Proposition 65 case involving 4-MEI in soda
For news on the first alleged Proposition 65 violation concerning 4-Methylimidazole (4-MEI) in soda, see my blog posting in the environmental law blog. 4-MEI exists in some food and beverage products, including certain sodas, beers, soy sauces, breads, and coffees, among others.
New Bill To Set Arsenic And Lead Limits In Juice
United States House Representative, Frank Pallone, Jr. introduced H.R. 3984 on Wednesday that would set arsenic and lead limits in juice. The "Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012," otherwise known as the "APPLE Juice Act of 2012" is in direct response to Consumer Reports investigations. The investigative reports found levels of arsenic and lead exceeding federal drinking water standards in 10 percent of apple and grape juice samples tested in New Jersey, New York and Connecticut. The Act would require FDA to establish standards for the juices within two years.
For those of us in the California market, we can expect potential limits to be set, but how they match up to potential Proposition 65 warning levels and whether any preemption issues may be raised will remain to be seen.
Acrylamide Unlikely To Cause Health Effects According To IFIC
The International Food Information Council’s expert panel, organized for the January 26, 2012 press webinar, found that acrylamide cannot be shown to pose any health risks. Acrylamide, which is also listed as a Prop 65 chemical was thought to be a carcinogen based on tests performed on rats at high doses. A study that included approximately 40 human epidemiological studies reviewed levels in food and none of which conclusively associated acrylamide with any increased heath risks.
Most notably, acrylamide is produced by browning or burning foods. It is also thought to be in coffee and many baked goods. Plant-based foods that are rich in carbohydrates may form acrylamide when baked, fried or roasted –French fries, potato chips, other fried and baked snack foods, coffee, roasted grain-based coffee substitutes, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, prune juice, breakfast cereals, crackers, cookies, breads, and toast all may contain varying amounts of acrylamide. Foods that have been boiled or steamed do not contain acrylamide.
Upcoming Events
On December 8, 2011 I participated in a webinar organized by the Strafford Publication Group. In conjunction with Jonathan Cohen from the Gilbert firm and Joseph Bottiglieri with Bonner Kiernan Trebach & Crociata LLP, we presented Food Safety Claims: Products Liability Issues on the new requirements under the Food Safety Modernization Act.
Nicole Hancock of our Boise office and I will be presenting on Tuesday, January 10, 2012 a webinar on The FDA Food Safety Modernization Act – Part I on related topics including the relation of FSMA to feed and pet products. This webinar will be managed by the University of Idaho farm extension. David Atchison of the Leavitt Partners firm will also be presenting.
Amy Edwards and I will be speaking on January 16, 2012 at the Northwestern Food Processors Association Expo on protecting the attorney-client privilege and how that interaction relates to the new FSMA requirements.
Melissa Jones from our Sacramento office, and I will make a presentation on Proposition 65 and Food Safety litigation at the 2012 Food Claims & Litigation GMA Conference at Dana Point California in February 21-23, 2012.
FDA Creates The Food Safety Preventive Controls Alliance (FSPCA) To Develop Training Courses And Materials For Prevention Of Contamination
The U.S. Food and Drug Administration (FDA) in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) created the Food Safety Preventive Controls Alliance (FSPCA) to develop materials to will help the industry comply with the new preventive control rules.
The Alliance is composed of members from the FDA, loca and state food protection agencies, the food industry and academia.
Under the FSMA, facilities are required to develop food safety plans that evaluate food safety hazards and identify the preventive measures to guard against those hazards. Facilities must also monitor preventive measures and manufacturers must also develop a plan of action to correct any problems that are discovered.
The Alliance will develop training modules, to train the trainer, develop industry specific measures, assess the need for future research, and prioritize the need for specific controls.
"All Natural" Class Action Litigation in California: What's in Store for 2012?
California litigators Tom Woods and Melissa Jones have prepared a Litigation Legal Alert on "All Natural" class action litigation in California and what to expect in 2012.
