Phosphatidylserine Structure/Function Claims: A US Supplement Buyer's Review

Most US supplement brands meet structure/function claims during label development, when marketing asks what a 포스파티딜세린 (PS) product may say about memory, focus, or cognitive function. The direct answer: a US dietary supplement may carry a structure/function claim such as "supports memory" only if the brand holds substantiation that the claim is truthful and not misleading, notifies FDA within 30 days of first marketing, and displays the mandatory disclaimer; claims that diagnose, treat, cure, or prevent a disease are not allowed on a supplement label. Supplier documents such as specifications and certificates of analysis support ingredient identity and quality, but they do not by themselves substantiate a finished-product claim.

This review is a regulatory and document-review discussion for B2B buyers, not medical advice and not a substitute for qualified counsel on a specific label.

Where Nutranexa is mentioned, only verified public facts are used. Nutranexa identifies itself as Shandong Baianrui Biopharmaceutical Co., Ltd., founded in 2013, operating a 110,000+ m2 campus, and primarily serving export markets in Europe and North America. Its public product pages list 두유 PS 그리고 해바라기 PS, its published minimum order is 25 kg with 25 kg net per drum, and buyers can request current specifications and COA evidence from the sales team.

The Direct Answer Buyers Need First

The structure/function claim framework comes from the Dietary Supplement Health and Education Act of 1994 (DSHEA), which added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act. Under that section, a dietary supplement may bear such a claim if three duties are met:

1. Substantiation. The firm has substantiation that the claim is truthful and not misleading before the claim is used.
2. Notification. FDA receives a notification with the claim text no later than 30 days after the product is first marketed with the claim.
3. Disclaimer. The claim appears with the exact disclaimer, prominently displayed and in boldface type.

The three requirements are separate: a brand cannot skip the disclaimer because it notified FDA, and a supplier COA cannot substitute for claim substantiation. For PS specifically, the practical question is whether the wording describes a normal structure or function ("supports memory") or implies treatment of a disease ("reduces memory loss in Alzheimer's"), and whether the evidence file supports the claim as consumers will understand it.

The Four Claim Categories FDA Recognizes for Dietary Supplements

The relevant categories are:

Two points matter for PS buyers. First, structure/function claims do not require FDA pre-approval, but the firm must have the evidence before marketing. Second, a claim that mentions a disease is not a structure/function claim; a supplement bearing a disease claim is regulated as a drug unless the claim is an authorized health claim for which the product qualifies.

How to Test Whether a PS Claim Is a Structure/Function Claim or a Disease Claim

FDA's rule at 21 CFR 101.93(g) defines a disease as damage to an organ, part, structure, or system of the body such that it does not function properly, or a state of health leading to such dysfunction. The rule lists ten criteria for deciding whether a statement claims to diagnose, mitigate, treat, cure, or prevent disease. The criteria that most often surface in PS label review are:

Context decides the outcome. FDA's compliance guide explains that a phrase such as "mild memory loss associated with aging" can be an acceptable structure/function claim, while "Alzheimer's disease or senile dementias in the elderly" is a disease claim. Words such as "support" and "maintain" do not automatically create a disease claim, but they can if the surrounding label implies an effect on a disease, and the same is true for pictures, product names, and cited publications.

A five-question claim screen for PS labels

Run every draft claim through this screen before artwork approval:

1. Does the claim name or imply a specific disease or class of diseases?
2. Does the claim reference signs or symptoms that are characteristic of a disease?
3. Does the product name, imagery, or packaging context imply a disease use?
4. Would a reasonable consumer read the claim as treatment or prevention?
5. If the claim has more than one reasonable meaning, is there substantiation for each meaning?

If any answer points to disease, the claim is outside the structure/function lane for a supplement and should be revised or removed.

Substantiation: What Evidence Supports a PS Claim

FDA's 2009 guidance on substantiation for claims under section 403(r)(6) recommends that manufacturers hold adequate substantiation for each reasonable interpretation of a claim. FDA applies a standard consistent with the Federal Trade Commission's "competent and reliable scientific evidence" test: tests, analyses, research, or other evidence based on the expertise of professionals in the relevant field, conducted and evaluated objectively using procedures generally accepted in the profession.

