FDA Ingredient Review Attorneys

An FDA ingredient review checks every ingredient in your formula against FDA rules before you manufacture or sell because the FDA regulates a product based on its ingredients as much as its marketing claims. Shehadeh Giannamore, PLLC performs FDA ingredient reviews for food, beverage, dietary supplement, and cosmetic companies to catch prohibited ingredients, missing New Dietary Ingredient (NDI) notifications, and allergen-declaration errors before they become a warning letter or an import hold.

What Is an FDA Ingredient Review?

An FDA ingredient review is a legal check of whether a product, as formulated, can be legally marketed in the U.S. without further regulatory approval. The FDA classifies products based on both their ingredients and their intended use  so an ingredient review is often the very first step before any label or marketing review even makes sense, because the wrong ingredient can put you in an entirely different, more strictly regulated category.

Some ingredients are lawful in one product category and illegal in another. An ingredient that’s a routine food additive in a beverage can require an approved drug application if it’s added to a topical cream with a health claim attached. An ingredient review identifies exactly where your formula sits before you commit to packaging, production, or a launch date.

Why Ingredient Classification Drives Everything Else

The FDA’s rules split almost entirely along product classification lines: food, dietary supplement, cosmetic, or drug. Ingredients determine that classification as much as your marketing does. Getting it wrong doesn’t just risk a labeling fix — it can mean your entire product needs to be reformulated, relabeled, or pulled from the market as an unapproved new drug.

What Our FDA Ingredient Review Covers

• FDA and regulatory database research to determine whether your formulated product, as-is, can be legally marketed
• New Dietary Ingredient (NDI) status  whether an ingredient in a dietary supplement was marketed before October 15, 1994 (grandfathered) or requires a New Dietary Ingredient notification to FDA at least 75 days before marketing
• Prohibited and restricted ingredient screening against FDA’s food additive, color additive, and cosmetic ingredient restrictions
• Ingredient nomenclature  confirming each ingredient is declared under its correct common or usual name, not a marketing name
• Allergen declaration review for all major food allergens required under federal law
• Drug-ingredient overlap  flagging ingredients that would push a food, supplement, or cosmetic into being regulated as a drug

Common Ingredient Issues We Catch

• An ingredient still awaiting FDA response on a New Dietary Ingredient notification, marketed as though it were already cleared
• A “natural” or novel ingredient with no history of safe use in that product category
• An active pharmaceutical ingredient added at a sub-therapeutic dose, which does not exempt it from drug regulation
• Ingredients declared under a proprietary or brand name instead of the FDA-required common name
• Undeclared allergens or cross-contact risk not reflected on the label

Our FDA Ingredient Review Process

1. Submit your formula  full ingredient list with quantities, sourcing, and any existing safety or NDI documentation
2. Classification and database review against FD&C Act provisions and FDA ingredient databases
3. Written findings on each ingredient’s status: clear, needs NDI notification, restricted, or prohibited
4. Reformulation guidance where an ingredient poses a legal risk, including compliant alternatives
5. NDI notification support if your supplement requires one before you can market it

This page is for general informational purposes only and does not constitute legal advice or create an attorney-client relationship.