Joined: 13 Dec 2006
Location: Cleveland, OH
|Posted: Dec Fri 15, 2006 10:40 pm Post subject: Excipients In Products
|Excipients In Products
Letter From Dale Lee
Excipients In Products- Letter From Dale Lee Regarding
Angelica Pattison wrote NSP and got this as a reply. Just remember, when you have this type of a question - the company is the one to ask, not the forum. Do share the answers with the forum though as Angelica did, because those of us too lazy to write like to hear the answers.
August 1998 Dear Manager,
As you may know, as a result of the Dietary Supplement Health and Education Act (DSHEA), new labeling laws will go into effect in March 1999. Nature's Sunshine has been busy designing new product labels. We are also putting new information on the labels in the Supplement Facts box. This will be to our advantage as every company will now be required to list the part(s) of plants used in their products. For instance, you know that the root is the most beneficial par of the golden seal plant.
So, when you look at other companies' bottles of golden seal and read that they use "golden seal herb," you know you are not getting an effective product. In contrast, NSP uses only golden seal root in its product, a fact that is clearly spelled out on our new labels.
You may also notice things like cellulose or maltodextrin listed under Other Ingredients. These are a few of the manufacturing aids (excipients) NSP uses in some of its products. The purpose of this letter is to answer any questions you have on this important topic.
Q: Do All NSP Products Contain Excipients?
A: No, Currently over 70% of our encapsulated products do not require the use of any mfg. aids. We only use these aids when it is necessary, and then we find the smallest amount that will do the job.
For the overwhelming majority of our encapsulated products, the excipient level rarely exceeds 1% of the total volume of the product.
Q: Why Does NSP Use Excipients at All?
A: As much as we try, we simply cannot manufacture certain products without the minimal use of manufacturing aids. Unlike most companies, NSP doesn't use any fillers it it's products. But like all companies, NSP does use excipients in the preparation of some supplements, though they are kept to a minimum. They are only used for their functionality, never merely to fill remaining space in a capsule or tablet. For example, look at any NSP capsule product label under Other Ingredients, you'll see gelatin, glycerin and water. These three elements comprise the capsule itself. Think of the empty capsule as an excipient because without it, the product cannot be manufactured.
Q: Am I Getting Less herb(s) in My Products?
A: Every NSP capsule product label declares the amount of herb material included in each capsules. This claim represents the amount of actual herb material in the product; it does not include the weight of any excipients. You always receive the amount of herb or herb blend stated on the label. The weight of any excipient is in addition to the amount of herb listed. You are never "short changed" due to manufacturing aids.
Q: What Functions Do They Perform?
A: Excipients assist in the machinability and flow of raw materials used in mfg. They prevent clumping and provide for an even distribution of the different materials. Their use results in products that are more uniform from capsule to capsule and from batch to batch. Manufacturing aids help prevent problems like dosage uniformity issues, splitting, machine jamming, product disintegration problems, and many other issues common to the food supplement manufacturing process. Using excipients actually allows us to manufacture products of consistently high quality that hold up better.
For example, adding cellulose powder to a product mixture allows the mixture to uniformly flow into the manufacturing equipment, providing consistent dosage fill. And, because cellulose powder prohibits clumping, it ensures the proper distribution of the herbs and vitamins in those mixtures, enabling us to make accurate content claims. In addition to the functions they perform, excipients also provide a few nutritional benefits. Disintegrants enhance the bioavailability of compressed products. As natural sources of fiber, many excipients have nutritive value.
Q: How Many Types of Excipients Are There?
A: Manufacturing aids are classified by the functions they perform: compression binders, lubricants, flow aids, disintegrants (aid tablet disintegration), carriers, and flavoring agents.
See the attached chart for examples of NSP excipients, their functions and sources.
Q: Are They Safe?
A: All NSP manufacturing aids are natural-source and most are vegetable-derived. They are completely safe, contain no toxins and meet nited States Pharmacopocia (USP), National Formulatory (NF) or Generally Recognized as Safe (GRAS) safety standards. Dr. Alvin B. Segelman, Vice President of Health Sciences and the person most directly responsible for ensuring the efficacy and safety of all NSP products, said this regarding excipients: "I think of excipients as quality control and manufacturing aids which allow NSP to offer products of the highest quality with maximal health benefits."
Throughout 1998, NSP has focused on quality. Indeed, our theme is Quality to Change a Life.
We honestly feel that the manufacturing aids we use and the methods in which we use them allow us to product higher-quality products -- products we are proud of, and of which you can be proud. We hope this information has been helpful. If you have additional questions regarding manufacturing aids, please direct them to NSP Health Sciences at 1-801-342-4405.
Best Wishes for continued health and success!
Sincerely, Dale Lee President of U.S. Sales
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Following is from Lynda Hammons, Quality Assurance Director in response to a letter from Angelica Pattison of our forum.
Concerning your specific question on the sources of four ingredients, the following is the information:
Cellulose - Derived from fiber from the cotton plant Maltodextrin -
Complex Carbohydrate from vegetables such as corn Magnesium Stearate -
Vegetable oil from soybeans
Silicon Dioxide - comes from naturally occurring silica. Same type as found in horsetail herb.
In addition, none of these are derived from wheat.
I hope this answers your questions. I can be reached at the below number.
Lynda Hammons, NSP Quality Assurance Director