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FDA has no formal regulation defining 'natural' as a food label claim — a decades-long gap that has generated substantial litigation, enforcement questions, and consumer confusion. FDA's informal policy is that 'natural' means nothing artificial or synthetic has been added, but this standard has never been codified in a regulation. The absence of a formal definition does not mean 'natural' is a safe, unconstrained claim — it means 'natural' claims are evaluated under the general misbranding standard, which plaintiffs' attorneys and the FTC use aggressively.

"Natural" is one of the most commercially significant claims in the food and supplement industry — and one of the most legally precarious. FDA has never formally defined the term through notice-and-comment rulemaking, despite multiple proceedings where it considered doing so. What exists instead is an informal policy, active litigation, and FTC enforcement.

FDA's Informal Policy

FDA does not have a regulation defining "natural" for conventional food labels. However, FDA has stated informally — through letters, guidance, and public comments — that it considers "natural" to mean:

A food is "natural" if it does not contain added color, artificial flavors, or synthetic substances.

This informal position has never been codified. It does not address:

  • Whether bioengineered (GMO) ingredients may appear in "natural" products

  • Whether heavily processed ingredients (corn syrup, xanthan gum) qualify as "natural"

  • Whether ingredients derived from natural sources through chemical processes are "natural"

  • Whether the "natural" claim applies to processing methods as well as ingredients

The 2016 Request for Information

In November 2015, FDA issued a request for information on the use of the term "natural" in food labeling, following three citizen petitions. FDA received over 7,600 comments. In 2016, FDA stated it was considering three potential approaches:

  1. Prohibit the term entirely as inherently misleading

  2. Define the term based on ingredient processing standards (similar to USDA's approach for meat)

  3. Leave the informal policy in place

As of 2026, FDA has not issued a final rule or formal guidance. The informal policy remains the operative standard.

What Makes a "Natural" Claim Risky

The absence of a formal definition does not mean "natural" is unconstrained. Three enforcement mechanisms apply:

1. FDA Misbranding Standard

Under 21 U.S.C. 343(a), a food is misbranded if its label is false or misleading in any particular. A "natural" claim that consumers would reasonably interpret as meaning something the product does not satisfy can be a misbranding violation — regardless of whether there is a formal definition.

2. FTC Advertising Standards

FTC's Section 5 authority covers deceptive advertising, including "natural" claims in food marketing. Under FTC's general deception framework, "natural" must be substantiated and not mislead consumers in a material way. FTC has brought actions against food companies for "all natural" claims on products containing synthetic or highly processed ingredients.

3. Class Action Litigation

"Natural" claims on products containing:

  • High fructose corn syrup (HFCS)

  • Artificial preservatives (sodium benzoate, potassium sorbate)

  • Synthetic vitamins and fortification (added as nutrients)

  • GMO-derived ingredients

  • Synthetic flavor compounds (even derived from natural sources through synthesis)

...have generated hundreds of consumer class action lawsuits. Courts have applied varying standards, with plaintiffs arguing the reasonable consumer would expect "natural" to exclude such ingredients.

USDA's Approach: "Natural" for Meat and Poultry

For USDA-regulated meat and poultry products, USDA FSIS has established a definition: "natural" means:

  • The product contains no artificial ingredient or added color and is only minimally processed

  • "Minimal processing" means processing that does not fundamentally alter the product (e.g., smoking, roasting, freezing, drying)

This definition applies specifically to USDA-regulated products. For FDA-regulated foods and supplements, USDA's definition does not control — but it provides useful benchmarking for what a defensible "natural" standard looks like.

"Natural" on Dietary Supplement Labels

Dietary supplements present additional complexity:

  • Most supplement ingredients undergo significant processing (extraction, isolation, concentration)

  • Vitamins produced via fermentation or chemical synthesis may be chemically identical to naturally derived vitamins but were synthesized

  • Botanicals in extract form are processed significantly beyond their natural state

FDA's informal "natural" policy was not developed with dietary supplements specifically in mind. Supplement brands that use "natural" face the same litigation risks as conventional food brands, with the additional complexity that virtually all supplement ingredients are processed.

