FDA GRAS — Generally Recognized as Safe Food Additives

"Generally Recognized as Safe" (GRAS) is the FDA's legal category for food ingredients that qualified scientific experts agree are safe under their intended conditions of use — meaning food companies can add these substances to food without obtaining pre-market FDA approval, so long as the safety determination is supported by scientific evidence and general scientific consensus. The GRAS framework covers thousands of common food ingredients: salt, vinegar, baking powder, spices, preservatives, nutrients, stabilizers, and flavor enhancers. Two regulatory lists govern GRAS substances: the codified list at 21 CFR Part 182 (the original FDA-established GRAS list, updated through the 1980s–1990s), and the modern self-affirmation system under 21 CFR § 170.36, which allows companies to notify FDA of their own GRAS determinations. Ingredients on either list can be used in food without separate FDA approval, subject to good manufacturing practice and the concentration limits specified in the regulations.

Current Rule (2026)

What This Rule Does

GRAS status is the legal gateway between food additives (which require FDA pre-market approval under 21 U.S.C. § 348) and ingredients companies can use freely. The Food, Drug, and Cosmetic Act requires that any substance intentionally added to food must either be approved as a food additive by FDA — a potentially multi-year process — or fall under the GRAS exemption. GRAS status means the scientific community (not just FDA) broadly agrees the substance is safe for its intended use.

The codified GRAS list at 21 CFR Part 182 enumerates specific substances in seven categories that FDA has determined are GRAS when used in accordance with good manufacturing practice: spices and natural flavorings (§ 182.10); natural extractives used in conjunction with spices (§ 182.20); natural substances used in conjunction with spices (§ 182.40); multiple-purpose GRAS food substances including glutamic acid, phosphoric acid, and glycine (Subpart B); anticaking agents like calcium silicate and magnesium carbonate (Subpart C); chemical preservatives including sodium benzoate, sorbic acid, and BHA/BHT (Subpart D); sequestrants including citric acid and calcium EDTA (Subpart G); stabilizers like guar gum (Subpart H); and nutrients including vitamin A, riboflavin, and niacin (Subpart I).

Good manufacturing practice is the controlling constraint: the regulations specify that the quantity of any GRAS substance added to food must not exceed the amount reasonably required to accomplish the intended technical effect. Substances that become components of food incidentally during processing must be reduced to the extent reasonably possible. Compliance with GMP is not optional — a substance that is GRAS at low concentrations can become an unapproved food additive if used in excessive quantities.

The modern GRAS notification program (21 CFR § 170.36), distinct from the codified list at Part 182, allows manufacturers to notify FDA of their own conclusion that a new ingredient is GRAS. FDA reviews the notice and may respond with a "no questions" letter (effectively a safety concurrence), a request for additional data, or a statement that the notice is insufficient. Companies may use an ingredient under a self-determined GRAS conclusion even without FDA's response — but doing so carries legal and reputational risk if FDA later disagrees.

Key Provisions

• § 182.1 — Core GRAS standard: a substance is GRAS when used in a quantity not exceeding that reasonably required for its intended technical effect, consistent with good manufacturing practice. Common examples cited in the rule: salt, pepper, vinegar, baking powder, monosodium glutamate.
• § 182.10 — Spices and natural seasonings: lists over 100 plant-derived spices and flavoring agents (allspice, anise, basil, bay, cardamom, cayenne, cinnamon, cumin, garlic, ginger, nutmeg, oregano, paprika, rosemary, sage, thyme, turmeric, vanilla bean, etc.) — all GRAS when used as spices, seasonings, or flavorings
• § 182.1045 / § 182.1047 — Glutamic acid and glutamic acid hydrochloride: GRAS as salt substitutes in accordance with GMP (glutamic acid is the amino acid backbone of MSG)
• § 182.1073 — Phosphoric acid: GRAS as a buffer and neutralizing agent; widely used in colas and other acidic beverages
• §§ 182.3013, 182.3089, 182.3109 — Chemical preservatives (Subpart D): sodium benzoate (used in acidic beverages and condiments), sorbic acid and potassium sorbate (used in cheese, baked goods, wine), and BHA/BHT (antioxidants used in fats and oils) — all GRAS at specified use levels with labeling required to disclose the preservative and its function
• §§ 182.5013–182.5930 — Nutrients (Subpart I): vitamins and minerals including vitamin A, thiamine, riboflavin, niacin, vitamin C, vitamin D, vitamin E, calcium carbonate, ferrous sulfate, zinc sulfate — GRAS when added for nutritional purposes at levels consistent with GMP and with applicable fortification standards
• §§ 182.6085–182.6769 — Sequestrants (Subpart G): substances that bind metal ions in food to prevent oxidation and discoloration; includes citric acid, tartaric acid, calcium EDTA, and sodium hexametaphosphate

