Herb Regs Primer

Regulations Pertaining to Herbalism & 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.

NHHN offers this information not because support the regulations but because we want to help small scale herbal businesses understand what laws may apply to their products. 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.

If you have any suggestions for updates, corrections, or additions, please email  nhherbalnetwork@gmail.com. Thanks!

This is for general information and does not constitute as legal or regulatory advice. Always double-check and do your own research.

Regs that May Apply To Herbalist/Teachers/Practitioners

REGULATIONS RELATING TO 
MAKING AND SELLING PRODUCTS

A nice overview of Dietary Supplement GMPs can be found on this blog by Suchil Coffman (who teaches an herbalist-friendly course on GMPs via the Herbal medics).

Basic Overview of FDA Categories

The FDA has three main levels of regulating products on the market:

  1. Food: Not used for a specific health benefit. Some regulations including state, federal/FSMA.
    • Tea without any claims or medicinal sounding names
    • Dried herbs and blends (spice blends, powders, etc.)
    • Herbal Vinegars
    • Herbal Honeys – powders in honey, herbs infused in honey
    • Herbal Oils – topical or culinary

Note that if you name your product something health-sounding like “cold care tea” or put any sort of health or structure/function claim, your product is now considered a dietary supplement (or drug, depending on the claim), not a food, even if the ingredients are identical. The claims allowed for food products are minimal and based on things like nutrition, fiber.

  1. Dietary Supplements: No health/drug (disease) claims but may be used to support health/wellness (structure-function). Significantly regulated. Tinctures and capsules pretty much always fall into this category. Teas, powders, etc. could be considered a food, dietary supplement, or drug depending on how you market it.
    Dietary supplements are not permitted to be marketed for the purpose of treating, diagnosing, preventing, or curing disease – that would make it a drug. They are allowed to support healthy body functions.
    • Any food item listed above that is marketed as having a health-promoting purpose (including anything that tastes so terrible that there’s no way you’d use it for anything other than a wellness purpose) = wellness
    • Tinctures (liquid extracts), elixirs, glycerites, and similar medicinal herb extracts, includingblending those you purchased elsewhere (it’s not considered “resale/retail” if you open it and tinker with it)
    • Capsules
  2. Drugs: Heavily regulated and the only way to make a health claim that something cures, manages, treats, prevents, or reduces the risk of a disease. You’re probably not going to want to go there. Note that bodycare products with any marketed health benefit are going to be considered a drugs. (Suppositories are being pulled from product lines for this reason, though some companies are reintroducing them under homeopathic product labeling laws. If you’re selling a cream, topical oil, etc., market it very vaguely to avoid drug regs.) A few herbs can qualify as over-the-counter (OTC) herbs and certain claims, but this is a more involved process than dietary supplement laws and claims.

Additional Regulatory Considerations

Bodycare

Food Regulations

Food-like herbal products without wellness claims (dried herbs, tea, infused honey, vinegar, etc.) may be able to be sold under food regulations.

These vary by state and sometimes county/town/city. Federal laws kick in generally when you sell across state laws. Which specific regs you need to follow will depend on the type of product, safety/perishability, claims, how/where it’s sold, and your local laws.

Local Food Laws:

NH’s Homestead Food Laws and “Cottage Laws”

Low-risk foods sold in small quantities in certain settings may require no legal oversight or minor legal oversight/regs under homestead food laws as long as you meet certain specs including labeling.

State by State Cottage/Homestead Laws

Commercial kitchen regs are more stringent and required for foods that pose a greater safety risk (such as perishability) and for larger sales and additional retail venues. This is closer to what restaurants need to follow. Check FDA food GMPs, state regulations, and any local county/town/city regs.

Food Safety Modernization Act (FSMA)

This relatively new legislation (September 2017) aims to reduce food safety issues and is geared towards farmers/growers and food processors/manufacturers. It’s mainly focused on farm foods that might be consumed raw (not cooked). They are good things overall, but designed more for large-scale businesses to follow and can be difficult for small-scale farmers and producers to affordably implement.

Most Small-Scale Herb Farms will be Exempt or Get a Qualified FSMA Exemption:

  • You’re totally exempt if your farm has an average annual value of produce sold during the previous three-year period of $25,000 or less.
  • If you make less than $500,000 per year, you get a “qualified exemption” (slightly easier rules to follow).

