Joined: 13 Dec 2006
Location: Cleveland, OH
|Posted: Dec Thu 14, 2006 7:36 pm Post subject: Quality Control - NSP
|Quality Control - NSP
By Jeff Tuttle
Our products actually are the highest quality products available.
Long before science isolated substances in herbs, man had successfully used herbs. Science now verifies that the herbs really do have effects.
Gene Hughes, one of the founders of Nature's Sunshine, had an ulcer, found that capsicum was helpful, but taking teaspoons of it burned his mouth, so he encapsulated it by hand, which is very difficult. As he began to encapsulate it, his friends and relatives became interested in using it too. In a short while, he had to rent a machine to encapsulate it. He began to sell it.
From there, we have a company with over 300 products. Quality Control is very important to Nature's Sunshine. What sets us apart from other companies?
Each product that comes in is sampled. We use a statistical sampling plan that helps us to ensure that what we sample is representative of the whole lot.
Most of our products come in powdered form. Each can vary somewhat. We purchase our herbs from all over the world. 50-60 come out of China. Eastern Europe. South America. Middle East. And other countries.
E.g. Peppermint leaves: one year we may purchase from Yugoslavia, the next year from Washington. We're able to pick the best sources and then buy a contract for each year.
Psyllium Hulls - from India or Pakistan. It would be easier to be out on a farm growing our own herbs so that we could be sure no pesticides are used, only organic fertilizers, grown properly, watered properly, so that there are no insect contamination problems. We can't do that, so we set up a lab to test for those kinds of things.
e.g. Pau d'Arco: best comes from South America. Some other herbs come only from Canada or Europe. So, we can't grow them all, but we check them out.
Pilots - we are growing our own herbs - some alfalfa, red clover, some others - looking at the quality to see if we can get as high quality growing it our self.
Many of our herbs are wild-crafted - harvested in the wild - Golden Seal, Parthenium Echinacea, Slippery Elm, Cascara Sagrada - all come from the wild and are not cultivated.
More difficult to identify a plant when it is in powdered form - most of the herbs we buy are already powdered.
Most leaves will be green from chlorophyll. Brown - might be root. Look under the microscope to see cell structure, chloroplasts. One of the ways we identify the herbs is under the microscope - looking for certain characteristics.
Starch granules are typical to root products. If we have black walnut leaves and look under the microscope and see starch granules, what is the problem? They've harvested the root along with it. That happens occasionally. When you buy an herb, it's supposed to be everything above the ground. What they'll do is pull the whole herb up, pull the whole plant out of the ground, and chop it up.
Freeze-cracking some of the herbs - trichomes - mullein leaves are soft and fuzzy; they're thick because of the trichomes. What happens when you grind up products such as mullein and red raspberry? The trichomes tend to get disoriented and fragmented, and you end up with a furry mess. You also begin to generate heat, because the material does not pass through the grinder. After a period of time in that grinder, if it goes into a barrel after it is ground, there will be so much heat that it can catch on fire.
What we do with herbs like that is to freeze them with liquid nitrogen (it is sprayed onto the herb). The product is ground and it cracks, actually shatters the herb, and thus heat is not generated like it is when you use a traditional grinding technique.
If we're looking for white pine bark and we see parts of pine needles under the microscope, we know they ground the whole branch. Many of the herbs have special physical characteristics.
Psyllium must swell. When it's first harvested, the whole seed is harvested. At the first threshing, the hull is removed. You then have 99+% purity of the hulls. Then they do it 7 more times. They cut the herb and each time the purity of the herb goes down. First-cut psyllium is 99+% purity. If you buy seventh-cut psyllium, it's about 80-85% purity (the purity goes way down). So, you can buy different qualities of psyllium. We buy only the best.
This is typical of most herbs. You can buy different grade and quality of herbs. So it is very important that we check them out.
In order for psyllium to work it needs to swell (absorb water). To check that, we put it into graduated cylinders and measure how much swelling it does. This is the reason that one year we may buy psyllium from India and another we may buy it from Pakistan. We're able to ascertain the quality and then buy the product which has the best quality.
Ginger, Golden Seal, Ginseng look very similar.
One problem with goldenseal is that it is harvested when it is very muddy to get all of the small rootlets. If it's harvested when it's muddy and not properly cleaned, they make more money when they sell it. They sell it by the pound (if you sell a pound of dirt with a pound of herb, that's two pounds. If you washed away the dirt, you'd only have one pound). Occasionally, they will sell the herb without washing it properly. We test for this by burning it in a furnace. The herb burns up; what's left is the ash residue. This is the amount of foreign material.