How It Affects You

GRAS status is largely invisible to consumers — it's the legal framework that allows the ingredients listed on food packages to be there without a separate FDA approval stamped on each product. If you're reading a food label and seeing "sodium benzoate," "BHA," "sorbic acid," or "citric acid," those are GRAS substances operating under 21 CFR Part 182.

The policy debate around GRAS has intensified in recent years because the self-affirmation system allows companies to determine GRAS status for new ingredients without any FDA review. A 2022 FDA report found that thousands of GRAS determinations have been made by industry without any formal FDA notification. Critics argue this creates safety gaps for novel ingredients — particularly for food additives that may not have had the benefit of decades of use. FDA's 2023 action on brominated vegetable oil (BVO) — revoking its GRAS status and prohibiting its use after studies raised thyroid concerns — illustrated that GRAS determinations are not permanent.

If you're a food manufacturer adding ingredients beyond the codified Part 182 list, the GRAS notification program is the practical alternative to a full food additive petition. An FDA "no questions" letter provides significant legal protection if a substance's safety is later questioned. Without a notification or pre-market approval, using a self-affirmed GRAS ingredient is legal but carries the risk that FDA could challenge the determination — potentially requiring reformulation.

If you're a consumer concerned about a specific additive: look it up in 21 CFR Part 182 (the codified list) or the FDA GRAS notices database (accessible at fda.gov). Substances not listed in Part 182 may be on FDA's separate 21 CFR Part 184 list (directly affirmed GRAS substances with specific use conditions) or may be operating under company self-affirmations without FDA review.

Statutory Authority

This rule implements:

• 21 U.S.C. § 321(s) — Definition of "food additive": explicitly exempts substances GRAS by qualified experts based on scientific procedures, or substances used in food prior to January 1, 1958 without known harm. This statutory carve-out is the foundation of the entire GRAS system.
• 21 U.S.C. § 348 — Food additive pre-market approval requirement: establishes that all new food additives require FDA approval unless they qualify for a GRAS exemption. GRAS status is the principal practical alternative to the food additive petition process.

Implementing Regulations

• 21 CFR Part 170 — Food Additives — the procedural and safety framework for both the formal food additive petition process and the modern GRAS notification program. Part 170 defines what counts as a "food additive" requiring pre-market approval and establishes the pathways for obtaining FDA authorization. Key provisions:

  • § 170.3 — Definitions: critical definitional distinctions that determine which FDA approval pathway applies — "food additive" (must go through petition process), "prior-sanctioned ingredient" (used before 1958 with FDA or USDA written permission, exempt from pre-market approval), "GRAS" (broadly recognized by qualified experts as safe, exempt from pre-market approval), and "food contact substance" (indirect additive that migrates into food from packaging or processing equipment, subject to its own FCN pathway); these four categories create the taxonomy that governs all ingredient approvals
  • § 170.20 — General safety principles: in evaluating any food additive petition, FDA gives full consideration to the probable consumption of the additive (including exposure from all food sources); the cumulative effect of the substance in the diet along with other additives with similar effects; safety factors appropriate for extrapolation from animal studies to humans (the default factor is 100× — a safety margin of 100-fold below the no-observed-adverse-effect level in the most sensitive tested species); and functional utility in food. The 100× safety factor principle is embedded in § 170.22 for carcinogenicity assessments
  • §§ 170.100–170.106 — Food Contact Substance Notification (FCN) Program: a faster alternative to full food additive petitions for indirect additives (substances that contact food through packaging, equipment, or processing and may migrate into food in small quantities). An FCN must contain: (a) comprehensive discussion of the scientific evidence establishing safety, (b) identity of the substance, (c) conditions of use, (d) migration data, and (e) dietary exposure estimates. If FDA does not object within 120 days, the notification becomes effective and the manufacturer/supplier may market the substance — no formal FDA approval letter is issued. However, the FCN is effective only for the specific manufacturer/supplier named in the notification; competitors who want to use the same substance must file their own FCN. FDA may subsequently determine an FCN is "no longer effective" if new safety information emerges
  • §§ 170.203–170.265 — GRAS Notification Procedure (Subpart E): the voluntary process by which manufacturers notify FDA that they have determined a substance is GRAS. A GRAS notice must include: (a) the "generally recognized" part — evidence that qualified experts have publicly and broadly accepted the safety determination (published scientific literature, peer review); (b) the "safe" part — the safety evaluation itself showing the substance has no adverse effects at intended use levels. FDA acknowledges receipt, reviews the file, and may respond with a "no questions" letter (FDA concurs), a letter stating the notice is insufficient to support a GRAS conclusion, or a letter terminating FDA's evaluation at the notifier's request. Critically: the notifier may use the substance regardless of FDA's response or non-response — a pending notice without a "no questions" letter does not legally prevent marketing; but using a substance without FDA affirmation carries regulatory risk
  • § 170.22 — Carcinogens and the Delaney Clause: no substance found to induce cancer in humans or animals may be approved as a food additive — the Delaney Clause from the 1958 Food Additives Amendment is absolute; zero-tolerance for carcinogens in the food additive approval pathway; this is why Red No. 3 was revoked (male rat carcinogenicity at high doses) despite limited human relevance; GRAS substances are technically subject to Delaney but the practical enforcement mechanism runs through FDA's authority to revoke GRAS status rather than deny an additive petition

