Tag Archives: FDA

‘Dairy Pride Act’ Introduced Again

As previously reported on this blog, U.S. Senator Tammy Baldwin’s (D-WI) introduction of the Dairy Pride Act  in 2017 was met with controversy. On March 14, 2019, Sen. Baldwin, along with Sens. Jim Risch (R-ID) and Mike Crapo (R-ID), reintroduced The Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake … Continue Reading

FDA Announces New Policies on e-Cigarettes and Cigars to Stem Surge in Youth Smoking

On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored cigars, in an effort to curb youth smoking rates.  The compliance policy permits “deemed” tobacco products on the market when FDA’s Deeming Rule went into effect on August 8, 2016 to remain … Continue Reading

FDA Releases Second Installment of Intentional Adulteration Draft Guidance

FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first installment was published in June 2018, and a third installment is to follow. The second installment outlines two flexible methods for how facilities can conduct vulnerability assessments … Continue Reading

FDA Removes Import Alert for GE Salmon

U.S. Food and Drug Commissioner Scott Gottlieb, M.D., announced on March 8, that the Agency was deactivating a 2016 import alert that prevented genetically engineered (GE) salmon from entering the U.S. By way of background, in 2015, FDA approved a New Animal Drug Application (NADA) related to AquAdvantage Salmon after determining that it met the … Continue Reading

USDA and FDA Provide Additional Details on Joint Regulation of Cell-Cultured Meat

As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) in a November 16, 2018 joint press release, announced an agreement on joint regulation of cell-cultured meat.  Though the framework was not released at the time, the press release indicated that … Continue Reading

FDA Commissioner Scott Gottlieb Resigns

On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House … Continue Reading

This Week’s Cannabis Highlights

As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marihuana”.  The 2018 Farm Bill also assigned responsibility for regulating the manufacture of hemp to the states under plans approved by USDA … Continue Reading

National Milk Producers Federation Petitions FDA on Non-Dairy Alternative Labels

As previously reported on this blog, FDA’s comment period on the use of the terms, such as milk, yogurt, and cheese, in the labeling of plant-based products ended on January 28, 2019. FDA’s standard of identity for milk defines milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one … Continue Reading

FDA’s Outlines Plans to Modernize Oversight of Imported Food

The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA),  with existing ones to improve the safety of imported foods in a newly released publication, “Strategy for the Safety of Imported Food.” (For background information on … Continue Reading

FDA Publishes Findings from Investigation of Romaine Lettuce E. coli Outbreak

As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, … Continue Reading

FDA Takes Action on Dietary Supplements Claiming to Treat Alzheimer’s Disease and Other Serious Conditions

FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act. The products in question include … Continue Reading

New York Judge Lifts 2-Year Stay on KIND “All Natural” Suit (subscription to Law360 required)

A New York federal court ordered a consumer class action against KIND LLC to move forward after a two-year stay. Consumers are suing KIND for allegedly mislabeling its snack products as both “non-GMO” and “all natural,” even though the products purportedly contain synthetic and genetically modified ingredients.  On September 15, 2016, U.S. District Judge William … Continue Reading

FDA to Strengthen Dietary Supplements Regulation

On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the … Continue Reading

New York City, Ohio, and Maine Crackdown on Food Products with CBD

City and state officials in New York, Ohio, and Maine have placed embargoes on food products containing cannabidiol (CBD).  The embargoes, which appear to have all begun in January, require restaurants and retailers to remove all CBD-containing food products from their shelves and prohibit their sale.  In all three jurisdictions, however, restaurants and retailers were … Continue Reading

Plant-Based Milk Labeling Comment Period Ends; Debate Continues

As previously reported in September on this blog, FDA requested comments on the use of dairy terms—such as milk, yogurt, and cheese—in the labeling of plant-based products. FDA’s Standards of Identity define milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” The original deadline … Continue Reading

FDA and USDA Are Back to Work, But Getting Back to “Normal” May Still Take Time

  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 … Continue Reading

Senators Ask FDA to Update Federal Regulations Governing Use of CBD in Food, Beverages, and Dietary Supplements

As previously reported on this blog, the Agriculture Improvement Act (also known as “the 2018 Farm Bill”) removed hemp from the Controlled Substances Act, which means it is no longer an illegal substance under federal law.  However, the 2018 Farm Bill does not affect FDA’s authority to regulate derivatives of cannabis (e.g., CBD) or other … Continue Reading

USDA and FDA Continue to Call Back Workers Amid Partial Shutdown

As previously reported 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. This blog has also reported that as of January 15, FDA resumed inspections … Continue Reading

NGO Publishes Report on Food Safety

The United State Public Interest Research Group (PIRG) published “How Safe is Our Food? Recent trends and case studies, and what they mean for our health”, a review and commentary of the food safety system in the United States.  PIRG reviewed trends in food safety, with an emphasis on recalls, as well as case studies … Continue Reading

FDA Resumes Inspections of High-Risk Food Facilities

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
LexBlog

We and our analytics and advertising providers may use cookies and similar technologies to enhance the browsing experience, facilitate sharing of content, and generate statistics about use of the website. For more information or to change your preferences, click here.

I Agree