Pharmaceutical grade supplements

Discussion in 'Fibromyalgia Main Forum' started by LouiseK, Jun 20, 2006.

  1. LouiseK

    LouiseK New Member

    Hello,

    What does this expression mean? I am leery as many are of that (if anything . . .ha ha) is in these unregulated supplements and vitamins so NATURALLY this expression "pharmaceutical grade" sounds enticing.

    Would love to hear from folks as to what it means and how to find such supplements.

    I am about to undertake a whole fresh regime and would like to try to buy the best I can.

    Thank you and good health, everyone!

    LouiseK
  2. usanagirl

    usanagirl New Member

    Good for you Louisek, to realize that your health is priceless.

    1. All supplement manufacturers have the choice to follow Food Grade or Pharmaceutical Grade standards.

    2. Food Grade standards allow for a large margin of error, so they don't have to meet label claim.(over 90% will not) Generally speaking, they choose the least expensive, synthetic ingredients...which the body doesn't recognize.

    3. Pharmaceutical Grade has much higher standards. Any nutritional company that voluntarily follows these practices must test the raw ingredients, test during manufacturing and test before they are shipped and most importantly...have a potentcy guarantee. Which means that what's on the label is actually in the bottle AND in each and every pill!

    I take USANA supplements, which has been a godsend for me and my family!!! Also, there is a book called The Comparative Guide to Nutritional Supplements by Lyle MacWilliam available through Amazon that explains the amazing benefits of taking a high-quality, complete and balanced supplement and should help you determine what is best.

    Hope this helps, take care!
    usanagirl
  3. bioman85

    bioman85 New Member

    You sure you don't work for usana?
  4. usanagirl

    usanagirl New Member

    that's how I was introduced to it...I believe in the products and I have a very strong interest in health and nutrition.

  5. mme_curie68

    mme_curie68 New Member

    I work in the industry so I think I can help out here -

    Pharmaceutical grade can be equal to or better than food grade.

    It may be that the food grade material is of sufficient quality to be pharmaceutical grade also.

    People say "pharmaceutical grade" because it sounds better - it's better for marketing.

    There is a compendium that is used in the industry called the "United States Pharmacopoeia" or USP.


    The USP publishes "standards" for all kinds of materials - in order to meet USP standards, the ingredients used must be manufactured and tested by the tests laid out in this book, these groups of tests for any one ingredient or dietary supplements are called "monographs".

    The ONLY required testing for dietary supplements in the USP for ALL dietary supplements are : Microbial Limits (Total Aerobic Plate Count, Total Yeasts and Molds and Absence of Staph aureus, pseudomonas aeruginosa, salmonella species and E. coli), Disintegration, and Weight Variation.

    If a dietary supplement has its own monograph, that generally includes more tests in addition to the basics.

    Lots of supplements are labeled "Meets USP limits for disintegration" - meaning when it is put into water, it disintegrates.

    Supplements that have monographs and meet all monograph standards can be labeled "Meets USP requirements" or could be labeled, for example as "Calcium Carbonate Tablets, USP".

    FDA holds us (for prescription drugs and OTC drugs) to the test methods of the USP, unless we in industry come up with better tests and prove, side-by-side that the tests we developed are better than those published in the USP. Many dietary supplements now have monographs in USP.

    Methods of manufacture for dietary supplements are regulated to the extent that they must at least be Food Grade level. They can be higher (RX and OTC drug-level) but they don't have to be.

    In my company, our equipment lines for manufacture are not dedicated, which means if we are manufacturing drugs and supplements then our procedures for the supplements will be the same as for the drugs - this way we don't have to worry about one set of rules for the supplements and a different set of rules for the drugs - we treat them all as drug-level.

    Here is a link to Dietary Supplement Guidelines at FDA:

    http://www.cfsan.fda.gov/~dms/supplmnt.html

    Hugs,
    Madame Curie


    [This Message was Edited on 06/21/2006]
  6. LouiseK

    LouiseK New Member

    I did go to the site, Mme. Curie and see that it basically says "buyer beware". . .

    There are a couple of organizations who provide "seals of approval" type things for vitamins I've noticed -- one is something like Good Manufacturing Practices (GMP)

    Anyone know if these mean a darn thing either?

    Thanks a lot!
  7. LouiseK

    LouiseK New Member

    The book sounds interesting. I will check out the website for this brand although I haven't seen it for sale anywhere.

    Thanks again.

    LouiseK
  8. mme_curie68

    mme_curie68 New Member

    GMP's mean "Good Manufacturing Practices" - these are the federal laws that regulate the manufacture of OTC and Rx drug products in the United States.

    The Code of Federal Regulations has books called "Titles"

    Title 21 pertains to food and drugs.

    21 CFR Parts 210 and 211 pertain to manufacture, processing, packing and holding drugs for human consumption.

    Here is a link to this section in the Federal Register:

    Part 210:pART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
    http://www.access.gpo.gov/nara/cfr/waisidx_06/21cfr210_06.html

    Part 211:pART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
    http://www.access.gpo.gov/nara/cfr/waisidx_06/21cfr211_06.html

    Hugs,
    Madame Curie

  9. usanagirl

    usanagirl New Member

    Could you tell us what the requirements are for a drug to be listed in the PDR?

    Thanks,
    usanagirl