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…In addition, section 204 authorized FDA to issue a regulation imposing additional recordkeeping requirements on facilities that manufacture, process, pack, or hold foods that FDA designates as “high risk” (such…
…serious injury. On August 15, the congressmen sent a letter to Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (“CDRH”), expressing their concern “about weaknesses in…
…Act Amendments of 1988 defining “medical food” permit certain disease-related claims, there are no such provisions applicable to products intended for animals. However, as FDA explains in a new guidance, under…
…In the preamble, FDA explained its rationale as follows: Under the proposed definition, the importer of an article of food might be, but would not necessarily be, the importer of…
…company at the heart an outbreak of salmonellosis five years ago that was traced to the company’s peanut products. In particular, PCA owner Stewart Parnell was convicted of conspiracy, mail…
By Riëtte van Laack – On December 4, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) added Aloe vera, non-decolorized whole leaf extract and Goldenseal root powder to…
…food manufactured, processed, packed, received, or held by a facility has “a reasonable probability of causing serious adverse health consequences or death to humans,” and “the facility created, caused, or…
…that, among other things, GRAS determinations employ outdated science, are rife with conflicts of interest, and the data supporting GRAS determinations are secret. As we previously reported, in October, 2014…
…Third Circuit interpreted Escobar as requiring specific representations that, in conjunction with the claimant’s purposeful omissions, renders the ensuring claims legally false. 657 F. App’x 89, 94 (3d Cir. 2016)….
…went further, however, and found that, even if the product were compounded, the FDCA would still apply. Being bound by the Medical Center Pharmacy decision in the Fifth Circuit, the…
…2012, some Novo Nordisk representatives failed to comply with the REMS by giving information that the FDA-required message was “erroneous, irrelevant, or unimportant.” Complaint ¶ 24. And after FDA modified…
…Moreover, California recently enacted the California Food Safety Act, prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as…
…the Commission to “conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children,” including with AVA. The Commission is interested in public comment…
By Ricardo Carvajal – In a recently issued guidance document, FDA makes clear that a company with a reportable food located in multiple facilities can submit a single report to…
…possibly disrupt absorption of other minerals, as well as vitamins. The in vivo experiments, which were conducted in chickens, further indicate that chronic exposure can result in remodeling of intestinal…