Additional Regulations that May Apply to Food & Dietary Supplements

  • Weights & Measures regarding scales, certified scales, label accuracy, etc.
  • Water Testing
  • Organic Certification, optional, rules do affect how and if you can label your product and ingredients as “organic.” Cost-share programs often available.
    NOP website https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program
    NH Organic Certification https://www.agriculture.nh.gov/divisions/regulatory-services/organic.htm NH offers some of the least expensive certification options. Cost-share programs are often available, too.
  • “Local” defined differently (if at all) by each state. In NH, you can only call it local if it comes from within NH.
  • Alcoholic Beverages are a whole other ball game! They’re covered by the state liquor commission and Federal Alcohol, Tobacco, and Trade Bureau (TTB). Dietary supplements are exempt (they follow their own rules). If your herbal dietary supplement tastes really good and/or is consumed in large-ish doses, it may be considered an alcoholic beverage. Does that bottle of choc-love elixir taste so good you can drink the whole bottle? Are you dosing by the ounce or more? Are you selling a cordial? You’re probably dealing with alcoholic beverages. Labeling, advertising, product name, packaging size, dosing recommendations matter. This FDA guidance doc distinguishes dietary supplements from alcoholic beverages: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-distinguishing-liquid-dietary-supplements-beverages
  • Shipping laws may prohibit shipping alcoholic dietary supplements due to flammability. There are also shipping laws specific to alcoholic beverages.
  • Retail/Resale/Inventory Laws and Taxes vary by location and state. NH is relatively lenient on this but do your research.
  • Naming Your Herbs – you can use Latin or common names but you should follow the current guidance of the most recent Herbs of Commerce book by the American Herbal Products Association (AHPA). AHPA’s $100 Herbs of Commerce 2ndedition book. http://www.ahpa.org/Resources/HerbsofCommerce,SecondEdition.aspx (3rd edition is underway). The first edition is avaialble for free (though outdated) at https://archive.org/details/gov.law.ahpa.herbs.1992

Though not official, you can look at http://www.botanicalauthentication.org/index.php/Category:Botanical and then once you click on an herb, see the “nomenclature” section.

  • A small-scale biz might be able to get by looking at the more rule-abiding businesses like Gaia Herbs, but note that a lot of companies big and small do not follow the appropriate rules for names, labeling, claims, etc. You can’t assume because something is on a store shelf that they’re doing it the right way.

 

FDA DIETARY SUPPLEMENT GMPS

Food and Drug Administration (FDA) Dietary Supplement Good Manufacturing Practices (GMPs)

aka 21 CFR Part 111 (another way to refer to dietary supplement GMPs)

Note that GMPs and cGMPs (current GMPs) can technically refer to any good manufacturing processes… food, drug, bodycare, etc. But, for our purposes, we’re usually referring to the FDA’s dietary supplement cGMPs when we say “GMPs.”

FDA GMP Guidance Documents – This is what matters most to the Feds!

Potential “Exemptions” for Dietary Supplement GMPs

  • The Practitioner “Exemption”: The FDA is currently choosing not to enforce GMPs for practitioners who are selling products directly to their clients. This is not technically an exemption because you’re actually still expected to follow the rules, but you don’t need to register with the FDA, and they’re not likely to come knocking on their door. Also, the practitioner-client relationship is specific to those with whom you’re consulting about their health, not any direct sale to any customer.
  • There are no exemptions for dietary supplement GMPs based on the size of your company or how much money you make. An herbal company with just one employee needs to follow the same exact rules as Gaia Herbs. (Actually, it’s not possible to be 100% compliant with one employee… you need at least two people to sign off on things.) Selling things in-state only does not exempt you from federal GMPs even though it might from food GMPs (although you might be more under their radar). For dietary supplements, you’re considered to be crossing state lines if you purchase any of your ingredients from outside the state, including alcohol, empty capsules, bottles and jars, dried herbs, etc.
  • There are exemptions for various food regulations (state-based cottage/homestead/home kitchen, federal FSMA, etc.) depending on what kinds of products you sell (how likely it is to pose a food safety risk), how you market and sell your products (direct vs online vs across state lines, no claims, what kind of product it is), and/or how much money you make.
  • Raw Materials: If you’re a raw materials supplier (such as dried or fresh bulk herbs that are resold to another company), then you don’t need to abide by these GMPs but you would still need to have some sort of GMPs and other regulations you may need to follow. Companies that buy from you may still want you to test your products and supply Certificates of Analysis. Please refer to AHPA’s raw materials guidelines for tips.
  • If you have a farm/garden that is growing and selling fresh or dried herbs to sell directly or use to make herbal products, you may need to comply with FSMA (above) and any local food (see above) or farming (check with your local ag department) regulations, and make sure you’re not making any wellness claims, but you’re otherwise generally exempt from dietary supplement GMPs.
  • Retail/Resale Exemption: If you’re reselling packaged products, then you do not need to follow these regs, just whatever resale rules are in your state. For example, if you’re selling someone else’s product and are not opening and tinkering with it in any way. (And if it’s a bulk commodity that you’re just dividing up, that’s usually considered resale/retail, too. For example, repacking one large bag of a particular spice or blend into smaller bags of the same exact thing.) If you’re formulatingfrom someone else’s product (for example, buying Herb Pharm tinctures and then making client formulas from those to resell to your client), you’re no longer exempt and must abide by full GMPs.

