Author |
Herbal Wisdom: FDA Guidlines on HERBS |
corporatefarmgirl
True Blue Farmgirl
389 Posts
Tamara
Pikeville
TN
USA
389 Posts |
Posted - May 03 2009 : 07:08:07 AM
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The FDA CFR 111 ~ which by June of 2010 requires anyone who makes or sales herbal products for consumption or placement on the human body, and has less than 20 employees ( including yourself) to be registered as an FDA Manufacturer and meet all FDA guidelines. This bill means if you make herbal teas, tinctures, salves you must be registered and licensed as an FDA facility, IF you make any claims ( salve can heal hands, a tea to help with sleep or one for tummy aches, how about a tincture for healing the skin?) This bill passed a while back and has been slowly put into place. I call it a modern day witch hunt. This new bill puts all herbs in the hands of BIG manufacturing after all who else can afford to make herbal products.
The FDA lumps Dietary products and herbs into one big mess of a catagory. So when they make changes in over the counter dietary aids the changes automatically hit the herbal industry.
I can not believe this has been passed with so little fan fare. I just found out about it a couple of weeks ago and started researching the new guidelines. Here is just a portion of what the rational behind this bill:
"controls for herbal and botanical dietary supplements. Botanicals are often complex mixtures that can vary in [[Page 34762]] composition depending on factors such as the part of the plant used, the location of harvesting and growing conditions that can vary from year to year even in the same location. It can be difficult to distinguish between closely related species of botanicals, and the biological activity of components of an incorrectly identified species can lead to adverse consequences. In addition, different species may be present in different ratios or blends in a particular product. Various products might contain different parts of the plant--flower, leaf, root, stem, extract--and the test methods for each can vary in the nature, sensitivity, and specificity of the test. Well-established principles of CGMP require process controls at each step of the manufacturing process as early in the production process as possible. Quality cannot be tested into the product only at the end (Ref. 9). Instead, the quality of the dietary supplement must be built into the product throughout the manufacturing process; quality begins with the starting material and continues with the product being manufactured in a reproducible manner according to established specifications.
The next thing will be gov. controlling the herbal seeds............
live well, Tamara www.thegoodearthfarm.com "We do not inherit the earth from our ancestors, we borrow it from our children" http://thegoodearthfarm.blogspot.com follow me!
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Mother Hen
True Blue Farmgirl
604 Posts
Cindy
Peck
ID
USA
604 Posts |
Posted - May 03 2009 : 2:16:34 PM
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Tamara, I agree. It seems they are butting their noses into everything anymore.
Cindy
FARMGIRLS CAN DO ANYTHING!!!
I will bless the Lord at all times: his praise shall continually be in my mouth. Psalms 34:1 |
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corporatefarmgirl
True Blue Farmgirl
389 Posts
Tamara
Pikeville
TN
USA
389 Posts |
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Miss2Missus
True Blue Farmgirl
407 Posts
Karen
Asheville
NC
USA
407 Posts |
Posted - May 03 2009 : 6:46:31 PM
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ahg, this is just down right ridiculas it's so infuriating how much the government as started to over govern. i know that we need rules and regulations, but there is such a thing as taking it too far.
Karen ^_^
http://apple-and-eve.blogspot.com/ |
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prariehawk
True Blue Farmgirl
2914 Posts
Cindy
2914 Posts |
Posted - May 03 2009 : 6:49:14 PM
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this bill will just force people like me to grow my own herbs for my own use. I wonder if the pharmaceutical companies are behind all this. Cindy
"Dog is my co-pilot" |
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Miss2Missus
True Blue Farmgirl
407 Posts
Karen
Asheville
NC
USA
407 Posts |
Posted - May 03 2009 : 6:54:38 PM
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its the same as the handmade stuff for kids now. it's just screwing over everyone who isn't already a billioniar.
Karen ^_^
http://apple-and-eve.blogspot.com/ |
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corporatefarmgirl
True Blue Farmgirl
389 Posts
Tamara
Pikeville
TN
USA
389 Posts |
Posted - May 04 2009 : 07:24:01 AM
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I think many people will turn to growing herbs BUT will you be able to purchase herbal seeds if they consider them a "Drug"? I don't know. I do know I am learning more about wildcrafting and making all my own stuff. Maybe we need to share some different herbal recipes for tinctures, ois, ect... Lets be farmgirl proactive!
live well, Tamara www.thegoodearthfarm.com "We do not inherit the earth from our ancestors, we borrow it from our children" http://thegoodearthfarm.blogspot.com follow me!
