Manufacturer Compliance for Dietary Supplements

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					Manufacturer Compliance for Dietary Supplements

Dietary supplements include botanicals, minerals, amino acids, vitamins, and minerals - and
the U.S. Food and Drug Administration (FDA) has started looking at the supplements'
market closely for compliance and safety issues. Of primary concern is the safety of
consumers, making sure they are safeguarded from those dietary supplements that are not
actually as safe as being projected by the manufacturers.

Dietary supplements must follow new FDA guidelines to ensure that they are reasonably
safe to take and that manufacturers are not making any false health or medical claims
regarding their use. Acceptable methods of proof include scientific data based on
experiments, trials conducted on animals or humans, or data from foreign countries that
have significantly tested the specific products.

The current good manufacturing practices (CGMP) Final Rule issued by the U.S. Food and
Drug Administration (FDA) states that dietary supplements should be manufactured with
strict and consistent quality controls. It is no longer legal for manufacturers or providers to
state claims that specific supplements should be used medicinally in the treatment of any
health or medical issue or condition. However, saying that a particular supplement
contributes to overall good health is allowed.

Manufacturers must adhere to the following guidelines, though keep in mind that the
medical community believes these are not adequate and stricter standards should be set.

All dietary supplements should be labeled properly.
Only qualified supervisors and employees should be employed.
The manufacturing physical plant must be built properly and should function to prevent any
adulteration during manufacture, packaging, etc.
Equipment should be appropriate for the manufacture of dietary supplements.
There should be master records for batch production.
There should be proper procedures for ensuring quality control.
The holding and distribution of ingredients and materials used in the manufacture of dietary
supplements should be in proper conditions with controlled temperature, light, humidity, and
sanitation to ensure proper quality.
Records should be maintained for every single product complaint.
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.

Manufacturers may petition the FDA for exemption from the need to provide 100 percent
identity testing of ingredients used in the manufacture of a dietary supplement. But, the
manufacture must provide data to show that the exemption would not diminish quality
control and the correct dietary ingredient would continue to be used in the manufacture of
the supplement.

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