Tag: Food and Drug Administration

Register Today for FDA’s Public Meetings on Two Major FSMA Proposed Rules

Earlier this year, the Food and Drug Administration (FDA) made some progress toward implementing the Food Safety Modernization Act (FSMA) by issuing two new proposed food safety rules. Specifically, the agency published proposed rules to establish standards for (1) growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Rule”) and for … Continue Reading

Oregon to Adopt 2009 FDA Food Code

The Oregon Public Health Division’s (OPHD) Foodborne Illness Prevention Program announced that it is moving forward with the adoption of the 2009 Food and Drug Administration (FDA) Food Code.  The new rules will take effect on September 4, 2012. Oddly, however, the agency noted that it would not be adopting the “No Bare Hand Contact” section … Continue Reading

Are FDA Reinspection Fees An Opportunity?

Fred Degnan, from King & Spalding, led a very insightful presentation on "Responding to Government Investigations and Warning Letters" at the recent ACI food regulatory summit. His presentation led to an interesting discussion about FDA’s close out of investigations. It was generally agreed that the FDA, in essence, is not notifying parties when it has decided to … Continue Reading

FDA’s Right To Photograph In Your Plant

The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States … Continue Reading

FDA’s Reportable Food Registry Makes a Profound Impact

Here is a link to my article, "FDA’s Reportable Food Registry Profoundly Impacts Litigation and the Food Industry," posted this week by the American Bar Association‘s Litigation Section (Products Liability). The article is a follow-on to lively discussions over the litigation impacts of the federal Reportable Food Registry ("RFR") at the ABA’s recent Food & … Continue Reading

What’s in a Name? – Trade Organizations Push for HFCS Flexibility

The Corn Refiners Association (the “CRA”), a trade organization representing the US corn refining industry, recently petitioned the Food and Drug Administration (the “FDA”) to allow the term “corn sugar” as an alternative label declaration for high fructose corn syrup (“HFCS”). The the FDA’s decision on whether to approve the renaming is expected to take … Continue Reading

The Show Goes On: USDC Allows Vitaminwater Lawsuit to Proceed

In an opinion issued on July 21, 2010, Judge John Gleason of the United States District Court for the Eastern District of New York largely denied the defendant’s motion for dismissal and held that 10 of the 13 claims in a class action suit brought against Coca-Cola for alleged unlawful health claims on its Vitaminwater … Continue Reading

A Traceability Story: Request for Comments

Jim Prevor has an intriguing story in one of his latest Perishable Pundits, updated here and here, that frankly has me wondering.  According to Jim, Freshway Foods discovered E.Coil 0145 in some romaine and, using tracking numbers, was able to trace it to a specific lot supplied by a grower in Yuma, Arizona.  It then … Continue Reading

On the Horizon: TTB and FDA to Jointly Consider Additives to Alcoholic Beverages

Coauthored by Susan Johnson As we have blogged about previously, the Food and Drug Administration (the “FDA”) has been closely monitoring the appropriateness of additives to alcoholic beverages, with a particular emphasis on caffeinated alcoholic beverages. A recent release from the Alcohol and Tobacco Tax and Trade Bureau (the “TTB”) indicates that the two agencies … Continue Reading

Media Headlines and Food Labels Each Might Be Misleading (Film at 11)

A recent headline in the Huffington Post breathlessly importuned:   "Restaurant Food Has Up to 200% More Calories Than Advertised."  If you only read the headline, you might think this was some important information that might change your eating habits.  If you read the article, you would discover a balanced set of conclusions from a fairly limited study. … Continue Reading

From Onions to Chicken Soup: The Wall Street Journal Weighs in On Home Flu Remedies

Melinda Beck has a terrific article in today’s Wall Street Journal about home remedies for the H1N1 virus and (as we have previously blogged) the FDA’s efforts to reign in those making unsupported marketing claims for their remedies.  One remedy sweeping the blogosphere like wildfire is the use of onions to soak up flu bugs.  … Continue Reading

FDA Warning to General Mills: Cheerios is a Drug

The U.S. Food and Drug Administration is taking issue with claims that Cheerios cereal can lower cholesterol. In a letter to General Mills, the FDA says that statements made on Cheerios packaging like the claim that the cereal is “clinically proven to help lower cholesterol” make the product a drug under federal law. The agency suggests … Continue Reading

FDA Seeks Largest Budget Increase in Agency’s History

The Food and Drug Administration is seeking to increase its budget for Fiscal Year 2010 by nearly 20 percent more than FY 2009 – to $3.2 billion. The Washington Post reports that the increase is the largest in the agency’s history. The FDA’s spending request includes $259.3 million to be devoted to the “Protecting America’s Food … Continue Reading

FDA Commissioner Nominee Faces Confirmation Hearing

Dr. Margaret Hamburg, President Barack Obama’s nominee to oversee the Food and Drug Administration, is appearing before a U.S. Senate committee this afternoon regarding her nomination. The confirmation hearing before the Senate Health, Education, Labor and Pensions Committee began at 2:00 p.m. ET. Streaming video is available here. The Associated Press is reporting that, if confirmed, one … Continue Reading

FDA and CDC Warn of Salmonella in Raw Sprouts

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are recommending against eating raw alfalfa sprouts because of potential salmonella contamination. According to the FDA, the salmonella contamination appears to be in seeds for alfalfa sprouts. As of yesterday, 31 cases of illness with Salmonella Saintpaul have been reported to the … Continue Reading

Update: Supreme Court Declines Review of Methylmercury Case With Potential Preemption Implications

An update to a case we’ve been following: the U.S. Supreme Court has refused to review a decision by the U.S. Court of Appeals for the Third Circuit involving state-law claims over methylmercury content in canned tuna. The Supreme Court’s order in Tri-Union Seafoods, LLC v. Fellner leaves in place the Third Circuit’s ruling that … Continue Reading

FDA Seeks Input on Intentional Adulteration of Products

The Food and Drug Administration has announced an effort to explore the intentional adulteration of products to increase a producer’s bottom line. So-called “economically motivated adulteration,” or EMA, is the topic of an FDA-sponsored public meeting to be held on May 1 in College Park, Maryland. The meeting follows last year’s concerns about products tainted with … Continue Reading

California Lawmakers Announce Proposed Food-Safety Reforms in Wake of Pistachio Recalls

As pistachio recalls continue to be announced in the wake of salmonella-tainted pistachios from Setton Farms, two California lawmakers this week announced legislation that is expected to strengthen food-safety standards in that state. The bill to be introduced in the California State Assembly by Assembly Speaker Karen Bass and Assemblyman Mike Feuer is expected to … Continue Reading

Obama Administration Focuses on Food Safety

The Obama administration placed food safety front and center over the weekend. In his weekly radio address, President Obama on Saturday announced new leadership at the Food and Drug Administration and the creation of a panel to toughen food safety laws. Characterizing outdated food safety laws and the lack of resources at the FDA as “a … Continue Reading

FDA’s Searchable Widget for Peanut Product Recall

UPDATE to the Salmonella-driven peanut product recall: as the number of peanut products recalled continues to rise, the U.S. Food and Drug Administration has created a Web widget that allows users to search for peanut-containing product recalls (see below).  The FDA updates the list as it receives new information from companies that have recalled products. As … Continue Reading
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