US Supplement Facts Panel: Complete Labeling Compliance Guide

Dietary supplement labeling in the US is regulated by the FDA under the Dietary Supplement Health and Education Act (DSHEA) of 1994 and the Nutrition Labeling and Education Act (NLEA). The specific labeling requirements for dietary supplements are codified in 21 CFR Part 101, Subpart D, with the Supplement Facts panel governed primarily by 21 CFR 101.36. Every dietary supplement sold in the US must carry a Supplement Facts panel on the principal display panel or information panel. The Supplement Facts panel is a mandatory disclosure of the supplement's serving size, servings per container, dietary ingredients and amounts, and percent daily values for applicable nutrients. Failure to include a compliant Supplement Facts panel is a federal misbranding violation under 21 USC 343, rendering the product adulterated and subject to FDA enforcement action including import detention, recall, and civil penalties.

The regulatory framework for US dietary supplements positions the Supplement Facts panel as the consumer's primary information tool, and FDA has enforced 21 CFR 101.36 with increasing rigor since 2020. FDA's Dietary Supplement Program issued 134 Warning Letters to dietary supplement companies between 2023 and 2025, with labeling violations (including Supplement Facts panel errors) cited in 47 percent of all Warning Letters. For Taiwan supplement exporters, the most common FDA Warning Letter trigger is inadequate Supplement Facts panels on products imported without US-specific label review. Before shipping any dietary supplement to the US, engage a US regulatory affairs consultant specializing in dietary supplement labeling (cost: USD 2,500 to USD 5,000 for a label review per product) to confirm 21 CFR 101.36 compliance.

The Supplement Facts panel must be presented in a specific format with a bold "Supplement Facts" heading, a hairline rule below the heading, the serving size and servings per container declaration, another hairline rule, the dietary ingredient declarations, and a thick bottom rule. The entire panel must be in a single color on a contrasting background, presented in a legible sans-serif font with a minimum type size of 6 points (with specific elements such as "Supplement Facts" heading in at least 8-point bold type). All type must be clearly legible, meaning sufficient contrast between the text and background. A white-on-white embossed Supplement Facts panel, even if technically present, is considered non-compliant by FDA because it is not clearly legible.

Net quantity of contents declaration on the principal display panel must reflect the quantity of the dietary supplement in the container, declared in weight (grams, milligrams), count (capsules, tablets, softgels), or volume (mL for liquid supplements), with the metric quantity followed by the US customary equivalent in parentheses. Supplement products that contain both a powder and capsule form (for example, a protein powder in a tub) must declare the net weight of powder in the container, not the number of servings, as the principal net quantity statement. The net quantity declaration must be consistent with what the FDA calls the "identity statement" of the product on the principal display panel.

The Supplement Facts panel layout follows strict format specifications in 21 CFR 101.36. The "Serving Size" declaration uses common household measures (for example, "1 capsule," "2 softgels," "1 scoop (30g)") and must reflect a reasonable, customary amount consumed per serving. The serving size cannot be misleadingly small: if a product is intended to be taken as 3 capsules per day, the serving size must be 3 capsules, not 1 capsule (which would require consumers to multiply all nutrient quantities by 3 to determine their actual daily intake). FDA inspectors specifically scrutinize serving size declarations to identify situations where manufacturers set artificially small serving sizes to make nutrient amounts appear lower per serving than they would be at actual use levels.

Dietary ingredients are listed in the Supplement Facts panel in the following order: macronutrients (calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, Vitamin D, calcium, iron, potassium) if present and if the supplement provides them in significant quantities, followed by vitamins and minerals (in the order specified in 21 CFR 101.9(c)), followed by other dietary ingredients (botanicals, herbs, amino acids, proprietary blends) in descending order by weight per serving. Dietary ingredients with established Reference Daily Intakes (RDIs) must declare the % Daily Value; those without established RDIs must state "Daily Value not established" with a dagger symbol (†) referring to a footnote.

Proprietary blend labeling is permitted under 21 CFR 101.36(c)(3): a blend of two or more dietary ingredients may be declared as a single component with a trade name, followed by the total weight of the blend per serving, and listing the individual ingredients of the blend in descending order by weight with no individual weights required. The trade name of the blend must be followed by the word "blend" or "matrix" or "complex" in the Supplement Facts panel. The weight of the proprietary blend as a whole must be declared. Individual ingredient weights within the blend are not required but may optionally be included. Consumer advocacy groups and Amazon have both increasingly flagged proprietary blends as a trust signal issue: transparent individual ingredient quantity disclosure is commercially advantageous even when not legally required.

