Legal and Regulatory FAQs

Legal and Regulatory FAQs

Disclaimer: The following is intended exclusively for educational purposes and should not be construed as legal advice.  Every effort at accuracy has been made but AHG cannot guarantee that the information provided here is fully correct or up-to-date.  Laws, regulations, and their interpretation can change rapidly and can also vary from place to place; individuals are advised to seek professional legal advice regarding their specific needs and situation. 

Note: these FAQs are applicable to the United States only; regulations and laws vary greatly around the world related to herbal practice and products.

Practice and Teaching Related Questions

Is there any licensing for herbalists in the United States?
The licensing of medical and many health practices (e.g. massage therapists) occurs on a state level. There is currently no licensing or certification for herbalists in any state that precludes the rights of anyone to use, dispense, or recommend herbs.  However, in a small number of states such as California, Naturopathic (ND) and acupuncturist licensing laws (LAc) include clauses that define natural remedies and sometimes specifically herbal remedies within the scope of the licensed practice.  There is currently no state-level licensing for herbalists other than those linked to an acupuncture license (LAc).  However, no current license precludes the right of other health professionals or lay persons to use, dispense, or recommend herbs, and additional legal protections granted to the license holder specifically related to the use of herbs are not always clear.

Besides the AHG’s professional membership, non-licensed credentials include the Diplomate in Chinese Herbology offered by the National Certification Commission of Acupuncture and Oriental Medicine (NCCAOM).

AHG professional membership is a voluntary, peer-reviewed credential that allows the practitioner to refer to him/herself as a Registered Herbalist (RH).

The AHG does not support the imposition of licensing for herbalists.  The AHG mission statement  as revised and adopted in 2013 includes the promotion of “freedom of practice”.

What laws protect my rights as an herbalist?
In the absence of licensing, the First Amendment of the Constitution protects our freedom of speech to provide information to clients related to their health.  However, this is restricted by the necessity to avoid practicing medicine without a license. 

Medical practice is regulated on the state level, and herbalists should familiarize themselves with the language of the statutes in the state in which they practice.  Generally speaking, only physicians (and in some cases some others such as nurse practitioners) can legally diagnose, prescribe, treat, or cure disease. 

Herbalists (who are not also MDs) should be clear and transparent with all clients and the public about this; the AHG advises all practitioners to utilize an Informed Consent and Disclosure form that makes this clear.  (You can find templates of such forms in the AHG Mentorship Handbook, available here).
To avoid practicing medicine without a license, herbalists should familiarize themselves well with this language, and bear in mind that it applies to all communications: verbal communication to the public and clients, written recommendations, brochures or other literature, and website language.

In addition, if you provide herbs to your clients, and use language that can be construed as diagnosing, preventing, treating, or curing disease, you may also be violating FDA and FTC regulations regarding product claims, since in that context the herbal remedy can be considered an unapproved drug.

There are ongoing efforts to loosen some of these legal restrictions on herbalists and other alternative/holistic practitioners, some with varying degrees of limited success, generally under the rubric of Health Freedom.  These are state-based initiatives.  For more information you can go to:  http://www.nationalhealthfreedom.org/InfoCenter/laws_passed.html
(The AHG cannot independently confirm the accuracy of all the information found here.)

As a small-scale pharmacy or herb shop you may have further restrictions.  Depending on the nature of your business you may have to comply with Good Manufacturing Practices of the FDA (see below).  Labeling and advertising would come under FDA and FTC regulations and would have to comply with language guidelines (see below for more information). In some states there are state laws restricting certain words from being used in the name of the business, such as “apothecary”, “pharmacy”, “medicine shop”, etc.  It is incumbent on you to educate yourself about state laws wherever you are practicing or running a business.

Bear in mind that there are many ethical practices that are not necessarily legally required but highly recommended.  Refer to the AHG Ethics policy as one resource.

If I teach a workshop or lead an herb walk, am I under the same restrictions as when I see a client?
No.  If you are providing information purely in an educational setting - meaning there is no association whatsoever with a product, product line, or brand, and does not in any way involve giving any individual(s) health advice – then you are mainly free to discuss the therapeutic and historical uses of herbs.  This would include leading an herb walk, teaching a class, or writing an article or book.  But bear in mind that these lines can get blurry quickly – a discussion in a workshop can turn into providing health recommendations; an in-class intake could potentially be considered a clinical, not an educational setting.  And of course the First Amendment has its limitations – we are always ethically accountable as well as potentially legally liable for what we say or write.

Product and Manufacturing Related Questions

What is DSHEA?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the main piece of legislation regulating the manufacture of dietary supplements, including herbs.  DSHEA established the new category of dietary supplement, a subcategory of food but in some respects falling between the categories of food and drug.

The legal definition of dietary supplement according to DSHEA includes “vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”

Although there are many DSHEA-related challenges for the herbal community, the restrictions it has imposed on the FDA have also protected public freedom of access to herbs to a stronger degree than in some other industrialized nations.

What are the Good Manufacturing Practices (GMPs)?
The Dietary Supplement GMPS or cGMPs (current Good Manufacturing Practices) are now in force for all manufacturers.  Prior to this, herbal manufacturers complied with food GMPs, which are less stringent.  GMPs  address all aspects of the manufacturing process, including: positive identification and assurance of purity (for whole herbs organoleptic and macro-identification may be sufficient; for powders and extracts it is necessary to utilize  tools such as microscopy, thin layer chromatography, and/or high pressure liquid chromatography); tracking of source materials; comprehensive documentation; training of personnel, and hygiene.

It is highly advisable to consider being trained in the GMPs appropriate to your scale of business.  It is a highly complex set of regulations and these FAQs are intended solely as a broad overview and introduction the topic.  See below for more resources.

