Food & Drug Law Prof Blog

FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C

FDA News Release:

The U.S. Food and Drug Administration [Friday, Oct. 30] sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:

• To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and
• Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.

The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.

(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)

For more information

FDA Warning Letter to Procter & Gamble
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm

Food Import Enforcement Actions

From FDA Law Blog:

On October 21, 2009, First Fishery Development Services filed suit against FDA seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 - Detention Without Physical Examination of Processed Foods for Pesticides.  According to the Complaint, the Company contends that its bulk Olive Leaf Powder Extract is not adulterated, in violation of section 402(a)(2)(b) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), because the presence of a pesticide in the product is a result of the presence of the pesticide in an antimicrobial solution used on food contact equipment.  The Company contends that this use of the pesticide conforms to an exemption from a pesticide tolerance granted by EPA and is permissible under FDA's threshold of regulation program for substances used in food contact articles that migrate into food.  

read more of this interesting post

Junk food binges may lead to addiction

Using junk food as rewards stimulates the reward centers in the brain, leading to addictive behavior. A recent study presented at Neuroscience 2009 last week is being reported all over the internet. 

Interestingly, this is the basic premise of former FDA Commissioner David Kessler's recent book, The End of Overeating (blogged here).  

From Science Daily.com:

Brain pleasure centers became progressively less responsive in rats fed a diet of high-fat, high-calorie food, a new study has found. As the changes occurred, the rats developed compulsive overeating habits -- and became obese. The overeating continued even when it meant the rats had to endure an unpleasant consequence (a mild foot shock) in order to consume the food. . . .

The researchers also found that as the activity of the brain's pleasure centers decreased, the rats became less likely to eat a well-balanced, nutritious diet -- even when the less palatable healthy food was the only food available to them.

Read the rest of this article at Science Daily.com -- Junk Food Diet Causes Rats’ Brain Pleasure Centers To Become Progressively Less Responsive

New York Daily News:Binging on junk food encourages addictive behavior: study

Science News: Junk Food Junkies -- Rats on a junk food diet behave like drug addicts

NRDC Growing Green Awards

Received by email:

The Natural Resources Defense Council (NRDC) has just announced this year’s Growing Green Awards 2010, a sustainable food award contest hosted by NRDC to honor extraordinary individual contributions to the sustainable food world.

 

NRDC would like to attract as many applicants as possible in order to garner attention and support for the sustainable food movement. We've also added a 4th category special to this year, Water Steward, and we are very excited to see the submissions for this new category.

 

We have a great group of panelists this year who will be selecting the winners. The panelists include Michael Pollan, author of The Omnivore’s Dilemma, California Secretary of Agriculture, A.G. Kawamura and others.

More about the Growing Green Awards is available on the NRDC website:

Nominations are due by December 4, 2009

$10,000 cash prize to be awarded in the Food Producer category

Through this national award, NRDC will recognize extraordinary contributions that advance ecologically integrated farming practices, climate stewardship, water stewardship, farmland preservation, and social responsibility from farm to fork.

A Growing Green Award will be given to an outstanding individual in each of four categories, including Food Producer, Business Leader, Thought Leader, and Water Steward. A $10,000 cash prize will be awarded in the Food Producer category and all winners will be widely celebrated through outreach to media and NRDC’s networks.

No more Big Macs in Iceland

From the Associated Press by way of the NY Daily News:

The Big Mac, long a symbol of globalization, has become the latest victim of this tiny island nation's overexposure to the world financial crisis.

Iceland's three McDonald's restaurants - all in the capital Reykjavik - will close next weekend, as the franchise owner gives in to falling profits caused by the collapse in the Icelandic krona.

Read more

Hamburg: Need stronger food safety bill

FDA Commissioner Margaret Hamburg addressed the Senate Committee on Health, Education, Labor and Pensions this week.  The full text of her testimony is available on the FDA's website. 

Keeping America's Families Safe: Reforming the Food Safety System

. . .From FDA’s perspective, there are three key questions to ask about food safety legislation:  

• First, does the legislation refocus the system to place greater emphasis on prevention? 
• Second, does the legislation provide FDA the legal tools necessary to match its existing and new food safety responsibilities?  
• Third, does the legislation provide or anticipate resources for the Agency to match its responsibilities?  

I will focus on S. 510 for a discussion of these questions.  I will address each of these three questions in turn and highlight a few of the many important authorities in this bill.

Does the legislation support a new food safety system focused on prevention?

The legislation would indeed transform FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them.  It would do so by requiring and then holding companies accountable for understanding the risks to the food supply under their control and then implementing effective measures to prevent contamination. . . .

more

Fraud Plagues Sugar Subsidy System in Europe

From the New York Times:

Call it the mystery of the European sugar triangle.

It began when Belgian customs officials examined shipping records for dozens of giant tanker trucks that outlined an odd, triangular journey across Europe. The trucks, each carrying 22 tons of liquid sugar, swung through eight nations and covered a driving distance of roughly 2,500 miles from a Belgian sugar refinery to Croatia and back — instead of taking the most direct, 900-mile route.

