FDA Targets Hangover Products in Warning Letters

FDA Targets Hangover Products in Warning Letters

In warning letters to several companies, FDA  announced targeting products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers. These products are unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act...
Ensure Use of Legal Ingredients in Sports Products

Ensure Use of Legal Ingredients in Sports Products

The Food and Drug Administration (FDA) is particular when it comes to body building products and any dietary supplements that are mislabeled or misbranded, as evident from their many warning letters and enforcement actions to companies out of compliance. Regulators...
Oleandrin Not Classified as Supplement per FDA

Oleandrin Not Classified as Supplement per FDA

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...
Supply Chain Transparency is Not Optional

Supply Chain Transparency is Not Optional

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...
What Makes Non-Compliance a Big Threat?

What Makes Non-Compliance a Big Threat?

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...