  The practical takeaway: a food manufacturer's legal risk turns on which pathway an ingredient follows. Codified Part 182 GRAS = lowest risk (FDA has already determined it safe). GRAS notification with "no questions" letter = strong protection. GRAS notification pending = moderate risk. Self-affirmed GRAS (no notification) = highest risk of FDA challenge. Food additive petition approved = definitive. Food contact substance FCN effective = safe for that specific manufacturer's use. The current MAHA regulatory environment (post-2025) has elevated the risk of FDA action against self-affirmed GRAS determinations that haven't been reviewed by FDA staff.

• 21 CFR Part 82 — Listing of Certified Provisionally Listed Colors — the FDA's registry of synthetic color additives that are "provisionally listed" for use in food, drugs, and cosmetics while FDA continues safety reviews. Color additives require a different approval process from food additives: manufacturers must submit each batch for FDA laboratory certification (testing to verify chemical composition meets specifications) before marketing — unlike GRAS substances which require no pre-market review. Part 82 lists colors in three categories by permitted use:

  • FD&C colors (Subpart B): certified for use in Food, Drugs, and Cosmetics — the most broadly permitted category; currently, FD&C Blue No. 1 (Brilliant Blue FCF, used in sports drinks, blue candies, medications) and FD&C Blue No. 2 (Indigotine, used in blue and purple food items) are among the actively certified FD&C colors; other FD&C colors (Red 40/Allura Red, Yellow 5/Tartrazine, Yellow 6/Sunset Yellow) are listed in the "permanently listed" Part 74, not Part 82
  • D&C colors (Subpart C): certified only for Drugs and Cosmetics (NOT food) — these colors may contact mucous membranes or skin but are not safe for ingestion in the quantities that food use would involve; examples include D&C Blue No. 4 (externally applied drugs and cosmetics) and D&C Green No. 5 (cosmetics); the "D&C" designation signals the limitation on food use
  • Externally applied D&C colors (Subpart D): the most restricted category — may be used only in drugs and cosmetics intended for external use only (not near eyes, mouth, or mucous membranes); the restriction reflects that external skin contact has different safety considerations than ingestion or mucous membrane contact
  • "Provisionally listed" vs. "permanently listed": the 1960 Color Additives Amendment created two tracks — permanently listed colors (with full safety data, listed in 21 CFR Part 74) and provisionally listed colors (pre-1960 colors still in use while FDA completed safety reviews, listed in Part 82); some provisionally listed colors have remained in this provisional status for 60+ years as FDA's review queue moved slowly; the MAHA regulatory agenda has accelerated pressure on FDA to resolve long-pending provisional listings

  The FDA color additive certification program is mechanically different from the GRAS system: every commercial batch of a certified color (Red 40, Yellow 5, Blue 1, etc.) must be submitted to FDA's Office of Cosmetics and Colors, which tests representative samples and issues a certificate number that must appear on the shipping invoice; uncertified batches may not be used in food or drug products. This batch certification requirement is what gives FDA the ability to exclude adulterated or misspecified dye lots from the food supply — something that isn't possible for GRAS substances, which are not batch-certified. The current regulatory attention to artificial dyes (from RFK Jr. and MAHA advocates, and from multiple state bans on Red 40, Yellow 5, Yellow 6) may accelerate FDA action to either delist provisionally listed petroleum-based synthetic dyes or require labeling warnings.