. . . Because Russia, and not Croatia, was listed as the intended destination, the shipments qualified for valuable special payments known as export rebates from the European Union’s farm subsidy program.

more

Yes, we have no bananas: Dole judgment can't be enforced in U.S.

From the L.A. Times :

Dole Food Inc. can't be forced in the U.S. to pay a $97-million judgment ordered by a Nicaraguan court, a federal judge said.

The award, won four years ago by 150 Nicaraguans who said they suffered injuries from pesticides used at Dole's banana farms in the 1970s, can't be enforced because it was based on a law that violates international legal standards, U.S. District Judge Paul Huck in Miami said in a ruling Tuesday.

FDA analyzing front of package labels

The FDA has issued a Dear Industry letter on front of package or point of purchase nutrition labeling.

From the Institute of Food Technologists Weekly:

The U.S. Food and Drug Administration (FDA) said Oct. 20 that it would seek to clear up the confusion caused by a surge of nutritional claims that manufacturers have begun to make on packaged food labels. Point of purchase labeling including Front of Package (FOP) labeling is voluntary information that is intended to convey to consumers the nutritional attributes of a food. Point of purchase labeling often includes symbols that are typically linked to a set of nutritional criteria developed by food manufacturers, grocery stores, trade organizations, and health organizations. The selected nutrients and the nutrient levels required for eligibility vary among the different symbol programs in use.  continue

The graphic above is the traffic light version that has been floating about for some time now.

  

Farm protests over milk prices ahead of EU meeting

From the Associated Press. There are great photos on the linked website! How often do you see a man in a suit and an actual cow in the same photo? On a city street? (Thank you to Neal Axton and Mary Ann Archer for forwarding this along.)

BRUSSELS — Hundreds of dairy farmers drove tractors into Belgium's capital Monday to pressure EU farm ministers on declining milk prices, as 20 of 27 member nations called for more protection from the volatile world market.

About 1,000 farmers from Germany, France and other EU nations protested outside the emergency meeting, throwing bottles and eggs at police, and burning tires and hay. Police closed off the EU Council building and set up a major security perimeter, snarling traffic in parts of Brussels for much of the day.

more

Wrestling Promoter, Wine School Butt Heads in Trademark Smackdown

This is a little off the wall, but I've been saying for a while that Food Law encompasses just about every area of law taught in law school.  Here's trademarks in a context I might not have thought of.  This is from The National Law Journal via Law.com (thank you to Steve Sholk for forwarding it!)

World Wrestling Entertainment Inc. is attempting a legal smackdown against a wine school that it says is violating its trademark.

WWE is opposing the Philadelphia Wine School's attempt to register the name Sommelier Smackdown for the food and wine pairing competitions it has held since 2007. The WWE's "SmackDown" program has aired on television since 1999.

"The WWE has been the registered owner of the trademark SmackDown for entertainment purposes for many, many years," said K&L Gates partner Jerry McDevitt, who represents the WWE. "We sent a letter saying, 'Guess what, you can't use that.'"

Philadelphia Wine School owner Keith Wallace said that he received the WWE's cease-and-desist letter in September. He has no intention of backing off the Sommelier Smackdown name, however.

more

Anatomy of a Burger

Seems like the news is all about contaminated meat.  This is part of the New York Times spread on Stephanie Smith's case of HUS from eating E coli O157:H7 contaminated burgers.

Click here to see a graphic showing the sources of meat that went into the burger she ate, along with a summary of the food safety practices of each supplier.

This patty was made by the food giant Cargill, which recalled 844,812 pounds of ground beef on Oct. 6, 2007, after an estimated 940 people were sickened, including Stephanie Smith, 22, of Cold Spring, Minn.

Hamburger Confidential -- NYT video showing "safe" food handling

I'm tossing kitchen towels in the wash daily from here on!  Yuck. 

Watch this video:  Hamburger Confidential, in which a reporter and an editor do everything right and way more carefully than I ever do, and still end up with E. coli in the kitchen.

Can consumers prevent cross-contamination by simply following directions on a package of ground beef?

NYT: E. Coli Path Shows Flaws in Beef Inspection

Two people sent me this article.  There's also a video:

 

 

 

 

By MICHAEL MOSS

Published: October 3, 2009

Stephanie Smith, a children’s dance instructor, thought she had a stomach virus. The aches and cramping were tolerable that first day, and she finished her classes.

Then her diarrhea turned bloody. Her kidneys shut down. Seizures knocked her unconscious. The convulsions grew so relentless that doctors had to put her in a coma for nine weeks. When she emerged, she could no longer walk. The affliction had ravaged her nervous system and left her paralyzed.

Ms. Smith, 22, was found to have a severe form of food-borne illness caused by E. coli, which Minnesota officials traced to the hamburger that her mother had grilled for their Sunday dinner in early fall 2007.

read more

See the video, Tainted Meat, (above or on the NYT website)  about E. coli and Stephanie Smith.  Bill Marler is interviewed at about 3:55.

