The United States Food and Drug Administration Food Safety

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

FDA Should Address Adverse Impacts of Artificial Food Coloring

Grocery store shelves are filled with foods that contain artificial coloring. Breakfast cereal. Cake frosting. Candy bars. Drink mixes. Up and down the aisles, Blue 2, Red 40, Yellow 5 and other chemical combinations lurk on...more

Addressing Adulterated Food Risk

As we enter 2016, adulterated food-related investigations are leading the headlines—and should be leading companies in the food and beverage industry to ask what they can do to prevent and prepare for a potential outbreak on...more

FDA Issues Final Rule Amending Food Additive Regulations

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances...more

Agriculture, Food, and Health Issues to Watch for 2016

As the agriculture and food industries head into the new year, a number of important cases and regulatory issues that have the potential to dramatically affect the industry are front and center. Below, Armstrong Teasdale’s...more

Food Safety, Labeling, and Nutrition Update - December 2015 #2

As 2015 wraps up, there have been several important developments in Food Safety, Labeling, and Nutrition, most notably the FY 2016 Omnibus Appropriations Bill expected to pass the House and Senate on Friday, December 18. The...more

Wrap-Up of Federal and State Chemical Regulatory Developments, December 2015.

EPA Issues Final Rule Adding 1-Bromopropane To EPCRA Section 313 List: On November 23, 2015, the U.S. Environmental Protection Agency (EPA) issued a final rule adding 1-bromopropane to the list of toxic chemicals subject to...more

Food Safety, Labeling, and Nutrition Update - December 2015

The past few weeks have seen significant action within the Food and Drug Administration (FDA) on food safety, labeling, and nutrition issues. With the release of three final rules on Food Safety, approval of the first...more

New FDA rule places increased food safety responsibility on importers, foreign suppliers

On Nov. 27, 2015, the FDA published its Final Rule outlining how the food industry, already in the midst of implementing Hazard Analysis and Risk Based Preventive Controls, or HARPC, will be responsible for ensuring that...more

Food for Thought: FDA Approves Genetically Engineered Salmon

On November 19, the U.S. Food and Drug Administration approved genetically engineered (GE) salmon for consumption as food. AquaBounty Technologies, Inc. filed an application with the FDA for the approval of AquAdvantage...more

FDA Issues New Food Safety Rules

The U.S. Food and Drug Administration (“FDA”) issued three new rules on November 13 implementing the 2011 Food Safety Modernization Act. The Final Rule on Produce Safety establishes microbial water quality standards for water...more

FSMA Comes Down on the Farm: FDA Finalizes Produce Safety Standards

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released the prepublication version of its final rule regarding Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human...more

It Will Only Cost You an Audit: FDA Releases FSMA Third-Party Certification Rule

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications...more

Food from Faraway Lands: FDA Releases FSMA Foreign Supplier Food Safety Rule

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Foreign Supplier Verification Programs for Food Importers (FSVP Rule). The new rule requires importers to ensure that...more

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

Will the FDA’s Proposed Rule on the Sanitary Transportation of Food Apply to International Shipments?

Yes, the FDA’s Proposed Rule, required to be published by March 31, 2016, will apply to food shipments being transported into the U.S., directly, by motor or rail vehicle, or transferred onto a motor or rail vehicle for...more

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...more

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series, we will discuss the FDA’s changes to cGMPs, noting the changes...more

Long-awaited overhaul of FDA food safety rules arrives – Part III: Hazard Analysis and Risk-Based Preventive Controls

In the first two articles in this series, Life Sciences Decoded explored the FDA’s new Rule revamping the food Good Manufacturing Practices (cGMPs) and creating the new Hazard Analysis and Risk-Based Preventive Controls...more

Food Safety Does Not Exist In A Vacuum, and Neither Do the FSMA’s Rules: What the New Rules on Preventive Controls for Human and...

On September 17, 2015 the FDA published the first two of its seven rules in conjunction with the Food Safety Modernization Act’s (the “FSMA”) regulatory scheme. The rules, which focus on Current Good Manufacturing Practices...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

FDA Releases Two Final Food Safety Rules: What You Need to Know

Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more

Finally Coming to Fruition: FDA’s Rule on the Sanitary Transportation of Food

Twenty-five years after Congress first tried to ensure that garbage trucks aren’t also used to haul fresh produce, a federal regulation establishing sanitation standards for the transportation of human and animal food by...more

FDA Warns Companies About Powdered Caffeine

We Americans love our energy-boosting drinks, never mind that so many have been shown to pose threats of heart disease, high blood pressure and other problems for some people. The newest form of caffeine-infusion is a powder...more

FDA Finalizes First Two Rules Under FSMA

On September 10, 2015, the U.S. Food and Drug Administration (FDA) finalized its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good...more

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