Tag Archives: FDA

FDA and CDC Investigate Multistate E. coli Outbreak Linked to Romaine

The FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, are investigating a multistate outbreak of E. coli O157:H7 illnesses that are likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or … Continue Reading

FDA Authorizes Qualified Health Claim for Oleic Acid

A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14). A health claim must contain the elements of a substance and a disease or health-related condition. In addition, health claims are limited to claims about disease risk reduction, and cannot be … Continue Reading

Important Details Remain Unsettled Following USDA and FDA Announcement of Decision to Jointly Regulate Cell-Cultured Meat

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 … Continue Reading

FDA Announces New Steps to Protect Youth From Tobacco Harms; National Youth Tobacco Survey Results Released

On November 15, FDA and the Centers for Disease Control (CDC) published the results of the National Youth Tobacco Survey (NYTS).  As summarized in their joint Statement, the “NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”  Results of the survey showed a 78 percent increase from 2017 … Continue Reading

New Report Reveals Sources of Foodborne Illnesses

On November 9, 2018, the Interagency Food Safety Analytics Collaborations (IFSAC) released a report on foodborne illnesses caused by four pathogens. The data in the report, titled, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States,” came from 1,255 foodborne disease … Continue Reading

FDA Announces Meeting to Discuss Eliminating Youth E-Cigarette Use

On September 12, 2018, FDA Commissioner Dr. Scott Gottlieb announced FDA’s Youth Tobacco Prevention Plan in response to the perception that use of e-cigarettes has become an “epidemic”.  Dr. Gottlieb’s concern is based on preliminary data from the National Youth Tobacco Survey, expected out in November, which suggests that the number of high-school-age children reporting … Continue Reading

FDA Releases Initial Findings on Food Safety in Restaurants

According to the Centers for Disease Control and Prevention (CDC), more than half of foodborne illness outbreaks that occur each year are associated with food from restaurants. CDC has identified five major risk factors related to food safety practices within the retail food industry that contribute to foodborne illness: (1) poor personal hygiene; (2) improper … Continue Reading

FDA Publishes Q&A Guidance on Mandatory Food Recalls

The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to … Continue Reading

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

In an October 30 press release, FDA announced their new Plant and Animal Biotechnology Innovation Action Plan in an effort to foster advances in the field as new technologies to edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity, and food security. For example, new forms … Continue Reading

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce tobacco-related disease and death, with particular emphasis on protecting kids from the dangers of nicotine. In order to do so, FDA asserted the critical need to have an efficient regulatory process that puts novel products, … Continue Reading

FDA Issues Draft Guidance on Produce Safety Requirements under FSMA

FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 … Continue Reading

Ostroff Retires as FDA Deputy Commissioner for Foods and Vet Medicine; FDA to Undergo Food Safety Reorganization

As reported by multiple outlets, Stephen Ostroff, FDA’s Deputy Commissioner for Food and Veterinary Medicine, will retire January 5. Ostroff assumed the role of Deputy Commissioner in 2016, previously serving as the acting FDA Commissioner on two occasions. Walmart’s Vice President for Food Safety and Health, Frank Yiannas, is set to replace Ostroff. Yiannas will … Continue Reading

USDA Secretary Signals USDA Role Over Animal Cell Culture Technology Regulation Ahead of Joint USDA-FDA Meeting

As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. The meeting will focus on potential hazards, regulatory … Continue Reading

FDA Removes Clearance for 7 Synthetic Flavoring Substances

As we previously reported on this blog, a group of non-government organizations (NGOs) sued FDA in an effort to compel the Agency to act on a Food Additive Petition (FAP) concerning seven synthetic flavoring food additives. The FAP, which the NGOs submitted to FDA, requested that FDA remove the clearances for these seven synthetically derived … Continue Reading

FDA Issues Policy and Related Draft Guidance on Publicizing List of Retailers in Certain Food Recall Situations

FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.  Historically, the agency has not released … Continue Reading

ITIF Petitions FDA to Prohibit Non-GMO Claims on Food Labels

A citizen petition filed on September 24, 2018 by the Information Technology & Innovation Foundation (ITIF) asked FDA to prohibit “non-GMO” food labeling claims, including the Non-GMO Project butterfly logo and label. ITIF argues in the petition that such claims mislead and deceive consumers about foods, food ingredients, and their characteristics related to health and … Continue Reading

FDA Publishes Goals for Supporting Antimicrobial Stewardship in Veterinary Settings for Fiscal Years 2019-2023

On July 31, 2018, FDA announced that it was working on a five-year blueprint to combat antimicrobial resistance in animals.  On September 14, 2018, FDA published Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023. FDA provides action items to promote three goals; we summarize several major steps for each; Align Antimicrobial Drug … Continue Reading

FDA Commissioner Discusses FDA’s Efforts to Prevent Foodborne Cyclospora Outbreaks

FDA Commissioner Scott Gottlieb has issued a press release in the aftermath of this summer’s Cyclospora (C. cayetanensis) outbreaks in fresh produce, highlighting the Agency’s efforts to prevent outbreaks of this foodborne illlness.  Cyclospora is an intestinal parasite that is spread through contamination of food with human waste. FDA has been surveying the food supply … Continue Reading

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data.  As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

USDA and FDA Announce Joint Meeting on Animal Cell Culture Technology

Yesterday, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. As we previously reported on this blog, FDA held a public meeting on … Continue Reading
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