USDA Joins FDA Efforts on New Food Safety Regulations

 FDA AND AMS NEWS RELEASE:

USDA Joins FDA Efforts on New Food Safety Regulations
Agencies Unite on Outreach to Produce Industry

USDA’s fresh produce chief will join FDA to help develop new food safety rules, as part of a cooperative initiative between FDA and the U.S. Department of Agriculture (USDA). Today’s announcement comes amid beefed up outreach efforts with key agriculture and safe food stakeholders to better share and exchange produce safety “best practices” and ideas.

Leanne Skelton, chief of the Fresh Products Branch of the USDA’s Agriculture Marketing Service (AMS), has extensive experience working with the fruit and vegetable industry. Skelton has been with the Fresh Products Branch at AMS for more than 22 years, working in inspections, grading and certification, standardization, training, and managing the Branch’s financial and information technology activities. Skelton will be on detail with the FDA for six months as she helps the FDA develop new safety regulations for produce.

“President Obama, like most Americans, wants immediate improvements in our food safety system,” said Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services. “As such, we are pulling together all our best resources -state and federal - to improve the safety of our foods and to work with growers protect and promote the health of our nation.”

“USDA is committed to working with our partners to ensure that Americans have access to safe, healthy, and nutritious food,” said Agriculture Secretary Tom Vilsack.  “Today’s announcement is another example the Obama Administration’s innovative and aggressive effort to strengthen protections against unsafe food and food-borne illness.”

Through the initiative, FDA is gathering information and seeking feedback from the fresh produce industry, including small and organic farmers, on the impact such rules may have on their businesses and lives. In addition, USDA and FDA officials have been traveling together to meet with farmers and local food safety officials. Most recently, FDA and USDA visited farms in North Carolina and will soon visit Florida.

"We are delighted that the FDA sought USDA’s counsel and cooperation as they tackle the challenges of ensuring the safety and availability of fresh produce and healthy foods,” said AMS Administrator Rayne Pegg. “The USDA and the FDA have joined together on listening sessions and farm tours, and are eager to develop a system of regulation that will work for American families and the growers.”

FDA Commissioner Margaret Hamburg iterated the agency’s commitment to listen and learn from all those with a role in protecting the safety of the food system.

"It is vitally important for us to hear ideas, concerns, and experiences directly from local growers around the country as we develop rules to help protect the safety of fresh produce from the farm to the table,” she said. “We will be that much more effective by working closely with farmers, our USDA partners and with state and local food safety agencies."

The detail and the joint outreach efforts further underscore the two agency's commitment to work cooperatively on food safety.

FDA 101: Product Recalls (Video)

Here's another of the FDA's new consumer update videos.  This one is about recalls.  Cute doggie at 22 seconds.

When an FDA-regulated product is defective or potentially harmful, removing it from the market may be necessary. In this Consumer Update video, FDA Recall Operations Team Leader Armando Zamora, explains how FDA manages product recalls.

FDA Video Update on Food Allergies

FDA has posted a series of videos for consumers.  Here's the one on Food Allergies:

  Food Allergies: Reducing the Risks (video)

Food allergies can range from merely irritating to life-threatening. FDA is working to ensure that major allergenic ingredients in food are accurately labeled. In this Consumer Update video Felicia Billingslea, FDA Director of Food Labeling and Standards, provides tips to help prevent allergic reactions and explains the difference between food allergies and food intolerance.

Dietary Supplement Labeling Guide

Here's a nifty table showing some of the differences between dietary supplement labeling rules and conventional food labeling rules.  The table is presented on Food Label News, an online newsletter by Food Consulting Company, which provides nutritional analysis and labeling advice. From their labeling guide:

A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet; “dietary ingredients” include: vitamins, minerals, herbs/botanicals, amino acids, enzymes, organ tissues, glandulars, metabolites, extracts or concentrates. Dietary supplements have many forms: . . .

CDC: Majority of Americans not Meeting Recommendations for Fruit and Vegetable Consumption

From the CDC News Release:

No U.S. state is meeting national objectives for consumption of fruits and vegetables, according to the first report to provide state–by–state data about fruit and vegetable consumption and policies that may help Americans eat more fruits and vegetables. 

“State Indicator Report on Fruits and Vegetables, 2009”  was released [Sept. 29, 2009] by the Centers for Disease Control and Prevention.

The Healthy People 2010 objectives aim for at least 75 percent of Americans to eat the recommended two or more daily servings of fruit, and for at least 50 percent of Americans to eat the recommended three or more servings of vegetables daily. However, CDC surveys indicate that only 33 percent of adults meet the recommendation for fruit consumption and 27 percent get the recommended servings of vegetables.  The statistics are even worse for high school students – 32 percent report eating at least two servings of fruit daily and 13 percent say they eat at least three servings of vegetables each day.

Read more of the news release.  The map below shows the percentage of adults eat at least 2 servings of fruit and 3 servings of vegetables per day.

Put a trial lawyer out of business

Bill Marler (Marlerblog.com) is presenting T-shirts to Senators:

(That's Marler in the circle.)

Also in an effort to convince Congress of the need for Food Safety Legislation, Marler asked us to post the video below.  It's the story of a little girl who died of illness linked to a ground beef recall because of E. coli O157:H7. 

Caution: tear-jerker