New Fda Regulations Ensure Neutraceutical Product Quality

In the past three decades there has been increased interest in the role of diet to

overall health with the recognition that specific nutrients and supplements have value to both the prevention and treatment of disease. In the 1989, Dr. Stephen DeFelice coined the term nutraceutical to define a product purified from food that is demonstrated to provide protection from disease or have a medical or health benefit. This would include such supplements as folic acid that is used to prevent neural defects in a developing fetus and antioxidants to neutralize free radicals associated with a number of diseases such as heart disease, cancer, and premature aging.

These dietary supplements are widely used in the United States with an estimated 55 percent of adults taking some nutraceutical product at any given time. Most who take supplements report feeling better with an increased sense of well being. Many take supplements to prevent illness and to live longer. Others use the products to build muscle and increase strength and/or for weigh management. Others take specific supplements upon the advice of their doctors. The majority of those taking supplements report benefits that are not offered by conventional drugs with the added benefit of being free of as many side effects.

Neutraceutical compounds are now subject to increased FDA regulatory control. The 1994 Dietary Supplement Health and Education Act (DSHEA) places the manufacturing and labeling of dietary supplements under the control of the FDA for industry regulation. Additionally, as of June, 2010, all neutraceutical manufacturing companies must be in compliance with the current Good Manufacturing Practices (cGMPs) required of pharmaceutical manufacturers. This requires that specifications are set for limits on contaminants, including solvent residues, heavy metals, and microorganisms in the products.

HPLC (high performance liquid chromatography) method development and validation ensures the quality and safety of raw materials and purity of finished neutraceutical products. This is the most efficient analytical method of botanical agents to meet US Pharmacopoeia (USP) verifications for quality assurance that the dietary supplements provide the biological activities and concentrations claimed. Under the USP Verification Program, ingredients are tested and confirmed for consistency with each batch meeting the specifications for purity, strength, and quality, independent of claims from raw material suppliers. The finished products are in compliance with accepted manufacturing processes and meet the requirements for acceptable limits of contaminants.

The new FDA legislation has specific requirements for laboratory facilities to perform the necessary tests for compliance to assure the specifications are met at all steps in the manufacturing process of neutraceutical products. With the tremendous growth of the industry, there is increased demand for expert method development strategies to increase the growth potential of the industry while meeting compliance standards for the trust and safety of consumers.

by: Art Gib

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