In this article, learn:
Which product claims have legally defined standards and which do not
How certain marketing claims can unintentionally trigger FDA drug regulations
How to keep product claims consistent across labels, retailer listings, and product data
Product claims in health, beauty, and wellness (HBW) fall on a spectrum, and understanding where each one sits is the first step to determining which you should use on your labels.
At one end are claims with real regulatory backing, like "organic," which is governed by the USDA's National Organic Program and tied to a certification process. At the other end are claims with no federal definition at all, like "natural" and "hypoallergenic," which a company can use largely as it wishes, but which still cannot mislead. In between sit efficacy claims like "clinically proven," which carry no special legal definition but a heavy substantiation burden under FTC law.
Every claim on a health or beauty product is a legal promise, and the obligation behind it depends on which kind of claim it is:
Certified claims like "organic" require meeting a defined standard set by a regulator or an accredited third party.
Efficacy claims like "clinically proven" require competent and reliable scientific evidence, even without a fixed legal formula for what that means.
Undefined claims like "natural" and "hypoallergenic" still cannot mislead, even though no statute spells out what they mean.
Structure-function claims that promise to treat a condition or change the body can silently convert a cosmetic into an unapproved drug in the FDA's eyes.
Why This Matters for Suppliers
Whenever an HBW brand makes a claim on a label, there are risks involved.
First, brands should be able to fully substantiate their claims. They need to be able to survive FTC enforcement action, challenges from advertising watchdogs like the National Advertising Division (NAD), and class-action litigation from consumers who relied on the claim. None of these require proof of intent to deceive; an unsubstantiated claim is a liability the moment it ships, whether or not anyone meant harm by it.
Second, a claim that promises to treat a condition or change the body's structure or function could change a product’s category from a cosmetic into an unapproved drug. Under the FD&C Act, phrases like "treats dandruff," "restores hair growth," or "reduces cellulite" establish an "intended use" that shifts a product out of cosmetic regulation and into drug regulation. A brand can trigger this shift without ever meaning to; the FDA looks at what the claim implies, not what the brand intended.
Related Reading: Recall Readiness for Health and Beauty Brands
Natural and Ingredient Sourcing Claims
Claim / Term | Specific Legal Standard? | Definition | Who Defines / Enforces It | What It Requires of a Brand |
Natural / All-Natural | No | No standard statutory definition; courts often treat it as ambiguous rather than automatically misleading. | FTC, on a case-by-case basis | Avoid implying a product is entirely free of synthetics unless it is — the FTC has settled with brands over "100% natural" claims on products containing synthetic ingredients. |
Organic | Yes | Tiered standard: "100% Organic" (only organic ingredients, excluding water/salt), "Organic" (95%+ organic), "Made with Organic Ingredients" (70%+, no seal allowed). | USDA National Organic Program, via accredited certifying agents | Complete the five-step certification process, including inspections and a system plan; only use the USDA seal within the tiers that qualify for it. |
Non-GMO Project Verified | No | Independent verification that a product's ingredients meet a defined non-GMO sourcing standard. | Non-GMO Project (third-party nonprofit) | Enroll the product in the verification program and maintain sourcing documentation. Note: the bare term "non-GMO" without the seal has no legal definition at all. |
Non-Nano | No | Claim that mineral particles (e.g., zinc oxide, titanium dioxide) exceed nanomaterial size thresholds. | No single federal definer; broad federal nanomaterial definitions apply | Frequently flagged as misleading, since nearly all micronized minerals fall under federal nanomaterial definitions — verify actual particle-size data before using this claim. |
Radical Fragrance Transparency | No | Full disclosure of fragrance ingredient components, beyond legal minimums. | Not legally required; retailer-driven (e.g., Credo) | Voluntarily disclose fragrance components in full if making this claim. |
Performance and Efficacy Claims
Claim / Term | Specific Legal Standard?
