FDA’s Office of Dietary Supplement Programs has responded to a new dietary ingredient notification regarding an ingredient called Oleandrin, the subject of several news stories in the mainstream media and trade press in recent weeks. A biotech company in Texas...
Brand owners working with contract manufacturers must prioritize supply chain transparency in order to meet all the regulatory obligations. This includes brand owners knowing specifications for their product testing, stability and ingredients. Also a contact...
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...
