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Dietary supplement safety for consumers
Dietary Supplements
   Easily obtainable
     Grocery stores
     Pharmacies
     Health food stores
     Ordering them on the internet
 Do not replace food
 Used when person requires higher
  levels of vitamins, minerals, or amino
  acids
Supplements
   Supplements found in
     Pills
     Tablets
     Capsules
     Liquid varieties
   People take supplements for reasons
    relating to health
The Law
 Promoted as something with potential to
  have positive effects on peoples general
  health and well-being
 Manufacturers prohibited by law from
  asserting that given supplement will
  prevent, treat, or cure disease
 Common ingredients in dietary
  supplements are substances that are
  found in natural world
History
 Substances been used throughout
  history in treating illness and the
  maintenance of wellness
 People suffering from fever were treated
  with willow bark tea
 Ingredient in dietary supplements are
  also sometimes used in medicines.
Growing Industry
   According to ‘The Dietary Supplements
    Regulatory and Market Outlook,’
    industry for dietary supplements in USA
    has potential to experience a yearly
    growth rate of 3.8% between 2010 and
    2015
High Standards
 According to current good manufacturing
  practices (CGMP) Final Rule dietary
  supplements are made using consistent
  processes which result in a product that
  meets high standards of quality control
 CMGP Final Rule issued by the FDA (US
  Food and Drug Administration) to make
  sure all dietary supplements available to
  consumers are free from contamination
  and labelled
Regulation
   Main objective of the Final Rule
     Ensure consumers of dietary supplements have
     peace of mind that composition of their
     supplements is reliable and consistent
 FDA primarily concerned that processes for
  manufacture of supplements do not
  contravene the guidelines in the Final Rule
 Regulate clinical trials and research on the
  health ramifications of dietary supplements
  nor does FDA seek to block access to
  supplements on the consumer market
How Safe are Dietary Supplements?
   Best taken after consulting a dietician,
    pharmacist or physician
   Should be bought from reputed
    manufacture
   Not be viewed as replacements for
    conventional medicinal treatment
   Might be combined with other treatments
    under a doctor's supervision
   Women who are breast-feeding or
    pregnant should be particularly careful
    about dietary supplements
Side Affects
 Side effects and allergic reactions can
  sometimes occur when dietary
  supplements are consumed
 Also interact with other drugs
Compliance Experts
   Compliance Insight, Inc.

   Your Hands-On Quality and Regulatory Specialists

   Our services include GMP consulting, audit
    preparation, FDA mock inspections, FDA response
    assistance, vendor/contract audits, GMP training and
    accreditation, new construction compliance, regulatory
    consulting, investigations, biosafety and viral testing
    consulting; clinical trial audits and more.

   For more information visit http://compliance-
    insight1.com/

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Dietary supplement safety for consumers

  • 2. Dietary Supplements  Easily obtainable  Grocery stores  Pharmacies  Health food stores  Ordering them on the internet  Do not replace food  Used when person requires higher levels of vitamins, minerals, or amino acids
  • 3. Supplements  Supplements found in  Pills  Tablets  Capsules  Liquid varieties  People take supplements for reasons relating to health
  • 4. The Law  Promoted as something with potential to have positive effects on peoples general health and well-being  Manufacturers prohibited by law from asserting that given supplement will prevent, treat, or cure disease  Common ingredients in dietary supplements are substances that are found in natural world
  • 5. History  Substances been used throughout history in treating illness and the maintenance of wellness  People suffering from fever were treated with willow bark tea  Ingredient in dietary supplements are also sometimes used in medicines.
  • 6. Growing Industry  According to ‘The Dietary Supplements Regulatory and Market Outlook,’ industry for dietary supplements in USA has potential to experience a yearly growth rate of 3.8% between 2010 and 2015
  • 7. High Standards  According to current good manufacturing practices (CGMP) Final Rule dietary supplements are made using consistent processes which result in a product that meets high standards of quality control  CMGP Final Rule issued by the FDA (US Food and Drug Administration) to make sure all dietary supplements available to consumers are free from contamination and labelled
  • 8. Regulation  Main objective of the Final Rule  Ensure consumers of dietary supplements have peace of mind that composition of their supplements is reliable and consistent  FDA primarily concerned that processes for manufacture of supplements do not contravene the guidelines in the Final Rule  Regulate clinical trials and research on the health ramifications of dietary supplements nor does FDA seek to block access to supplements on the consumer market
  • 9. How Safe are Dietary Supplements?  Best taken after consulting a dietician, pharmacist or physician  Should be bought from reputed manufacture  Not be viewed as replacements for conventional medicinal treatment  Might be combined with other treatments under a doctor's supervision  Women who are breast-feeding or pregnant should be particularly careful about dietary supplements
  • 10. Side Affects  Side effects and allergic reactions can sometimes occur when dietary supplements are consumed  Also interact with other drugs
  • 11. Compliance Experts  Compliance Insight, Inc.  Your Hands-On Quality and Regulatory Specialists  Our services include GMP consulting, audit preparation, FDA mock inspections, FDA response assistance, vendor/contract audits, GMP training and accreditation, new construction compliance, regulatory consulting, investigations, biosafety and viral testing consulting; clinical trial audits and more.  For more information visit http://compliance- insight1.com/