What does an FDA consultant do?

An FDA consultant helps companies bring products to market in compliance with FDA law. That includes classifying the product, reviewing ingredients and labels, handling registrations and filings, reviewing marketing claims, and responding to FDA enforcement. Our firm provides these services through a licensed FDA attorney.

Why hire an FDA attorney instead of an FDA consultant?

An attorney provides the same practical compliance work a consultant offers, plus legal advice, attorney-client privilege, and the ability to represent you if FDA, the FTC, a retailer or a plaintiff challenges your product.

How does FDA decide how my product is regulated?

FDA looks at a product's ingredients and its intended use, which is shown by its labeling, marketing and claims. The same ingredient can be regulated as a food, dietary supplement, cosmetic or drug depending on how the product is sold and what it claims to do.

Does FDA approve labels or products before they are sold?

For most foods, dietary supplements and cosmetics, no. FDA does not pre-approve these products or their labels, and the company is responsible for compliance. Many medical devices need 510(k) clearance or Premarket Approval, and new drugs generally need FDA approval before sale.

Which FDA registrations does my company need?

It depends on the product and your role. Food and supplement facilities register with FDA and renew every two years, cosmetic facilities register and list products under MoCRA, device establishments register and list devices annually, and drug establishments register and list their products. Foreign firms usually need a U.S. agent.

Can you help foreign companies selling into the U.S.?

Yes. We help foreign manufacturers and exporters with product classification, U.S. labeling, registrations, U.S. agent questions, and FDA import detentions.

How much do FDA consultant services cost?

Cost depends on the product and scope of work. Many ingredient, label and website reviews are offered on a flat-fee basis so you know the cost before work begins.

FDA Consultant Services | Attorney-Led FDA Compliance

Who it’s for	Brands, manufacturers, private label sellers, importers, e-commerce and Amazon sellers, and startups selling FDA-regulated products in the U.S.
Products covered	Food and beverages, dietary supplements, cosmetics, medical devices, and OTC drugs
What’s covered	Product classification, ingredient reviews, label and packaging reviews, FDA registrations, marketing and website reviews, filings, imports, and enforcement responses
Legal basis	Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and FDA regulations in Title 21 of the Code of Federal Regulations
Who reviews it	A licensed FDA regulatory attorney, not a general consultant

What Are FDA Consultant Services?

FDA consultant services help companies develop, label, market and sell products that comply with the laws FDA enforces. The work starts before a product is manufactured and continues through launch, marketing, importation, and any FDA inquiry that follows.

Our services are industry and product specific. A protein bar, a probiotic capsule, a face serum and a wearable device each face different rules, and a mistake that is minor in one category can make a product illegal in another. We tailor every review to the product in front of us.

Unlike a traditional FDA consultant, our firm provides this work through a licensed attorney. You get practical, product-level guidance along with legal analysis, attorney-client privilege, and representation if your product is ever challenged.

Why Product Classification Comes First

FDA regulates a product based on two things: what is in it and what it is intended to do. Intended use is shown by the label, the website, social media, and even customer reviews a company shares. The same ingredient can be regulated in very different ways:

Food: sold for taste, aroma or nutritional value
Dietary supplement: sold to supplement the diet, with structure/function claims allowed under DSHEA
Cosmetic: sold to cleanse, beautify or change appearance
Drug: sold to diagnose, treat, cure, mitigate or prevent disease, or to affect the structure or function of the body outside the food and supplement rules
Medical device: an instrument or product that achieves its intended purpose without chemical action or metabolism

Getting classification wrong is one of the most common reasons products receive Warning Letters or import detentions. It is also the easiest problem to prevent.

Not sure how FDA will classify your product? Talk with an FDA attorney before you finalize your formula, label or marketing.

Schedule a Consultation

FDA Consultant Services, by Product Category

Product Category	Key Regulations	How We Help
Food and beverages	21 CFR Parts 101 and 117; FSMA	Ingredient and GRAS reviews, Nutrition Facts and label reviews, FSMA compliance, facility registration
Dietary supplements	DSHEA; 21 CFR Parts 101 and 111	Ingredient and NDI reviews, Supplement Facts panels, structure/function claims, 30-day notifications
Cosmetics	FD&C Act; Modernization of Cosmetics Regulation Act (MoCRA)	Ingredient and color additive reviews, labeling, drug claim screening, facility registration and product listing
Medical devices	21 CFR Parts 807, 814 and 820	Classification, 510(k) clearance, Premarket Approval, labeling and quality system guidance
OTC drugs	OTC monographs; 21 CFR Parts 201, 210 and 211	Monograph compliance, Drug Facts labeling, registration and listing, claim review

What’s Included in Our FDA Consultant Services

Product classification to confirm how FDA will regulate your product
Ingredient reviews to determine whether each ingredient is lawful for your product category and intended use
Label and packaging reviews covering placement, formatting, required statements and panels
Marketing and website reviews of claims across websites, social media, Amazon listings and advertising
FDA registration services for food, cosmetic, device and drug facilities, including U.S. agent guidance
FDA filings such as 30-day notifications, NDI notifications, 510(k)s and PMAs
Import support for pre-shipment compliance, detentions and Import Alerts
Enforcement response to Warning Letters, untitled letters and Form 483 observations
A written compliance memo explaining each issue, why it matters, and the specific fix

Core Service Areas

FDA Ingredient Reviews

Ingredients decide whether a product can be legally sold and how it will be regulated. Some ingredients may only be used in drugs, some require premarket notification, and others are restricted to certain uses or amounts. We review your full formula, identify ingredients that create regulatory risk, and advise whether to proceed, file with FDA, or reformulate. Learn more about ingredient reviews.

