Understanding Supplement Labels & Regulations

FDA rules, what labels can and can’t say, and how to read a Certificate of Analysis — what every herbalist needs to know before buying

Walk into any health food store or browse any online herb supplier and you will encounter hundreds of products making various claims — some of them meaningful, some of them marketing language, some of them carefully worded to avoid legal problems while implying something they cannot legally state. The supplement industry is a multi-billion-dollar market with significant variation in quality, honesty, and regulatory oversight.

Understanding how herbal supplement regulation actually works — what the FDA requires, what companies are allowed to say, and what they are not — gives you a significant advantage as a consumer. It helps you recognize genuine quality claims from meaningless ones, understand why certain statements appear on labels the way they do, and know what independent verification to look for.

This article covers the regulatory framework for herbal supplements in the United States, explains the specific rules around label claims, and walks you through how to read and interpret a Certificate of Analysis (COA) — the most important quality document you can request from a supplier.

The Regulatory Framework: DSHEA

In the United States, dietary supplements — which includes herbal products, vitamins, minerals, and other nutritional products — are regulated under the Dietary Supplement Health and Education Act of 1994, almost always referred to as DSHEA (pronounced “de-shay”).

DSHEA established a regulatory category distinct from both foods and drugs, with its own set of rules and its own oversight challenges. Understanding DSHEA’s key provisions explains almost everything that seems confusing about supplement regulation.

The most important thing DSHEA established: supplements don’t need pre-market approval

Unlike pharmaceutical drugs, which must be proven safe and effective before they can be marketed, dietary supplements do not require FDA approval before they go on sale. A supplement company can formulate a product, put it on the market, and begin selling it without FDA review — as long as they comply with the other requirements of DSHEA.

This is the fundamental difference that shapes everything else about supplement regulation. The FDA’s role is primarily reactive rather than preventive: they can act against a product if it is found to be unsafe or if the company is making illegal claims, but they are not reviewing products before they reach consumers.

What this means practically: the quality, potency, and safety of a supplement are the manufacturer’s responsibility, not the FDA’s responsibility to verify. This is why third-party testing and Certificates of Analysis matter so much — they provide the independent verification that regulatory pre-market approval would otherwise provide.

What DSHEA does require

Good Manufacturing Practices (GMPs): Since 2007, the FDA has required dietary supplement manufacturers to follow Good Manufacturing Practice regulations, which cover facility standards, testing procedures, quality control, record-keeping, and product identity verification. Compliance with GMPs is a baseline quality requirement, though enforcement varies.

Adverse event reporting: Supplement companies are required to report serious adverse events to the FDA within 15 days. This is how the FDA learns about safety problems after products are on the market.

Label requirements: DSHEA specifies what must appear on supplement labels (covered in detail below) and what kinds of claims are and are not permitted.

Identity of the product: The product must contain what the label says it contains. Adulteration and mislabeling are illegal under DSHEA, though enforcement depends on the FDA having the resources and evidence to act.

What Labels Must Include

DSHEA specifies several elements that must appear on every dietary supplement label:

Required label elements
1. The statement “Dietary Supplement” — products must be identified as dietary supplements, distinguishing them from foods and drugs

2. Net quantity of contents — how much is in the container (number of capsules, total weight, etc.)

3. Supplement Facts panel — the equivalent of a Nutrition Facts panel for food; lists serving size, servings per container, and the specific ingredients with amounts per serving

4. List of other ingredients — any excipients (fillers, binders, capsule material, etc.) not listed in the Supplement Facts panel

5. Name and place of business of the manufacturer, packer, or distributor

6. Directions for use

7. Any required warnings (e.g., “Do not use if pregnant or nursing” for herbs with pregnancy contraindications; “Keep out of reach of children”)

Reading the Supplement Facts panel

The Supplement Facts panel is the most information-dense part of any supplement label, and knowing how to read it well makes you a more informed purchaser.

Serving size: The quantities listed in the panel are per serving, not per container. If a serving is 2 capsules but you’re only taking 1, halve all the amounts listed.

