Tag: Drug

Supreme Court Creates New Food Labeling Battleground, plus GMO Labeling Primer

My colleague Anne Glazer recently co-authored an article with Connie Kirby of Northwest Food Processors Association titled “Summary of Regulatory Intersection between the Federal Trade Commission and the Food and Drug Administration over the Labeling and Advertising of Food Products: Implication for Genetically Engineered Foods.” Prepared for Oregon Governor Kitzhaber’s Task Force on Genetically-Engineered Agriculture, … Continue Reading

I Can Believe It’s Got No Fat *

*  But then again, I’m a lawyer. In the fifth episode of "The Hitchhiker’s Guide to the Galaxy", by Douglas Adams, Peter Jones played The Book.  At one point, The Book gives some "helpful" information about the universe.  First, that it is infinite.  Next, it goes on to prove, through comical science and mathematics pulled … Continue Reading

New Retail Food Action Plan

In its latest step to increase the safety of the American food supply, the U.S. Food and Drug Administration (FDA) announced a Retail Food Safety Action Plan that includes several measures to help assure the safety of food sold in stores, restaurants, schools, and other foodservice operations. In support of the Action Plan, FDA also … Continue Reading

Product Traceability Pilot Studies

In the wake of recent recalls the progress of implementation of the Food Safety Modernization Act (FSMA) has become more significant. The Pilot Traceability Project was announced as of last week. This project is intended to provide a structure for tracing ingredients back to their source in the event of a recall. Section 204 of … Continue Reading

American Cheese Society Conference

I attended the American Cheese Society conference in Montreal earlier in the month. The conference was attended by cheese producers and suppliers from around the world. At the conference I presented a PowerPoint on Food Safety Modernization Act  (FSMA) .  There were several talks on Food Safety and clearly, the industry is concerned about the new provisions where cheese in … 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

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

Difficult Week for the Food Industry (Good Week for the Plaintiffs’ Bar): HVP Salmonella and FDA Warning Letters

The week of March 1 saw a double whammy hit food manufacturers. I. Open Letter to Industry on Marketing Claims First, on March 3, FDA sent warning letters to 16 food manufacturers concerning their labeling practices. FDA also issued an Open Letter to Industry warning against certain practices. For example, FDA warned that: o Nutrient content claims … 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

Court’s Decision on CR 12(b)(6) Motion In Zupnik: FFDCA Preemption Under Further Attack and Twombly Ignored

We previously cited the motion to dismiss in Zupnik, et al. v. Tropicana Products, Inc. as an example of good pleading practice in a putative consumer fraud class case. United States District Judge Dale S. Fischer apparently disagreed with our assessment, this week issuing an order denying the motion. Tropicana’s lead argument was a failure of … 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

Oil and Water Meet Caffeine and Alcohol: FDA to Look into Safety of Caffeinated Alcoholic Beverages

By Guest Bloggers Tyler Anderson and Stephanie Meier On November 13, the FDA notified nearly 30 manufacturers of caffeinated alcoholic beverages that the agency intends to look into the safety and legality of their products. As the FDA explained in a news release announcing this action, under the Federal Food, Drug, and Cosmetic Act any … 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
LexBlog