As a consumer you may already be aware of the regulations involved in producing pharmaceutical drugs, but you should also be aware of changes that the FDA has implemented in the production of dietary supplements. CGMP manufacturing, or Current Good Manufacturing Practices, applies to the regulatory guidelines the FDA has set up to hold manufacturers, both U.S. and foreign, to quality and safety standards in production.
Though vitamins and dietary supplements were once unregulated by the FDA, ruling changes have created a quality assurance norm for many products that you may consume everyday. These changes help to make your dietary supplements safer, but there are still some facts you should be aware of before you buy.
What The FDA Regulates
The Food and Drug Administration controls the manufacturing of your pharmaceuticals and supplements through regulations that establish minimum standards. Minimum standards must be met in the manufacturing facilities, how the drug or supplement is produced, and how pure the end product is before it goes to packaging. In order to regulate manufacturing, drug and supplement producers must show adequate records, pass safety and hygienic inspections, and maintain technology that is current enough to abide by quality standards. If a manufacturing facility doesn't pass inspections, or there are problems with the product being manufactured, the FDA then has the duty to suggest voluntary recalls or ultimately seize production altogether.
What Adulterated Means
In terms of pharmaceuticals and supplements, "adulterated" products are being manufactured in a facility that isn't abiding by FDA guidelines. Though the product may still be pure or have high quality, the labeling is placed to ensure that every consumer is aware of practices that can pose potential dangers from a specific manufacturer. Because court injunctions are required to initiate seizures, adulterated labels are a way for the public to be aware of poor manufacturing processes and hold the facility or manufacturer accountable with voluntary recalls.
The Difference Between Drugs and Supplements
Vitamins and nutritional supplements were once completely unregulated by the FDA, but now they are. However, the difference in how the FDA implements regulations regarding dietary supplements is extreme.
According to Cancer.org, drugs are considered unsafe until proven safe, whereas dietary supplements are considered safe until proven otherwise. The lengthy testing process to bring a drug to manufacturing is non-existent in supplement production and purity standards are not implemented either. A dietary supplement manufacturer can basically bring a product to market and sell it until someone gets sick or complains about side effects. Though supplement manufacturing facilities are regulated by quality standards, there is a less than 100% ruling in place that says a supplement is still effective even if it does not contain the entirety of the stated ingredient.