Making a Defensible "Natural" Claim

If a brand uses "natural" on food or supplement labels:

  1. Document the basis for the claim — which ingredients are "natural" and why, what processing steps were used, and why those steps are consistent with the "natural" characterization

  2. Audit the ingredient list against FDA's informal standard: no added color, no artificial flavors, no synthetic substances

  3. Address GMO and processing questions explicitly — if the product contains GMO-derived ingredients, consider whether "natural" is defensible or whether "no artificial ingredients" is more precise

  4. Avoid "all natural" if any ingredient could reasonably be characterized as artificial or synthetic — even by a creative plaintiff

  5. Monitor consumer perception — "natural" claims are evaluated against the reasonable consumer's interpretation, not just the technical ingredient specification

Alternatives to "Natural"

Given the legal and regulatory uncertainty around "natural," many brands use more specific claims that are easier to substantiate and less likely to generate litigation:

Alternative Claim

What It Means

Standard

"No artificial flavors"

Complies with 21 CFR 101.22 natural flavor definition

FDA-defined

"No artificial colors"

No synthetic certified colors (FD&C colors)

FDA-defined

"No synthetic ingredients"

More specific than "natural"

Internal definition

"Non-GMO"

No bioengineered ingredients

Non-GMO Project Verified or USDA BE disclosure

"Organic"

USDA organic certification

USDA NOP (7 CFR 205)

"Minimally processed"

Processing that doesn't fundamentally alter the product

USDA standard (for context)

How Truli Helps with "Natural" Claim Risk Management

  • Ingredient classification audit: Truli reviews ingredient lists against FDA's informal "natural" standard — flagging synthetic substances, artificial colors, and artificial flavors that would be inconsistent with a "natural" claim

  • Class action risk flagging: Truli identifies specific ingredients (HFCS, synthetic preservatives, certain GMO-derived ingredients) known to have generated "natural" litigation and flags their presence on products bearing "natural" claims

  • Claim specificity recommendations: Truli identifies more defensible, narrower claims ("no artificial flavors," "no artificial colors") that convey similar consumer messaging with lower litigation risk

Related Regulations

  • 21 CFR 101.22 — Flavors, Colorings, Spices — Definition of "natural flavor" vs. "artificial flavor"

  • USDA BE Bioengineered Food Disclosure — GMO/BE disclosure requirements that interact with "natural" claims

  • USDA Organic / NOP — The regulated alternative to "natural" for products meeting organic standards

  • FTC Health Claims in Advertising — FTC's authority over deceptive "natural" claims in advertising

Frequently Asked Questions

Is there any official FDA guidance on what "natural" means?
No — FDA has an informal policy (no added color, artificial flavors, or synthetic substances) but has not issued a formal regulation or binding guidance. Multiple attempts to define the term through rulemaking have not resulted in a final rule.

We add vitamin C (ascorbic acid) to our "all natural" juice for antioxidant preservation. Is that a problem?
Potentially yes — ascorbic acid, while vitamin C is found naturally in foods, is typically the synthesized form when added as a fortification ingredient. Adding a synthetic substance is inconsistent with FDA's informal "natural" standard. You could remove the "natural" claim, use ascorbic acid from a natural source (and document this), or use a more specific claim like "no artificial preservatives" (if the ascorbic acid is added for vitamin fortification rather than preservation, though the distinction matters).

A competitor uses "natural" on a product with HFCS. Can we do the same?
A competitor's unenforced use of "natural" on a product with HFCS does not make the practice compliant or safe. FDA has not formally prohibited it, but class action litigation risk is significant. The absence of enforcement is not an endorsement of the claim.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. FDA's position on "natural" claims has not changed since 2016. Truli monitors FDA and FTC developments related to natural and clean label claims. Book a demo to see how Truli monitors food label compliance.

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Privacy Policy | Terms of Service | © 2026. All rights reserved.

Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

Truli Logo

The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.

Grow fast. Stay compliant.

If regulatory delays are consuming months and thousands in fees, see how Truli delivers fast and continuous compliance coverage at a fraction of the cost.

Truli Logo

The first AI-powered platform that streamlines compliance for businesses in the food/supplement industry.

Privacy Policy | Terms of Service | © 2026. All rights reserved.