• 21 CFR Part 570 — Food Additives (FDA/CVM, 28 sections — the procedural and scientific framework governing animal food additives under FDA's Center for Veterinary Medicine (CVM); the direct counterpart of 21 CFR Part 170 (which covers human food additives) applied to substances incorporated into or used in the preparation of animal feed, pet food, and veterinary dietary products; authority: 21 U.S.C. § 321). Part 570 establishes who must petition FDA before adding a new substance to animal food and what safety standards apply — it is the gateway through which the animal food GRAS list (21 CFR Part 582) and the formally approved animal food additive lists (21 CFR Parts 573–578) are populated. Key provisions:

  • §§ 570.13–570.14 — Indirect additives from packaging materials: substances that migrate from packaging materials into animal food or pet food are considered indirect additives regulated under Parts 174–179 (the same indirect food additive regulations that apply to human food packaging); a material that is "prior sanctioned" — meaning FDA or USDA gave specific written approval for its use in animal feed packaging before 1958 — is exempt from the petition requirement; § 570.14 cross-references the applicable packaging standards to avoid duplicating human food packaging rules for animal food applications
  • § 570.15 — Commissioner-initiated regulations: FDA may propose and adopt regulations for animal food additives on its own initiative, without waiting for a petition from a manufacturer; the Commissioner's authority to act proactively is important when a substance is widely used without formal GRAS status, when new safety concerns emerge for a previously unchallenged ingredient, or when harmonization with USDA or international standards requires regulatory updating; FDA has used this authority to add and revoke animal feed additive permissions based on new safety data
  • § 570.17 — Investigational use exemption: a food additive or animal food containing a food additive intended solely for investigational use (research purposes) is exempt from the pre-market approval requirement, provided the investigation is conducted under conditions that prevent the experimental animal's products (meat, milk, eggs) from entering the human food supply; the investigational use exemption is the animal feed counterpart of the IND exemption for human drugs — allowing feeding studies to test new substances without triggering full regulatory approval before the safety assessment is complete
  • § 570.18 — Tolerances for related food additives: food additives that cause similar or related pharmacological effects are treated as a class for tolerance purposes; in the absence of contrary evidence, related additives are assumed to have additive effects — a manufacturer cannot avoid a cumulative dose limit by using multiple structurally similar compounds each below the individual limit; this provision prevents the regulatory gap that would otherwise allow splitting of total additive use across multiple congeners of the same chemical class
  • § 570.19 — Pesticide chemicals in processed animal foods: when a raw agricultural commodity used in animal feed (grain, oilseed meal) bears a pesticide residue within established tolerances, and that commodity is processed into animal feed (grinding, pelleting, heat treatment), the resulting processed animal food may carry the same pesticide residue even if the concentration changes through the manufacturing process; § 570.19 clarifies that pesticide residues that carry over from lawfully treated agricultural commodities into processed animal feed do not automatically make the processed feed an "adulterated food" subject to the food additive petition process — a critical provision for feed manufacturers using grain from conventional agriculture
  • § 570.20 — General principles for evaluating food additive safety: FDA's safety evaluation framework for animal food additive petitions considers: (a) probable consumption of the additive by the target animal species under the proposed conditions of use; (b) cumulative effects when the additive is used in multiple feed types a species may consume; (c) appropriate safety factors for extrapolating animal toxicology data (the standard factor is 100× below the no-adverse-effect level in the most sensitive tested species); (d) the safety of any metabolites formed in the target animal; and (e) the safety for humans who consume edible products (meat, milk, eggs) from animals fed the additive — the human food safety dimension is unique to animal food additives and is why CVM's review involves both veterinary and human health toxicologists
  • §§ 570.203–570.210 — GRAS notification for animal food (Subpart E): any person may notify FDA of their conclusion that a substance is GRAS for use in animal food; a Part 570 GRAS notice must include: (a) a "generally recognized" component demonstrating that qualified animal nutritionists or veterinary scientists broadly accept the safety conclusion based on publicly available published evidence; (b) a safety assessment showing no adverse effects on the target animal at intended use levels, no harmful metabolites in edible tissues, and no human food safety concerns from residues; FDA acknowledges the notice, reviews the file, and may respond with a "no questions" letter or a letter identifying deficiencies; as with Part 170 GRAS notices for human food, manufacturers may begin using the substance before FDA responds — but the risk of a negative FDA response remains