GMPs include…

  • LOTS of written documentation – standard operating procedures, master manufacturing records, batch manufacturing records, raw material specifications, certificates of analysis, logs, checklists, who does what, what training they have, cleaning logs, etc. Most things should be signed (ideally by two people – the person that did it and the person that inspects and approves it) and dated, paper is generally preferred over electronic because it’s harder to fudge. Get a general idea on the FDA’s preferred format from this Write it Right document (even though it’s for medical devices, not herbs, and quite old).
  • Quality, Identity, Adulteration, Laboratory Operations control and tests, documentation, quality control personnel training
  • Facility Cleaning, Hygiene, Pest Control – it’s like a cross between a commercial kitchen and going in for surgery
  • Traceability, Recalls etc.
  • Register your Food or Dietary Supplement Facility with the FDA

Useful Free Guidance Documents

Resources for GMP Training, Sample Documentation Forms:

Resources for Claim Substantiation, Identity/Quality Specs, Dose, Warnings:

  • WHO Monographs on Selected Medicinal Plants
  • European Medicines Agency monographs
  • Health Canada Monographs
  • Expanded German Commission E Monographs by American Botanical Council (available with certain levels of membership)
  • Maud Grieve’s Modern Herbal (for historical/traditional info)
  • King’s Dispensatory (for historical/traditional info)
  • Books and for-pay resources:
    • Official pharmacopeias: British, People’s Republic of China, European, United States (USP), Ayurvedic Pharmacopoeia of India, Quality Standards of Indian Medicinal Plants, WHO Monographs, United States Pharmacopeia Dietary Supplements Compendium… mostly expensive books or subscription-based
    • American Herbal Products Association Botanical Safety Handbook edited by Zoe Gardner and Michael McGuffin.
    • Herbal Contraindications and Drug Interactions for Herbal Adjuncts with Medicine by Francis Brinker, N.D.
    • The Essential Guide to Herbal Safety by Simon Mills and Kerry Bone
    • British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume1 edited by Peter Bradley.
    • Adverse Effects of Herbal Drugs, Volume 2, edited by De Smet, PAGM, Keller, K., Hansel, R., & Chandler, R.F.
    • ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition by European Scientific Cooperative on Phytotherapy
  • Identity, Quality, Adulteration Resources. Aforementioned sources as well as…
    • AHPA Botanical Identity References Compendium An evolving free collaborative source where companies share their reference info for various plants, organized by Organoleptic, Botanical, Macroscopic, Microscopic (and various chemical) entries, then by plant.
    • ABC Botanical Adulteration Prevention Program offers a wealth of information
    • The Identification of Medicinal Plants: A Handbook of the Morphology of Botanicals in Commerce by Wendy Applequist, $50-65, best found on the ABC website store or via high-level membership. Includes very brief macroscopic, organoleptic, and botanical descriptions of many common plants as well as research summaries and other info.
    • American Herbal Pharmacopoeia Monographs, $40-50 per plant and some available via AHP membership They also offer Botanical Reference Standards and other services.
    • AHP’s Microscopic Characterization of Botanical Medicines, $169.95, very useful if you’ve made the jump to using a microscope for identification for raw materials or powders
    • Field Guides, Local Flora/Botanical Keys, Herbarium Pressings, GoBotany.com for botanical descriptions that are useful both for whole raw materials and if you can tease out enough small bits from your cut/sifted herbs to confirm various features.
    • Herbals that offer useful macroscopic and organoleptic (“tastes” “energetics”) information including those by Michael Moore, Sharol Tilgner, KP Khalsa, Michael Tierra, JJ Pursell.
    • Old Pharmacognosy Resources available online for free such as the 1915 Scientific and Applied Pharmacognosy for Students of Pharmacy by Henry Kraemer https://archive.org/details/scientificandap01kraegoog

Labeling Guidance

Compiled by Maria Noël Groves, Wintergreen Botanicals, LLC, Last Updated Feb 2023