Catnip typically has 10% ash because it has 10% minerals which are inherent to that product. A couple of weeks ago, eight different lots of catnip came in; the average amount of ash in the catnip was about 38% ash. In other words, if the maximum ash allowed is 12%, then 26% was dirt. Needless to say, we rejected that product.
How we do our contracts: We have an agreement with all of our suppliers. Before we do a contract, we say "These are our specifications." If the product does not meet all of our specifications, they get the product sent back to them at their expense. Then they have to supply us again with new product. If they can't supply us with new product and we have to go out into the open market for product, then they have to pay us the difference between the contracted price and what we have to pay on the free market.
We had a problem a couple of years ago with our goldenseal. We had to go out on the market and pay twice the normal cost.
For the most part we have a good relationship with our suppliers and they supply us with good quality herbs, because they know it's going to cost them if they don't. We work very closely with our suppliers.
Another test we perform is floatation testing. We use the principle that oil and water don't mix. We take the herb and put it in two liquids. The herb goes to the bottom and any materials such as insect fragments or rodent hairs which float up are skimmed off and checked under the microscope. We also do it for heavy things; we float the herb in the upper layer and things such as metal fragments or animal excrement fall to the bottom of the liquid. We take them out and analyze them under a microscope. If we have problems like this, we reject the product.
We have had samples of product come in with as many as 600 insect fragments per kilo. They had product contaminated with insects, so they ground the herbs and killed the insects. This causes insect contamination. If we find any kind of insect contamination, we reject the product. We don't want any contamination. Typically, if we find this insect contamination we have a problem with live insects in a short period of time. Because the insects lay eggs in the herb, which hatch, and they like to eat the herb. A notorious example is bee pollen, typically having a problem with wax moths.
In each vitamin batch that we produce, we check our tablets for DISINTEGRATION and DISSOLUTION. Disintegration is the way the tablet breaks down. An article was published a time ago about sewage treatment plants; screens were getting plugged up with tablets - vitamin tablets that passed through people's bodies and into the sewer, not even breaking down after weeks and weeks. It's important that tablets break down and that you have the confidence that they will break down in your body. We had several other products that we tested in our equipment for two days, and they didn't even break down.
Some companies say put the product in vinegar, and if it breaks down it's a good calcium supplement. That's a little misleading, because if you use calcium carbonate, which is basically chalk, it does react with vinegar (it foams). But this is basically a chalk form of calcium. We choose not to use that. People say that they put our product in vinegar and it does not break down. That's because we use bone meal source, and that's not typically a calcium carbonate source, so it won't foam up like the other product does.
When we put our product in the machine it actually simulates the movement through the body. First we put it through a simulated gastric solution, and then we put it through a simulated intestinal solution to simulate the passage through the body. Certain tablets are designed to break up quickly in the stomach, like Food Enzymes. Others are designed to break down slowly over a timed-release period so that they are absorbed in the small intestine.
There are different methods of making time-release products. An article spoke of one company which drilled holes in plastic and packed the product in so that the product came out over time through the holes in the plastic. However, many people experienced problems, not being able to pass the plastic matrices out of the stomach. One lady, after taking these products for a long period of time, had to be opened up surgically to have many of these plastic matrices removed from her stomach.
What we use for our time release is a special coating process that makes the layers dissolve off slowly, typically over four hours. For the coating, we use a vegetable coating. What happens is, the vegetable coating breaks down a little bit slower than a regular tablet.
We use a gas chromatograph. We can determine synthetic and natural oils, such as peppermint. Say the peppermint oil has 50 active ingredients, and they'll find the one active ingredient which gives the oil its natural flavor and they make that synthetically. So when you buy the synthetic, you get that one flavor and not the complete array of natural ingredients.
Tea Tree Oil - of the samples that we tested, ours was 2.7 times stronger than the others on the market.
Another test: Looking at different kinds of minerals with a direct current plasma emissions spectrometer (dcp). We're able to look at 12 different minerals at a time in 30 seconds, such as arsenic, lead, mercury, other toxins. Also, each batch of vitamins, we test for calcium, magnesium, selenium and all other minerals.
We have close to $500,000 just in lab equipment. We've tried to get a wide variety of pieces of equipment. An interesting story: Someone from another herb company called (this herb co. is now bigger than ours) and asked for help in setting up a quality control lab. They asked for a list of what to buy, and I asked how much they had budgeted for it. The caller said $2,000! I told him for $2,000 he could buy a mid-range microscope. He said he'd get back with me and he never did. They really still don't do anything about lab testing. They have the attitude that "herbs are herbs."
