Regulations Pertaining to Herbal Product Making
This information is simply meant to guide you and does not constitute as legal advice. It’s also a work-in-progress meant to support small-scale herbal product makes make sense of complicated regulations. If you have any suggestions for updates, corrections, or additions, please email email@example.com. Thanks!
FDA GMPs & Labels for Dietary Supplements
Dietary Supplements basically includes herbal products that are ingested and used for improving overall health. Tinctures, capsules are prime examples. Raw materials (fresh or dry herbs), including teas, are often exempt and considered food (easier regs – you may be able to stick under state regs only) unless you make a health/structure-function claim or give it a medicinal-sounding name – then it becomes a dietary supplement. Herbal honeys and herbal vinegars could be considered food or dietary supplement depending on its intent. Bodycare/topical products are subject to cosmetics rules – GMPs for them are in the works – to the best of our knowledge, the FDA is not currently inspecting/enforcing businesses for bodycare products. For more on health claims vs structure-function claims, see the “labeling” sections/info – it’s a complicated topic.
- Overview of GMPs
- FDA Small Business Guidelines for Dietary Supplement GMPs
- FDA Label Laws (All)
- FDA Label Guide for Small Entities, Structure/Function Claims
- FDA Acronym & Abbreviation Lookup – what’s the difference between an SOP and a NDI??
NH State Laws
- Homestead Food Fact Sheet – Updated! Specifically useful for items sold as food off the farm and at farmers markets. Once it has a health benefit attached, it would be subject to FDA GMPs. (ie: dry culinary spice blends ok, but medicinal herb teas belong under FDA – this can be a case for semantics and labeling on your part). Many herbal products don’t fall under the NH Department of Health & Human Services (which handles Food Protection in our state – in some other states it’s the Ag department), such as tinctures, but some can. You can call and ask. The food regs are generally much easier to comply with than dietary supplement regs. There are different levels of state food regs depending on how shelf stable your product is (and how likely/unlikely to grow germs) and how you sell it.
- Hawker & Peddlers License: For selling at markets, on the street, at events. Exemptions include selling your own farmed product, so many herbalists would be exempt. Most events don’t care if you’re licensed, but you may technically/legally be required depending on what you’re selling.
- Liquor License Most herbal products are technically dietary supplements, not alcohol for general consumption, and so you do NOT need a liquor license. If you’re following the regs for Dietary Supplement FDA GMPs and not selling something that would be consumed in large amounts and taste good (ie: medicinal tincture that tastes bad and dispensed in small bottles with doses of a few millileters vs a really delicious herbal cordial/elixir that you might want to keep drinking). If you want to sell herbal wine, herbal beer, herbal mead, cordials, etc. then you will need to research and go through the process with the NH Liquor commission or you could be in BIG trouble.
- Weights & Measures: scale clinics, license info, legal-for-trade scales (They are helpful if you call and ask, too) Per NH law, scales only need to be licensed/certified if they are a “direct sale” which means that the customer is there watching as the product gets weighed and packaged (ie: the deli counter, cashier scale). An herbal example would be the purchase of bulk herbs in a store. It does not need to be licensed/certified if the weighing/packaging takes place out back/not in front of the customer. NH W&M does not certify/license pharmaceutical scales, for example. You should still ensure that your scale is accurately measuring product if you sell by weight (required by FDA GMPs for dietary supplements). It only costs $20 for a regular scale license in NH, $30 for a precision scale. The scale itself may be more expensive.
- Also, the University of Maine Cooperative extension has lots of great info and resources on its website for small-scale producers. For example, this one on making safe herb-infused oils and another on how to start a specialty food business in Maine.
- Organic Certification (overview) – some things may have changed slightly since it was written, there may now be a combo producer/processor/handler certification option in NH. The cost share program may or may not still be available.
- Organic Certification
More Useful Resources:
Identifying Herbs per GMPs
- AHPA Botanical Authentication Wiki: This work-in-progress shares information for free on identifying herbs. Small-scale herbalists will find the Botanical Voucher, Organoleptic, Macroscopic, and Microscopic entries most useful (see left sidebar). Also refer to the AHPA Known Adulterants Guidelines. A membership to AHPA (expensive! but they do have a lot of public info on their website, too) or AHP will give you access to greater/more detailed resources.