The guidance asks firms to weigh four things:

• The meaning of the claim. Identify every express and implied claim, including the net message when all label statements are read together.
• The relationship of the evidence to the claim. Studies should concern the same ingredient, product, dose, and conditions of use as the claim.
• The quality of the evidence. Well-controlled human studies carry more weight than isolated reports or animal data alone.
• The totality of the evidence. One favorable study does not outweigh a body of inconsistent evidence.

For a PS product, the evidence question is not "does some published research mention PS?" It is "does the evidence relate to this product, this dose, this population, and this claim wording?" A study of a different PS source, dose, or age group may not substantiate the claim as written.

Where Supplier Documents Fit in the Claim File

Bulk ingredient buyers often ask what documents they should collect from a PS supplier while claims are being drafted. The answer is that supplier evidence supports the ingredient's identity and quality, and it can support truthful background statements, but it does not by itself substantiate a finished-product structure/function claim.

Nutranexa's public materials support the document side of this picture: the company publishes specification and COA evidence paths, describes manufacturing and quality-control activity, and offers a 품질 및 연구개발 page and a document request path for current files. What Nutranexa does not do is publish finished-product health or disease claims for brands to copy; the claim file is built by the brand, usually with regulatory counsel, from evidence that relates to the finished product.

FDA Notification Within 30 Days of First Marketing

Under 21 CFR 101.93(a), the manufacturer, packer, or distributor of a dietary supplement that bears a structure/function, general well-being, or nutrient-deficiency claim must notify FDA no later than 30 days after the first marketing of the supplement. The notification must include the firm's name and address, the text of the statement, the name of the dietary ingredient, and the name of the supplement.

The person who signs the notification must certify that the information is complete and accurate and that the firm has substantiation that the statement is truthful and not misleading. Notification is a filing, not an approval: FDA does not pre-review structure/function claims, and receiving a notification does not mean FDA has evaluated the claim.

Buyers planning a first PS launch should confirm the current submission route with FDA before the product ships. The deadline is tied to first marketing, so the notification belongs on the launch checklist, not in a follow-up folder.

The Mandatory Disclaimer and Its Placement

If a dietary supplement label includes a structure/function claim, the claim must appear with the exact disclaimer:

> This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Under 21 CFR 101.93(c) through (e), the disclaimer must be prominently displayed in boldface type in letters no smaller than one-sixteenth inch, placed adjacent to the statement with no intervening material, or linked to the statement with a symbol such as an asterisk. Multiple claims may share one plural disclaimer under the same placement rules.

In December 2025, FDA announced enforcement discretion regarding the requirement that the disclaimer appear on each panel of a product label where a 403(r)(6) claim appears, while making clear it does not intend to relax the requirement to include the disclaimer on the label and link it to each claim. In practical terms, the disclaimer stays on the label and next to or linked to each claim; the pending change concerns repeating it on every panel.

The FTC View: Advertising Claims Need the Same Evidence

FTC's Health Products Compliance Guidance explains that advertisers must have adequate substantiation for all objective product claims, express or implied, and that health-related claims generally require competent and reliable scientific evidence. FDA has primary responsibility for labeling and FTC for advertising, but both agencies apply the same evidence discipline.

For PS brands this means the same claim discipline applies on the label, website, social media, influencer posts, retail listings, and brochures. A phrase that is carefully worded on the Supplement Facts panel but exaggerated in an ad is still a problem. The FTC guidance also warns about implied claims: a product name, an image, or a "clinically proven" page creates a claim that must be substantiated.

