What the law requires about identity, and what it does not

Start here, because it is the foundation and it is frequently misdescribed.

Federal manufacturing rules for supplements, at 21 CFR Part 111, require a manufacturer to establish an identity specification for every component, plus specifications for purity, strength and composition, and limits on contamination.

One requirement cannot be delegated:

"Before you use a component, you must… Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency… and the agency exempts you from such testing."

The manufacturer must test the identity of the actual botanical itself. A supplier's certificate of analysis does not substitute for that. The only way out is a formal petition to FDA showing "no material diminution of assurance, compared to the assurance provided by 100 percent identity testing," and the firm has to keep FDA's response on file.

Certificates of analysis are allowed to stand in, but only for components that are not dietary ingredients, and only on five conditions: the firm must first qualify the supplier "by establishing the reliability of the supplier's certificate of analysis through confirmation of the results"; the certificate must include the method used, its limits, and the actual results; the firm must document how it qualified the supplier; it must periodically re-confirm; and quality control personnel must review and approve.

No audit is required, and neither is a site visit. There is no defined frequency for "periodically," no duty to know the country, and no duty to trace material to a farm.

"Supplier qualification" in this framework means the firm checked once that a supplier's paperwork matched reality, and rechecks it sometimes. That is a real and useful requirement. It is considerably less than the phrase sounds like.

The regulation also permits several kinds of identity method, ranging from chemical analysis down to a trained person examining the material by eye and nose, and finished-product verification may cover a statistically selected subset of batches rather than every batch. Both ends of each range are lawful, and the phrase "we test everything" covers both. A companion article on contacting a supplement company sets out how to ask which one you are being told about.

Why the bottle does not say where it came from

Two separate regimes govern origin, and neither puts a country on a supplement label in the ordinary case.

FDA's labeling rule requires "the name and place of business of the manufacturer, packer, or distributor." That is the firm's address, not the plant's. Nothing in it concerns where ingredients were grown, and no country-of-origin requirement for supplements could be located anywhere in the food labeling regulations.

Customs has a country-of-origin marking rule, but it works differently than people assume. The general requirement is that an imported article be marked to indicate its country of origin to "an ultimate purchaser in the United States." The decisive provision is what counts as the ultimate purchaser:

"the manufacturer or processor in the United States who converts or combines the imported article into the different article will be considered the 'ultimate purchaser'… The outermost containers of the imported articles shall be marked."

So when a US manufacturer imports bulk botanical material and turns it into a finished supplement, the marking duty attaches to the drum the material arrived in, not to the bottle on the shelf. The consumer's bottle carries no origin marking, and that is lawful, not evasion.

(A supplement imported and sold in its imported retail form is a different case: there the retail buyer is the ultimate purchaser and marking applies.)

Keep the agencies straight, because they are routinely conflated. FDA handles labeling, Customs handles import marking, USDA runs organic certification, and FTC governs "Made in USA" claims, including on e-commerce product pages as well as on physical labels.

What "organic" certifies, and what it does not

USDA organic is a real, enforced standard with tiers: "100 percent organic" means exactly that, excluding water and salt; "organic" means "not less than 95 percent"; and "made with organic [ingredients]" means "at least 70 percent." Those products may not display the USDA seal.

It helps to look at what the standard is about. The regulation says the term may be used only on products "that have been produced and handled in accordance with the regulations in this part." It is a production and handling standard, a set of rules about what may be applied to a crop and how it must be managed.

Even so, organic products are not untested. Certifying agents must "conduct periodic residue testing," and must sample from a minimum of five percent of the operations they certify each year. Product whose residues exceed 5 percent of EPA's tolerance for the substance detected cannot be sold as organic.

In practice, organic testing is risk-triggered plus a five-percent annual sample, and it is keyed to prohibited substances and pesticide residues measured against EPA tolerances. Nothing in the organic rules sets a heavy-metal limit, requires an identity test, or specifies a potency.

Organic tells you how the plant was grown and handled. It does not tell you the lead content, the marker-compound level, or that the species in the bottle is the species on the label. Those are different questions with different answers, and a buyer who treats the seal as a purity guarantee is asking it to do a job it was never designed for.

The same logic applies in reverse to purity-focused marks: a third-party certification testing what is in the bottle says nothing about how the plant was farmed. And as NIH's Office of Dietary Supplements puts it about certification marks generally: "These seals do not guarantee that a product is safe or effective."

"Wildcrafted" is a sourcing description, not a quality claim

This is the finding in this article most likely to be new to you, and it is well supported.

Wild-harvested botanicals carry a premium and an implication: that a plant growing where nature put it is somehow richer than a cultivated one. The research on American ginseng, the botanical where this has been studied most carefully, does not support it.

A 2003 study in the Journal of Agricultural and Food Chemistry analyzed wild populations across Ontario, Quebec, Maine, Vermont and Wisconsin. Total root ginsenoside content ranged from 1 percent to 16 percent, with most samples between 4 and 5 percent. The conclusion:

"There was no statistical difference in mean ginsenoside content between wild and cultivated P. quinquefolius roots at 4 years of age, suggesting there is no phytochemical justification for wild crafting."

A 2006 study in Phytochemistry examined ten populations and identified two distinct chemical types. "Chemotype did not vary by production type (wild versus cultivated)," and the differences were "likely influenced more by genotype than environmental factors." (That study grew everything in a single location, which is a limitation the authors state.)

Does anything about growing conditions matter? Yes, substantially. A 2003 study found that understory light level accounted for up to 48 percent of the variation in ginsenoside content in one-year roots and 62 percent in two-year roots. That study examined only one- and two-year roots, while commercial ginseng is harvested at four years or more. A 2021 review of 48 studies found environmental variables can move secondary metabolite content "by up to 50 percent." That is a ceiling across many species, not a typical figure.