- WHO Monographs: Although tedious to sift through, it’s a great resource for free identifying information – including macroscopic, botanical, organoleptic – on common herbs, as well as some study summaries, etc.
- The Identification of Medicinal Plants: This is a useful book to own for identifying common medicinals in commerce using botany and macroscopic techniques. Nice illustrations. Comparisons for common adulterants. Unfortunately, it only covers 113 plants, but it’s still very nice to have on hand. See the “look inside” link on the site to get a feel for what it covers.
Labeling is pretty straightforward and easy until you make any sort of claim or implication for health benefit. Dietary supplements *are* allowed to make structure-function claims per DSHEA; however, it’s complicated. The “claims” section of the FDA Labeling Guide and the DSHEA Labeling Primer gives you more details on how you can legally go about that, if you so choose. Most expert recommend that small-scale herbalists *don’t* go down that rabbit hole because it’s hard to make the FDA happy. Note that these claims don’t just apply to your label but also to all printed materials – your website, signs, flyers, handouts, etc. You can usually say what you want (within reason), you just can’t write it down. Just because you see a product on the marketing doing something or making a specific claim doesn’t mean it’s legal. Often, it’s not.
- FDA Dietary Supplements Labeling Guide: From the horse’s mouth, AND it’s not too hard to understand!
- FDA Label Guide for Small Entities, Structure/Function Claims
- Herbs of Commerce: The AHPA’s official list of how herb names should appear on labels in commerce. You can list the common name, Latin name, or both.
- DSHEA Labeling Primer: LOONG but detailed and user-friendly explanation (with example pictures) of how to follow the labeling requirements – including/especially structure-function claims – put into effect with DSHEA law. Note: Most experts suggest that small-scale herbalists should avoid making *any* label claims since it’s so convoluded. If you do make claims, remember that you need to register them with the FDA and have adequate proof (in the FDA’s mind) to back them up. But if you DO want to go for it (within the legal framework) this website will help you out.
Good Practices & Recordkeeping
The FDA wants to see ooodles and oodles of paperwork and recordkeeping. Everything needs to be written down. “If it’s not written down, it didn’t happen.” Refer to the FDA GMPs for what you need to include. The below resources are for extra info and guidance. Let us know if you come across other good resources we should include! Email firstname.lastname@example.org
- AHPA-AHP Good Agricultural Collection Practice: Nice resource for herb growers and wildcrafters! These are suggested guidelines for raw materials suppliers (ie: fresh or dry whole herbs) wildcrafting and cultivating, including handling the material, preventing contamination, hygiene, training, recordkeeping. Pretty easy to understand.
- FDA Wright It Right: FDA’s suggested way to organize your files, Standard Operating Procedures, records, etc. You don’t *have* to organize your files this way, but if the FDA comes knocking, they will look more fondly on your biz and possibly not dig quite so much if you have your files organized the way they are used to seeing htem.
GMP Training & Consultants
The folks at both these businesses really know their stuff! Keep an eye out at American Herbalist Guild Symposiums – sometimes they offer classes and intensives there.
- BioNetwork (Sarah Schober) is run through the North Carolina Community Colleges and offers a range of classes and services, some on-site, some online, and possibly other opportunities. Some services are quite affordable.
- GreenTree Consultants (Erin Leary & Eric McKinney) in Washington State offer consulting to herbal businesses one-on-one and all aspects of getting them set up to be GMP compliant. Various levels of assistance available for varying prices.
More to come…
This information is not meant as legal advice. The NH Herbal Network is offering this information not because we feel that this level of regulation is necessary for quality herbalism but because it is the law, and we want to make it easier for small-scale herbalists who grapple to comply with some or all of the laws. NHHN does not in any way try to enforce regulations or pressure companies to comply with regulations. Many businesses choose/hope to fly under the radar – that is a personal choice.