Peptides are increasingly used in functional foods, beverages, and performance nutrition products. From protein hydrolysates to precision-designed bioactive peptides, these short chains of amino acids are gaining commercial traction across sports nutrition, healthy aging, and wellness categories.

But when it comes to regulatory status in the United States, many companies ask: are peptides considered Generally Recognized as Safe (GRAS) for food use?

The short answer: peptides can be GRAS, but status depends on the specific ingredient and its intended use.

The GRAS concept in brief

Under the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is considered a food additive unless it is exempt. A substance is exempt if it is generally recognized, among qualified experts, as safe under the conditions of its intended use.

GRAS status may be established through:

• A long history of safe use in food prior to 1958, or
• Scientific procedures demonstrating safety

For most modern peptide ingredients, the scientific procedures pathway applies.

Are peptides inherently GRAS?

Peptides are fragments of proteins, typically composed of 2–20 amino acids. Many are naturally formed during digestion, fermentation, and food processing. Peptides derived from traditional food proteins (such as milk, whey, soy, egg, fish, or gelatin) may benefit from a strong safety foundation due to the long history of consumption of their source materials.

However, regulatory status is not automatic. GRAS eligibility depends on:

• Source material
• Manufacturing process (e.g., enzymatic hydrolysis, fermentation, purification)
• Degree of concentration
• Intended use level and food categories
• Target population
• Nature of marketing claims

A novel peptide, a highly purified fraction, or a product used at elevated functional doses will typically require a formal GRAS evaluation.

Evidence that peptides can achieve GRAS status

Peptide ingredients have successfully reached the U.S. market through GRAS conclusions supported by safety data and exposure modeling.

For example, in human food applications, companies have also received FDA “no questions” letters for peptide-based ingredients after submitting GRAS notifications supported by identity data, toxicology assessments, and dietary exposure analysis (i.e. GRN 1171).

FDA also responded to Animal GRAS Notice (AGRN) 59 for a porcine oligosaccharides–peptides complex intended for use in cat and dog food, stating it had no questions regarding the notifier’s conclusion that the ingredient was GRAS under its intended conditions of use [link needed]

These precedents demonstrate that peptides can qualify as GRAS when supported by appropriate scientific evidence.

How to bring a peptide to market under GRAS

Bringing a peptide ingredient to market typically involves the following steps:

1. Regulatory pathway assessment

Determine how the ingredient will be evaluated:

• Self-affirmed GRAS
• FDA-notified GRAS
• Or, in rare cases, a food additive petition

For novel or high-visibility ingredients, an FDA-notified GRAS often strengthens commercial acceptance.

2. Ingredient characterization

FDA expects detailed compositional data, including:

• Source protein (for naturally derived peptides) and/or raw materials (for synthetic peptides)
• Peptide profile and degree of hydrolysis
• Amino acid composition
• Purity and specifications
• Residual solvents or processing aids
• Heavy metal and microbiological limits

Clear identity and manufacturing controls are essential to demonstrate consistency and safety.

3. Safety assessment

A GRAS conclusion must be supported by a comprehensive safety narrative, which may include:

• Literature review of the peptide and/or source protein
• Subchronic animal studies, if warranted
• Genotoxicity and metabolic data (if not available, necessity determined on a case-by-case basis)
• Human tolerance or clinical data, if available
• Allergenicity evaluation
• Margin-of-safety calculations based on exposure

4. Exposure modeling

Estimated Daily Intake (EDI) must be calculated across all intended food categories. Safety must be demonstrated at anticipated consumption levels, including cumulative exposure from multiple product types.

5. Expert panel and dossier development

A formal GRAS dossier compiles identity, manufacturing, exposure, and safety data into a structured document reviewed by qualified experts. For FDA-notified GRAS, the dossier is submitted to the agency, which may respond with a “no questions” letter if it agrees with the conclusion.

Additional regulatory considerations

Even if a peptide is GRAS, companies must ensure:

• Claims are not false or misleading (Section 403(a))
• The ingredient does not trigger drug-related provisions (Section 301(ll))
• Allergen labeling requirements are met
• Marketing language does not cross into drug claims territory

Regulatory positioning must align with both safety and labeling compliance.

Why this matters

The peptide market continues to expand rapidly. Achieving GRAS status allows peptide ingredients to be used lawfully in conventional foods and beverages, supports retailer and investor confidence, and facilitates broader commercialization.

However, because peptides vary widely in structure, source, and dose, each ingredient requires its own defensible safety strategy.

Bottom line

Yes, peptides can be recognized as GRAS for food use in the United States. But GRAS status is ingredient-specific and must be supported by robust scientific evidence demonstrating safety under the intended conditions of use.

If your company is developing a protein hydrolysate, bioactive peptide, or precision-designed peptide ingredient, dicentra’s regulatory and toxicology team can help assess your pathway, prepare a defensible GRAS dossier, coordinate expert review, and manage FDA engagement. Contact dicentra to learn more about our GRAS consulting and submission services.