A dietary supplement is a product containing a dietary ingredient intended to add nutritional value to the consumer. Dietary ingredients often include essential vitamins or minerals necessary for a balanced human diet.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA regulates both finished dietary supplement products and dietary ingredients. Dietary supplements are governed by a distinct set of regulations, separate from those that apply to "conventional" foods and drug products.

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Services offered by Prologos Law:

• FDA Administrative Proceedings

• Form 483, Warning Letters and Consent Decree

• Action Indicated Notices

• US Customs Product Entry

• Product Exports

• Regulatory Strategy

• Supplement Safety Audits

• Marketing Materials Review

• Training

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