Thursday, August 13, 2009

FDA on GMPs (Notes on a lecture by Roy Upton)


Good Manufacturing Practices and the

Community Herbalist
Written by Rosalee de la Foret
Based on notes from a lecture by
Roy Upton

“In God we trust. Everyone else must show data.”

Robert Temple
Director, Office of Medical Policy, CDER, FDA

Many of you know that the FDA has issued new laws and mandates for the manufacturing of herbal products. However many of us community herbalists are confused about how these new regulations will affect us.

This article is a collection of notes taken from a lecture by Roy Upton for the American Herbalist Guild (AHG). Members of the AHG can access this lecture and the accompanying power point presentation for free on the AHG website.

I originally wrote this article for

In researching this topic I am very grateful to Roy Upton for taking the time to understand these new laws and then to explain them to the herbal community.

First a brief history of the DSHEA (Dietary Supplement Health and Education Act)

In 1991 FDA threatened to remove the majority of herbal products from the market. The DSHEA (pronounced “de shay”) was the counter bill to keep herbal products on the market and was passed in 1994.

The passing of the DSHEA was one of the biggest defeats in FDA history. This resulted in the dietary supplement health and education act and the now the new Good Manufacturing Practices (GMPs), which are the topic of this article.

Besides setting up guidelines to allow herbal products to stay on the market he DSHEA also gave the right to make limited health claims on the product label. Before the DSHEA it was illegal to list any potential benefits.

A word about labels and nomenclature:
Herbs of Commerce is the primary source of herb nomenclature. By law, all herbal products must be labeled with a complete ingredients list. Herbs can be listed with the common name, but it has to be the common name that corresponds to the Latin name in the Herbs of Commerce. Of course, botanical names are always the most accurate.

FDA reasoning on the necessity of the GMPs
GMPs were instated because herbal products were considered to need more regulation than conventional foods, but less than what was mandated for drugs.

The FDA gave a compliance timeline for the GMPs based on the size of the company. If a company had more than 500 employees, they needed to comply before June 2008. If they had less than 500 employees, but more than 20 they needed to comply before June 25th 2009. If a company has less than 20 employees, the date for compliance is set for June 25th 2010. So, in the end this applies to everything from the largest companies to the smallest of companies. The one exception is a Native American herbalist on a reservation under the sovereign treaty of their tribe.

Herbal products are licensed as a dietary supplement, which is a sub category of food. Herbal products include capsules, alcohol extracts, syrups, tablets, or any herbal product intended for oral consumption.

Salves, lotions and balms for soothing purposes are regulated as cosmetics.

Liniments, bolus, suppositories, nasal sprays, or other products similar to these are considered a drug.

Whole plant herbs are listed as food. So, if you are a wildcrafter or a farmer who grows herbs you have to adhere to food GMP policies.

If you make herbal products, you have to adhere to dietary supplement guidelines. If claims are made on herbal products to “cure” a disease then they are then considered a drug and fall under different regulations. This is why it’s important not to make medical claims on products.

So what are Good Manufacturing Practices?

GMPs are a set of policies that encompass everything from the buildings where the herbal products are made (such as plumbing, pest control, water supply, and equipment) to the processes of receiving ingredients, processing, handling, testing, manufacturing, bottling, labeling, cleaning, personnel, and documentation.

Under the new GMPs there is a written procedure for everything that must be done in the manufacturing of herbal products. There are then regulations to ensure that there are people overseeing that the procedures are being followed correctly and then further personnel to ensure they are doing their job correctly.

Larger companies are already legally required to adhere to these policies. However, it’s small herbal products business owners that will be most affected by these mandates.

GMPs are aimed to ensure:
• Authentication
• Purity
• Quality
• Consistency
• Documentation
• Traceability
• Accountability

They are for the prevention of:
• Adulteration
• Contamination
• Sophistication
→ (Leading to public health problems like ecoli outbreaks of spinach for example.)

The goals of the GMPs are hard to argue against. Who doesn’t want to know their herbs are pure and not adulterated with unknown herbs or contaminated with heavy metals? In recent history alone there have been several problems of herbs (especially herbs shipped from overseas) that have been adulterated with plant material. This adulteration has been anywhere from benign to life threatening.

These problems can arise because of the unfortunate reality that in modern times the general public gets their herbal knowledge from the herbal marketplace, not from the herbalist. Currently many naturopathic doctors and some herbalists depend on large manufacturing companies to distribute herbs. Many times these large companies (especially overseas, certainly in north America as well) are out for the bottom line and do not have policies set in place to determine correct ID of a plant and prevent adulteration. When someone receives plants in capsules, or liquid extracts how do they know what that plant really is? GMPs are supposedly put forth to ensure authentication of the herbs and therefore public safety in this arena.