The Supplement Facts panel must include a specific footnote if any dietary ingredient in the panel has a percent Daily Value of 20% or more: "Percent Daily Values are based on a 2,000 calorie diet." This footnote is optional when all listed dietary ingredients have % Daily Value declarations based on non-caloric reference amounts. For products using non-standard serving sizes or caloric profiles, an additional footnote defining the caloric basis for the Daily Value calculation may be required. The standard footnote format specified in 21 CFR 101.36(e) must be included verbatim when the 2,000-calorie reference is triggered; modifications to the footnote language constitute a labeling violation.

Reference Daily Intakes (RDIs) and Daily Reference Values (DRVs) form the basis for % Daily Value calculations on Supplement Facts panels. The FDA updated the RDI values effective January 1, 2020, for large manufacturers (annual food sales over USD 10 million) and January 1, 2021, for small manufacturers. The 2020 RDI values must be used for all current Supplement Facts panels. Key RDI changes from the prior standard that affect Taiwan supplement formulations include: Vitamin D increased from 400 IU to 800 IU (20 mcg), Calcium decreased from 1,000 mg to 1,300 mg, Potassium increased from 3,500 mg to 4,700 mg, and Vitamin C increased from 60 mg to 90 mg. Products that were labeled using pre-2020 RDI values will show incorrect % Daily Values on their current Supplement Facts panel and require immediate label correction.

Vitamins and minerals in Taiwan supplement formulations are often declared in Taiwan or EU units that differ from US label requirements. For example, Taiwan and EU labels may declare Vitamin D in IU (International Units), while FDA requires the declaration in mcg (micrograms) with the IU equivalent in parentheses: "Vitamin D 25 mcg (1,000 IU)." Similarly, Vitamin A must be declared in mcg RAE (Retinol Activity Equivalents) with the IU equivalent in parentheses for mixed forms (retinol and beta-carotene). Iron, zinc, and selenium must be declared in mg or mcg (not percentage of elemental metal weight). When creating Supplement Facts panel nutrient declarations from your Taiwan CoA data, systematically convert all units to FDA-required units before building your US label.

For dietary ingredients without established RDIs or DRVs, the Supplement Facts panel must include the amount per serving (in weight units: mg, mcg, or g) without a % Daily Value, and include the notation "† Daily Value not established" at the bottom of the panel referenced by a dagger symbol (†) in the panel body. Botanical ingredients, amino acids, enzymes, and most herbal extracts fall into this category. Common errors in this area include: omitting the dagger symbol, incorrectly assigning a % Daily Value to an ingredient without an established RDI (which creates false precision), and declaring the botanical ingredient weight as a dry herb equivalent rather than the actual extract weight in the serving. Declare the actual weight of the extract as supplied in the finished product, not the dry herb equivalent weight, unless the label specifically identifies the ingredient as a dry herb equivalent.

Conversion factors for botanical extract standardization must be disclosed correctly in the Supplement Facts panel. If you use a 10:1 extract of a botanical ingredient, the Supplement Facts panel should declare the weight of the extract as taken (for example, "Ashwagandha extract 300 mg"), with the "10:1" standardization ratio and the active constituent percentage disclosed as a sub-component below the ingredient name (for example, "with 5% withanolides, 15 mg per serving"). The sub-component quantity (active constituent) must also be listed with its own "daily value not established" notation. Failure to properly disclose standardization ratios and active constituent amounts for botanical extracts is a frequent FDA Warning Letter trigger for imported supplement products.

The distinction between permitted structure/function claims and prohibited drug claims is the most important regulatory concept in US dietary supplement marketing. Under DSHEA and 21 USC 343(r)(6), a structure/function claim describes the role of a nutrient or dietary ingredient in affecting a normal structure or function of the human body, or characterizes the documented mechanism by which a nutrient or ingredient acts to maintain health. Examples of permitted structure/function claims include: "Calcium builds strong bones," "Vitamin C supports immune function," "Ashwagandha helps the body maintain a healthy stress response," and "Magnesium supports muscle function and relaxation." These claims do not reference any disease and are evaluated against the standard of "truthful and not misleading" supported by "competent and reliable scientific evidence."