The Alert, which is linked above, provides background information regarding "All Natural" class action litigation in California. It also discusses why the authors believe that class action litigation in this area will persist in 2012. Finally, the Alert concludes with suggestions for companies that have litigation risks regarding "All Natural" claims associated with their products.
What I Learned on My Winter Vacation, or Is Water Good for You?
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I spent the last three weeks mainly in Europe, and mainly on a cruise, but unlike Newt Gingrich, I don't purport to have learned anything about Europe's debt crisis, although the Greek, Italian and Spanish governments did all fall the moment we left each country. What I did learn, or was reminded of, is that there is a very different way of thinking in Europe. Instead of blaring out instructions at the security line at the airport, there is just one discreet sign, and if you don't do it right you are admonished for not having read or comprehended the sign. To rebook our flights when we missed a connection due to fog, we were given the instruction to "Like" KLM on Facebook, without the further instruction to then post a message asking to be rebooked (that didn't work for me, by the way, after I finally figured it out).
So I read with some interest the various stories that have circulated around the Internet with titles like "EU Says Water is Not Healthy" and "Now barmy EU says you CAN'T claim drinking water stops dehydration." And this, of course, is to answer yesterday's pop quiz, which you'll recall asked if the following statement is true:
The regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance.
This was the question asked of a particular European Union agency with respect to a particular European Union law and the answer they gave was negative. Which of course set off a firestorm of laughter and ridicule, followed by a reverse firestorm of alleged common sense explanations for why the EU was right. With respect, pretty much everyone has exaggerated something here, intentionally or unintentionally.
For reference, here are the EU Scientific Opinion and the EU regulation implementing the scientific opinion. I'm afraid they're not quite Shakespeare or even Stephen King.
First, let's parse the words a bit. The claim relates to "water" not "bottled water" or some particular brand of bottled water. The claim also states that "regular consumption" of water "can reduce" the development of dehydration, not that it is necessary for it, or that other beverages or water ingested in other ways are or are not another way to achieve it.
Now, let's affirm what the EU has done and not done. It has stated that in connection with a claim for foods within the EU, this claim is not authorized (20 days after publication in the official journal of the EU). It expressly states that it is "binding and directly applicable in all member states." Thus, the EU official who stated, as quoted in The Express as saying, "Either way the final decision is for member states", was saying something directly contradicted by the regulation's own words. A British bottled water seller has vowed to defy the ban and British health officials have not ruled out taking action against it.
Clearly, the EU has also not said water isn't good for you, or that it's bad for you, or anything of that sort. And there is some question as to whether the law the application was sent in under was the right one; is "dehydration" a disease or a condition, for instance? Yet even the most cogent defense of the ruling I've read, by a professor of nutritiion at Robert Gordon University in Aberdeen, takes liberties with the facts. I'm no nutritionist, and I'll accept that someone can live a perfectly healthy life without ever once ingesting water in its pure form (the comments on most of these articles include at least one person who suggests that beer is a fine substitute). I also accept that pure water alone may not solve all cases of dehydration. But the claim is not that drinking water as such is necessary, or that it is sufficient, but that it is useful. So when the professor, in defending the EU ruling, said, "Also, it could be used to imply that there is something special about bottled water which is not the case," he's simply wrong. If I say that Drug X may lower your cholesterol that doesn't imply that there is something about Drug X that is special compared to Drug Y which may also lower your cholesterol. The same is true of water.
Here's a Pop Quiz
You can't Google this and you can't refer to anything but your own common sense:
Is the following statement true or false?
The regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance.
I'll be back with the "answer" tomorrow.
Green Chemistry Is Back
The Department of Toxic Substances Control (DTSC) released new informal draft regulations whose stated purpose is: "to make safer consumer products ....widespread in California...[and].... provide more protection against toxic chemicals in products on store shelves, while creating market opportunities for industry."