It would be all but impossible for a community herbalist or small herbal products business to follow the GMPs.

The AHG and American Herbal Pharmacopeia both commented to the FDA that herbal practitioners should be exempted from GMPs because they would not be able to follow the same guidelines set forth for larger companies.

The FDA disagreed:

“We decline to exempt herbalist practitioners from the proposed rule. If an herbalist practitioner introduces or delivers for introduction into interstate commerce, a dietary ingredient or dietary supplement, that practitioner must use the same good manufacturing practices as other manufacturers to ensure that their clients receive dietary supplements that are not adulterated. The risks of adulteration are not eliminated just because the practitioner is an herbalist.
Therefore, we decline to exempt “herbalist'' practitioners who manufacture dietary ingredients and dietary supplements. Herbalist practitioners who introduce or deliver for introduction into interstate commerce, a dietary ingredient or dietary supplement, are manufacturers who must meet CGMPs.”

However, in the end the FDA acquiesced to a degree by saying they chose to exercise their regulatory discretion by not forcing practitioners to adhere to GMPs, although they still have the right to do so if they feel the need.

There was one stipulation however, which said for an herbal practitioner to avoid FDA scrutiny when selling their herbal wares they must have a direct personal consultation with the person buying their herbal products.

This means that if you are an herbal practitioner and you have a client that you consult with prior to selling them an herbal product then you are not outright expected to follow the GMPs.

However, if you are an herbal practitioner or a small herbal products company and you sell products at the farmer’s market or online then you would be expected to be in compliance with the GMPs. It is suggested then, if you are selling at the local market, or at a conference, and you do not follow the GMPs that you have a mini consultation prior to selling the product.

So how often does the FDA persecute small herbal companies or herbal practitioners? It’s not entirely common and historically the FDA most often goes after the products that claim to cure disease, especially if the word “cancer” is used. However it is important to note that herbalists have had the FDA come knocking on their door.

It’s also important to note that the FDA maintains the right to enforce GMPs on herbal practitioners, they are just not choosing to do so at this time.

Upton says this will most likely continue until a patient makes a claim that they were injured because of a practitioner’s product. At that point the FDA will have the political motivation to step in and will most likely do so.

Another important note is that regulatory discretion does not extend to the use or trade of prescribing of unsafe products. The question is how will the FDA define “unsafe products”. Herbalists using drop dosage herbs like Aconite will certainly raise eyebrows. However herbs like skullcap could also be worrisome because of historical adulterations of this herb. So the question of “unsafe products” is something to be aware of.

So how can we avoid the attention of the FDA and ensure our products are safe? Upton urges practitioners who manufacture their herbal products for clients to have some sort of quality assurances so that the FDA does not feel the need to enforce their regulations.

The potential of the repercussions of the FDA stepping in to stop community herbalists manufacturing their own products would be disastrous. We can imagine that there would be a big outcry and a legal battle would ensue, however, Upton points out that it is far better to prevent this by enacting some basic principles.

Of course our motivation for quality assurance is not just for the FDA, but also to maintain safety for our clients.

The first step is to ensure the identity of the plants that we buy or pick for our herbal products. By FDA standards you are required to perform at least one test to ensure the identity of the original plant material.

To do these tests you can use the most sophisticated analytical instruments out there. Your nose, tongue, and brain.

That’s right organoleptic testing is considered legit by the FDA, if you can correctly identify a plant by it’s genus and species and prove this through documentation. So, if you can only identify the genus, but not the species by your own senses, then this would not qualify as adequate testing.

So how do we go about doing this?

The best scenario is that the plant ID is confirmed at the growing site and accompanied by some type of identification/affidavit. Most companies or wild crafters don’t do this, which is why the manufacturer (or you) has to do further testing. If you are able to get this from your herbal supplier, this is ideal. It is recommended to keep this documentation on file in case there are any questions.

Since the above scenario is not always an option Upton suggests that practitioner herbalists who make their own products need to know how to correctly botanically key the plants we use down to the genus AND species. In order to do this herbalists need to be botanically trained and Upton recommends keeping the records of this training on file.

Of course as the herbs are more processed it is harder to know what it is. Organoleptic testing (again through sight, taste, smell, etc) can easily be done when receiving a whole fresh plant. But this becomes considerably more difficult the more a plant is processed. Whether it is dried, dried cut and sifted, or even powdered or extracted.

The good news is that as herbalists we will be served in honing our organoleptic skills.

Upton gives the following basic guidelines of what one should know intimately about the plants we are working with. (Also in the original lecture he gives a good amount of information on organoleptic testing procedures.)

