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GRAS for Proteins & Amino Acids

Unlock U.S. market access with expert GRAS strategies for protein, peptide, and amino acid ingredients.

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What Is GRAS for Proteins & Amino Acids?

GRAS (Generally Recognized as Safe) lets protein and amino-acid ingredients enter the U.S. market when qualified experts agree they’re safe for the intended uses. While 21 CFR §172.320 lists 18 amino acids for nutritional fortification, many modern applications (functional doses, novel matrices, hydrolysates, blends) require a self-affirmed or FDA-notified GRAS. We build the science, exposure modeling, and safety rationale to support your claims—efficiently and defensibly.

When Is GRAS Status Needed?

  • Uses beyond basic fortification or outside §172.320 scope
  • Novel proteins (e.g., hydrolysates, precision-fermented proteins) or higher functional doses
  • Multi-amino-acid blends (cumulative exposure)
  • Retailer/investor diligence requiring FDA-transparent positioning
  • Global expansion where FDA GRAS strengthens acceptance

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Our GRAS Services for Proteins & Amino Acids

  • Regulatory Pathway Assessment (self-GRAS vs FDA-notified vs food additive petition)
  • Ingredient Characterization (identity, specs, peptide profile, L/D purity, residuals)
  • Toxicology & Safety Strategy (NOAEL, special-population considerations)
  • Exposure/Use-Level Modeling (EDI across categories; cumulative exposure)
  • Stability & Matrix Performance (heat, pH, moisture, Maillard, compatibility)
  • Digestibility & Bioavailability (PDCAAS/DIAAS context, absorption kinetics)
  • Allergenicity/Immunogenicity (especially dairy/animal proteins)
  • GRAS Dossier & Expert Panel (authoring, coordination, FDA liaison)
  • Post-Market Surveillance (literature monitoring, updates)

Common Ingredients We Support

  • Whey Protein (WPC/WPI) & Fractions – Identity, specs, lactose/residuals, allergen considerations; stability in RTD, bars, and high-heat processes.
  • Casein & Caseinates – Solubility/dispersion, heat stability, sodium/potassium caseinate labeling, allergen and peptide-profile assessment.
  • Protein Hydrolysates & Peptides – Degree of hydrolysis, peptide distribution, bitterness mitigation, bioavailability data, and immunogenicity review.
  • L-Theanine – Identity and purity (often from green tea or fermentation), intended cognitive/relaxation positioning, exposure modeling at common dose ranges.
  • L-Carnitine (and salts) – Identity and counter-ion characterization (e.g., tartrate), cardio-metabolic use cases, GI tolerance limits, cumulative exposure.
  • Taurine – Energy/beverage matrices, high-use scenarios, interactions with caffeine/other actives, stability at low pH.
  • Branched-Chain Amino Acids (Leucine, Isoleucine, Valine) – Ratios and combined exposures across categories; sports-nutrition dosing.
  • Other L-amino acids (e.g., L-Arginine, L-Glutamine, Glycine, etc.) – L/D purity, salt forms, total nitrogen load, and synergistic effects in blends.

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Example Use Cases We Support

  • RTD/RTM beverages fortified with whey or casein (heat/acid stability, protein quality, allergen labeling)
  • High-protein snacks/bars (Maillard risk, texture, shelf-life)
  • Amino-acid blends for performance or cognition (cumulative EDI and interaction rationale)
  • Hydrolysate-based products (peptide fingerprinting, bitterness control, digestibility)
  • Functional beverages with taurine or L-carnitine (dose justification, co-actives, pH stability)
  • L-theanine in beverages and gummies (purity, exposure, claim boundaries)

Why Choose dicentra?

  • 20+ years of regulatory success across proteins, peptides, and amino acids
  • Cross-functional team: toxicology, protein chemistry, formulation, regulatory
  • Pragmatic strategies balancing safety rigor with speed-to-market
  • Experience across North America and Europe to support global entry
  • End-to-end: feasibility → dossier & expert panel → FDA engagement → post-market

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Related Services

  • GRAS Notifications (all ingredient classes)
  • Food Additive Petitions
  • Novel Food / Global Market Entry
  • Safety & Toxicology Consulting

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