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The U. S. Food & Drug Administration (FDA) is the federal agency responsible for regulating the manufacturing process of food, drug, cosmetic, and dietary supplements. In order to help regulate the supplement industry, the FDA has established a set of guidelines called "Good Manufacturing Practices (GMP)" for manufacturing, packaging, holding, and labeling dietary supplements. These guidelines or practices can be found in the Code of Federal Regulations Title 21 part 111, often referred to as 21 CFR.
Additionally, the 1994 Dietary Supplement Health and Education Act (DSHEA) regulates dietary supplements more like food than drugs. According to DSHEA, all supplement manufacturers are personally responsible for the purity and safety of supplement ingredients and that claims made on packaging (or in advertising) are substantiated by adequate scientific evidence.
To enforce GMP regulations, the FDA monitors:
When problems are detected with a dietary supplement, the FDA investigates with facility audits and third-party laboratory analysis.
It is important to note that although the FDA enforces GMP from time to time when problems arise, the FDA does not administer a certification program to ensure manufacturers are complying with GMP at all times.
Since there is no FDA GMP certification or accreditation program to acknowledge GMP compliance, how can you know if Primal Pharm or any other supplement manufacturer is in compliance for the purity, quality, and safety of their products?
To put our customer's minds at ease, Primal Pharm has partnered NSF International (the gold standard in GMP certification and customer safety) for supplement manufactures to inspect our manufacturing facilities and products to ensure we are in compliance with FDA GMP.
These private companies' certification programs require:
We know customer service is the origin of our success. As such, we happily answer all potential clients' questions and concerns. If we do not manufacture or package what you want, we will gladly refer you to a trusted manufacturer who does. Contact us today.
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