The draft released on October 31, 2011, creates regulations identifying consumer products that contain toxic chemicals. The DTSC claims it will use a science-based process that requires the identification of toxic ingredients and the analysis of alternatives to that ingredient. Based on the results of the analysis, removal of the toxic ingredient and/or posting product information may take place.
The DTSC’s draft regulations encompassed the following:
1) The regulations establish a list of Chemicals of Concern (~3,000) based on the work already done by other authoritative organizations. The rules also allow DTSC to identify additional chemicals as Chemicals of Concern.
2) The regulations require DTSC to develop a list of “Priority Products” that contain Chemicals of Concern for which an alternative assessment must be conducted.
3) The regulations require responsible entities (manufacturers, importers, and retailers) to notify DTSC when their product is listed as a Priority Product. DTSC will post this information on its website. Manufacturers (or other responsible entities) for a product listed as a Priority Product must perform an alternatives assessment (AA) for the product and the Chemicals of Concern in the product to determine how to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the Chemical of Concern in the product.
4) The regulations require DTSC to identify and impose regulatory responses to effectively limit potential adverse public health and/or environmental impacts posed by the Priority Product/Chemical of Concern (if the manufacturer decides to retain the Priority Product), or the potential adverse impacts posed by the alternative chemical/product selected to replace the Priority Product.
A prior proposed set of regulations were introduced in 2010, but additional time was required to refine the concepts. The version released in October greatly shortens timeframes, immediately establishes a list of chemicals of concern, and is intended to stimulate a change in the way products are created by incorporating impacts to health and the environment into the design phase. The regulations will be discussed by DTSC’s Green Ribbon Science Panel on November 14-15 in Sacramento.
No Slow Down to Class Action Lawsuits in California Regarding Food Labeling and Marketing
By California litigators Tom Woods and Melissa Jones
Consumer class action plaintiffs remain very active in California, with cases continuing to be filed against food manufacturers and suppliers regarding alleged misleading labeling and marketing claims. Just this week, plaintiffs filed a class action lawsuit against Trader Joe’s alleging that it falsely advertised and sold cookies and apple juice as “All-Natural” even though the products contained synthetic ingredients. In the past few months alone, several other large companies have been sued over allegedly false “All Natural” claims in lawsuits involving ice cream, juice, granolas, energy bars, and cereal. In the same time period, other class actions have been filed in California regarding the marketing of products that are made from genetically modified plants and grains, such as cooking oil.
These actions are most commonly brought under California’s unfair competition law (referred to as the “UCL” or § 17200 of the California Business and Professions Code). The problem for companies sued under California’s UCL is that it is difficult to get claims dismissed at an early stage. Lawsuits frequently survive the pleading stage because claims are evaluated from a subjective, and not objective, standard. Cases are allowed to proceed even though only one plaintiff establishes standing to sue by showing they actually relied on a company’s statement. Finally, preemption defenses are frequently inapplicable.
Companies should get proactive in light of this litigation trend, which isn’t going away, and examine their labels to minimize the risk of litigation. Those that have been sued should consider creative ways to address these class actions by developing and preserving constitutional challenges. Despite recent California cases making it easier for plaintiffs to maintain their lawsuits at an early stage, aggressive discovery may prevent plaintiffs from certifying the proposed class.
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 unveiled a cooperative agreement with the National Association of County and City Health Officials . FDA and the Association will promote the use of best practices by local authorities and attempt to increase retail food safety oversight as well as encourage the implementation of FDA’s Voluntary National Retail Food Regulatory Program Standards for retail food programs.
FDA today also released a Supplement to the 2009 FDA Food Code. The Food Code contains model food-safety regulations for retail and food-service operations including restaurants, schools and food stores. Local, authorities use the Food Code to develop food safety rules consistent with national regulatory policy.
