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T O P I C    R E V I E W
corporatefarmgirl Posted - May 03 2009 : 07:08:07 AM
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!
25   L A T E S T    R E P L I E S    (Newest First)
cajungrammie Posted - Feb 21 2010 : 07:09:25 AM
wow what is next?big brother has to step in on everything.our world is based on greed these days.it is all about the money.we should start a seed coop and train each other to save seed and how to preserve what is so dear to us.big brother can't beat down a farmgirl!

Sometimes I think I know Everything!!Then I wake Up!!
Annab Posted - Feb 14 2010 : 03:29:27 AM
OK now that makes more sense, and is why I don't go bigger w/ my jams and jellies. The health dept would shut me down for sure, what w/ all the country dirt and dog hair on the floor

But boy what I wouldn't give for an all stainless steel kitchen just for this!
willowtreecreek Posted - Feb 13 2010 : 12:41:53 PM
Truthfully most states already REQUIRE this but most people do not register their home business properly and do not follow these rules. In fact MOST states require that if you make any of these products that you must have a health department Certified kitchen that is dedicated Soley to these products! Meaning you cant cook family meals in this kitchen!!!

Farmgirl Sister #17
Blog
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Annab Posted - Feb 13 2010 : 04:03:15 AM
It's almost like outlawing MJ simply b/c the governmnet can't get their cut. It's a natural herb too, and a mighty fine one at that especially for cancer and AIDS patients. Which BTW, this USED to be legal I think before the 1940's??

I can see it now, bootleg herbs and time served for treating something with a home remedy. "Yea, I;ve been sentinced for 2 years in jail for washing with an herbal soap and applying a comfrey poltace on my bruise."

Extreme and pathetic
smiley Posted - Feb 02 2010 : 5:43:21 PM
Another thought along this line is to learn the medicinal value of plants growing in the wild where you live. Here we have mullen for example. Study what it is good for etc.Be sure to properly identify it and see if there are laws against harvesting it. Echinecea cant be harvested on the side of the road here I'm told. If they make it where we cant buy the supplements we can know which food is high in what we need and get more of it into our diet. Just thoughts hopefully it wont come to that. I remember writing to my congressman 30 yrs ago when they were talking fda regs on herbs and vitamins. It isnt new.
5 acre Farmgirl Posted - Jan 20 2010 : 9:50:24 PM
I guess that leads to the "underground"?

Farmgirl Sister #368
~~~**Terri**~~~
My blog is up again, please go and read....
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brightmeadow Posted - Jan 20 2010 : 9:49:15 PM
I think it is part of the "amusement park" mentality. People want to be entertained (or treated with herbal medicines) but don't want to take any risks at all- "the government" should protect them, just like when they go to Disney World - they want to be thrilled by the "risk" but don't really want any danger at all- if anything bad happens they think they should be entitled to sue someone.

Life isn't safe. It is all about taking risks. (Ask any farmer) Protecting the general population from risks costs a lot of tax dollars. Unfortunately consumers also don't want to pay the price in either goods or taxes....





You shall eat the fruit of the labor of your hands - You shall be happy and it shall be well with you. -Psalm 128.2
Visit my blog at http://brightmeadowfarms.blogspot.com ,web site store at http://www.watkinsonline.com/fish or my homepage at http://home.earthlink.net/~brightmeadow
LakeOntarioFarmgirl Posted - Jan 20 2010 : 5:32:15 PM
I've read these posts with interest! As a new herbalist "wannabe", it definitely worries me that we may not be able to get herbs that are needed for much longer. I can see how important is to learn all we can about herbs now, and how to grow, harvest, store and use them.
I know so little.... but am excited to know more!! :)
Where is a good place to begin buying herb seeds?

Brenda
FarmGirl # 711

Nothing we achieve in this world is achieved alone. It is always achieved with others teaching us along the way. Lee J. Colan

http://theviewfromhere-brenda.blogspot.com/
ramonaj Posted - Jan 15 2010 : 6:36:36 PM
If you want to know where this nonsense comes from, google Codex Alimentarius. While I agree that this is a political topic, it is also an attack on our right to choose what we put on and in our bodies, as well as a way of life for many people. here in canada the government is trying(again) to make it illegal to buy natural health products without a prescription. so for people like me and probably many of the rest of y'all, we would be subject to fines and/or jail time. making herbal products will be illegal if the bill passes. It is already illegal for me to sell a dozen eggs or other "farm gate" products. A local CSA recently lost 100s of gallons of fresh milk because it was deemed too dangerous for people to drink raw milk. This is happening all over Canada and no doubt will happen in the States too. OK, end of rant, just had to reply to this topic.

happiness to all sentient beings
Sarahpauline Posted - Jan 14 2010 : 11:16:15 AM
thats just nuts. What about herbal soaps? How many folks are making body butters and shampoos and such. Etsy is just full of that kind of stuff.

Not all those who wander are lost...
www.SarahPauline.com
www.AbraxasBaroque.com
Melina Posted - Jan 14 2010 : 07:40:55 AM
I wanted to bump this subject back to the top, and also comment.
I know I need to avoid political discussions, and I think this transcends politics and comes under the heading of basic human rights.
We all need to educate ourselves as much as possible about growing food, herbs, etc. I've been buying all the books I can find in thrift stores and used book stores about seed saving, making herbal compounds, heirloom seeds, etc. Over time, I've seen many kinds of vegetable seed disappear from the seed catalogs, mainly because of small sales and consolidation of companies. If you have an open pollinated variety that you trust and rely on, save the seed! If you don't know how, learn. That's where those old gardening books come in handy.
With what happens in Washington every 4 or 8 years, policies change. Growing a garden and feeding your family stays the same. It's, as I said, a basic human right. I've always believed, control the food and you control the people. Take control of your own food supply. It's the farmgirl way!

The morning breeze has secrets to tell you. Do not go back to sleep.
Rumi
Bear5 Posted - Jun 15 2009 : 9:22:46 PM
Personally, I don't like all the busy bodies in my business. Next they'll insist that we tell when we plant a garden. What's next?
Marly

"It's only when we truly know and understand that we have a limited time on earth- and that we have no way of knowing when our time is up- that we will begin to live each day to the fullest, as if it was the only one we had." Elisabeth Kurler-Ross
greyghost Posted - Jun 10 2009 : 10:10:27 AM
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.
ranchetta Posted - Jun 09 2009 : 11:43:36 AM
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/
JessieMae Posted - Jun 09 2009 : 11:09:10 AM
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
herbquilter Posted - May 21 2009 : 08:05:20 AM
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
pmorello Posted - May 18 2009 : 5:35:53 PM
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
JojoNH Posted - May 18 2009 : 08:31:37 AM
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

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JojoNH Posted - May 18 2009 : 08:22:34 AM
The email campaign sounds great Pat! For me, I am devising an herbal gift basket of some sort to send out to the different members. If they can "see, feel and smell" some of these herbs while reading a hand written letter, it might have a lasting impression with them.



Joanna #566
JojoNH

http://www.CountryCents.com
http://CountryCents.Blogspot.com
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pmorello Posted - May 17 2009 : 8:16:49 PM
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
JojoNH Posted - May 15 2009 : 04:57:07 AM
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
JoyIowa Posted - May 14 2009 : 10:56:52 AM
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!
electricdunce Posted - May 07 2009 : 12:00:28 PM
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
herbquilter Posted - May 07 2009 : 10:15:45 AM
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
Tn.Earthmama Posted - May 06 2009 : 10:16:23 AM
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

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