Ingredient names: Herbal ingredients are listed by their common name and often their Latin binomial (scientific name). The Latin name matters — echinacea purpurea and echinacea angustifolia have different constituent profiles and may have somewhat different effects. Knowing the Latin name of the herb you want helps you verify you’re getting the right species.

Plant part: Good labels specify which part of the plant is used: root, leaf, flower, aerial parts, bark, seed. This matters enormously for herbal products. Echinacea root tincture behaves differently from echinacea leaf tea. A label that does not specify the plant part is missing important information.

Standardization: Many herbal extracts are standardized to contain a minimum percentage of specific active compounds — e.g., “standardized to 5% withanolides” for ashwagandha, or “standardized to 0.3% hypericin” for St. John’s Wort. Standardization ensures consistent potency from batch to batch and is generally a positive quality indicator for products where the research was done on standardized extracts.

Extract ratio: Some labels list an extract ratio like “4:1 extract” or “10:1 extract” — this means 4 or 10 parts of herb were used to make 1 part of extract. Higher ratios indicate more concentrated extracts. This is not the same as standardization and is less informative on its own.

Amount per serving: The quantity of each ingredient per serving is listed in milligrams (mg), micrograms (mcg), or as a percentage of the Daily Value where one exists. For herbal products, there is often no established Daily Value, and amounts should be compared to the doses used in research or traditional practice.

What Labels Can and Cannot Say: The Claims Framework

The rules around what herbal supplement labels can claim are specific and consequential. Getting this right is what the “what herbalism is and isn’t” article covered from a practice perspective — here we cover it from a regulatory perspective.

The three categories of claims
DSHEA established three categories of claims that apply to dietary supplements:

1. Disease claims (PROHIBITED without drug approval)
2. Health claims (require FDA authorization based on significant scientific agreement)
3. Structure/function claims (permitted with notification and disclaimer)

Disease claims — what companies CANNOT say

A disease claim is any claim that a supplement diagnoses, cures, treats, mitigates, or prevents a disease. Making a disease claim about a dietary supplement automatically makes it a drug claim — which means the product is now classified as an unapproved drug and is subject to enforcement.

Examples of prohibited disease claims:
“Cures arthritis” — not allowed
“Prevents cancer” — not allowed
“Treats depression” — not allowed
“Lowers blood pressure” — this one is in a gray zone; by itself it could be a disease claim
“Heals diabetes” — not allowed

This is why you rarely see these claims on legitimate products, and why you should be suspicious of any supplement that does make them — it is either breaking the law or operating outside reputable channels.

Structure/function claims — what companies CAN say

Structure/function claims describe how a supplement affects the structure or function of the body, without claiming to address a disease. These are permitted under DSHEA, with two conditions: the company must have substantiation that the claim is truthful and not misleading, and they must notify the FDA within 30 days of marketing and include a specific disclaimer on the label.

Examples of permitted structure/function claims:
“Supports healthy immune function” — allowed
“Maintains healthy blood pressure already within the normal range” — allowed (note the careful language)
“Supports a healthy stress response” — allowed
“Promotes joint comfort and flexibility” — allowed
“Helps maintain healthy cholesterol levels already within the normal range” — allowed

Notice how the language is carefully constructed to avoid claiming to treat a disease. “Maintains healthy blood pressure already within the normal range” sounds odd until you understand that “lowers blood pressure” could be a disease claim, while “maintains normal blood pressure” is a structure/function claim.

The required disclaimer
Any product making structure/function claims must include this specific statement:

“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.”

You have seen this disclaimer on virtually every supplement you have ever purchased. It is not a sign that the product does not work or that the company is hiding something. It is a legally required disclosure that explains the regulatory status of dietary supplements. It means the FDA has not reviewed or approved the specific claim, which — as we established above — is true of virtually all dietary supplement claims by design.

Quality Claims: What to Actually Look For

Beyond the legal framework, certain quality certifications and practices indicate a more reliable product. None of these are required by law — they are voluntary indicators that a company is going beyond the regulatory minimum.

