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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

Second Circuit Remands “Whole Grain” Cheez-It Lawsuit

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The United States Court of Appeals for the Second Circuit held that a New York district court erred in ruling that labeling Kellogg’s Cheez-It crackers as “whole grain” was not misleading, despite the fact that the snacks were primarily made from enriched white flour.  Thus, the Second Circuit vacated the decision and remanded the case … Continue Reading

Mixed Reactions to Final Rule on School Meal Flexibilities

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As previously posted on this blog on November 30, 2017, the U.S. Department of Agriculture (USDA) announced temporary exemptions to some of the rigid nutrition standards for school meals established by the Healthy, Hunger-Free Kids Act in 2010 and published an interim final rule, titled the “School Meal Flexibility Rule,” that would make some of … Continue Reading

U.S. Department of Justice Sides with California Against States Opposing Egg Production Standards That Require Room for Chickens to Move

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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 … 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

EFSA Releases Evaluation of Cyanide Risk from Foods

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The European Food Safety Authority’s (EFSA) Panel on Contaminants in the Food Chain (CONTAM) has opened a public consultation into a draft opinion on the health risks of cyanogenic glycosides in foods other than raw apricot kernels. Cyanogenic glycosides contain chemically bound cyanide and are present in foods such as apricot kernels, almonds, linseed, or … 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

California Proposes Amendments to Proposition 65 Regulation on the Responsibility to Provide Consumer Product Warnings

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In response to confusion regarding Section 25600.2 of the new Article 6 warning regulations, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify how a product manufacturer—and other parties that may receive the products before the retailer—can pass warning information (and the responsibility to warn) along the supply chain and ultimately … 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 Action Against Dietary Supplements Containing Tianeptine Signals Renewed Focus on Protecting Consumers from Dietary Supplements with Unauthorized Drug Claims

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  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 … 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

CDC Issues Update on Multistate Salmonella Outbreak Linked to Raw Turkey

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An outbreak of Salmonella Reading linked to raw turkey that began in November 2017 continues to sicken Americans in 35 states.  Raw turkey pieces, ground turkey, whole turkey, and turkey pet food have been linked to illnesses in humans. A total of 164 people have been infected, 47% of whom have been hospitalized.  There has … 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

Stakeholder Comments Reflect Discontent with FDA’s Draft Guidance for Quantitative Labeling of Supplements Containing Live Microbials

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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 … 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
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