Tag Archives: FDA

FDA Resumes Inspections of High-Risk Food Facilities

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As previously reported on this blog, the partial federal government shutdown stalled FDA’s ability to conduct routine inspections of domestic food facilities.  However, as of January 15, FDA resumed inspections of food facilities that produce high risk foods, such as cheeses, other dairy products, seafood, produce, and infant formula, which had been stopped as a result of … Continue Reading

Nebraska Bill Defines Meat as Derived from Livestock or Poultry

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Introduced January 10, 2019, Nebraska Legislative Bill 14 would prohibit “misrepresenting a product as meat that is not derived from livestock or poultry.” The bill, which was referred to the Agriculture Committee on January 14, was introduced by Sen. Carol Blood. “I’m not bringing this bill to tell people what they can and can’t eat. All … Continue Reading

CDC Declares End to Latest E. Coli Outbreak Linked to Romaine

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As previously reported on this blog, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce. This latest outbreak, which began in the Fall 2018, is not related to the E.coli outbreak … Continue Reading

Lapse in Government Funding Continues to Affect FDA, USDA

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As previously covered on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. As of the time of this blog’s publication, the government has … Continue Reading

Amongst FDA SOI Conversation, Ninth Circuit Agrees Consumers Are Not Misled by Plant-Based Milks

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The Ninth Circuit upheld the dismissal of a proposed class action that alleged Almond Breeze almond milk is mislabeled and instead should be labeled as “imitation milk.”  Plaintiff Cynthia Painter focused on the nutritional differences between almond milk and 2% dairy milk and argued that the plant-based milk lacked the essential nutrients that are inherent … Continue Reading

FDA, USDA Impacted by Lapse in Government Funding

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As of the time of this blog’s publication, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact departments and agencies across the federal government. Both the U.S. Department of Agriculture and the U.S. Food and Drug Administration are directly … Continue Reading

In Light of 2018 Farm Bill, FDA Issues Statement on Use of CBD in Food; Completes Evaluation of 3 Hemp-Related GRASNs

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The Agriculture Improvement Act (also known as “the 2018 Farm Bill”) was signed into law on December 20, 2018.  Among other things, the law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on … Continue Reading

FDA Issues Technical Amendments to Final Nutrition and Supplement Facts Rule

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FDA will publish in the December 21, 2018 Federal Register a final rule that makes technical amendments to its 2016 final rule on Nutrition and Supplement Facts labeling.  The amendments, which are not substantive in nature, affect both 21 C.F.R. 101.9 (“Nutrition labeling of food”) and 21 C.F.R. 101.36 (“Nutrition labeling of dietary supplements”). While … Continue Reading

FDA and CDC Identify One Source of E. Coli Contaminated Romaine

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As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, … Continue Reading

Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD

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Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status of cannabidiol (CBD) in foods.  However, the relevant provisions under Subtitle G (“Hemp Production”) affect only the Drug Enforcement Administration’s (DEA’s) authority over hemp farming and allow states to … Continue Reading

FDA Develops Educational Module on Menu Labeling

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The U.S. Food and Drug Administration (FDA) announced the availability of an online educational and training module that explains the types of establishments and foods that are covered by the menu labeling regulations. The Agency also recently published two fact sheets for industry on menu labeling and declaring calories. By way of background, FDA issued … Continue Reading

FDA Finds High Levels of Heavy Metals in Kratom Products

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In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, … Continue Reading

Multistate E. Coli Outbreak Linked to Romaine Lettuce Grown in California

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As we reported on this blog last week, FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, were investigating a multistate outbreak of E. coli O157:H7 illnesses that was likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and … Continue Reading

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

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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

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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

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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

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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

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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

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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

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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

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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
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