Comfrey

[Thistle Creek Honey]

Hi Everyone,

I am Thistle Creek Honey guy's wife. (Just wanted to disclose that right away.) I have a question about selling products containing comfrey. I make a salve I use myself and have given away to others. This salve works like nothing else I have ever used to heal my cracked, chapped hands. I believe it is due in large part to its comfrey infusion. I would like to sell the salve but I am more than a little scared by the information about comfrey found on web searches. From what I can figure out most of the scary information (about possible liver damage) mostly comes from one study done with synthetically derived pyrrolizidine alkaloids injected into lab rats. Comfrey is banned for internal usage in the US. Does anyone here sell salves or lotions in the US that are made with comfrey? Are you worried about the possible liability issues? I would in most cases avoid any liability I could but this stuff is really truly amazing and I would like to share it.

 

[dagmar88]

I contacted the FDA last July.

Dear (...)


Thank you for contacting the Center for Food Safety and Applied Nutrition.

Our archives indicate comfrey (Symphytum officionale)present serious health hazards whether they are placed into dietary supplements and cosmetics. The use of products containing comfrey has also been implicated in serious adverse incidents over the years in the United States and elsewhere. The pyrrolizidine alkaloids that are present in comfrey, in addition to being potent hepatotoxins, have also been shown to be toxic to other tissues as well. However, while information is generally lacking to establish a cause-effect relationship between comfrey ingestion and observed adverse effects humans, the adverse effects that have been seen are entirely consistent with the known effects of comfrey ingestion that have been described in the scientific literature. There is also evidence that implicates these substances as carcinogens. The agency strongly recommends that firms marketing a product containing comfrey or another source of pyrrolizidine alkaloids remove the product from the market and alert its customers to immediately stop using the product. The agency advises that it is prepared to use its authority and resources to remove products from the market that appear to violate the Act. As a consequence of this stance, skin care products containing comfrey have been seized.
If you have come across any products containing this ingredient, please contact your nearest district office consumer complaint coordinator and place a complaint.

We hope this addresses your concerns; please contact us if you require further assistance.

Best Regards,


Stephanie Socgfack

 

[Obsidian]

Yikes, I had no idea comfrey was considered dangerous. Maybe try Mullein flowers in you salve instead.

 

[bodhi]

If memory serves, the study 'proving' the danger of the whole comfrey plant was done with isolated alkaloids from a species not propagated in the US and injected daily into rats over a period of several weeks. It was not done with the whole herb which also contains hepatoprotective constituents and the amount injected would be nearly if not impossible to achieve. There have been studies done debunking this claim. Peanut butter also contains a carcinogen and although i have not directly read the study, Dr. Ames who i think is a biochemist at UC Berkley found comfrey to be about as carcinogenic as a peanut butter sandwich and many other commonly eaten foods. Here is a link to a bunch of comfrey info. http://www.comfreycentral.com/research/comfrey_pa.htm I'm in the US and i grow, use, and sell it.

 

[Thistle Creek Honey]

Here a couple of links I just ran across. The first is a fairly short discussion of the issue. The second is a not-so-succinct analysis of the scientific testing methods from a forum discussion a few years ago (see the post 16 of 3/1/2005 post by JohnyB.

http://www.kerrysherbals.com/articles/comfrey_safety.shtml

http://forums2.gardenweb.com/forums/load/herbal/msg122246277604.html?43

All I know is that I have suffered from eczema all my life and from very chapped hands for years now. In more than 50 years, I have tried just about every last lotion and medication available. The only two things that ever worked for me are my comfrey salve and steriodal hydrocortisone lotions. Even though the dangers of steroids are well-known and well-documented, hydrocortisone is still readily available over the counter. Comfrey, on the other hand, is banned based on what seems to be a very few, very lightweight scientific studies. It all sounds so depressingly familiar, doesn't it? I am thinking I should sell the salve as form of social protest if nothing else. On the other hand, while I don't really care if the FDA shuts us down since our business is a hobby for the most part, I am not so willing to be sued by someone trying to make a quick buck.