Building a PS Claim File: A Buyer Checklist

When a US brand or contract manufacturer receives a PS quotation and starts claim development, the workflow looks like this:

1. Lock the exact product: source (soy or sunflower PS), PS content, serving size, and formulation.
2. Review the supplier's specification, COA, and quality documents for the quoted lot.
3. Draft claim wording, then screen each statement with the five-question disease-claim test.
4. Collect the substantiation file: studies and data that relate to the finished product, dose, population, and claim wording.
5. Prepare the FDA notification with the exact claim text and sign-off.
6. Place the disclaimer next to or linked to each claim, in boldface, at the required size.
7. Extend the review to every marketing channel before launch.

For teams that have not yet selected a PS source, the source decision affects the document set: 두유 PS 그리고 해바라기 PS have separate specification and COA evidence paths, and the supplier COA qualification review explains how US contract manufacturers decide what incoming evidence is required. The NDI review covers the separate question of whether a new dietary ingredient notification is needed before marketing, and the Supplement Facts label review covers the panel itself.

Need current PS specifications, COA samples, source documentation, and manufacturing evidence for your claim file? Request the specification and document evidence with your target assay, source preference, application, and destination market.

결론

The US structure/function claim path for a phosphatidylserine supplement is clear but demanding: substantiation before marketing, notification to FDA within 30 days, and the exact disclaimer with each claim. The harder work is keeping memory and cognitive wording inside the normal structure/function lane and out of disease territory, and making sure the claim file relates to the finished product rather than to ingredient marketing language. Supplier documents support identity, quality, and sourcing decisions, while claim substantiation belongs to the brand.

자주 묻는 질문

What is a structure/function claim for a dietary supplement?

A structure/function claim describes the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body, or characterizes the documented mechanism by which it maintains that function. For example, "supports memory" or "supports normal cognitive function" are structure/function-style claims, subject to substantiation, FDA notification, and the disclaimer.

Is "supports memory" a structure/function claim or a disease claim for PS?

It can be a structure/function claim, because memory is a normal function, but context decides. Under 21 CFR 101.93(g), the claim becomes a disease claim if the label, product name, imagery, or surrounding text implies an effect on a disease such as Alzheimer's or dementia. FDA's compliance guide treats "mild memory loss associated with aging" as an acceptable structure/function claim and disease references as disease claims.

What substantiation does FDA expect for a PS structure/function claim?

Firms must hold substantiation that the claim is truthful and not misleading before marketing. FDA's guidance recommends adequate evidence for each reasonable interpretation of the claim, using the "competent and reliable scientific evidence" standard, and weighs the claim's meaning, the relationship of the evidence to the claim, evidence quality, and the totality of the evidence.

Do supplement brands need to notify FDA of a structure/function claim?

Yes. Under 21 CFR 101.93(a), the manufacturer, packer, or distributor must notify FDA no later than 30 days after first marketing a supplement that bears a structure/function, general well-being, or nutrient-deficiency claim. Notification includes the claim text and a certification that the firm has substantiation; it is a filing, not an approval.

What disclaimer must appear with a PS structure/function claim?

The claim must appear with the exact disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." It must be prominently displayed in boldface type in letters no smaller than one-sixteenth inch and placed adjacent to or linked to each claim.

Can a PS supplier's documents substantiate a finished-product claim?

No. Supplier specification sheets, COAs, manufacturing evidence, and R&D references support ingredient identity, quality, and sourcing decisions, but claim substantiation must relate to the finished product, its dose, its population, and the exact claim wording. The brand builds the claim file, usually with regulatory counsel.

출처

• FDA: Structure/Function Claims (dietary supplements)
• FDA: Guidance for Industry - Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the FD&C Act (January 2009)
• FDA: Small Entity Compliance Guide on Structure/Function Claims (January 2002)
• eCFR: 21 CFR 101.93 - Certain types of statements for dietary supplements
• FDA: Letter to the Dietary Supplement Industry on the DSHEA Disclaimer (December 11, 2025)
• FTC: Health Products Compliance Guidance (December 2022)
• FDA: Notifications of Structure/Function and Related Claims

추천 다음 단계

• 검토 포스파티딜세린 제품 페이지.
• 비교 두두 PS 그리고 선바라기 PS.
• 체크 제조 증명 그리고 품질 및 연구개발.