Key changes contained in the new Supplement include:
- Requiring that food establishments have a certified food protection manager with the following additional requirements:
- that all operating procedures required by the Food Code are developed and implemented;
- that it can be verified that all employees are informed about their obligation to report certain health conditions that relate to transmission of food borne illness; and
- that any food the establishment receives after operating hours is delivered in a manner that does not create a food safety hazard;
- Requiring that food establishments have a plan for responding to and properly cleaning-up after an employee or other becomes physically ill in areas where food may be prepared, stored or served;
- Clarifying appropriate exceptions to the prohibition of bare hand contact with ready-to-eat foods prepared in the establishment;
- Clarifying the requirements for the safe storage and display of ground and whole-muscle meat and poultry;
- New requirements for devices used to generate chemical sanitizers on- site in the food establishment;
- Establishing clearer guidelines for the amount time a food establishment should be given to correct violations of different types of provisions in the Food Code.
Listeria Outbreak/FSMA Produce Regulations
The FDA confirmed this week that Listeria matching the strain that has caused health effects, was found on equipment and fruit at the Jensen Farms packing facility in Colorado.FDA Link..The recall that was announced on September 14 apparently actually began several days earlier and according to press reports included shutting down operations, the harvest and calling back trucks that were on the road. Four deaths out of 35 reported illnesses have occurred.
This recall brings into focus the new regulations that are to be promulgated by the FDA by January 2012 with respect to produce safety. Under Section 105 of FSMA the FDA is to establish standards for the safe production and harvesting of produce where the FDA has determined that standards would minimize the risk of serious adverse health consequences. FDA is required to publish a proposed rule on the minimum standards and publish updated Good Agricultural Practices by January of 2012. The standards are intended to include science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, nearby animals, water, and other hazards.
By this month, September 2011, the FDA is also expected to also publish a Notice of Proposed Rule Making which indentifies activities that constitute on -farm packing, holding, manufacturing and processing that will be subject to, or exempt from the Preventive Control Plan requirements under Section 103 of FSMA.
Arsenic in Apple Juice: Strong Poison or Much Ado About Nothing?
It's the battle of the network talking heads, M.D. division. In this corner, Dr. Mehmet Oz, host of the Dr. Oz Show on FOX, and former Oprah Winfrey contributor. In the other corner, Dr. Richard Besser, former head of the Centers for Disease Control and now chief health and medical director of ABC News. The issue: is there too much arsenic in apple juice marketed to consumers, including kids?
Click on the links above to see the positions of the two sides. Basically, Dr. Oz did a study of apple juice and found elevated levels of arsenic in excess of the amounts the FDA approves for simple bottled water. Weighing in on the side of Dr. Besser (or perhaps vice versa), though, is the FDA itself, which rather loudly is proclaiming "tosh." Or, rather, "Apple Juice is Safe to Drink."
It's hard to wade through the rhetoric here to figure out who's "right", particularly when even Dr. Oz is not recommending anyone give up apple juice because of the risk of arsenic. The FDA and the manufacturers all dispute both Dr. Oz's test results--they both tested juice from the same batches and came up with significantly lower levels of total arsenic--and criticize him for testing only for total arsenic, instead of distinguishing between inorganic arsenic, which is really bad, and organic arsenic, which the FDA says is generally safe and is ordinarily the kind of arsenic found in apple juice (but not in bottled water). Dr. Oz's response doesn't seem to be all that persuasive; if the juice doesn't test for too much inorganic arsenic (or too much total arsenic), does it matter that it comes from countries that use arsenic as pesticides? And arguments about whether apple juice is better for you than eating raw apples are neither made stronger nor weaker if the level of arsenic is insignificant.
Although known to the ancients as a poison, arsenic has many benign uses, including being used in the first effective treatment of syphillis. Along with other poisonous chemicals, it was used for centuries in makeup. The plot of Dorothy L. Sayers novel Strong Poison centers on a murder by arsenic poisoning, where the murderer (SPOILER ALERT!) developed a resistance to arsenic over time, and thus survived while eating the exact meal as his victim. The story was suggested by the tale of King Mithridates, as A.E. Housman wrote in "A Shropshire Lad,"
They put arsenic in his meat And stared aghast to watch him eat;
Today, arsenic is used in semiconductors and light-emitting diodes.
