FDA is applying greater attention to and enforcement of dietary supplement regulations than ever before. This is not unexpected. The course of implementation of the regulations has come in waves of effort as inspections occurred after the finalization of GMPs (good...
As U.S. cases spike back up, hospitals are once again overwhelmed, but this time it’s happening in smaller cities. France has expanded its curfews to cover two-thirds of the population. The Food and Drug Administration said Thursday that it had formally approved...
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...
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...
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...
