsel.
Frequently Asked Questions
- What does an FDA consultant for food services do?
- An FDA consultant for food services reviews labels, ingredients, facilities and import practices to confirm they meet FDA requirements. Our firm provides this service through a licensed attorney, so the review also covers legal risk and is protected by privilege.
- Does FDA approve food labels before they are sold?
- No. FDA does not pre-approve food labels. Companies are responsible for compliance, and FDA reviews labels after products reach the market, often during inspections, import entries, or in response to complaints.
- Do I need to register my food facility with FDA?
- Most facilities that manufacture, process, pack or hold food for U.S. consumption must register. Registration must be renewed between October 1 and December 31 of each even-numbered year, including 2026. Some operations, such as certain farms and retail food establishments, are exempt.
- Does my business need a FSMA food safety plan?
- Most registered facilities subject to the Preventive Controls for Human Food rule need a written food safety plan. Qualified facilities and some small businesses may be subject to modified requirements. We can review your operations and confirm which rules apply.
- How do I know if my ingredient is GRAS?
- Some ingredients are listed in FDA regulations or have received “no questions” letters through the GRAS Notification Program. Others rely on independent GRAS conclusions. We review the status of each ingredient in your formula and advise on documentation and risk.
- What are the major food allergens that must be declared?
- Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. These must be declared on the label using the specific food source name.
- Can you help if my food shipment was detained at the border?
- Yes. We respond to FDA import detentions, prepare supporting documentation, and pursue release of the shipment or removal from an Import Alert when applicable.
- How much do FDA consultant food services cost?
- Cost depends on the number of products and the scope of review. Many label and ingredient reviews are offered on a flat-fee basis so you know the cost before work begins.
Not sure if your food product or facility is compliant? Our attorney will review your situation and give you a clear answer.
Toll-free: (866) 785-0873
Direct: (305) 507-9843
Email: contact@giannamore-law.com
Schedule a ConsultationThis page provides general information and is not legal advice. Reading it does not create an attorney-client relationship. Regulatory requirements and compliance dates may change; contact our office for advice about your specific products.