It is not for this blog, of course, to weigh in on the actual merits of the controversy. But we note that comments in the popular media about the safety of food can have a really strong, negative impact on purveyors of food items, whether they are true or not. A strong debate about food safety is always welcome, but the use of sensationalist headlines and a failure to meet scientific arguments head on can leave misleading impressions that can have really significant impacts on real people. Stay tuned.
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 FSMA requires the FDA to “establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a food borne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated …or misbranded."
The Pilot projects will be carried out by the Institute of Food Technologists (IFT) at the direction of FDA.
A product tracing system involves documenting the production and distribution chain so that a product can be traced back to a common source or forward through distribution channels if there’s evidence of contaminated food. The actions that follow may include removing the product from the marketplace and alerting the public if it has already been distributed.
The FDA indicated that: “What we’re looking for is a system that is practical, feasible, and rapid,” says Sherri McGarry, senior advisor in FDA’s Office of Foods. “Our No. 1 priority is protecting public health.”
McGarry explained that IFT will work with the key groups that have a stake in this endeavor—food industry, state and federal government agencies, and consumers—in developing the pilot programs. The goal is to include industries that represent the food supply chain, including farms, restaurants, and grocery stores.
The pilot programs will evaluate the types of data that are most needed for tracing, ways to connect the points in the food supply chain, and how quickly data can be made available to FDA. A key goal in the pilot projects will be to explore methods to track food and identify a common source or supplier starting at multiple points of sale. “We’re looking for a system that will allow FDA to quickly connect the dots along the food supply chain,” says McGarry.
Business should keep an on eye on this process as the resulting programs may impose similar requirements on FSMA registrants in the future.
On Monday, September 19, 2011, I will be speaking at The DEMATIC Material Handling and Logistics Conference in Salt Lake City , Utah and presenting, "Field to Fork: How the new Food Safety Modernization Act Will Affect You."
Introducing David Goodnight
We at the Food Liability Law Blog, and at Stoel Rives, are extremely pleased that David Goodnight, one of our most noted trial lawyers, has agreed to join the team as a point person for food and beverage litigation. David brings a wealth of trial experience as well as an incredibly calm "bedside manner" to the team. He's the perfect person to talk to if there's someone standing outside your door with what appears to be a subpoena or a warrant. He not only will know what you should do, he'll help to lower your anxiety level.
Here's what one of his food and beverage clients just said about David:
Stoel Rives, under David Goodnight's leadership, provided absolutely outstanding legal counsel for our small business. The partners at our firm marveled at his ability to litigate a very complex arbitration case to a successful outcome and then help connect us to the deep resources of Stoel Rives to solve the varied corporate and tax challenges we face as a small business. We were very impressed by the breadth and depth of legal counsel at Stoel Rives and have recommended your firm to a number of our friends who own small businesses and people that were in need of professional legal advice. Truly, we can't thank David Goodnight and the legal team at Stoel Rives enough for what they have done for our company.
And here's another testimonial from a client in the pharmaceutical industry:
I could not have been more fortunate than to have the opportunity to work with David as our attorney to handle a legal matter for my company. His expertise and clear explanation of options, strategies, possible outcomes, and recommendations helped me to make the right decisions for our company. I never felt worried about our position with David on our team. He helped me and our company to take a strong position in a difficult legal matter without putting us at risk to overspend or overextend ourselves at anytime. His calm, strong, and thoughtful attitude made me feel that he was working for our good at all times. Thanks to David, we achieved success in the legal matter that he handled for us. If our company or I am ever in the position to need an attorney with David’s expertise, I would not hesitate to call on him again. He’s remarkable.
David's clients include GE, Amazon.com, International Paper, Qwest Corporation, Century Link and Weyerhaeuser Company. He has been selected numerous times as one of Washington's top 100 lawyers, is recognized by Chambers and selected as a litigation star by Benchmark and Washington CEO. We're extremely pleased to have him join our team.
Please join us in welcoming David to the blog.
