Active ingredients supplier Graminex has received Good Manufacturing Practices (GMP) registration from public health and safety company NSF International, preparing the ground for tougher regulations from the FDA.
The requirements - included in NSF American National Standard 173-Dietary Supplements - are composed of manufacturing facilities audits, quality control procedures, personnel training, cleanliness, equipment maintenance and record keeping. NSF said this week that it will align its GMPs with FDA's GMPs when they are published in the next year or two.
"NSF GMP Registration comes at a critical time as it confirms Graminex is well prepared for FDA's GMPs," said Kathleen Pompliano, manager, dietary supplements program.
In July the federal government proposed the first manufacturing standards for dietary supplements. The FDA does not require supplement-makers to prove that their products are safe or effective, as it does for prescription drugs, and the new rules will not change that.
But supplement-makers will have to list their ingredients, ensuring they are not adulterated with contaminants or impurities and that the dosages promised on the label are indeed correct. They also must be labeled accurately to reflect active and other ingredients.
Located in Deshler, Ohio, Graminex supplies bulk ingredients to the pharmaceutical and nutraceutical industries and markets its own line of dietary supplements, mainly focusing in the area of prostate care & support and immune system support.