Is there an exemption from the GMPs for small businesses?
No there is not.  Whether you are a business with 100 employees, or making tinctures in your kitchen and selling them at the local farmers’ market, legally you are a manufacturer and the GMPs apply to you.  (See below for more information on individual herbalists selling herbs only to clients).

I purchase extracts from established manufacturers that I believe are GMP-compliant.  All I do is compound them into formulas and re-label them for sale to the public.  Am I exempt from the GMPs?
No.  If you open the packaging or change the label, you are now considered a manufacturer and the GMPs apply to you.

I make or compound formulas for my clients but do not sell to the general public.  Am I exempt from the GMPs?
There is no exemption from the GMPs for the individual herbalist.  However, the FDA has decided to use its discretion to not focus on individual practitioners who sell supplements to clients as part of an individualized consultation.  Theoretically the FDA could decide at any time to modify this practice. 

It is advisable for individual herbalists in this situation to familiarize themselves with the GMPs and implement some of the most important best practices such as methods for positive identification of ingredients, tracking of source materials, and proper documentation.

I work in a student clinic at an herb school.  Are we considered a manufacturer required to comply with the GMPs?
This is somewhat of a grey area but for now the FDA appears to be considering this category in a similar fashion to the individual herbalist.  It is advisable for schools to initiate some of the most important best practices and begin to position themselves to gradually implement the GMPs more fully.

I grow and/or gather herbs and sell them fresh or dried, in a whole, unprocessed form, such as teas or tea blends, with no label claims regarding their use.  Do I need to comply with the GMPs?
For herbal teas labeling, marketing, and intended use dictates the regulatory category.  For a tea to be considered a general food it can make no claims to affect the human body.  In that case food-related GMPs and/or other regulations may apply (such as local or state health or agriculture departments, or USDA), but not the Dietary Supplement GMPs.
For more guidance, according to the AHPA guidance document: “Dried unprocessed herb” means an herb or other botanical that is dehydrated from its fresh state and that has not been subjected to any further processing other than cleaning, grading, or size reduction (e.g., cutting or powdering).

Similarly, products intended only for topical use may fall under regulations for cosmetics, which are less stringent than those for dietary supplements.

What am I required to put on the labels of the herbal remedies I make?
Requirements for labels include: statement of identity, net quantity of contents, directions for use, other ingredients in descending order of predominance and by common name or proprietary blend, and a Supplement Facts panel.

Manufacturers are also now required to put contact information on their labels and must report all serious adverse effects (whether causation has been determined or not), defined as  “death; a life-threatening experience; inpatient hospitalization; significant or persistent disability; congenital anomaly or birth defect, or requires, based on reasonable medical judgment, medical or surgical intervention to prevent above”.

A dietary supplement manufacturer wishing to make a claim for the product must ensure that it falls strictly under the definition of a structure/function claim.  If a claim is made or implied that the product can cure, mitigate, treat or prevent disease the FDA can consider this to be an unapproved drug claim.  Bear in mind that this applies to not only the product label itself but also any associated literature, brochures or catalogs, website information (potentially even links on the website), and verbal communications in product-related presentations or trainings.  The Federal Trade Commission (FTC) also has jurisdiction over some of these areas, in addition to the FDA.

If a structure/function claim is made the following disclaimer must also be present:
“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."

Prior to making structure/function claims you must possess substantiated evidence supporting that the claim is truthful and not misleading.  “Appropriate evidence” has not been defined by FDA; however a guidance document has been issued.  Generally FDA would like to see randomized, placebo controlled studies.  In the event these studies are pre-clinical (animal) they also require an explanation for why a similar reaction might be expected in humans.  Manufacturers are expected to submit pre-market notification of any claims made for dietary supplements.  This notification also includes a statement that the manufacturer can substantiate the claim.  The pre-market notification has been a requirement since DSHEA was passed, but has only begun to be enforced within the last year.

Traditional use claims are not recognized by FDA.  Generally FDA would consider traditional use claims to be drug claims.  In contrast the FTC has stated that it will not pursue fines for traditional use claims that do not address serious health conditions, and are not false or misleading.  However, the FTC also states that FDA may choose to pursue enforcement action, regardless of the FTC’s stance.   

Names of products do not have to be submitted to the FDA, but the FDA has the authority to consider a name to be a drug claim if it implies the treatment of a disease.  The FTC can also consider the name of a product to be false advertising and may require “proof” of claim.

Claims-related violations are one of the more common categories of FDA citations of manufacturers.

What else am I required to do as a manufacturer of any size?
There is a general requirement for site registration:  All manufacturers, regardless of scale, must register their site with FDA.  Site registration can be completed on the FDA website.  An unregistered manufacturer will be ordered to cease manufacturing until registration has been completed.  FDA also reserves the right to take legal action.

There are other regulations you may need to comply with such as paying a tax on ethyl alcohol if used in your business, unless you have thoroughly investigated how to be legally exempt.  State laws regarding ethyl alcohol vary.

You must also educate yourself about the use of other terms or labels, such as organic that are outside the scope of this FAQ page. 

For more information on organic
And/or contact your local or state organic certification agency.

Other useful links:

FDA cGMP for Dietary Supplements Small Entity Compliance Guide
FDA cGMP Clearinghouse of Info Page
FDA Labeling Guide
FDA Small Entity Guide to Structure Function Claims
American Herbal Pharmacopoeia
American Herbal Products Association
American Botanical Council 
Roger Wicke website discussion of herbal practice

 


 

 

 

© Copyright 2013 American Herbalists Guild • All Rights Reserved • Contact Us