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Results 1 to 18 of 18
  1. #1
    ...just because
    Join Date
    Jun 2003
    Location
    Metro Manila

    [MERGED] No Approved Therapeutic Claims ?

    ...we are being bombarded with ads(from Mercury Drug) of various food supplements; for the heart, liver, kidney, brain, etc...and yet there is always this disclaimer "no approved therapeutic claims." Why place this ad in the first place if these products aren't therapeutic?!

    Doctors in the house, your inputs please...

  2. #2
    oo nga no... bakit nga po kaya mga doc!! thanks...

  3. #3
    kasi magiging gamot ito pag may nakalagay na therapeutic iyon ang pagkakaalam ko and besides iyong approval nito sa FDA at BFAD ay napakamahal na proseso kaya ginagawa nilang no approved therapeutic claims.

  4. #4
    Business Guru
    Join Date
    Jul 2007
    Location
    My Office!
    Because they are treated as "food," they could not place a therapeutic claim. But just because they are food, it doesn't mean they do not have therapeutic benefits.

    Also, most supplement companies do not undergo the rigorous testing drug companies run on their drugs. For example, a supplement company may put in an insignificant (not meaningful, i.e. according to research, it takes 500 mg of this substance to have an effect, but some manufacturers put in less than half of that amount and claim that it has benefits) amount of green tea and claim that it can help you be healthy.

    There are some supplement companies that conduct rigorous tests on their products to ensure safety and efficacy. Understandably, their products cost more than the usual brand, but at least you are sure of what you are taking.

    Finally, and this is just an observation of mine, I think drug companies deliberately pull down the value of supplements to sell more of their drugs. I know this because Merck forced our company to stop manufacturing a red yeast rice supplement for high cholesterol in the United States (and BFAD, an FDA copycat, followed suit). It's still available in Asian countries like China, HK, Singapore and Taiwan, though.

    But to help you choose the right supplement for you, we have asked the help of Dra Yolanda Robles, Dean of the UP College of Pharmacy in choosing a supplement.

    How to Choose a Supplement
    By Dr. Yolanda Robles Dean, UP College of Pharmacy; OIC Institute of Pharmaceutical Sciences, National Institute of Health

    What are Nutritional Supplements? They add what is lacking in the diet.

    Do we need supplements? YES!
    Statistics show that we get inadequate amounts of essential vitamins and minerals

    There is a direct relationship between diet and lifestyle and development of chronic diseases
    Stress due to type A lifestyle
    Proliferation of fast food and instant foods
    Meal planning is practiced to the health conscious few


    US Pharmacopeia (USP)
     independent, non profit organization
     gives supplement standards
     checks for integrity – what is in the label and what is not

     Purity – some supplements contain lead, mercury, other heavy metals, pesticides, mold, toxins
    -- these must not be present in levels that can cause health problems
     Dissolution – if the supplement does not break down properly to allow its contents to be used by the body, then you are not getting its benefits
     Safe Manufacturing – assurance of safe, sanitary, well controlled and well documented manufacturing and monitoring process

    So… is your supplement USP grade?

    Tips
    If you have a question, ask the manufacturer
    • Can they substantiate their claims?
    • Beware that sometimes firms supply so-called “proof” of their products by citing undocumented reports from satisfied consumers (like testimonial), or charts that can be mistaken for valuable scientific research
    • Do they have info to show on safety and efficacy?
    • Do they follow Good Manufacturing Process?
    • Has the firm received adverse effects reports from someone who took the product? They should be documenting these reports for reference.
    Seals of Approval
    • Indicate that the product has passed the organization’s standards
    • Seals of approval does not mean that the product is safe and effective; it only means that the manufacturing process is ok.
    • Assurance that what’s on the label is in fact in the bottle; but still, rigorous testing from multiple test centers is needed to be certain
    • Assurance that it does not contain harmful substances (like stimulants which are common in slimming supplements)
    • Assurance that the ingredients will break down and release ingredients in the body
    • Assurance that the supplement is made under Good Manufacturing Process

    Seals you would want in your supplement:

    1. Good Manufacturing Process
    2. USP (US Pharmacopeia) grade
    3. BSCG (Banned Substances Control Group) – assures no banned substance in your supplement
    4. Consumer Labs – another independent tester



    So if your supplement does not even carry those seals of approval, you may be wasting your money on them.

    Try this website SupplementWatch.com to see how your supplement fares.

  5. #5
    As mentioned previously, there are certain regulations and standards that govern the production, marketing, sale/distribution of supplements and of therapeutic drugs.

    The label "No Approved Therapeutic Claim" means that the product has not been verified (by the proper authorities) to produce the results and/or benefits it markets or claims to do. So any testimonials, you hear or see regarding the product may be solely based on personal experiences, and not scientific/statistical studies.