Drug claims are statements that a product is intended to diagnose, cure, mitigate, treat, or prevent a disease. Any dietary supplement label, website, Amazon listing, or advertising that includes a drug claim causes the product to be classified as an unapproved new drug, subject to FDA seizure and removal from the market. Drug claims include: "relieves anxiety disorder," "treats osteoporosis," "prevents Type 2 diabetes," "reduces blood pressure," and "cures insomnia." The FDA evaluates drug claim determinations on a "totality of evidence" basis: even if the label itself avoids drug claims, if the website, social media, and consumer testimonials promoted by the brand collectively convey that the product treats a disease, the FDA may characterize the product as an unapproved drug. Review your entire US marketing ecosystem (not just label copy) for drug claim risks.

Structure/function claim notification to FDA is required within 30 days of first marketing a dietary supplement with a structure/function claim. The notification is submitted through FDA's online structure/function claim notification system (sfc.fda.gov) and includes the text of the claim, the ingredient supporting the claim, and the submitter's contact information. The notification is not an approval: FDA does not review or approve structure/function claims in advance, and submission of the notification does not imply that the claim is accurate or that FDA endorses it. However, failing to submit the notification when using a structure/function claim is itself a labeling violation under 21 CFR 101.93. Submit notifications for all structure/function claims on your US dietary supplement labels within 30 days of first sale.

The required disclaimer for structure/function claims on US dietary supplements must appear prominently and conspicuously on the label, immediately adjacent to the claim or in a visible location on the same panel: "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." This disclaimer must be in at least 1/32-inch (approximately 0.8mm) type, highlighted with a box or bolded heading, and presented in a color contrasting with the background. The disclaimer also must appear on your product's website and in any advertising that makes structure/function claims. Omission of the disclaimer from any of these locations independently constitutes a labeling or advertising violation.

The five most frequent Supplement Facts panel errors identified in FDA Warning Letters involving imported dietary supplements from 2023 to 2025 are, in order of frequency: (1) incorrect serving size declaration (either misleadingly small, inconsistent with directions for use, or expressed in non-standard units without common household measure equivalents); (2) missing or incorrect % Daily Value declarations (using pre-2020 RDI values, omitting % Daily Value for vitamins/minerals with established RDIs, or incorrectly assigning % Daily Values to ingredients without established RDIs); (3) incorrect net quantity of contents (declared in non-US units, inconsistent with label claims, or not matching the actual fill quantity); (4) drug claims in the product description or Amazon listing that differ from the structure/function claims on the label; and (5) missing or incorrect required disclaimer for structure/function claims.

Amazon-specific Supplement Facts issues are a growing compliance area. Amazon's dietary supplement listing policy requires that the product's Supplement Facts panel be uploaded as a verified, readable image in the product images, and that the label information in the listing matches the physical label. Amazon's compliance team regularly audits dietary supplement listings for consistency between the listing information and the uploaded label image. Discrepancies (such as a listing claiming 500mg of an ingredient when the Supplement Facts panel shows 250mg per serving) result in listing suppression. For Taiwan supplement brands, ensure that your Amazon listing is updated simultaneously with any label revision, and upload a fresh Supplement Facts panel image every time you make a label change.

Country-specific additive and excipient declaration rules differ between Taiwan and the US. Taiwan supplement labels typically list excipients (binders, fillers, coatings, lubricants) separately from dietary ingredients in a "non-dietary ingredient" disclosure. In the US Supplement Facts panel, excipients are disclosed in the "Other Ingredients" section below the Supplement Facts panel box, listed in descending order by weight. The "Other Ingredients" section uses FDA's nomenclature for excipients (for example, "microcrystalline cellulose" not "MCC," "silicon dioxide" not "silica," "magnesium stearate" not "Mg stearate"), and all ingredients including excipients must be declared on the US label. Common Taiwan supplement excipients that require specific US nomenclature mapping include: dicalcium phosphate (declare as "dibasic calcium phosphate"), HPMC (declare as "hydroxypropyl methylcellulose"), and PVP (declare as "polyvinyl pyrrolidone").

Foreign language on US dietary supplement labels is permitted but must be accompanied by English-language disclosures for all mandatory label elements. If a Taiwan brand uses Chinese or Japanese characters on any part of the US dietary supplement label (for example, for a brand name displayed in Chinese characters), the label must also include all mandatory information in English, and the English text must be at least as prominent as the foreign language text for required elements (product name, directions, warnings, Supplement Facts panel). Bilingual labels are commercially effective for marketing to ethnic communities in the US and are fully compliant provided all required English-language elements meet FDA typography and prominence requirements. The Supplement Facts panel itself is never bilingual under FDA rules: the panel must be entirely in English with numeric quantities expressed in standard US measurement units.