In the US, the FDA regulate the manufacturing of vitamin supplements and require they are manufactured following Good Manufacturing Practices (GMPs). The Food and Drug Administration passed these regulations in 2007 and they took effect over the next three years. Now vitamin manufacturers who are found to be out of GMP compliance may face seizure or other regulatory actions.

The FDA defines a dietary supplement as any ingested product intended to supplement the diet and marketed under the food law. The supplement contains a dietary ingredient which includes minerals, vitamins, herbs and botanicals, amino acids, enzymes, glandular, organ tissues and metabolites. Dietary ingredients may also be extracts or concentrates found in many forms such as tablets, soft gels, liquids, capsules, gelcaps or powders.

The FDA groups vitamin supplements under the category of foods and not drugs. Whereas pharmaceutical companies may require several FDA approvals before introducing any drug into the market, dietary supplements do not need any such approvals. However, manufacturers or distributors of health supplements are required to send a notification to the FDA informing them that the supplement in safe to be ingested. There is a stipulated 75-day gap, after filing this notification, within which the FDA does not allow them to distribute or sell their products. During this period, FDA reviews the claims on safety and adequacy of the product.

The cGMP regulations cover the manufacturing, packaging, labeling and storage procedures of these vitamins and dietary supplements. It also covers the requirements of construction and design of manufacturing plants, quality control, testing of ingredients used and final products, written procedures for every level, maintenance of records and handling of the complaint cycle.

These regulations spell out the responsibilities that manufacturers have about making a claim or representation about the products\’ authenticity. Undertaking these manufacturing practices ensures that safe dietary supplements are being put on the market.

References:

http://helpguide.org/life/supplements_dietary_nutritional_herbal.htm

http://www.livestrong.com/article/279478-fda-requirements-for-vitamins/

http://www.sharecare.com/question/is-there-regulating-agency-vitamins-minerals-herbs

http://www.instantgmp.com/DS/Dietary-Supplements-Resource-Page

Look for more articles like this one by searching for \”InstantGMP Compliance Series\”.

Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com, designed this electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com, an electronic batch record system for cGMP manufacturing. These make staying in compliance easy

Author Bio: Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Wellness, Fitness and Diet
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record