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CherryMeDarlin
True Blue Farmgirl
602 Posts
Cherry
Odenville
AL
USA
602 Posts |
Posted - May 04 2009 : 09:33:25 AM
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Ooooooo! Washington makes me absolutely crazy! We're suppoesd to trust the FDA when these billionaire pharmaceuticals will throw money at them to rush a drug on the market knowing the drug has deadly side-effects? Think about how many "FDA-approved" drugs have been yanked after people began dying. I have and always will trust a product that can be plucked from the ground before I will one that comes out of a laboratory! You can not and never will be able to improve upon a thing created by God. Period. Washington has way too many power-hungry, ego-maniacal, greedy control freaks! The love of money has replaced the love of personal freedoms!
Whew!
When I read FDA CFR 111, I immediately thought of a farmer I've talked to several times who is an herbalist. He's given me invaluable advice about the native plants growing on my land. He is a treasure-trove of information. A hundred or more years ago, he would have been known as the local "healer". And just as those healers of yesteryear were persecuted by the church, he will be persecuted by the FDA if they have their way. This digusts me and makes me ashamed of Washington.
We should start a black-market herb seed ring... Count me on-board Tamara!
~~Cherry~~
"A thing is as simple or as complicated as you make it." --TT Murphy |
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lacisne88
True Blue Farmgirl
1181 Posts
Chelsey
Lake Stevens
Washington
USA
1181 Posts |
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corporatefarmgirl
True Blue Farmgirl
389 Posts
Tamara
Pikeville
TN
USA
389 Posts |
Posted - May 04 2009 : 1:07:55 PM
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The fact that herbs which are gifts from the earth are now being regulated just does not feel right...The other thing is that if I want to purchase a herbal product i want to purchase it from a local herbalist who uses local herbs ~ not a corporation!
I believe the energies put into the herbs effect how the herbs work. Give me a good old fashioned wise women any day!
live well, Tamara www.thegoodearthfarm.com "We do not inherit the earth from our ancestors, we borrow it from our children" http://thegoodearthfarm.blogspot.com follow me!
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CherryMeDarlin
True Blue Farmgirl
602 Posts
Cherry
Odenville
AL
USA
602 Posts |
Posted - May 04 2009 : 1:41:31 PM
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Here, here, Sister! It's just one more way for them to gobble-up everything out there and be the only one's to profit from it! So, so many people are fed-up with putting chemicals in their bodies and their homes and these big wigs are getting nervous about their annual reports. "Convenience" became a god and the good people followed it like sheep. Now "convenience" is killing us and making us sicker and the more we educate ourselves, the more scared they're going to get. And you know how unpredictable and dangerous a scared animal can be. What's next? Regulations on handmade clothing?
~~Cherry~~
"A thing is as simple or as complicated as you make it." --TT Murphy |
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JojoNH
True Blue Farmgirl
1984 Posts
Joanna
Dunbarton
New Hampshire
USA
1984 Posts |
Posted - May 04 2009 : 3:27:15 PM
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It is very frustrating that we are being regulated to death. . . for example, the new lead law that effects anything for children ages 12 and under has caused my business to teeter on the edge of closing. The one thing we all can do is become as educated on the subject as possible. . . Know the facts. . . then pass on what we have learned to the next person . . . get involved with every aspect that we can so a positive change can come about.
To many times we get mad and then get complacent, we need to take positive steps to make a positive change. .. for the good! A good old fashion Farm Girl Can Do attitude!!!!
Joanna #566 JojoNH
http://www.CountryCents.com http://CountryCents.Blogspot.com |
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corporatefarmgirl
True Blue Farmgirl
389 Posts
Tamara
Pikeville
TN
USA
389 Posts |
Posted - May 06 2009 : 06:45:42 AM
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joanna ~ i so agree...i actually think some good may come out of this. ~ i think we need to start by sharing information with each other on wild crafting and cultivating herbs; making tinctures, salves, and oils; blending herbal teas; ect ~ basically us farmgirls that are interested becoming the herbalist for our families and friends and then passing the information on to others.
i am self taught through grandmothers, history and books. i grew up in the Appalachian Mountains were we gathered wild herbs and foods. My grandmothers made herbal remedies and i watched. over the years i left some of that behind. then several years ago i felt the land and the herbs calling me back. my memories became clear as i worked more and more with herbs.
maybe we can't change the fda ruling but we can be proactive in taking responsibility to learn as much as we can and then pass it on. isn't that what we should be doing anyway?
live well, Tamara www.thegoodearthfarm.com "We do not inherit the earth from our ancestors, we borrow it from our children" http://thegoodearthfarm.blogspot.com follow me!
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Tn.Earthmama
True Blue Farmgirl
451 Posts
Phyllis
Englewood
Tennessee
451 Posts |
Posted - May 06 2009 : 10:16:23 AM
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Hi all, when I moved back home to Tenn I was hoping to find someone to learn the old ways from. Tamara,sounds like you have done a good job of doing that. I have been reading Susun Weeds book about healing weeds and was surprised to learn all the good things about the things growing wild in my yard. At least they cant interfere with that.