Herbs are not necessarily just herbs!
Because of accidents like Chernobyl, we also do radiation testing, especially for all of our herbs out of Eastern Europe. Cesium 137 and 134 were the contaminants released. The contamination is still in very high quantity. What some manufacturers did is, right after the accident, they harvested the herb that was contaminated and in subsequent years they mixed and blended this contaminated herb with less contaminated herb to just meet specifications of other companies. Our specifications are very tight, much tighter than the lowest government standards. Because of our high standards, we have not found any contamination in our products, because it is not worth it for them to mix the contaminated with the good. The machine shows peaks to show radiation contaminant.
Another type of equipment we have that has put us quite a bit ahead of other companies is our two liquid chromatographs. We're able to check for things like synthetic vitamins and also for fillers in the herbs that we receive. We received some comfrey root that was full of lactose (milk sugar - very inexpensive). It cannot be detected by smell, touch, sight or taste when mixed with the powdered herb, but it can be detected by the liquid chromatograph. Each active ingredient shows up as a peak. The computer will actually name the different vitamins that it tests in the sample and give the quantity. The size of the peak tells you the amount of the active ingredient.
Why do active ingredients vary in a product? It could be due to growing conditions, whether the product was harvested too old or too young, or other factors.
When I went out to a trade show to buy samples of other products, I paid $27.00 for one bottle of golden seal concentrate. I tested it, and it had the same amount as our regular goldenseal. Active ingredients were also gone.
Another common practice for other companies is to take something like fennel and extract the oil out of it. Then they put a portion of the oil back in. Then they sell the fennel as regular fennel (with most of the oil gone). They sell the fennel oil and the fennel and make money on both. Under the microscope, you'll see the cellular structure of the fennel; but you'll have to do the liquid chromatography to see that it doesn't have the proper amount of active ingredient in it.
We can also compare our concentrates and our regular herb. We can see that the active ingredients are in higher concentrate in the concentrate, and we do this on a batch to batch basis.
We are also able to check our liquid extracts and make sure we've extracted all of the active ingredient from the herb.
Pau d'Arco has at least 31 active ingredients and you need these ingredients to work in synergy. Some studies have tested only certain of these active ingredients and have discounted the herb's ability to stop growth of tumors (not realizing that the active ingredients work together). This is the case with many herbs: The active ingredients work together.
Example: Foxglove - digitalis. Originally people would chew the foxglove leaves, and the doctors would have them increase their dosage little by little each day, until they got to the point where they would feel sick. Then the doctor would have them cut back just a little bit to the dosage right before they became sickened by the herb. There were other active ingredients in that plant to help the body know when it had had enough. Now that they have the synthetic, purified digitoxin, that is much different because you can overdose on that. I'm not recommending using foxglove, a controlled substance. It's just a good example of how the whole plant is much different from an isolated, synthesized substance.
Another type of testing we do is for bacterial contamination, our most common contaminant. Without testing, you don't know if herbs were fertilized with human waste or dried on a barn floor in some foreign country. An herb can look fine under a microscope structurally and it may pass the ash test (no foreign inorganic material), but microbiological testing is critical to find bacteria.
There was a company nearby us who found salmonella in one of their products. To get rid of the problem, they decided to dilute it by putting one batch into ten. They weren't thinking properly, because all it takes is a tiny amount of salmonella to get in your stomach and breed, causing food poisoning.
We have had licorice and other products come in with salmonella, and we reject those contaminated products. Also, we have had products come in with sewage contamination.
I purchased various products in a health food store to test for bacterial contamination. Of the 12 products I purchased, 6 of them would have been rejected by us because of too high bacteria counts. People think all herbs are purchased from the same place, but that's not true. We may buy some herbs from the same company, but we have special sources for many of our products. It only takes one contaminated lot of licorice root to contaminate 22 or 23 of our products which contain licorice. Of the 12 samples I purchased, 4 contained sewage contamination right in the product. A study was done by the FDA several years ago. Two of the three products they tested contained salmonella, right off the shelf of the health food store. We check and make sure that our products are free from bacterial contamination.
If we say it's a 500 mg Vitamin C tablet, we put in overages so that at 2 years you will be at least 100% potency. With Vitamin C, we might put it 140% Vitamin C. So the potency remains over time. -Georgiana Duncan