  Part 570 governs the regulatory pathway for a rapidly growing category of animal feed ingredients — functional feed additives, novel protein sources (insect meal, single-cell protein), fermentation-derived feed supplements, and performance-enhancing feed components. The human food safety dimension (§ 570.20's requirement to assess residues in edible animal products) makes the CVM review more complex than FDA's human food additive review: a feed additive that is safe for cattle may still require residue tolerance setting by EPA (for crop protection chemical residues) or USDA/FSIS monitoring (for unapproved veterinary drug residues). Recent rulemakings: 81 FR 55052 (August 2016) — CVM clarification on the GRAS notification procedures for animal food; the 2024 FDA Animal Food Modernization Initiative has created renewed focus on updating CVM's animal food additive framework.

• 21 CFR Part 582 — Substances Generally Recognized as Safe (Animal Food): the GRAS list for animal food — the direct counterpart of 21 CFR Part 182 (which covers human food). Part 582 enumerates substances that FDA has determined are GRAS when incorporated into or used in the preparation of animal feed in accordance with good manufacturing or feeding practice. The same basic GRAS logic applies: substances on this list may be added to animal food without a separate food additive petition, so long as use is consistent with good manufacturing practice and does not exceed the amount reasonably required for its technical purpose. Part 582 is organized into the same functional categories as Part 182:

  • Subpart B — General Purpose Food Additives (§§ 582.1005–582.1839): organic acids and salts used as acidulants, antimicrobials, or pH adjusters in animal feed — acetic acid, adipic acid, citric acid, fumaric acid, lactic acid, malic acid, propionic acid, and their calcium, sodium, and potassium salts
  • Subpart C — Anticaking Agents (§§ 582.2122–582.2906): mineral substances added to feeds (particularly pelleted feeds) to prevent clumping — aluminum calcium silicate, calcium silicate, magnesium silicate, and sodium aluminosilicate
  • Subpart D — Chemical Preservatives (§§ 582.3013–582.3109): antimicrobial and antioxidant preservatives for animal feed — sodium benzoate, sorbic acid, and the same BHA and BHT antioxidants used in human food
  • Subpart E — Emulsifying Agents (§§ 582.4505–582.4521): mono- and diglycerides and propylene glycol; used to improve fat distribution and palatability in feeds
  • Subpart F — Nutrients and/or Dietary Supplements (§§ 582.5000–582.5985): vitamins, minerals, amino acids — vitamin A, all B vitamins, vitamin C, vitamin D, vitamin E, vitamin K, calcium carbonate, ferrous sulfate, magnesium oxide, manganese sulfate, zinc oxide, and the amino acids DL-methionine and L-lysine; these are GRAS when added for nutritional supplementation of animal diets; the list substantially parallels the human food nutrients in Part 182 Subpart I
  • Subpart G — Sequestrants (§§ 582.6085–582.6769): metal-chelating agents that prevent mineral-induced oxidative rancidity in feed fats — citric acid, sodium hexametaphosphate, tartaric acid; same substances as in human food Subpart G
  • Subpart H — Stabilizers (§§ 582.7085–582.7614): hydrocolloids and gums that improve texture and pellet integrity in manufactured feeds — agar-agar, carob bean gum, guar gum, gum arabic; same list as human food

  The "good manufacturing or feeding practice" standard in § 582.1 is substantively identical to the § 182.1 standard for human food: amounts must not exceed what is reasonably required for the intended technical effect, and incidental components must be reduced to the lowest practicable levels. The key practical difference is that Part 582 GRAS status is specific to animal food — a manufacturer cannot cite Part 582 to justify use in human food, and vice versa. Most substances listed in Part 582 are also listed in Part 182 (the overlap is extensive for basic food chemicals), but the regulatory bases are separate. Recent amendment: Part 582 was last significantly amended in the 1970s–1990s; the FDA Center for Veterinary Medicine (CVM) maintains the animal food GRAS list as part of its broader animal food additive program under 21 CFR Parts 570–582.

