Dietary supplement compliance for manufacturers
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Dietary supplement compliance for manufacturers

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The FDA is making sure that dietary supplements for consumers are being safeguarded by taking a closer look at the market. Read this article to learn more.

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Dietary supplement compliance for manufacturers Presentation Transcript

  • 1. Dietary SupplementCompliance for Manufacturers
  • 2. The Market Market for dietary supplements is being looked at closely by the FDA (the US Food and Drug Administration) FDA wants to ensure that safeguarding is put into place for the dietary supplements that arent as safe as the manufacturers are projecting Supplements include  Amino acids  Minerals  Botanicals  Vitamins
  • 3. Information FDA guidelines manufacturers must offer a reasonable safety expectation for these supplements Products used in other countries or animal studies need to be documented and passed to the FDA to show their safety Human trials are not mandatory  Can be documented and submitted as well for proof
  • 4. Final Rule FDA has issued a Final Rule according to the current good manufacturing practices  Manufacturing of dietary supplements should be performed with quality controls that are consistent and strict Final Rule does not allow manufacturers to state that a certain supplements prevents, treats or cures any disease  Allows them to say that supplements can be a contributor to good health
  • 5. Guidelines Overview of the dietary supplement guidelines for manufacturers  Proper labels should be affixed to dietary supplements  The manufacturer should be hiring employees and supervisors that are qualified  Should be a properly built physical manufacturing plant that prevents adulteration during the processes of packaging, manufacturing etc  Equipment should be appropriate for the manufacture of dietary supplements  Batch production master records should be kept  Proper procedures should be in place to ensure quality control  To ensure that proper quality is consistent any holding and the distribution of dietary supplement materials and ingredients should be done in the proper conditions using controlled sanitation, temperature, light and humidity  All product complaints should be recorded and maintained  Records should be maintained for at least one after the date of shelf life or, if the date of distribution is used then, for at least two years after the last batch was delivered
  • 6. Proof FDA will accept exemption petitions from manufacturers from providing identity 100% testing of a supplements ingredients Manufacturer must be able to show that the supplement would still have the indicated dietary ingredient There should be no diminishing in quality control practices by submitting an exemption Medical community wants to see enforcement of regulations and stricter FDA scrutiny
  • 7. 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/