Tincture labels.
Date: Sat, 26 Feb 1994 06:03:52 EST
Sender: "Medicinal and Aromatic Plants discussion list <HERB.TREARN.BITNET>
From: Howie Brounstein <howieb1991.AOL.COM>
Subject: US Herbal Tinctures-labelling
Johnathon,
You are lucky in Britain when it comes to herbal product labelling.There are separate laws for food, herbs, and drugs. This is not the case in the U.S. Herbs need to be sold as either food or drug.
Celestial Seasoning manufactures teas. They can not make medicinal claims. They are stretching the law when they call it "sleepy time" tea. They technically can make no reference toward any medicinal claim. Traditional Medicinals makes teabags that are drugs. They are licensed as a pharmaceutical company. The owner once told me it cost nearly half a million dollars in fees and setup to be this. They can legally call their tea "breathe-easy" and say on the box that Ma Huang is a stimulant and Bronchial dilator for relief of hayfever, etc. (Don't quote me, I don't have a box around).
A number of years ago Lily (a drug Co.) made Valeriana officinalis tincture, sold through drug stores. Claims and contra-indicatiuons could be on the label. The smaller tincture companies cannot afford the fees to do this.
Especially the tincture makers in the Eugene OR stores. The world is even smaller with the information highway we're riding. Your letter showed up on my screen. I make tinctures. They sell in all the Eugene health food stores, since 1982.
You write:
>Presumably because they are classed as foodstuffs the labelling on herbal products seems to be somewhat arbitary in the US, often based more on grabbing the potential purchasers dollar than on providing accurate information. (eg " Herp - eze" )
I remember in the eighties when the FDA busted all the tincture makers and herbal products in the Northwest, and other areas in the US. My Herbal Insect Repellant was removed from the stores, because it was a pesticide and the pennyroyal, eucalyptus and rosemary had to get the same health tests as "OFF!" But the same product named Summertime Woods Oil was fine. Companies had all there literature about dosage and usage confiscated. Labels were confiscated. No reference to medicinal use, even "herp-ease".
As the years went by, the laws didn't change. They weren't enforced, but they could be, at any time. This colors my labelling today.
There are 10 tincture companies on the shelves because the stores believe in our right to choose, but when I started there was only three including me. These newer companies have never had run ins with the FDA (Food and Drug Administration) because of the lack of enforcement. They are a bit looser with their labelling. Thus "Herp-ease" which technically is an implied med. use. River, the owner of of that co. takes a risk by that name. My own Fresh Lung Tincture is a small risk. We benefit from this because it sells more than Mullien/Coltsfoot/Horehound Blend, but it also helps the consumer who doesn't know what these herbs do. Its roundabout education.
We are licensed as an herbal tea concentrate, as a flavoring, as a kind of Vanilla Extract, inspected by the same folks who inspect bakeries.
If we get caught with faulty labelling claims, we can't sell till we change it. Even "herbalists have traditionally used this herb in the past for.........." is not allowed.
You can't print traditional uses literature, or have any reference books on medicinal herbs near the tinctures. This implies medicinal use.
Many stores and herbal product manufacturers do this anyway, because the laws haven't been enforced in so long.
The new laws we hear so much about in the US haven't started yet. The old ones are bad enough, with herbal products in a legal grey area.
Label specifics:
1. Species used (E.angustifolia, E. purpurea, and if both, what proportion)
2.Certified Origin of plant (organically wildcrafted)
3. Parts used (herb or root)
4. Strength of solvent
My labels contain this information.
5. Concentration of plant to solvent
My label doesn't contain this intentionally. It has to do with my personal beliefs and goals in tincture making. My explanation deserves its own letter and this one is long enough. Ask me if you want the details.
6. Date of manufacture and batch no.
I have batch #'s but no dates. I never knew anyone cared about dates, since most tinctures last years. Dated lot #'s are not required on the label by law, but every # has to have a date on record by the manufacturer. Any company would tell you when a lot # was made. I remove all old tinctures from the shelves and replace them regularly, but I use them myself and for friends because they're still good.
7. Doseage for acute AND chronic conditions
Dosages are not allowed specific for a problem. I use "1 to 4 dropperfuls in water as tea." I just take it straight. (crazed herbalists).
8.Contraindications and warnings
These are definated illegal. But I do put the warning "No medicinal claims" on the label to show my good faith to the FDA.
>Indeed it is often important to take an infusion rather than a tincture where alcohol may cause irritation eg urinary tract infections.
I consider a tincture similar to canning. A fresh herb is concentrated and preserved at peak strength. You can put the tincture in hot water to evaporate the alcohol in cases when the very small amount cannot be tolerated.
Howie Brounstein