| Definition | Who Defines / Enforces It | What It Requires of a Brand |
Clinically Proven / Science-Backed | No | No fixed legal threshold for what counts as "proven," but the claim must be backed by competent and reliable scientific evidence. | FTC, under general deceptive-advertising authority | Hold documented clinical or scientific evidence before making the claim, and keep the claim's language consistent across packaging and advertising. |
Dermatologist-Tested | No | Marketing claim with no standardized protocol or independent verification requirement. | None — self-declared | Document the actual testing performed so the claim can be defended if challenged. |
Broad Spectrum / SPF | Yes | Must pass FDA-specified UVA/UVB testing methods. | FDA, under the OTC sunscreen drug monograph | Test according to the FDA protocol; sunscreens are regulated as OTC drugs, not cosmetics. |
Structure-Function Claims (e.g., "treats dandruff," "restores hair growth," "reduces cellulite") | Yes | Establishes an "intended use" that can reclassify a cosmetic as a drug. | FDA, under the FD&C Act | Maybe rephrase for consistency in table: Avoid this language unless the product is prepared to meet drug regulatory requirements as these claims require drug level testing, labeling, and pre-market approval. |
Non-Comedogenic | No | No standardized test or legal definition for "won't clog pores." | None — self-declared | Avoid overstating; there is no regulatory backstop if the claim is challenged. |
“Clean” Claims and Retailer-Specific Seals
Claim / Term | Specific Legal Standard?
| Definition | Who Defines / Enforces It | What It Requires of a Brand |
Clean Beauty | No | No uniform FDA standard; generally understood as free of ingredients suspected to harm human health (e.g., parabens, sulfates, phthalates). | None federally; loosely defined by the industry | Define and disclose your own "free-of" list clearly — don't rely on the word "clean" alone to carry meaning. |
Formulated Without | No | Retailer-specific threshold; Target, for example, defines this as less than 100 parts per million of the named chemical. | Individual retailers (e.g., Target) | Meet the specific retailer's ppm threshold before using their defined language. |
Clean at Sephora / Target Clean | No | Proprietary seal indicating a product meets that retailer's own prohibited-ingredient list. | Individual retailers | Submit for retailer review against their specific standard — the seal isn't interchangeable across retailers. |
100% Free From | No | A high-bar claim that retailers acknowledge cannot be fully guaranteed, due to the possibility of trace contaminants from manufacturing. | Retailer guidance; general FTC deception law | Avoid absolute language when trace contamination is possible, or qualify the claim. |
Non-Toxic | No | No legal definition for cosmetics or general consumer products. | FTC Green Guides address it in an environmental-marketing context; general deception law applies otherwise | Substantiate any safety-related "non-toxic" claim — the FTC has scrutinized unqualified use of this term. |
Ethical and Sustainability Claims
Claim / Term | Specific Legal Standard?
| Definition | Who Defines / Enforces It | What It Requires of a Brand |
Cruelty-Free | No | Indicates a product was not tested on animals; no legal definition in the U.S. | None — self-designated by the brand | Consider independent certification for credibility, and document your own no-testing policy across the supply chain. |
Leaping Bunny Certified | No (not government-defined, but independently audited) | Requires no animal testing at any product or ingredient stage, verified through supplier audits and annual renewal. | Leaping Bunny Program / Coalition for Consumer Information on Cosmetics | Submit to independent audits, secure signed supplier agreements, and renew certification annually. |
Vegan / Certified Vegan | No | Indicates no animal-derived ingredients — distinct from cruelty-free, which addresses testing, not ingredients. | Vegan Society and other third-party certifiers (for the "Certified" designation) | Verify the full ingredient list, and certify through a recognized body if using "Certified Vegan." |
Fair Trade Certified | No (not U.S. government-defined, but third-party certified) | Verifies fair wages and sourcing conditions through independent audit. | Source through certified supply chains and maintain audit documentation. | |
Planet Aware | No | Retailer designation for brands with meaningful environmental commitments (e.g., sourcing, packaging). | Individual retailers | Meet the specific retailer's sustainability criteria to use this designation. |
Ethically Produced | No | Encompasses fairtrade sourcing and humane treatment; includes initiatives like the Responsible Mica Initiative, which works to eliminate child labor in mineral mining. | Varies by initiative | Join and document participation in the specific initiative referenced. |
Environmental and Origin Claims
Claim / Term | Specific Legal Standard?
