Lisa Alsobrook

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  As covered on this blog, FDA has worked to strengthen the recall process for food, drugs, medical devices, and cosmetics in response to a report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s recall process can be too slow and puts consumers at risk.  21 CFR Part 7, Subpart C provides guidance on policy, procedures, and industry responsibilities for recalls (including product…
  As previously covered on this blog, the City of San Francisco passed legislation in June 2015 that required health warnings to be placed on advertising for sugar-sweetened beverages (i.e., nonalcoholic beverages with caloric sweeteners that contain more than 25 calories per 12 oz.). Specifically, the warning would have read: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San…
  FDA and USDA employees furloughed during the 35-day partial government shutdown have returned to work this morning after the President signed legislation on Friday to temporarily reopen the government for 3 weeks.  While this is very good news, it will take some time before all activities are running smoothly again. FDA Commissioner Dr. Scott Gottlieb’s recent tweets on starting back suggest that much of today will be spent on administrative issues. We expect that government…
E. coli O157:H7 and other enterohemorrhagic E. coli (EHEC) typically cause acute bloody diarrhea, which can be severe and may lead to hemolytic uretic syndrome (HUS), a type of kidney failure that can be fatal.  Exposure to E. coli O157:H7 most often occurs through consumption of undercooked ground beef or raw vegetables including, as reported here, the Romaine lettuce that was linked to a multistate outbreak last year. Although E. coli are sensitive to most commonly…
  Whole genome sequencing (WGS) determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process.  A comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.  The analytical tools for WGS have become increasingly accurate, easy, and affordable such that health agencies have moved to…
As reported here, Missouri and twelve other states asked the U.S. Supreme Court on December 4, 2018 to hear their challenge to provisions of the California Prevention of Farm Animal Cruelty Act that require any eggs sold in the state to come from hens that have space to stretch out in their cages. The plaintiffs allege that California’s egg law violates the U.S. Constitution’s Commerce Clause and is preempted by the Egg Products Inspection…
  The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements.  DSHEA established a new category of permitted claims for dietary supplements called “statements of nutritional support.”  Claims of mitigating or treating a disease, however, are “drug claims” and are not permitted on products marketed as dietary supplements.  As reported on this blog, FDA has recently stepped up enforcement action…
As previously reported on this blog, the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have both claimed regulatory oversight of cell-cultured meat, a product that some say could be available for marketing in as early as three years.  Federal law grants regulatory authority over meat products, poultry, catfish, and egg products to USDA.  FDA has regulatory authority over all other food in interstate commerce.  Jurisdictional issues impact cell-cultured…
FDA’s regulation on nutrition labeling of dietary supplements requires that dietary ingredients for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has not been established must be listed inside the Supplement Facts label along with their quantitative amount by weight per serving in metric units, as described in 21 CFR 101.36(b)(3).  For microbial ingredients in probiotic products, the weight of the cellular mass (which can include dead and injured cells) does not…
  In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and also updating regulations on serving sizes to – among other things – provide realistic Reference Amounts Customarily Consumed (RACCs).  Detailed summaries of both rules may be found here. Today, FDA announced a final guidance, titled ‘‘Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of…