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.
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 aren't 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 supplement's 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
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