| Definition | Who Defines / Enforces It | What It Requires of a Brand |
Recyclable / Biodegradable / Compostable | Yes | Must meet FTC Green Guides conditions — for example, "recyclable" claims must be qualified if collection and processing aren't available to a substantial majority of consumers. | FTC, under the Green Guides and Section 5 of the FTC Act | Qualify claims when the necessary infrastructure isn't widely available, and don't make unqualified degradable claims for items destined for a landfill. |
Carbon Neutral | Yes | Requires disclosure of methodology (e.g., offsets used, scope covered); bare terms like "green" or "eco-friendly" are considered too vague to substantiate on their own. | FTC, under the Green Guides | Specify what the claim actually means — offsets purchased, renewable energy used, sourcing changes — rather than making a bare assertion. |
Reef-Safe / Reef-Friendly | No, at the federal level | No U.S. federal definition; state and local bans on oxybenzone and octinoxate (Hawaii, Key West, Maui County) function as a de facto definition in those markets. | No comprehensive federal definer; a handful of state and local governments | Comply with the specific banned-ingredient list where selling into affected jurisdictions; avoid implying scientific proof of reef safety nationally. |
Made in USA | Yes | Unqualified claims require that "all or virtually all" ingredients and components be made and sourced domestically, with final assembly in the U.S. | Maintain supply-chain documentation, qualify claims when the standard isn't met, and note that civil penalties apply for violations. |
Safety and Usage Indicators
Claim / Term | Specific Legal Standard?
| Definition | Who Defines / Enforces It | What It Requires of a Brand |
Hypoallergenic | No | Suggests a lower likelihood of allergic reaction; no rigid federal standard. | None | Avoid overpromising, and document any testing performed to support the claim. |
Period After Opening (PAO) | No | Voluntary symbol (open-jar icon) showing how many months a product stays safe once opened. | Voluntary industry practice in the U.S. | Support the stated period with actual preservative efficacy testing data. |
Tamper-Evident | Yes | Required safety indicator providing visible evidence if a package has been opened. | FDA | Comply with FDA tamper-evident packaging requirements for most OTC drugs and some cosmetics. |
Gluten-Free | Yes (for foods and ingestible categories) | Must contain less than 20 parts per million of gluten. | FDA, under the food labeling rule | Note that this is a food-labeling rule; using it on topical cosmetics borrows the term without the same binding definition — verify which regulatory category actually applies. |
Proprietary Blend | Yes (permitted, but triggers a disclosure requirement) | Supplement labels may list a blend without individual ingredient amounts, but any accompanying structure-function claim requires an FDA disclaimer. | FDA, under the Dietary Supplement Health and Education Act (DSHEA) | Include the required disclaimer language whenever a structure-function claim accompanies a proprietary blend. |
Related Reading: The Health, Beauty, and Wellness Category: A Brand's Guide to Selling and Scaling in Retail
Keep Every Claim Consistent, From the Label to the Listing
A "clean" or "organic" claim doesn't stop mattering once it's on the package. It has to hold up in the attribute fields, certifications, and product content suppliers send to every retail trading partner, each in its own required format. When that data gets copied by hand across spreadsheets and portals, small inconsistencies can creep in. Any of those gaps can turn a substantiated claim into an unsubstantiated one the moment it reaches a shelf or search result.
SPS Commerce Assortment gives suppliers one place to manage and check that product data before it reaches trading partners. It standardizes attributes into the format each retailer requires and checks them against business rules, so the same accurate claim and ingredient information reaches every channel the same way. Contact SPS Commerce to see how Assortment keeps your product data consistent across every retail relationship.