FDA Label Reviews

FDA sets detailed requirements for where information appears on a label, how it is formatted, and what statements must be included. Required elements vary by product and can include the statement of identity, net quantity of contents, ingredient list, Nutrition Facts or Supplement Facts panel, Drug Facts, allergen declarations, warnings, and manufacturer information. We give you marked corrections your designer can apply directly. Learn more about label reviews and Supplement Facts panels.

Marketing and Website Reviews

FDA treats websites, social media and marketplace listings as part of a product’s labeling, and the FTC oversees advertising claims. A single post or testimonial can turn a supplement or cosmetic into an unapproved drug. We review your marketing across every channel and suggest compliant wording that still sells. Learn more about website reviews.

FDA Registration Services

Most companies that make or handle FDA-regulated products must register with FDA. Food and supplement facilities register and renew every two years, with the next renewal period running October 1 through December 31, 2026. Cosmetic facilities register and list products under MoCRA, and device and drug establishments register and list their products annually. Foreign facilities generally must designate a U.S. agent. We handle registrations, renewals and updates so your products are not held for paperwork issues.

Product-Specific Filings

Some products need FDA filings before or shortly after launch. We prepare 30-day notifications for supplement claims, New Dietary Ingredient notifications, 510(k) submissions for medical devices, and Premarket Approval applications for Class III devices.

Imports and Enforcement

When FDA detains a shipment or issues a Warning Letter, response deadlines are short. We handle FDA import detentions, reconditioning requests and Import Alert removals, and prepare Warning Letter responses that address every violation and support a close-out.

Our FDA Consulting Process

Submit your materials: formulas, specifications, labels, website links, or FDA correspondence
Classification and scope: we confirm how FDA will regulate the product and what needs review
Attorney review: analysis against the FD&C Act, FDA regulations, and current guidance
Findings report: a clear written memo listing each issue by risk level with the required correction
Revision and filing support: we review updated materials and handle required registrations or filings
Ongoing counsel: available for new products, reformulations, and FDA inquiries as you grow

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 Consultant

Many companies search for an FDA consultant 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 weigh FDA and FTC exposure alongside competitor challenges and consumer class actions.
Enforcement representation. If FDA acts against your product, your attorney already knows it and can respond right away.
One point of contact. Product reviews, filings, contracts with manufacturers, and enforcement defense are handled by the same counsel.

Frequently Asked Questions

What does an FDA consultant do?: An FDA consultant helps companies bring products to market in compliance with FDA law. That includes classifying the product, reviewing ingredients and labels, handling registrations and filings, reviewing marketing claims, and responding to FDA enforcement. Our firm provides these services through a licensed FDA attorney.
Why hire an FDA attorney instead of an FDA consultant?: An attorney provides the same practical compliance work a consultant offers, plus legal advice, attorney-client privilege, and the ability to represent you if FDA, the FTC, a retailer or a plaintiff challenges your product.
How does FDA decide how my product is regulated?: FDA looks at a product’s ingredients and its intended use, which is shown by its labeling, marketing and claims. The same ingredient can be regulated as a food, dietary supplement, cosmetic or drug depending on how the product is sold and what it claims to do.
Does FDA approve labels or products before they are sold?: For most foods, dietary supplements and cosmetics, no. FDA does not pre-approve these products or their labels, and the company is responsible for compliance. Many medical devices need 510(k) clearance or Premarket Approval, and new drugs generally need FDA approval before sale.
Which FDA registrations does my company need?: It depends on the product and your role. Food and supplement facilities register with FDA and renew every two years, cosmetic facilities register and list products under MoCRA, device establishments register and list devices annually, and drug establishments register and list their products. Foreign firms usually need a U.S. agent.
Can you help foreign companies selling into the U.S.?: Yes. We help foreign manufacturers and exporters with product classification, U.S. labeling, registrations, U.S. agent questions, and FDA import detentions.
How much do FDA consultant services cost?: Cost depends on the product and scope of work. Many ingredient, label and website reviews are offered on a flat-fee basis so you know the cost before work begins.
How quickly can you review my product?: Most label and ingredient reviews are completed within five to seven business days. Rush timelines are available for launches and urgent FDA matters.

Not sure if your product 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 Consultation

This page provides general information and is not legal advice. Reading it does not create an attorney-client relationship. Regulatory requirements may change; contact our office for advice about your specific products.

FDA Consultant Services