FOOD SUPPLEMENT AUTHORIZATION in THE USA

In the United States, the regulation of food supplements operates differently from the system in Turkey. In the US, food supplements are regulated by the Food and Drug Administration (FDA), but they do not undergo the same rigorous approval process as drugs.

DSHEA (Dietary Supplement Health and Education Act of 1994):

The Dietary Supplement Health and Education Act of 1994 (DSHEA), which came into effect in 1994, defined dietary supplements as a separate category and granted the FDA regulatory authority. According to this law:

• Dietary supplements are considered foods, not drugs.

• Manufacturers are not required to obtain FDA approval before marketing their products.

• Manufacturers are responsible for ensuring that their products are safe and that the label information is accurate and not misleading.

• The FDA monitors the safety of products after they are marketed and intervenes when deemed necessary.
  
  

The Role of the FDA:

The FDA has the following authority regarding dietary supplements:

• Safety Monitoring: The FDA monitors the safety of dietary supplements on the market and can remove products from the market if serious side effects or health risks are identified.

• Labeling Inspection: The FDA conducts inspections to ensure that dietary supplement labels are accurate and not misleading. Labels must include the product's contents, instructions for use, and any necessary warnings.

• Good Manufacturing Practices (GMP): The FDA establishes GMP regulations for dietary supplements and inspects manufacturers to ensure compliance. GMPs ensure that products are consistently produced and controlled according to quality standards.

• Regulation of Health Claims: Dietary supplements cannot claim to treat, cure, or prevent diseases. However, they can make structure/function claims (for example, "calcium supports bone health"). These claims must be scientifically substantiated and not misleading.

Notification for New Dietary Ingredients (NDI):

For products containing a new dietary ingredient (NDI) that was not marketed in the US before October 15, 1994, manufacturers must notify the FDA at least 75 days in advance. This notification must include evidence demonstrating that the new ingredient is reasonably expected to be safe. However, this is not an approval process, and the FDA may "not accept" the notification (more accurately, may object to the notification).

Manufacturer Responsibilities:

• Safety: Manufacturers are responsible for ensuring that their products are safe and that label information is accurate and not misleading.

• GMP Compliance: Manufacturers must comply with Good Manufacturing Practices (GMP) established by the FDA.

• NDI Notification (when required): Notification to the FDA must be made for new dietary ingredients.

• Record Keeping: Manufacturers must maintain records related to production, testing, and distribution processes.

• Serious Adverse Event Reporting: Manufacturers are obligated to report serious adverse events associated with their products to the FDA.