Classification
Product TypeIngredient
Product FormDry powder
Industry PositionDairy-derived protein ingredient for food and dietary supplement manufacturing
Market
In the United States, casein and caseinates are traded and used as dairy-protein ingredients (HS 3501) in sports nutrition powders, meal replacements, and broader food manufacturing. Products marketed as dietary supplements are expected to be manufactured, packaged, labeled, and held under the dietary supplement cGMP regulation in 21 CFR Part 111. Imported casein shipments are subject to FDA import controls, including Prior Notice and food facility registration verification at entry, and may be detained or refused when filings are inadequate. Because casein is milk-derived protein, U.S. allergen labeling requirements for milk are a core compliance requirement for foods and dietary supplements containing casein/caseinates.
Market RoleDomestic consumer and manufacturer market (imports and domestic dairy-ingredient supply both relevant, depending on specification and channel)
Domestic RoleWidely used formulation ingredient for protein-focused dietary supplements and food manufacturing; compliance-driven procurement by importers and manufacturers
Specification
Physical Attributes- Powdered dairy-protein ingredient; moisture control and caking behavior are common handling and acceptance considerations for bulk buyers.
Compositional Metrics- Milk protein content (dry matter basis), moisture, fat, and ash limits are commonly referenced in buyer specifications and international standards for edible casein products.
Supply Chain
Value Chain- Milk collection → skimming/standardization → coagulation (acid or enzyme) → separation/washing → drying → milling/sieving → bulk packaging → ingredient distributor/importer → U.S. food or dietary supplement manufacturer
Temperature- Typically managed as a dry, shelf-stable ingredient; protect from heat and humidity to prevent quality loss and caking.
Atmosphere Control- Moisture/condensation control during storage and transport is important to maintain powder flowability and specification conformity.
Shelf Life- Shelf-life and usability are highly sensitive to moisture ingress and storage humidity for powdered dairy proteins.
Risks
Regulatory Compliance HighFor imported casein used in food or supplement supply chains, inadequate FDA import compliance (e.g., missing/incorrect Prior Notice, inability to verify required food facility registration, or weak importer FSVP controls) can result in shipment holds, detention, or refusal at U.S. ports of entry.Align broker and importer workflows to FDA Prior Notice and facility registration requirements; confirm the designated U.S. FSVP importer has an appropriate, documented FSVP for the product/supplier and that shipment/label data match filings.
Food Safety MediumU.S. importers subject to the FSVP rule must verify foreign suppliers’ controls and may require extensive documentation, audits, and corrective actions if hazards or supplier performance are not adequately managed; this can delay onboarding or disrupt continuity of supply.Provide a robust technical dossier (specifications, COAs, allergen control plan, hazard analysis) and support supplier verification/audit requests aligned to the importer’s FSVP obligations.
Allergen Labeling MediumBecause casein/caseinates are milk-derived proteins, failures in milk allergen declaration or allergen cross-contact controls can trigger enforcement actions and recalls in the U.S. for foods and dietary supplements containing these ingredients.Ensure labeling clearly declares milk as a major allergen and maintain validated allergen control procedures to prevent cross-contact and misbranding.
FAQ
Does a U.S. product that contains casein need to declare milk as an allergen on the label?Yes. In the U.S., milk is a major food allergen and packaged foods (including dietary supplements) must clearly declare the allergen source when an ingredient contains milk-derived protein such as casein or caseinates.
What FDA import steps are most likely to delay a casein shipment entering the United States?Common delay points include inadequate or incorrect FDA Prior Notice submissions and problems verifying required food facility registration information at entry; these issues can lead to holds, detention, or refusal.
If casein is used in a protein powder sold as a dietary supplement in the United States, what GMP rule applies?Dietary supplements sold in the U.S. are subject to the dietary supplement cGMP regulation in 21 CFR Part 111, which sets requirements for manufacturing, packaging, labeling, and holding operations.