True or false: Herbs really aren’t regulated and it’s easy to sell junk on the market.

authored by Helen Magnani, MSc. Aug 2026

This statement is true. Herbs really aren’t regulated in the same way medicines are, so it can become easy to sell all sorts of junk on the market and call it herbal medicines.

‍This doesn’t always happen and reputable companies will go out of their way to prove their efficacy and ingredients, but we do often see instances where a trendy ingredient makes it into products that have jumped on the bandwagon. These are the products that aren’t always clean, honest, or pure. There is an explanation for why these make it to the market place- and it isn’t because herbal medicines or dietary supplements aren’t regulated- it’s because they are regulated differently.

Substances generally regarded as safe (GRAS) are ingredients that are intentionally added to food is a food additive. “The use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food,” meaning that a lot of ingredients are grandfathered into what the FDA recognizes as safe, and are not checked for safety because they fall under “generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods” (FDA (1), n.d.). These ingredients can be used somewhat freely since they are pre-recognized as “safe.”

Herbs can be grandfathered in as a safe food since they lie on a spectrum of food to medicine, but the context with which they are used and how they are combined matters. On the pretext that they are regarded safe, manufacturers may create formulations can layer them in with other ingredients that aren’t necessarily safe, unadulterated nor perhaps meant to be paired in that way, creating a junk product that isn’t reminiscent of the herb it supposedly contains. The safe herb is present, it is just present with other junky things, or present in a meaningless amount that won’t give you the effect you are looking for. An article discussing the safety of multi ingredient pre-workout supplements (MIPS) states that “direct comparisons between formulations of MIPS or between a MIPS and a single ingredient are challenging and often impossible due to the widespread use of "proprietary blends" that do not disclose specific amounts of ingredients in a given formulation” (Hardy et al, 2008).

A good example is the aformentioned “proprietary blend” predicament. Supplement labels may display ingredients in the form of “a proprietary blend” with undisclosed amounts of what is actually in the product. The pro of this is that the formulator is not disclosing each amount of ingredient and therefore somewhat protecting themselves from being duped or copied on the marketplace. The con however, is that you don’t know how much of what thing you are getting. The FDA requires dietary ingredients be listed in descending order of predominance by weight, but listing something as a blend makes it difficult to determine not only what is actually in it, but how much of the key ingredient is included (Hardy et al, 2008). This may also be a sneeky way to list an ingredient without it being available in a meaningful amount- good for marketing, bad for your expectations. All this to say, just because a product is GRAS, it does not imply safety [in this context.]

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On top of this grey area, all herbs aren’t considered GRAS simply because there is a different quality assessed for herbs as dietary supplements: they fall under the Dietary Supplement Health and Education Act of 1994, called DSHEA. This act transformed the FDA’s ability to regulate supplements. Upon reading the second sentence on the FDA’s website explaining DSHEA, it reads “Under DSHEA, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. In fact, in many cases, firms can lawfully introduce dietary supplements to the market without even notifying FDA” (FDA (3), n.d.) This is where it can get worrysome and although the FDA does a decent job of catching bad products or falsely advertized supplements, they would have to first be made available on the marketplace. Again, this is imply because herbal medicines and dietary supplements are not considered “medicines” and are therefore regulated differently - but this does not mean they are not regulated at all. That part of the question would be false.

A 2019 study using DNA-based authentication found that 27% of all analyzed commercial herbal products “are not authentic when their content was tested with DNA-based analytical methods against their labeled, claimed, and expected composition (Ichim, 2019). The study was conducted in 37 countries and tested 5,957 commercially available herbal products found across the 6 continents- in other words, a lot of readily available, easy to find products across the world are junky and marketed as herbal medicine.

How do you choose between a good product and a bad one? Look for data. Look for designations like organic, fair trade and such. Do your research on the therapeutic amounts of an herb or ingredient studied to deliver the result you are looking for, and check the ingredient labels for that amount. Browse the website of the company you’re thinking of buying from; do they provide ingredient information, clinical studies or references for their claims (this can be tricky to publish so you might not find it even for the best companies but it’s worth looking for,) are they gimicky and salesy, or do they promote genuine wellbeing? These are not all fool proof, but they’re a good start in determining if you’re purchasing a decent product, or a junky one.

References:

Harty PS, Zabriskie HA, Erickson JL, Molling PE, Kerksick CM, Jagim AR. Multi-ingredient pre-workout supplements, safety implications, and performance outcomes: a brief review. J Int Soc Sports Nutr. 2018 Aug 8;15(1):41. doi: 10.1186/s12970-018-0247-6. PMID: 30089501; PMCID: PMC6083567.

U.S. Food and Drug Administration. (n.d.) (1) Generally Regarded As Safe. Retrieved from: https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

U.S. Food and Drug Administration. (n.d.) (2) Dietary Supplements. https://www.fda.gov/food/dietary-supplements

U.S. Food and Drug Administration. (n.d.) (3) Information for Consumers on Using Dietary Supplements. Retrieved from: https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements

Ichim MC. The DNA-Based Authentication of Commercial Herbal Products Reveals Their Globally Widespread Adulteration. Front Pharmacol. 2019 Oct 24;10:1227. doi: 10.3389/fphar.2019.01227. PMID: 31708772; PMCID: PMC6822544.