 

[bodhi]

All I know is that I have suffered from eczema all my life and from very chapped hands for years now. In more than 50 years, I have tried just about every last lotion and medication available. The only two things that ever worked for me are my comfrey salve and steriodal hydrocortisone lotions. Even though the dangers of steroids are well-known and well-documented, hydrocortisone is still readily available over the counter. Comfrey, on the other hand, is banned based on what seems to be a very few, very lightweight scientific studies. It all sounds so depressingly familiar, doesn't it? I am thinking I should sell the salve as form of social protest if nothing else. On the other hand, while I don't really care if the FDA shuts us down since our business is a hobby for the most part, I am not so willing to be sued by someone trying to make a quick buck.

IMO, comfrey vs steroids? Comfrey every time.
Social protest? Go you! I completely agree. I plant it everywhere i can.
Lighwteight science? Agreed.
Depressingly familiar? Yup.
It may have happened but ive never heard of anyone being sued over it. A disclamer would prevent that.
Banned? It may be officially, but in reality it is far from it.
Ill leave my fda comments out of this reply. Im sure they could find my IP address if they wanted to, lol.

Im happy you found something that works so well for you. Another comfrey convert! Yay!

 

[dagmar88]

A disclamer would prevent that.

Like what?

 

[bodhi]

Like what?

I'm not a lawyer so i dont want to give specifics that someone might use and have issues with, but if you check out the disclaimers on things in the health food stores you can get ideas of what can be used for different products.

Thistle creek honeys wife- i didnt read all the articles yet, but that one by johny b is very nice.

 

[dagmar88]

I'm not a lawyer so i dont want to give specifics that someone might use and have issues with, but if you check out the disclaimers on things in the health food stores you can get ideas of what can be used for different products.

Not the same thing. You can't cover yourself for something you aren't allowed to sell by any kind of disclaimer.

 

[bodhi]

Not the same thing. You can't cover yourself for something you aren't allowed to sell by any kind of disclaimer.

True, but it isnt illegal to sell comfrey.

 

[DeeAnna]

Hey, folks .... I kinda see where this discussion is headed. Can we go in a more productive direction, please?

In an article on toxic hepatitis, the Mayo Clinic staff wrote:

"...Some herbs considered dangerous to the liver include cascara, chaparral, comfrey, kava and ephedra. There are many others...."

Source: http://www.mayoclinic.com/health/toxic-hepatitis

An article from the National Center for Complimentary and Alternative Medicine about dietary supplements advises:

"...Keep in mind that although many dietary supplements (and some prescription drugs) come from natural sources, “natural” does not always mean “safe.” For example, the herbs comfrey and kava can cause serious harm to the liver...."

Source: http://nccam.nih.gov/health/tips/supplements?nav=gsa

Getting more specific, the alternative medicine guide from the University of Maryland advises against internal use of comfrey and recommends careful external use of comfrey:

"..Comfrey is no longer sold in the U.S., except in creams or ointments. The United Kingdom, Australia, Canada, and Germany also have banned the sale of oral products containing comfrey. The dangerous substances in comfrey are also absorbed through the skin, so harmful amounts may build up in the body. Be careful if you use an ointment containing comfrey (see "How to Take It" section), and never use it on broken skin...."

Source: http://umm.edu/health/medical/altmed/herb/comfrey

The website Oils and Plants contains similar information about comfrey:

"...Warning: Internal usage of comfrey should be avoided. Repeated doses of Comfrey may be dangerous. In recent years, this long used herb has come into disrepute. Historically, comfrey was also used to treat gastrointestinal illness. However, the herb contains dangerous substances called pyrrolizidine alkaloids that are highly toxic to the liver and can cause death. In July 2001, the U.S. Food and Drug Administration required that dietary supplement manufacturers immediately remove all oral comfrey products from the market. The United Kingdom, Australia, Canada, and Germany have also banned the sale of oral products containing comfrey. Pyrrolizidine alkaloids are also absorbed through the skin, and harmful amounts may build up in the body. New advise says that you should take care when using an ointment containing comfrey, and you should never use it on broken skin...."

