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.


The Purpose of Enteric Coating

New Jersey resident John Botzolakis holds a master’s degree in pharmaceutical sciences and a doctor of philosophy in industrial-physical pharmacy from the University of Maryland, Baltimore. John Botzolakis leverages his education and more than 30 years of experience in the pharmaceutical and nutrition sectors to lead Soma Labs, a developer and manufacturer of nutritional products.

One of the products available through Soma Labs is enteric coated tablets and capsules, which are oral medications or supplements coated with a polymer that minimizes dissolution as the tablet travels through the body to the small intestine. Without enteric coating, the product can prematurely dissolve in the stomach, causing irritation, instability of the active components and/or lower absorption.

Because enteric coating is made to withstand acidic environments and break down only in non-acidic, or alkaline conditions, a tablet or capsule should always be taken whole to maintain efficacy. Crushing the product is not recommended, as it can reduce the strength of a product. Enteric coating is often used in aspirin as well as arthritis medications. In addition, it is used in certain nutritional supplements, such as fish oil, to ease consumption and eliminate aftertaste.

Soma Labs’ Encapsulation Service

John Botzolakis has dedicated more than three decades to the pharmaceutical and nutritional industries, and in that time he has obtained three patents. John Botzolakis also founded Soma Labs in Middlesex, New Jersey, leading the company as president and CEO.

Soma Labs manufactures vitamins, supplements, probiotics, and other specialty products that help consumers maintain healthy lives. In addition, the company offers a variety of contract services, such as tableting and encapsulation.

From immediate to controlled release and enteric coated tablets and capsules, Soma Labs is equipped to develop tablets and capsules in various sizes. To create the nutritional products, Soma Labs uses various types of tablet press and capsule filling machines, producing up to 100,000 units per hour. Change parts of varying sizes allow the company to customize each type of tablet and capsule.

To learn more about the Soma Labs’ services, visit http://www.somalabs.com.