In response to the ever growing and changing world of dietary supplements, the FDA drafted a set of standards known as the Current Good Manufacturing Practices (CGMPs) for dietary supplements, which identifies the minimum requirements needed to ensure the identity, purity, strength and composition of all products and product components. The rules apply to anyone who manufactures, packages, labels, holds, imports or sells in bulk these items. Although effective in September, the CGMPs do not have to be implemented until June 2008 by large companies, June 2009 by moderately-sized organizations and June 2010 by small companies. Despite this time-delay, it is important that you, as a dietary-supplement consumer, are aware of the standards, as they were constructed for your protection and wellbeing.
Under the CGMPs, all companies must adhere to strict specifications regarding the personnel, plant, grounds and equipment used in processing. For example, all water involved must meet the EPA’s standards for drinking, and the grounds, including those that border a plant’s boundaries, must be maintained so as to eliminate the possibility of contamination. If the outlying areas are not well-kept, it falls to the supplement manufacturer/packager/labeler, regardless of land ownership, to rectify the fault. Further guidelines clarify necessary employee training, utensil calibration, building design and required documentation. Failure to comply with any of these rules will result in a failed inspection.
As far as production, each company is expected to consistently and reliably create what is intended. To do this, individual organizations must specify each point in production where control is necessary. This would include identifying all components, process steps and labels. The desired end result should be clearly detailed as should any received products. Appropriate testing must be done to ensure that every ingredient and product meets its claims and is safe for the consumer. An analysis certification or petition for exemption may be obtained to bypass this testing; however, both must coincide with the FDA’s approved methods of verification.
Once produced, the manufacturer must reserve a small sample of every item, which is to be stored as the item’s label instructs. The sample as well as written records, detailing every step in production, testing and distribution must be kept for at least one year past the shelf-life date or two years after the final shipping of the product’s last batch. This information must be available, upon request, for the FDA’s review. Such documentation will enable quality control.
The standards laid out by the CGMPs are minimum requirements. Individual organizations must comply with these rules but are not limited to them. Any safety regulations beyond these measures are to be done at the company’s discretion and can only better already carefully monitored practices. It is important to note, however, that the CGMPs do not address a supplement’s efficacy, merely the way in which it is manufactured.
For more information on dietary supplements check out the FDA’s overview, and for a more thorough description of the CGMPs, watch this video, which includes a summary of the standard’s 16 subparts as well as a question-and-answer section.