It’s no secret that many supplements are not highly regulated. Consumers need to take it upon themselves to understand what supplements can and can’t do and be savvy about what claims supplement companies put forth about their products. One way to discern a supplement of quality is the USP verified mark.
What is USP and what does it mean?
In 2007, the FDA issued its final guidance on Current Good Manufacturing Practices (cGMPs) for dietary supplements.1 Under the cGMPs, manufacturers are required to establish their own quality standards for manufacturing processes, packaging, storage, and ingredient testing, and must properly document that these standards are being met. USP stands for “United States Pharmacopeial Convention”. The U.S. Pharmacopeial Convention (USP) is a private, nonprofit body of 300 delegates representing state and national associations and colleges of medicine, nursing, and pharmacy; industry; and agencies of the federal government. Their mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
Why is cGMP important?
Per the Journal of Developing Drugs, “cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.” The FDA goes on to state, “cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.”
How cGMPs help consumers
CGMP helps protect consumers of drugs and supplements to assure quality. A supplement that has cGMP shows that the products are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products.
When looking for supplements, look for the cGMP logo
High-quality supplements such as Future Pharm clearly show the cGMP label on their products and on their website. If a company is not complying with cGMP regulations, any supplement or drug it makes is considered “adulterated” under the law. This kind of adulteration means that the product was not manufactured under conditions that comply with cGMP. It does not mean that there is necessarily something wrong with the product. However, it’s always best to look for cGMP on any supplement your purchase.
If you’re looking for a quality supplement, follow these guidelines to ensure you’re getting a high caliber supplement. Don’t settle for anything less!