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…1207, 116th Gen. Assem., Reg. Sess. (Ind. 2009). The bill would also require such establishments to make available to customers the amount of calories, fat, saturated fat, trans fat, cholesterol, sodium,…
…about animal welfare, environmental effects, and food safety. FDA’s press release attempts to address all of these concerns. With respect to food and feed safety, the approval of ATryn is…
…foods and a reduced risk of coronary heart disease. Before the amendment, food eligible for the health claim had to meet the nutrient content requirements for low saturated fat, low…
…or poultry products. The Petition referenced a study regarding transmission of viruses via food. However, as FSIS noted, the referenced study focused on common foodborne viruses, such as norovirus, which…
…Aug. 1, 2016, FDA extended the compliance date for the type size provision to July 26, 2018 to coincide with the original compliance date for the new nutrition labeling regulations….
…(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or…
By John R. Fleder – On October 2, 2013, HP&M posted the following on this blog: On September 26, 2013, the United States Attorney for the District of Colorado announced…
…in relevant part: An accredited auditor/certification body must immediately notify FDA electronically, in English, when any of its audit agents or the accredited auditor/certification body itself, discovers any condition, found…
…U.S.C. § 1320a-7j. HHS regulations require long-term care facilities to “[s]tore, prepare, distribute, and serve food under sanitary conditions.” 42 C.F.R. § 483.35(i)(2). “Sanitary conditions” is an ambiguous term, and…
On June 26, 2016, NuTek Food Science, LLC (NuTek) petitioned FDA to recognize “potassium salt” as an optional name for potassium chloride. Petitioner claimed (and presented evidence) that consumer acceptance…
…submit key trial documents to the Food and Drug Administration (FDA). This requirement, enacted under section 3601 of Food and Drug Omnibus Reform Act (FDORA), will apply to clinical trials…
…in dietary supplements and foods. Early in October, four of the major trade associations, AHPA, CRN, CHPA and UNPA, seemingly frustrated by the state of affairs, sent a letter urging…
…claims that comply with the proposed rule. However, beginning 75 days from December 8, 2010, FDA will no longer exercise enforcement discretion based on the 2003 letter. Written comments may…
…Food Safety Modernization Act to help ensure the safety of imported seafood. Notably, neither FDA nor GAO address what appears to be a key issue, namely why FDA has approved…
…307) March 31, 2016 Sanitary Transport of Food and Feed (FSMA Section 111) May 31, 2016 Intentional Contamination (FSMA Section 106(b)) Under the terms of the decree, FDA agrees “in…