• Size: length, width, diameter, thickness, etc.
• Shape: conical (carrot), cylindrical (astragalus), tear-shaped (tuber), entire, serrate, etc.
• Color: address differences in intensities, growth stage, variegation
• Taste: sweet, salty, pungent, bitter, bland, astringent, etc.
• Smell: Aromatic, hay-like, pleasant, unpleasant; intensity
• Texture: smooth, rough, wrinkled, corky, oily, hairy, etc.
• Fracture: complete, incomplete, fibrous, brittle, etc.
• Grades: Most specific for Chinese herbs; applicable to western and ayurvedic herbs as well.
• Adulterants: Understand how to differentiate between closely related adulterating species
• Relative purity

He also recommends that we keep a plant pressing of each herb that we use in our products. So if we wildcraft our herbs or if we buy our herbs fresh we press these plants are label them clearly including:

Name of plant
Where is was collected
Unique id #
Signature of the person who performed the ID

This should be done each time a new batch is procured/harvested. (Herbmentor members can use the search feature on the home page to find a video on how to make your own herb press.)

Upton says that each time you make an herbal product you should hold that plant in your hand and ask yourself if you can prove through documentation of your own testing that it is a certain genus and species.

Besides ensuring the genus and species of a plant and documenting the identification procedures (as outlined above) the FDA also requires that herbalists:

• Assess quality
• Prevent contamination and mix-up

The FDA defines quality as follows
“Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and limits on contaminates and has been manufactured, packaged, labeled and held under conditions to prevent adulteration.”

Prevent contamination and mix-up
Including things like heavy metal contamination or adulteration with different plants.

Of course wild crafting our own plants or purchasing plants directly from the herbal farmer will be easier to identify the plant with certainty. Buying dried herbal materials from middle-man companies will prove to be much harder to identify with 100% certainty.

Upton urges herbalists to question these companies about their own testing procedures. For example if you are buying powdered Ashwagandah whose origin is in India you will want to question that company on a couple of key points.

1. What testing did the company do to determine this powder is indeed Ashwagandah? If it is a plant that has historically been adulterated with other plant material, what tests did they do to determine that it has not been adulterated?

2. What tests were performed to ensure that this batch of plant material does not have contamination problems like high levels of lead?

If the company you are buying from cannot provide testing to ensure these qualities for the health of yourself and your clients you will want to consider a better source.

The FDA aside, it just makes good sense to know you are dealing with pure quality herbs in which to make your quality herbal products.

One more consideration: Upton also points out that if you manufacture an herbal product for which there is a known common adulterant then identity testing alone is not sufficient. In this case there must be a negative test to assure there is a limit or specification that assures freedom from the adulterant.

Examples of potential adulterants in the American market
• Ginkgo extracts spiked with pure flavonoids
• Plantain potentially adulterated w/ digitalis
• Hoodia adulterated with prickly pear
• Skullcap adulterated with the potential hepatotoxin germander (Teucrium)

So, to re-cap on what all this means.

Larger herbal product companies are already legally required to follow the GMPs that have been put forth by the FDA. Herbal companies with less than 20 employees will be required to follow suit in June 2010. If you are the owner of a small herbal company you will need to know and understand all the GMPs set forth by the FDA.

It seems to me that small herbal products businesses, especially those selling their wares online and to a larger general audience will be the most impacted from these GMPs. It seems likely that many of these quality businesses will close since they will not be able to financially continue their small operation while having to adhere to the many policies put forth in the GMPs. I would love to see a discussion from these small business owners who know more about the actual GMPs and how this will be affecting them.

Herbal practitioners who sell their own herbal products to people after a personalized consultation are not currently obligated to follow the GMPs set forth for larger companies who sell to the general public without a consultation. However, it is a good practice to follow certain guidelines and documentation to ensure you know the products you are selling contain high quality herbs that have not been adulterated or contaminated and that you can prove this if your herbal products are ever brought into question. This may include being personally familiar with the plants in order to test them organoleptically yourself, or being knowledgeable enough about chemical testing to hold third person suppliers responsible for ensuring quality from the grower/wildcrafter.

Upton covers the issue of common adulterations, and other topics much more in-depth in his lecture that can be found on the AHG website. The entirety of this article was written based on that lecture and I highly recommend those wanting more information to refer to it for deeper understanding. A heartfelt thanks goes out to Roy Upton for providing us with a better understanding of these new regulations.

American Herbal Pharmacopoeia®
PO Box 66809
Scotts Valley, CA
95067 US
Tel: 831-461-6318
FAX: 831-475-6219