Source: http://oilsandplants.com/comfrey.htm

Edit: These last two sources are consistent with the FDA warning from 2001 regarding the use of comfrey in commercial products:

"...All firms currently marketing products containing comfrey should also be aware of the fact that the Federal Trade Commission (FTC) has also taken action against unsafe products containing comfrey. The Commission recently announced an enforcement action it has brought against a firm for marketing comfrey-containing products. The Commission is challenging the safety and health benefit claims for a number of comfrey products sold by the firm. A stipulated preliminary injunction agreed to by the parties in the case prohibits the marketing of any comfrey-containing product intended for internal use or use on open wounds and requires a warning on comfrey products marketed for external uses. Information about the action is available through the FTC's web site...."

Source: http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm111219.htm --end edit

The flavor I am getting from all these sources is to not use comfrey internally and to use comfrey on the skin with moderation and care. Similar discretion is required for safe use of many medicines, including over-the-counter remedies such as aspirin, topical cortisone, etc.

Last, but not least, here's an article with suggestions for alternative herbs: http://umm.edu/health/medical/altmed/herb-use-links/herbs-with-similar-uses-as-comfrey

(all bolded phrases are my additions)

 

[forherbs]

I use comfrey both internally and externally. Although the FDA is making such claims, remember, they are all liars. They make drugs, artificial sweeteners, etc. sound safe.
They want to do away with one of Gods fantastic herbs, which was designed to be taken as a whole herb.


Sent from my iPhone using Soap Making

 

[bodhi]

Deeanna, i hope you didnt think i was going in any specific way with this one. I just really think the info is a little one sided and maybe self serving from the fda. So just to add some background info to the conversation...

There are approximately 6000 plants that are known to contain pa's...

In 2001 there were 2 companies cited by the fda for violations of drug labeling claims. One i cant remember the name of and the other was dr christophers company. one company was selling a chickweed salve as an anti cancer salve and a customer complained to the fda saying it caused a need to see a doctor. Well duh, if you have a leg cancer... that aside, the company is still in business and i believe is still selling all the products it was originally cited for but is now in compliance with the fda's labeling laws. dr christopher voluntaily removed its oral comfrey products without being convicted of or admitting wrong doing and agreed also to specific labeling-i think both companies had to add the same labeling, and both paid a fine.

Both of the cases can be found on the fda website which spells out the specifics of the settlements. Neither of the cases cited any health problems associated with any of the products afaik other than the one person who had to see a doctor for her pre existing cancer.

The fda has taken the stance that any PA's are toxic based on worldwide occurances of toxic reactions. most of these have nothing to do with comfrey. i think most of the cases were from food contamination or use of sencio. ill attach a link with all compiled studies at the end. Included in this are a couple incidents in the united states and it is stated in both that there may be other factors which caused or contributed to the toxicity and that it can not be definitively blamed on the comfrey but the cmfrey was at least a contributing factor. In the speculation that they could have been comfrey induced, the amounts taken are listed. one of them is the equivalent of eating 85 leaves and was treated with something else that can cause liver issues, and in the other it is speculated that the woman was probably taking several other undisclosed supplements and for probably a very extended period of time. In either scenario, the consumption was excessive. The studies also state that there are varying degrees of sensitivity with no reactions in some and toxic reactions in others-just as there are with any product and I dont believe any of the studies studied any of the hepatoprotective constituents in the plant.

While I'm not disagreeing that there is definitely the potential for harm from comfrey, its outright banishment is a little over zealous and fear mongering imo and the information which is being given to the public in bits and pieces is misleading.

Comfrey is available in this country in many forms, not just ointments and salves, the only thing that has really changed is the labeling and some oral preparations now say not for oral use. The warning labels referenced are parts of the fda's settlements for those two companies who were in violation of labeling laws and are not blanket rules for all sellers of comfrey products. As the fda stated, they were challenging the claims because the claims violated labeling laws.

