Federal investigators seized more than $1 million in strength-training supplements from LG Sciences in Brighton, Mich., on April 2 after the firm failed to respond to FDA's warnings about the use of adulterated ingredients in the products, the agency says. FDA asked the U.S. Marshalls Service and the U.S. Attorney's Office in the Eastern District of Michigan to seize the Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL products from LG Sciences, according to an April 4 release. The firm's products, which were cited in a March 2006 warning letter from the agency, allegedly contain one or more unapproved food additives or new dietary ingredients that lack adequate evidence to show they are safe, FDA says. LG Sciences legal representative, Ronald Berry, said the products' ingredients are "perfectly" compliant with the Dietary Supplement Health and Education Act. Berry added the products' seizure "makes no determination of liability or the correction of [FDA's] allegations"....
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.
As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.