Maybe we should start local co-ops for herbs and healing plants. sharing seeds and knowledge. that way if we were in groups close enough to visit in person, they couldn't stop us from sharing what they don't know about. boy, I'm sounding paranoid, but knowing the power of the drug industry nothing would surprise me.
well, off my soapbox. LOL. anyhow, I think you gals have a great idea going here and this is a great place to share our knowledge with each other. the revolution begins!!! hugs Phyllis |
Edited by - Tn.Earthmama on May 06 2009 10:18:20 AM |
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herbquilter
True Blue Farmgirl
891 Posts
Kristine
Bonney Lake
Wa
USA
891 Posts |
Posted - May 07 2009 : 10:15:45 AM
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I think we will need to start bartering with trusted friends for the products that we make & will help them.
They cannot regulate what you make, only what you sell to the public. If I understand the law correctly.
About a year ago I pulled my website, www.herbalmomma.com, down because of this. Alot of herbalist, myself included, struggle to make a good profit from our products already. There is no way for us to meet the FDA guidelines.
When one door closes, a better one opens!
Blessings, Kristine ~ Mother of Many, MRET & Wellness Coach
http://herbalmommasda.blogspot.com/
Farmgirl Sister #97
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electricdunce
True Blue Farmgirl
2544 Posts
Karin
Belmont
ME
USA
2544 Posts |
Posted - May 07 2009 : 12:00:28 PM
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I WONDER WHOSE BRIGHT IDEQA THIS WAS. IT IS JUST APPALLING TO me, whoops, sorry about the caps, it is a fumblefinger day for my arthritic hands. I remember when I was in high school ( forty years aago) and the government was trying to pass a pill aking vitamins available by prescription only. Geez, I think the drug companies meke enough money already. That thought, banning vitamins to the general public, died an early death. AIt is hard to believe with all the things that are going on in our country and the world that someone felt the need to do this. I'm going to have to look into this.
Discouraging. Ah well, all we can do is find out who the real culprits behind this idea, it really stinks.
Karin
Farmgirl Sister #153
"Give me shelter from the storm" - Bob Dylan http://moodranch.blogspot.com http://domesticnonsense.etsy.com |
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JoyIowa
True Blue Farmgirl
273 Posts
Joy
273 Posts |
Posted - May 14 2009 : 10:56:52 AM
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I am reminded of a warning my dad used to tell me about. Occasionally he would tell me to be sure to always have pure seeds on hand even if I didn't have a garden one year or another. He told me the day was coming when ordinary people wouldn't be able to purchase seeds because of redtape. He used to warn me about how there used to be many many seed companies and slowly they are becoming non-existent.
Gather up some seed ladies! You can grow anything if you have too!
If it's not illegal, unsafe, or immoral, why not try anything once? Who knows? You may come back for a second helping! |
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JojoNH
True Blue Farmgirl
1984 Posts
Joanna
Dunbarton
New Hampshire
USA
1984 Posts |
Posted - May 15 2009 : 04:57:07 AM
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The one thing I know for a fact is this: Congress, the ones who pass the laws, are not farmers, gardeners, herbalists, etc, etc. They pass laws based on greed and someone else's say so. I guarantee if they needed an herb or tincture etc, and it was against the law, they would get the law changed in their favor. . . because they needed it.
We have to start educating as many folks as possible about clean living, gardening, eating etc. . . which is what the big corporations don't want us to do. . . it will effect their bottom line and they will no longer be in control.
We also need to take the time and get involved with local government. . . it is the only way we are all going to start to see the changes in the right direction. Something as simple as a table outside the election hall with "Farm Girl Information" on any given election day will have a dramatic effect over time. . . look how much this forum has grown is such a short time!!
The Farm Girl Can Do attitude will make a positive difference!!
Joanna #566 JojoNH
http://www.CountryCents.com http://CountryCents.Blogspot.com http://Twitter.com/Eastwooddesigns |
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pmorello
True Blue Farmgirl
56 Posts
Patricia
Montgomery
NY
USA
56 Posts |
Posted - May 17 2009 : 8:16:49 PM
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Hooray, Joanna! Reading through this, what comes to mind is all the letters many of us wrote about the new regulations on clothing. The public groundswell got this turned around. It is time to start talking to our legislators. We can gather ideas here on the forum, but we have go to start speaking out. Spend a little bit of time this week composing a letter to each of your legislators and get it emailed off. Ask as many of your friends as you can to do the same. Small herbalists cannot be lumped in with the large pharmaceutical companies. I'm going to get my letter composed and sent off, those of us involved in this issue are the ones who have to start the wave of correspondence which will make the difference. Pat
Pat www.patriciarose-apotpourri.com www.patriciarose-apotpourriof.blogspot.com |
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JojoNH
True Blue Farmgirl
1984 Posts
Joanna
Dunbarton
New Hampshire
USA
1984 Posts |
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JojoNH
True Blue Farmgirl
1984 Posts
Joanna
Dunbarton
New Hampshire
USA
1984 Posts |
Posted - May 18 2009 : 08:31:37 AM
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Oh, I did forget to mention in my earlier posts, although this thread is boarder line of a "political discussion" It is not intended that way. I am working on my Merit badge for Community Action. So for me, this is about a change I am helping work through for the benefit of all with in my community and helping preserve our way of life here in the North Country.
