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…again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. A food would be misbranded unless its principal display panel bears “summary nutrition information that…
Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given…
…Issue, and a Possible Solution” We described the “Real Evergreening Issue” alluded to in the title of the post as follows: [T]here may be a real evergreening issue that’s probably…
…the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to issue this rule, the rule implements the Sanitary Food Transportation Act of 2005 (SFTA)….
…marketing. One point to bear in mind if you attempt to Google-search for the new database: an older and far more limited NIH database of dietary supplement labels remains online. …
…level, and found incorrect identification of fish species 15% of the time. Almost all mislabeling occurred in the snapper and grouper categories. It remains to be seen whether the educational…
…of duty. This is important information for every drug maker and its quality teams. Clinical Trials. We’ve recently discussed FDA’s clinical trial oversight, and OC didn’t miss the chance to…
…Facebook. It would not be surprising, however, to see even greater enforcement focus on privacy, data security, and online marketing matters during Ms. Rich’s tenure. There could also be more…
…ads. Additional consumer education materials The FTC has also created a website advertising a fake weight loss product called “FatFoe.” FatFoe is not a real weight loss product. The ad…
…Caffeine Effects on the Cardiovascular System Caffeine effects on the central nervous system and behavioral effects associated with caffeine consumption Other compounds impacting caffeine effects In a concurrently issued press…
…the Court already enjoined.” Zogenix also alleged that the regulations violate the Contract Clause and the Commerce Clause of the U.S. Constitution, as well as the Equal Protection Clause “by…
…would not apply to non restricted medical devices (i.e., almost all Class I and Class II devices). It may be that FDA would disagree with this analysis. Rather than allowing…
…From a field of more than 2,000 potential nominees, FDA Law Blog has received enough nominations to join the 250 legal blogs participating in one of the largest competitions for…
…to this global problem. The IOM also recommends creation of a centralized public database of suspended and revoked wholesale pharmaceutical licenses. The report recommends that FDA create this national database…
…of any Federal law as a controlled substance in Schedule I.”)) Schedule I substances have a high potential for abuse, have no currently accepted medical use in treatment in the…