FDA’s thinking on GMPs

A significant portion of the dietary supplement distributor community engaged in own-label sales utilize contract manufacturers to source ingredients, craft products and manufacture them to agreed-upon specifications. The reality is that the heavy lifting of qualifying materials and vendors is a shared responsibility between these distributors and the producers, and failure to adequately comprehend the cGMPs (current good manufacturing procedures) embodied in federal law can lead to unfortunate, embarrassing and expensive outcomes.

Ignorance of the law is no excuse. This is manifestly true in the context of reading warning letters or copies of form 483 observations requesting voluntary actions required by FDA to remedy either product or process deficiencies observed during an inspection of facilities and products.

In 2010, FDA issued a comprehensive dossier titled, “Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide.” A critical preamble in this document suggests that the guidance represents FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Companies are free to use alternative approaches, if the approaches satisfy the requirements of the applicable statutes and regulations. Companies have often attempted to perform cGMP functions with minimal adherence to the statutory framework, only to be discovered as willfully cutting corners.

The statute governing cGMP compliance covers the scope and nature of the written procedures required by this rule. Sections deal with the nature and content of the written records required in addition to addressing concerns about training and recurrent training of personnel, evaluation of physical plant and ground status and maintenance, and the type of equipment and utensils that are suitable for deployment.

Get more information on contract manufacturing for supplements in INSIDER’s Digital Magazine.

Mark A. LeDoux is founder, chairman and chief executive officer of Natural Alternatives International Inc. (NAI) an organization established in 1980 with facilities in the United States and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. LeDoux has been a proud member since 1980 of the Natural Products Association (NPA) based in Washington, currently serving as chairman of its Board of Directors. He is former chairman and current board member of the Council for Responsible Nutrition (CRN) based in Washington and was founding chairman of CRN-International based in Switzerland, serving currently on its board of directors. LeDoux also serves on the Nutrition Industry Association–West board of directors and is a recognized participant of the Codex Alimentarius Commission, the United Nations’ food and dietary supplement standard-setting body under joint supervision of its Food and Agriculture Organization and World Health Organization.