The growing concerns about nutraceuticals

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The growing concerns about nutraceuticals have led to industry self-regulation to prevent government intervention. Learn what the industry is doing.

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The growing concerns about nutraceuticals

  1. 1. The GrowingConcernsaboutNutraceuticals
  2. 2. United States Healthcare isChanging Patients participate more in the treatments Surgery and pharmaceutical drugs are less popular People are choosing their own treatments
  3. 3. Patients Choices Alternativenatural foods Dietary supplements Preventive supplementary approaches
  4. 4. Things Have Changed Dietary supplements are not as strict as pharmaceutical ones Dietary Supplement Health and Education Act (DSHEA) removed control from the FDA ◦ Removed the oversight of dietary supplements
  5. 5. Things Have Changed Dietary supplements not promoted as substitution for pharmaceutical FDA guidelines don’t apply to dietary supplements
  6. 6. Inadequate Information Uncertainty surrounding the packaging and advertising of nutraceuticals Growing concerns among consumers and professionals in the industry Not enough information about the quality and proper usage
  7. 7. Learning More Healthcare professionals seek to keep their training up to date Continuing medical education (CME) provides learning programs and conferences Awareness that nutraceuticals have not been properly monitored Not much is known about how ingredients are processed and grown
  8. 8. Not up to Par No trials or studies are conducted on them Question arise ◦ Are they safe? ◦ What are true benefits? Manufactures extravagate benefits due to early study results
  9. 9. Many Differences FDA regulates use of certain ingredients such as ephedrine No guidelines for what can and can’t be put in nutraceuticals ◦ Ephedrine often appears
  10. 10. More then Meets the Eye Belief is that dietary supplements have less side effects Doctors beginning to recommend nutraceuticals along with drugs Customers wonder about an agreement between doctors and manufacturers
  11. 11. Problem Solving The American Nutraceutical Association is interacting with the FDA to resolve problems Manufactures want information about nutraceuticals to be correct Do not want more regulation
  12. 12. 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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