Taken together, where and how a plant grows demonstrably changes what is in it. "Wild" is not the variable that predicts it. Genotype, plant age, light and population appear to matter more.

Which means "wildcrafted" on a label tells you how the material was obtained. It does not tell you the material is better, and the evidence suggests it probably is not.

The adulteration problem, sized fairly

Substitution and adulteration in the botanical trade are real, and the best available figure comes from a 2023 review in the Journal of Natural Products, which put adulteration at around 27 percent across two independent literature reviews.

Two things about that number. It is mostly economically motivated (cheaper material substituted for expensive material) rather than a safety problem, though the review notes exceptions. And it synthesizes published investigations rather than a random market survey.

A widely quoted, far more alarming figure (that most North American herbal products contain unlisted species) comes from a 2013 DNA barcoding study that was retracted in July 2024 after the authors' university found evidence of data fabrication. If you have seen that figure quoted anywhere, it should not be repeated.

NCCIH, the federal complementary-health research center, states the problem plainly for one botanical: "Some commercial goldenseal products have been found to contain other herbs or ingredients not listed on the label in addition to or instead of goldenseal."

Sustainability, precisely

Some botanicals are under real pressure, and the regulatory picture is more specific than most articles suggest.

American ginseng (Panax quinquefolius) is listed in CITES Appendix II, defined in the implementing regulations as covering "species that are not presently threatened with extinction, but may become so if their trade is not regulated." International trade in the listed material is controlled accordingly.

Read the listing annotation, though:

"Whole plants and roots (whole, sliced, and parts, excluding manufactured parts, products, and derivatives, such as powders, pills, extracts, tonics, teas, and confectionery)"

The control attaches to the raw root, not to the capsule. A finished American ginseng supplement sits outside the annotation. Anyone telling you your ginseng capsule is a CITES-regulated product is wrong.

Goldenseal is widely described as similarly listed. That could not be verified from any retrievable authoritative source for this article, so no CITES claim is made for it here. What is verified is NCCIH's February 2025 statement, "Wild goldenseal has been overharvested and is available in limited amounts," and that is enough to make the point.

United Plant Savers is a 501(c)(3) conservation advocacy organization, founded in 1994, and it publishes a widely cited at-risk list. The list carries no legal force, and the organization's page sets out no quantitative listing methodology. The list's "At-Risk" category includes American Ginseng, Black Cohosh, Bloodroot, Blue Cohosh, Echinacea, Goldenseal, Kava, Osha, Slippery Elm, White Sage and Wild Yam, and its "Critical" category is shorter and includes Lady's Slipper Orchid, Trillium, Sundew and Venus Fly Trap.

Treat it as what it is: a conservation organization's assessment, useful for orientation, not a regulatory or scientific determination.

Heavy metals, and a claim this article will not make

Soil is the main route by which metals enter botanicals (plants take up what is in the ground they grow in), and metal content varies by plant part and growth stage within a single plant.

What does not follow is a country ranking. No current survey of heavy metals in botanicals on the US market by growing region could be located. The best US data comes from two studies published in JAMA, sampling products purchased in 2003 to 2005, and their findings cut against the obvious assumption in two ways:

• US manufacture was not protective. Metals were detected in 21.7 percent of US-made products versus 19.5 percent of Indian-made ones, a difference that did not approach statistical significance (P = .86).
• A GMP claim was not protective either. Seventy-five percent of the metal-containing products carried one.

Those figures are twenty years old and should not be read as current prevalence. But they are the best available, and they do not support the idea that domestic sourcing solves this.

Any statement that a particular country's botanicals are uniformly worse is unsupported by retrievable evidence, and it is also, conveniently, the kind of claim a domestically-sourcing seller benefits from making. This article does not make it. The one documented exception worth knowing is lead adulteration in turmeric, a supply-chain problem concentrated in identifiable sources rather than a general hazard, which enforcement has demonstrably fixed in at least one country. A companion article covers it.

A note on imports and FDA

FDA maintains import alerts, which allow detention of shipments "without having to test or otherwise physically examine" them, based on a documented violation history. Several are directly relevant to botanicals: they cover products containing aristolochic acid, foods containing ginseng that fail to properly declare it, kratom, products containing an active pharmaceutical ingredient, and dietary supplement products from firms that have not met dietary supplement GMP. So there is real enforcement at the border, and that last alert is a reminder that manufacturing standards are not uniformly met.

The Foreign Supplier Verification Program is sometimes presented as an extra layer, and it mostly is not one. It applies to imported supplements and components, but where the importer or its customer already meets the Part 111 identity-testing and specification requirements, most of the program's separate obligations fall away. It is largely the same identity test described at the top of this article, not a second independent safety net.

What to ask

If you want to know where a botanical came from, these are the questions that produce useful answers.

"What is the Latin binomial and the plant part?" This should be on the label already. Root, leaf, seed and aerial parts are chemically different, and species within a genus are not interchangeable.

"What country was the raw material grown in, and was it cultivated or wild-harvested?" Nothing requires either to be disclosed. A company that knows is in a different position from one that does not. Ask about wild-harvesting because of sustainability, not because you expect wild to be better.

Two further questions (how the botanical's identity was verified and by what method, and whether you can see the test results for your lot) belong to a companion article on contacting a supplement company, which covers them and what the answers are worth.

What a non-answer means. A company that cannot say where a botanical came from is telling you something about its supply chain visibility. A company that declines to share a document is telling you about its disclosure policy. Neither tells you the product is bad, and neither is evidence of concealment, because there are ordinary commercial and legal reasons for both. What you learn is how much the company knows and how much it is willing to say, which is worth knowing on its own terms.