• 21 CFR Part 73 — Listing of Color Additives Exempt from Certification (129 sections across 4 subparts): the FDA's approved list of color additives that do not require batch-by-batch laboratory certification before use — in contrast to Part 82 (provisionally listed colors requiring batch certification) and Part 74 (permanently listed certified colors). The "exempt from certification" category primarily includes color additives derived from natural sources (plants, animals, minerals) and certain inorganic pigments where the natural consistency of composition makes batch testing redundant. Part 73 is organized by the type of product the color may be used in:

  • Subpart A — Foods (47 sections): the largest and most commercially important subpart; natural and nature-identical colors cleared for food use include:
    • § 73.100 — Cochineal extract and carmine: color additives derived from the dried bodies of the female cochineal insect (Dactylopius coccus); cochineal extract is the water-soluble red dye used in beverages, candies, and processed meat products; carmine is the aluminum lake of carmine acid, a more stable pigment used in dairy products, ice cream, and cosmetics; both are subject to mandatory labeling disclosure ("cochineal extract" or "carmine" must appear in the ingredient statement, not just "natural color") following FDA's 2011 rule requiring identification after reports of allergic reactions; cochineal and carmine are among the most frequently encountered FDA-approved natural colors because they provide stable, bright red and pink hues that many synthetic alternatives struggle to replicate
    • § 73.125 — Annatto extract: yellow to orange color derived from the seeds of the Bixa orellana (achiote) tree; widely used in cheese (cheddar color), butter, margarine, snack chips, and rice products; the active colorant is bixin and norbixin; annatto is GRAS as a spice at low concentrations (21 CFR § 182.10) and approved as a color additive at higher concentrations under Part 73 — the distinction between spice and color additive use is concentration-dependent
    • § 73.140 — Beta-carotene: the orange-yellow pigment from carrots and other vegetables (or synthetically produced to match the natural structure); used in margarine, butter, cheese, beverages, and dietary supplements; beta-carotene is also a vitamin A precursor — its dual function as both nutrient and colorant is addressed in Part 73 with separate standards for use as a food color vs. nutritional supplement; synthetic beta-carotene is approved under Part 73 because it is chemically identical to the natural form
    • § 73.160 — Caramel: the most widely used food color globally — produced by heating sugars (sucrose, glucose, fructose) with or without acid, base, or ammonium compounds; four classes of caramel color (plain/spirit caramel; caustic sulfite; ammonia process; sulfite-ammonia process) with different chemical characteristics and approved applications; caramel provides the brown color in colas, beer, soy sauce, bakery products, and soups; despite being derived from natural sugars, caramel is a processed color additive subject to Part 73 because its composition and properties depend on manufacturing conditions
    • §§ 73.200–73.300 — Other exempt food colors: fruit and vegetable juices, beet powder, grape skin extract, dried algae meal, saffron, paprika and paprika oleoresin, turmeric and turmeric oleoresin, titanium dioxide (white opacifier, limited to 1% by weight — subject of ongoing FDA review and an EU ban; California's 2023 AB 418 originally targeted titanium dioxide but it was removed before passage), iron oxides (red, yellow, black pigments used in food casings)
  • Subpart B — Drugs (31 sections): color additives for pharmaceutical products (tablets, capsules, solutions); includes FD&C colors in their lake forms (aluminum lakes that don't dissolve — used in tablet coatings), iron oxides (widely used in pharmaceutical coatings for both color and moisture protection), and titanium dioxide (white in tablet coatings); drug color additives face FDA manufacturing quality standards under cGMP in addition to Part 73 listing requirements
  • Subpart C — Cosmetics (29 sections): colors for personal care products applied to the body — iron oxides for foundations and eye makeup, ultramarines (blue, pink, violet silicate pigments) for eye shadows and blushers, chromium oxide greens for eye makeup, carmine for lipstick and blush; cosmetics color additives exempt from certification must still meet purity standards (heavy metal limits, microbial limits)
  • Subpart D — Medical Devices (22 sections): color additives for medical devices — including dental materials, surgical drapes, medical tubing — where color coding serves functional purposes (color-coded catheters, color-coded sutures by material type); the device subpart is smaller because most medical devices are colorless or use approved drug-grade colorants

  The practical distinction between Part 73 (exempt from certification) and Part 74/82 (requires batch certification) is not about safety — both lists contain FDA-approved colorants — but about manufacturing consistency. Synthetic petroleum-derived dyes like Red 40 or Yellow 5 can vary substantially in dye content by batch, making batch testing essential to ensure every use meets specification. Natural pigments like carmine, annatto, and beta-carotene have more inherent consistency from batch to batch (within production specifications), justifying the exemption. FDA can revoke exempt-from-certification status if it determines that batch variation has become a safety or adulteration concern. Notable recent action: titanium dioxide (§ 73.575), the most widely used white food opacifier (used in confections, chewing gum, and powdered products), has faced multiple regulatory challenges — France banned it in 2020, California included it in the California Food Safety Act (2023) — prompting FDA to review its ongoing approval; as of 2026, FDA has not revoked its approval.

