The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]
In their settlement with Dannon over claims on DanActive and Activia, the FTC again evoked its standard of “two well-control clinical trials” to support structure function claims. This standard was previously applied to Nestlé’s Boost® Kids Essentials drink and POM Wonderful Pomegranate Juice (POM is [...]
Once again I’d like to share information about FDA’s recent warning letters. This time, several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling. The first involves the use [...]