The dangers of PA's afaik from the studies are from the metabolized pa's and this metabolization does not happen through the cutaneous route, and topical absorption is about 1/40 th of internal use. The roots contain more pa's than the leaves, young leaves contain more than the older or dried leaves and mature leaves contain about 1mg of pa's per leaf. Readers, read the studies yourself if you want any info on oral toxicity amounts.

Here is a link which i find interesting based on all the the few cases of possible comfrey toxicity in all of the known medical documents: http://www.ncbi.nlm.nih.gov/pubmed/15239078

So, imo, just because the fda says its safe, does not mean it is, and just because its natural does not mean you can eat it by the pail full and not expect to have an adverse reaction.

Side info too just because its used a lot here. Alkanet contains PA's.

Here is the link to the info compiled by the WHO up to 1988 on PA's http://www.inchem.org/documents/ehc/ehc/ehc080.htm#SectionNumber:7.3

Dont shoot the messenger please. She just really likes comfrey and believes that used properly, it is a wonderful plant that should be revered and respected. And that means using it responsibly too

 

[dagmar88]

True, but it isnt illegal to sell comfrey.

If skin products containing comfrey can be seized at any time, I wouldn't consider selling them.
I personally have nothing against the use of comfrey whatsoever, to make that clear.
But I have replaced comfrey in all of my recipes with allantoin.

 

[Saswede]

I'm not American, but I can tell you that the FDA are considered (one of) the best drug regulators in the world. And while they are not perfect, their job is to evaluate the safety of food and drugs - in order to protect the population of the USA from taking or using harmful or toxic substances.

I don't have any personal position on whether or not comfrey has a positive benefit/risk profile, but I do know that I would definitely not try to sell any product that they have specifically stated is hepatotoxic. Whatever disclaimer you use on your packaging will likely not limit your legal liability if a customer uses your product and develops liver failure! So if you chose to use a known/proven hepatotoxin yourself, go right ahead. But I don't think that it's wise to sell it to anyone else.




Sent from my iPad using Soap Making

 

[Saswede]

Btw, my main concern would be absorption through broken or inflamed skin (as in eczema) - because absorption would increase, and any PA that is absorbed would be metabolized by the liver .....


Sent from my iPad using Soap Making

 

[DeeAnna]

"...Deeanna, i hope you didnt think i was going in any specific way with this one...."

Nope, I didn't think that at all. I was just hoping to keep the conversational ball bouncing rather than end up in an unproductive "it is - no, it isn't" deadlock. Sometimes this happens in threads that have been at first very interesting and helpful, and it's a bummer when it does. I am glad to see this discussion is still flowing, thoughtful, and productive, and I am learning a lot. Thank you for the background information, Bodhi. I appreciate the time and effort it took to write that!

 

[DeeAnna]

What I'm seeing in this discussion are these points of view:

Comfrey for personal use --

Whatever goes, goes.

Comfrey for sale to the general public --

The no-risk approach would be to not sell any products that contain comfrey. Reformulate products to use alternative ingredients that may provide a similar effect.

The moderate risk method would be to sell comfrey products formulated for external use with complete product information -- fully disclosed ingredients, clear directions for use, and a warning statement.

The higher risk approach would be to sell comfrey products for internal or external use with the same complete product information.

The "anything goes" method -- undisclosed ingredients, unsubstantiated health claims, and few or no directions for safe use.

The OP asked about liability issues --

Any product or service sold to the public entails some risk. Even plain ol' unscented lye soap can irritate the skin of some people. The "tipping point" where there is too much risk involved is different for each person, so it's an individual decision whether to sell or not. There is no clear-cut answer that works for all people all of the time.

If the risk of selling comfrey products to the general public is too worrying, then I personally wouldn't do it. If I thought the benefit of helping others outweighed the risks, however, I would carry liability insurance, formulate my product to be as safe and effective as possible, offer full product information to my customers, and sell the very best product I can make.