  6. #6
    ...just because
    Join Date
    Jun 2003
    Location
    Metro Manila
    ^^ very informative! Thanks!

  7. #7
    Business Guru
    Join Date
    Jul 2007
    Location
    My Office!
    Quote Originally Posted by marbles View Post
    As mentioned previously, there are certain regulations and standards that govern the production, marketing, sale/distribution of supplements and of therapeutic drugs.

    The label "No Approved Therapeutic Claim" means that the product has not been verified (by the proper authorities) to produce the results and/or benefits it markets or claims to do. So any testimonials, you hear or see regarding the product may be solely based on personal experiences, and not scientific/statistical studies.
    Unless of course, if the company backs up the claims with clinical studies.

  8. #8

    Question therapeutic claims

    hi!

    "no approved therapeutic claims", ano po meaning nito?!

    thanks!

  9. #9
    Business Guru
    Join Date
    Jul 2007
    Location
    My Office!
    It means that the FDA/BFAD has not examined the product for its therapeutic value, but it doesn't mean that it has none.

    It's worth noting that some international products have that label here and in the US, but has no such label in Asian countries such as China, Taiwan, Singapore, etc.

    Probably because those countries are not much influenced by Western medicine, i.e. synthetic drugs.

    Hope that helps!

  10. Nov 13, 2007, 09:40 PM
    Reason
    redundant

  11. #10
    ...likewise it means the product claims to offer a cure/relief of symptoms and diseases.

    But the phrase " no approved Therapeutic claims" acts as a disclaimer stating that whatever cure/relief their product claims, it has never been validated by a well documented medical study.

    So on the question of does it work? it leaves the question unanswered. But if you listen to most radio/tv interviews, all these products claim to work wonders.

    medyo ironic... parang oxymoron ang dating.

  12. #11
    Business Guru
    Join Date
    Jul 2007
    Location
    My Office!
    But the phrase " no approved Therapeutic claims" acts as a disclaimer stating that whatever cure/relief their product claims, it has never been validated by a well documented medical study.
    Not always true. There are products that have double blind, placebo controlled clinical studies that prove that they work. But they still have that label. Why? Because they are labeled as "food" and thus, does not need to be proven to be effective. But there are companies that do take steps in proving that their products work.

  13. #12

    No Approved Therapuetic Claims?

    Sabi ng Doctor sa TV - it means it has no basis that the meds is effective- no backing whatsoever. But if you read the inserts and the website , ang daming nakasulat duon na studies and testimonies even by MD's. Ano ba talaga kuya?

  14. #13
    Business Guru
    Join Date
    Jul 2007
    Location
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    Read the statements above. However, studies can be borrowed and doctor testimonies is not reliable scientific basis.

  15. #14
    This might help:

    AMENDMENT TO BFAD M.C. No. 25, s. 1992 OTHERWISE KNOWN AS
    "ADDITIONAL LABELING REQUIREMENT FOR FOOD SUPPLEMENTS"


    1. BFAD Memorandum Circular No. 25, s. 1992, confirms the BFAD requirement of printing the caption “No Approved Therapeutic Claim” on the labels of all food supplements to ensure that such products are not commercially sold or advertised with therapeutic claims.

    7. This requirement shall become mandatory beginning 30 June 1999, to give food establishment’s sufficient time to make the necessary modification to the labels.

    8. After this date, all food supplements found not in compliance with this labeling required shall be deemed misbranded subject to confiscation and penalties provided in R.A. 3720, as amended by E.O. 175, “The Food, Drugs and Devices and Cosmetic Act”.
    Personally, I think not all food supplements are the same. Some can be beneficial, some are not. The best person to ask regarding this is your personal doctor.

    I'm not a lawyer. From what I can understand, the law ( as seen in the quote above) strictly prohibits the advertising of food supplements as to having any "healing" or "curative" effect.
    Last edited by smilewarrior; Jan 18, 2008 at 04:02 PM.

  16. #15
    Business Guru
    Join Date
    Jul 2007
    Location
    My Office!
    That's the source of the misunderstanding: the law. And who made that law? Most likely, not doctors, scientists or health experts.

  17. #16
    kasi nga naman baka umasa ang mga tao na nagpapagaling ang vitamin ABC ng kanser, kahit walang sapat na pag-aaral.

  18. #17
    Business Guru
    Join Date
    Jul 2007
    Location
    My Office!
    The same law also disregards the thousands of clinical studies which prove that certain supplements do work.

  19. #18

    No Approved Therapeutical Claims

    *****post edited*****
    Nice. Very informative
    Last edited by jerwin17; Oct 30, 2009 at 07:09 PM.

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