With an increased number of people focused on living a healthy lifestyle and struggling to fulfill their nutrient requirements due to hectic work schedules, the demand for dietary supplements has substantially increased in recent years.
The global dietary supplement market was valued at 140 billion in 2020, with an expected compound annual growth rate of 8.6% in the next ten years. Much of this growth is attributed to the fact that supplements can got to market with any premarket approval from the Federal Drug Administration (FDA), since supplement are regulated as food, not as a pharmaceutical drug.
What Is GMP/CGMP?
Although supplements are not held to the same standards as pharmaceuticals, they are still governed by hundreds of federal regulations. All manufacturing facilities must follow what’s called Good Manufacturing Practices (GMPs), also recognized as CGMP or Current Good Manufacturing Practices, which are established, maintained, and updated by the FDA.
CGMPs provide systems for supplement manufacturers that assure proper design, monitoring, and control of manufacturing processes and facilities. These processes ensure the identity, strength, quality, purity, and composition of products by requiring adequately controlled manufacturing environments. These regulations help prevent instances of contamination, ingredient deviation, and any potential errors, to assure products meet their quality standards with a consistent and safe production environment.
What Does CGMP Mean For Supplements?
Supplements or nutraceuticals manufacturers are audited 1-2 times per year by a third party organization, to ensure they are complaint with FDA standards and manufacturing practices. Auditors inspect facilities for systems testing product purity and quality, specifications for finished products, cleanliness of facilities, laboratory controls, proper and accurate documentation, equipment control and operational deviations.
While the FDA requires all manufacturers to adhere to GMP regulations, not all supplement manufacturers are GMP certified. Manufacturers must go through a comprehensive audit conducted by a third-party organization (usually NSF) and disclose manufacturing records, processes and procedures, product complains procedures, and quality control protocols. If the manufacturer passes the audit and inspection, they will be a granted an NSF GMP certification, and be subject to routine audits throughout the year, in order to maintain that certification.
How Do You Know If A Supplement Is Manufactured in a Certified GMP Facility?
The FDA does not issue cGMP certifications or seals, and displaying one on a products packaging, is illegal. If a product is manufactured in a certified GMP facility, products can disclose that information, however they cannot display a seal, since the FDA does not issue certifications. This can be extremely misleading consumers. Third party organizations such as NSF must conduct an audit before a supplement manufacturer can become GMP certified and certification only pertains to the facility in which the product is manufactured, not the product itself.
NSF does offer additional testing, inspections and certification services, if a supplement brand wishes to use an NSF Certified For Sport Seal on their products. Inspections are conducted before, during, and after every new product batch is created. In order to qualify, product orders must meet minimum order quantity requirements, which can cost thousands of dollars in added costs and fees.
Example Of The Correct Labeling Process For GMP Certified Products
Below is the back panel, for Swolverine's product Clean Carbs. Here you can clearly see, the label complies with FDA regulations by stating that the product has been sourced and manufactured in GMP certified facility, as opposed to using a seal, which implies a certification.
Example Of The Incorrect Labeling Process For GMP Certified Products
Now that you know what to look for to ensure a product is manufactured in a GMP certified facility, below is a label used from FNX Fit, which shows a GMP seal, which can mislead consumers into thinking, this specific product is GMP certified. This seal also, does not indicate the product is made in a GMP certified facility, only that the facility follows GMP standards. This product also states the facts, under nutrition facts, which is also correct, since this is a dietary supplement not a food product.
GMP Certified Supplements: Takeaway
When you’re looking for a high-quality supplement brand, make sure their manufacturing facilities are GMP certified. Just because a supplement manufacturer follows GMP regulations, does not mean they are GMP certified. If a supplement brand does not disclose whether its products are made in a certified GMP facility, then ask. All Swolverine products are made in a certified GMP facility that comply with FDA standards and best practices.
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We believe that everyone can optimize not only their athletic performance but their human potential. The way we believe we can optimize performance is through transparency, clinically effective doses, and clinically proven ingredients with evidence-based outcomes. We provide the nutrients you need to power your active lifestyle.
