FDA Stipulations on Dietary Products

The owner of three patents related to the field of pharmaceuticals and nutrition, John Botzolakis, PhD, leads Soma Labs, Inc., as president and chief executive officer. John Botzolakis has dedicated 17 years to the vitamins-and-supplements company, during which he implemented a quality control program that meets Food and Drug Administration (FDA) regulations.

To protect the well-being of consumers, the FDA requires companies manufacturing and distributing dietary products, such as vitamins and minerals, to adhere to the following stipulations.

Label supplements accurately. Companies must ensure the quality and purity of a product as outlined in FDA’s Current Good Manufacturing Practice (CGMP). Labels must truthfully represent the product. Supplemental literature, including package inserts, may be used to provide other vital information.

Submit adverse event reports. Whether it is the manufacturer, packer, or distributor, the company that appears on the label is required to notify the FDA any time an adverse event occurs.

Notify use of new dietary ingredients. A manufacturer or distributor may only market a supplement containing a new dietary ingredient if there is reasonable evidence indicating safer consumption with the additional element, according to the Federal Food, Drug, and Cosmetic Act. As such, inclusion of new ingredients must be approved by the FDA.

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