Recent Rulemakings

• BVO revocation (2024): FDA revoked the GRAS status of brominated vegetable oil (BVO), a flame retardant-derived emulsifier once used in citrus-flavored sodas, based on animal studies showing thyroid effects. Manufacturers had already voluntarily removed BVO from most products; California had banned it in 2023. The revocation became effective August 2, 2024.
• Red No. 3 revocation (2025): FDA revoked authorization for erythrosine (FD&C Red No. 3) based on male rat carcinogenicity studies under the Delaney Clause. Food manufacturers have until January 2027 to reformulate; ingested drug manufacturers have until January 2028.
• Propylparaben revocation (2024): FDA revoked GRAS status for propylparaben as an antimicrobial food preservative based on studies suggesting endocrine disruption at low levels. The substance remains in use in pharmaceuticals under separate drug approval authorities.

Recent Developments

• Red Dye No. 3 ban (January 2025): FDA revoked authorization for erythrosine (FD&C Red No. 3) in January 2025, citing the Delaney Clause's prohibition on carcinogenic additives. The evidence was male-rat-specific carcinogenicity at high doses — human carcinogenicity was not established — but the Delaney Clause requires revocation based on animal studies. Food manufacturers have until January 2027 and drug manufacturers until January 2028 to reformulate. Products containing Red No. 3 include maraschino cherries, some fruit cocktails, candy-coated products, and certain preserved foods.
• RFK Jr. and the "Make America Healthy Again" agenda (2025): HHS Secretary Robert F. Kennedy Jr. brought a focused policy agenda targeting food additives, ultra-processed foods, and chemical preservatives. FDA is under political pressure to review GRAS status of numerous substances including artificial dyes (Red 40, Yellow 5, Yellow 6), titanium dioxide, brominated flour, and others. Congress held hearings on FDA's GRAS notification process and the adequacy of pre-market review for food additives.
• BVO revocation effective August 2024: FDA's revocation of brominated vegetable oil (BVO) authorization took effect on August 2, 2024. Most manufacturers had already removed BVO voluntarily years earlier, and major beverage brands (PepsiCo, Coca-Cola) stopped using it in their U.S. products well before the regulatory action. The revocation was largely symbolic for the current market but formally closed a long-standing regulatory anomaly.
• GRAS notification backlog and reform debate: FDA's voluntary GRAS notification program — where manufacturers notify FDA of their self-GRAS determinations — has a significant backlog, with hundreds of notifications pending review. Critics argue the system creates a gap where substances used at commercial scale have never received independent FDA review. The MAHA agenda intensified legislative and regulatory pressure to reform or replace voluntary GRAS with mandatory pre-market review.
• State-level food additive bans: California passed the California Food Safety Act (AB 418) in October 2023, banning Red Dye No. 3, brominated vegetable oil, potassium bromate, and propylparaben (titanium dioxide was removed from the bill before passage); the ban takes effect January 1, 2027 — prompting manufacturers to reformulate products for national distribution. Several other states introduced similar legislation. State action has outpaced FDA rulemaking in some areas and is reshaping food industry reformulation timelines.

Pending Action

The "Make America Healthy Again" food safety agenda — driven by HHS Secretary RFK Jr. — is generating multiple pending FDA actions. Watch for: (1) proposed rules or advance notices on artificial food dyes (Red 40, Yellow 5, Yellow 6), with Congressional pressure for faster action than voluntary industry phase-out; (2) proposed reform of the GRAS notification process to require mandatory pre-market notification (eliminating purely self-affirmed GRAS); (3) action on potassium bromate and titanium dioxide, where California's Food Safety Act ban may push FDA toward federal preemption rulings. The timelines for all of these depend on HHS/FDA staffing levels and the administration's regulatory priority-setting, but the political environment favors action on food additive review that would be unusual under prior administrations.