Third-party testing certifications

USP (United States Pharmacopeia): USP verification means a product has been independently tested to verify that it contains what the label says, in the amount stated, without harmful contaminants, and that it will break down appropriately in the body. USP testing is rigorous and meaningful.

NSF International: NSF certification includes independent testing for label accuracy, contaminants, and facility compliance with GMPs. NSF’s Certified for Sport program also tests for substances banned in athletic competition.

ConsumerLab: ConsumerLab independently tests supplement products and publishes results (subscription required). They regularly find significant discrepancies between label claims and actual content.

Informed Sport / Informed Choice: Testing programs primarily relevant to athletes but indicate rigorous quality testing and supply chain verification.

Organic certification

USDA Organic certification for herbal supplements indicates that the herbs were grown without synthetic pesticides, fertilizers, or GMOs, and that the processing facilities meet organic handling standards. This is relevant for people concerned about pesticide residues in herbal products, and is particularly meaningful for high-volume herbs where conventional cultivation may involve significant pesticide use.

Country of origin and sourcing transparency

Reputable herbal supplement companies are increasingly transparent about where their herbs are sourced, how they are grown or wildcrafted, and what testing they perform. Companies that can provide this information willingly and specifically are generally more trustworthy than those that cannot.

Certificates of Analysis: The Most Important Quality Document

A Certificate of Analysis (COA) is a document provided by a testing laboratory that certifies the results of testing performed on a specific batch of an herbal product or raw ingredient. Requesting and reading COAs is one of the most powerful tools available for assessing herb quality, and it is something that any reputable supplier should be able to provide.

What a COA contains

A COA should include the following elements:

Product identification: the product name, lot number, and batch identification. The lot number is important — it links the COA to a specific production batch. Ask for the COA for the specific lot you are purchasing, not a generic company COA.
Testing laboratory: the name and contact information of the laboratory that performed the testing. The laboratory should be independent from the manufacturer (though manufacturers sometimes test in-house as well; independent lab testing is more credible).
Testing date: when the testing was performed.
Identity testing: confirms that the plant material is what it claims to be. Methods include organoleptic testing (appearance, smell, taste), microscopy, and DNA barcoding. Identity testing is essential — adulteration and mislabeling (substituting cheaper herbs for expensive ones) is a documented problem in the herbal industry.
Purity testing: tests for contaminants including heavy metals (lead, arsenic, mercury, cadmium), pesticide residues, microbial contamination (bacteria, mold, yeast), and sometimes mycotoxins (toxins from molds).
Potency testing: for standardized products, confirms that the specified active compound is present at the stated percentage. For non-standardized products, may include HPLC (high-performance liquid chromatography) profiles that confirm the characteristic constituent pattern of the herb.
Pass/fail or specification results: each test result compared to the specification (the standard the product is expected to meet). Results should show the actual test result alongside the specification.

How to read a COA entry:
Test: Lead (heavy metal) | Specification: ≤0.5 ppm | Result: 0.12 ppm | Status: PASS

This tells you: lead was tested; the maximum allowed is 0.5 parts per million; the actual result was 0.12 ppm; the product passes.

Test: Identity (DNA barcoding) | Specification: Echinacea purpurea confirmed | Result: Echinacea purpurea confirmed | Status: PASS

This tells you: DNA testing confirmed the herb is the species claimed on the label.

Test: Withanolides (standardization) | Specification: ≥5% w/w | Result: 5.8% w/w | Status: PASS

This tells you: the standardized compound (withanolides in ashwagandha) is present at 5.8%, meeting the specification of at least 5%.

Red flags in a COA

Be concerned if a COA:
• Is not specific to a lot number — a generic company-level COA does not tell you about the specific batch you are buying
• Was produced by the company’s own internal laboratory without independent verification — not necessarily a problem, but less credible than independent testing
• Is undated or several years old — COAs should be current and relevant to the product being sold
• Does not test for heavy metals, microbial contamination, and identity as a minimum
• Shows results very close to the specification limit on heavy metals or contaminants — technically passing but with little margin
• Cannot be provided at all — a reputable supplier should be able to provide COAs on request

Practical Sourcing Guidance

Armed with this framework, here is what to actually do when purchasing herbal supplements:

Before you buy:
• Check for third-party certifications (USP, NSF) on the label or company website
• Look for the Latin binomial and plant part specified on the label
• For standardized extracts: verify the standardization percentage and the specific compound
• Look up the company’s testing practices on their website — transparent companies publish their quality standards
• For bulk herbs from suppliers: request a COA for the specific lot you are ordering
• For expensive or high-risk herbs: consider cross-referencing with independent testing sites like ConsumerLab

Questions to ask a supplier:
• “Can I have the COA for this lot?”
• “Do you use an independent laboratory for testing, or in-house?”
• “Do you test for heavy metals, pesticide residues, and microbial contamination?”
• “What species and plant part is this?”
• “Where is this herb sourced from?”

The Marketing Language Decoder

Supplement labels and marketing materials use specific language that can be confusing or misleading. Here is a plain-language translation of common terms:

“All natural”: Not a regulated term. Means nothing specific about quality, purity, or efficacy. Arsenic and mercury are natural. This phrase adds no meaningful information.

“Clinically proven”: May refer to clinical research on the specific product, on the same herb from a different manufacturer, or on a standardized extract that differs from what is in the product. Ask: clinical research on what, exactly?

“Pharmaceutical grade”: Not a regulated term for supplements. May indicate GMP compliance (which is already required) or may be marketing language without specific meaning.

“Whole food supplement”: Indicates the supplement is derived from whole food sources rather than isolated or synthetic compounds. Can be meaningful or may be marketing language; look for specifics about what whole foods and what testing is performed.

“No fillers” or “no excipients”: Some products genuinely do contain only the herb. Others use “no fillers” as a marketing claim while still including binding agents and flow agents. Check the “Other Ingredients” section of the Supplement Facts panel for the full picture.

“Proprietary blend”: A blend of ingredients where the individual amounts of each ingredient are not disclosed, only the total amount of the blend. This is legal but makes it impossible to know how much of any specific ingredient you are getting. In a proprietary blend, manufacturers may use very small amounts of expensive or active ingredients alongside large amounts of cheaper ones.

“Bioavailable” or “enhanced absorption”: May refer to genuinely improved delivery systems (like piperine with curcumin, liposomal formulations, or specific extraction methods) or may be marketing language. Ask for the evidence base for the specific bioavailability claim.

The proprietary blend problem:
Proprietary blends allow companies to include small — sometimes therapeutically insignificant — amounts of active ingredients while listing them prominently on the label. A product claiming to contain ashwagandha, rhodiola, holy basil, and five other adaptogens in a 1000mg proprietary blend might contain only 50mg of each active herb, with the remainder being inexpensive fillers.

When purchasing multi-herb formulas, look for products that list individual amounts for each herb, or be prepared to evaluate proprietary blends skeptically.

A Note on Homegrown and Small-Batch Herbs

Everything in this article applies primarily to commercial supplement products. When you are purchasing bulk dried herbs directly from a small reputable supplier, growing your own, or wildcrafting, the regulatory framework is less relevant but the quality principles remain.

For bulk herb purchasing from small suppliers, the most relevant principles are: ask about sourcing and testing, request a COA for heavy metals and identity at minimum, pay attention to the sensory quality of the herb when it arrives (color, aroma, freshness), and build relationships with suppliers you trust.

For herbs you grow yourself: you control the growing conditions and can be certain of the species identity. For herbs you wildcraft: proper botanical identification is essential, and awareness of potential environmental contamination in the harvesting area matters.

The label is the company’s self-report.
The COA is the evidence.
The third-party certification is the verification.
You now know the difference —
and that knowledge is worth more than any claim
you will ever see on a supplement bottle.

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Disclaimer

The information provided on this website is for educational purposes only and is not intended to diagnose, treat, cure, or prevent any disease.

Herbal remedies can affect individuals differently and may interact with medications or medical conditions. Always consult a qualified healthcare professional before beginning any new herbal regimen, especially if you are pregnant, nursing, taking medications, or have a medical condition.

Southwestern Herbal Academy does not provide medical advice, diagnosis, or treatment.