Non-Compliance is the biggest threat to growth of the Pharmaceutical and Nutraceutical industry today. The number of warning letters issued by the Food & Drug Administration (FDA) has increased drastically since 2016. The cost of a single non-compliance event is...
Nutraceutical manufacturers occupy a unique space in between consumer product and consumables regulations. The intended use of such items is similar to what would legally be considered drugs under the Food Drug and Cosmetics Act (FD&C Act), but dietary supplement...
The FDA has issued warning letters on SARMs in dietary supplements. FDA has cautioned products containing Selective Androgen Receptor Modulators (SARMs) are unapproved drugs the agency has not reviewed for safety and effectiveness. Recent warning letters show FDA is...
Products classified as drugs require to disclose all potential side effects to consumers and must get FDA approval before going to the market. Here we briefly go through drugs vs cosmetics. These products are also required to prove their safety and effectiveness. Any...
The Food and Drug Administration (FDA) is using all available tools at its disposal to crack down on dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers. These actions are being taken...
The Nutraceutical industry has found it self under serious scrutiny within the last few years. There is a new story almost every other week, shining the spotlight on a once trusted supplement brand. A brand that has been featuring products that have failed to meet...