Although the subject does effect everyone across the country, I am staying focused locally and working with my town and state officials to effect a positive change . . . hoping that it has a positive outcome for everyone!
Joanna #566 JojoNH
http://www.CountryCents.com http://CountryCents.Blogspot.com http://Twitter.com/Eastwooddesigns |
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pmorello
True Blue Farmgirl
56 Posts
Patricia
Montgomery
NY
USA
56 Posts |
Posted - May 18 2009 : 5:35:53 PM
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Joanna, I think when it really comes down to nuts and bolts, we are all really working for our own communities and trying to preserve a life style in our own little corner of the world. But by speaking out to our state legislators and the Representatives and Senators we elect to Congress we are affecting the national community. Just a matter of size and semantics. It's all good! By working hard on your immediate community for your badge doesn't necessarily preclude you sending letters on the national level.
Pat
Pat
Pat www.patriciarose-apotpourri.com www.patriciarose-apotpourriof.blogspot.com |
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herbquilter
True Blue Farmgirl
891 Posts
Kristine
Bonney Lake
Wa
USA
891 Posts |
Posted - May 21 2009 : 08:05:20 AM
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Congress does not pass the FDA regulations. The FDA is an enity unto it self. They are under a cabinet member. Or shall I say they answer to the pharmicutical companys that grease their palms.
I wish congress would regulate them. At least then, We the People, might be able to have come say.
Blessings, Kristine ~ Mother of Many, MRET & Wellness Coach
http://herbalmommasda.blogspot.com/
Farmgirl Sister #97
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JessieMae
True Blue Farmgirl
702 Posts
Jessie
Raleigh
North Carolina
USA
702 Posts |
Posted - Jun 09 2009 : 11:09:10 AM
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Uh oh...I have to kind of disagree with most of you all on this one. If you have less than 19 employees the new law doesn't apply to you, so "backyard" farmers and small-time herbalists aren't going to be affected. I've got to admit I sometimes get a little creeped out when buying herbals at our local health food store, especially if they come from a foreign country. I'm not talking about local stuff where I know and trust the herbalist; I'm talking about corporate made / distributed products. They could be cutting their herbals with anything to make it go further, or putting goodness-knows-what in their products and calling it something else. I mean, just because the box says "nettle tea," how do I know what is really in it?
Jessie Mae Farmgirl Sisterhood #134 |
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ranchetta
True Blue Farmgirl
318 Posts
carol
Marysville
Wahington
USA
318 Posts |
Posted - Jun 09 2009 : 11:43:36 AM
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Jessie, good point regarding what may be mixed in with some of those herbal products.
I'm lucky to have enough space to grow some of my own herbs and know enough to make my own tinctures, teas, etc. I've always been a little cautious and don't feel because it says organic or herbs it's got to be good! LOL
Kristine, thanks for the info on the FDA. I'm not sure if I want any more government regulations though, since it seems that the people really don't get to have much say anymore. I wish we were allowed to vote on issues instead of having to depend on our elected officials to be our voice. It seems that most of them don't really hear us once they're in office, no matter how hard we scream. OOOOps, hope this isn't too political!!!???
http://curlywillowsranch.blogspot.com/ http://alteredshots.blogspot.com/ |
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greyghost
True Blue Farmgirl
650 Posts
Lynn
Summerville
Georgia
USA
650 Posts |
Posted - Jun 10 2009 : 10:10:27 AM
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I have worried that in time, we will have a harder time procuring seeds we want for our own use. However, it just encourages me to know more backyard herbalists like myself - people who grow medicinals and are willing to share. I've gobs of lemon balm and self heal I could divide or dig up to share, and I keep seeds as often as I can. It's a shame Monsanto can "own" a plant - but they cannot stop it from spreading any more than any weed can be stopped. Look at how hard people have tried to rid their yards of Dandelion (one of the best things growing, I say!).
The herbs are there. The plants are there. You can try to make a plant illegal but it's a little hard to enforce - which is probably why some folks still have those beautiful castor bean plants, despite plans to make them illegal. |
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Herbal Wisdom: FDA Guidlines on HERBS |
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