On Tuesday, the U.S. Food and Drug Administration (FDA) announced that bisphenol A (BPA) is now formally banned from use in baby bottles and sippy cups. The announcement came as a surprise to some as the FDA had only just recently, on March 30, 2012, issued a decision to deny a petition by the Natural Resources Defense Council (NRDC) to ban the use of Bisphenol A (BPA) in all food and beverage packaging materials (see previous blog post on FDA’s denial here). The FDA explained in its denial letter that it appreciated the NRDC’s concern for consumer safety, and that it planned to continue to study the effects of BPA on human health.
Although the FDA is prohibiting the controversial chemical from baby bottles and sippy cups, the agency will continue to allow the presence of BPA in the packaging of other consumer goods. According to a statement by FDA spokesman Allen Curtis, “The agency continues to support the safety of BPA for use in products that hold food.” Rather than being based on safety, the FDA maintained that the ban is in response to the baby bottle industry’s voluntary phase out of the chemical over the last several years.
In related news, Washington State’s ban on the use of BPA in plastic sports bottles became effective last week. The ban is the result of a law passed in 2010 (RCW 70.280) prohibiting the sale of certain products containing BPA. Beginning in July 2011, manufacturers were banned from using BPA in bottles, cups and other containers for children under the age of 3. Now the law has been officially extended to prohibit the presence of BPA in sports bottles. A statement from the Washington State Department of Ecology explains that “[n]o sports bottles containing the chemical BPA can be made, sold or distributed in Washington as of July 1, 2012.” The ban will apply to all sports bottles up to 64 ounces. However, metals cans designed to hold or pack food will still be allowed to contain BPA.
In following up from a previous Food Liability Law blog post that was recently published on Law360, the U.S. Food and Drug Administration (FDA) announced on Friday, March 30, 2012, that is was denying a petition by the Natural Resources Defense Council (NRDC) to ban the use of Bisphenol A (BPA) in food and beverage packaging materials.
The NRDC had filed a petition with the FDA in October 2008. The petition challenged the FDA’s position that exposure to BPA in low levels is safe, and accordingly, requested that the FDA ban the use of BPA as a food additive or in any substance that may become a component of a food product, as defined by the Federal Food, Drug and Cosmetic Act (FFDCA). Pursuant to a court order issued in December 2011, the FDA had until Saturday March 31, 2012 to issue a response to the NRDC’s petition.
The FDA explained in its denial letter that it appreciates the NRDC’s concern for consumer safety, and it will continue to broadly and comprehensively review scientific data regarding the effects of BPA on human health. In addition, the FDA plans to complete studies already in progress at the agency’s National Center for Toxicological Research (NCTR). The letter concluded:
FDA has determined, as a matter of science and regulatory policy, that the best course of action at this time is to continue our review and study of emerging data on BPA. . . . FDA is performing, monitoring, and reviewing new studies and data as they become available, and depending on the results, any of these studies or data could influence FDA's assessment and future regulatory decisions about BPA.
Douglas Karas, a spokesman for the FDA, stated, “I cannot stress enough that this is not a final safety determination on BPA.” He added, “This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging.”
Yet, despite the FDA’s decision to deny the NRDC’s petition, many major food companies have already begun using alternative packaging methods thereby eliminating BPA in order to quell public concern over the potential risks associated with the chemical.
Bisphenol A (BPA) is an industrial chemical that has been present since the 1960s in plastic used in consumer products, including reusable water bottles, sippy cups, and baby bottles, to prevent cracking. BPA is also used in the protective lining inside metal-based food and beverage cans to avoid corrosion. In recent years BPA has become the focus of a heated debate. Citing an increasing body of scientific evidence, consumer and health advocates argue that there is a link between disruptions in the endocrine system and the consumption of products packaged with materials that include BPA. Certain studies have identified BPA as a risk factor in breast and prostate cancer, early puberty, childhood obesity, autism, and hyperactivity. Accordingly, critics of BPA believe it is a substance unfit for human consumption and have urged a ban on its use in food and beverage containers.
The U.S. Food and Drug Administration (FDA) and the National Toxicology Program of the Department of Health and Human Services maintain that low level exposure to BPA does not pose a serious risk to human health based on studies employing standardized toxicity tests. However, both agencies have noted some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. The FDA has since undertaken to do further research into the potential health risks associated with BPA.
In attempt to put pressure on the FDA to clarify its stance on BPA, just over three years ago the National Resources Defense Council (NRDC) filed a petition with the FDA challenging its position that exposure to BPA in low levels is safe. The petition requested that the FDA ban the use of BPA as a food additive or in any substance that may become a component of a food product, as defined by the Federal Food, Drug and Cosmetic Act (FFDCA). For several months, the FDA delayed responding to the NRDC’s petition.
Prompted by the FDA’s failure to respond, NRDC filed suit in 2010 seeking judicial intervention that would require the FDA to decide by a date certain whether the use of BPA, particularly in food packaging and any material likely to come in contact with food, should be banned. In a settlement agreement, the parties agreed FDA would make its decision about the use of BPA by March 31, 2012 - a date that is rapidly approaching. The FDA’s decision will come on the heels of France’s decision in early February 2012 to ban the use of BPA in all food packaging.
What impact would a ban of BPA have on industry if imposed? Almost certainly as companies adapted to the new ban, their costs would increase. The extent of those costs would likely differ based on the size of the company and the extent of required changes to production. The disruption may be dampened a bit because several food companies have anticipated the issue. A recent report issued by the U.S. Department of Agriculture indicates that several major U.S. companies have already begun using alternative packaging methods to comply with BPA bans on both state and international levels, and to meet increasing consumer demand for BPA-free products. Eden Foods, Muir Glen, Edward & Son, Trader Joe’s, Vital Choice, Wild Planet Foods, Oregon’s Choice Gourmet and Eco Fish already use BPA-free containers for some or all of their products. In addition, Heinz, Hain Celestial and ConAgra have begun taking steps toward eliminating the use of BPA in their packaging.
It will be interesting to see what decision the FDA will announce by the end of this month.
Here's a link to an article that appeared recently in Inside Washington's FDA Week concerning the issue of front-of-package labeling (FOP). The article takes aim at the debate about state vs. federal regulation of FOP labeling. Here's a link to a recent post in this blog on the FOP issue.
Yes, someone has actually filed a putative class action on the basis that she was “mislead by the packaging and marketing, which she argues convey the message that the Product contains real, nutritious fruit.” U.S. District Judge England in the Eastern District of California dismissed the complaint captioned as Sugawara v. Pepsico, Inc.
Though Sugawara seems purely frivolous, the claim follows predictably from the Ninth Circuit’s decision in Williams v. Gerber discussed previously on this blog. In Williams, the Ninth Circuit reinstated a putative class action that alleged labeling on “fruit juice snacks” (1) constituted misrepresentation and breach of warranty under California common law and (2) violated California’s statutes on unfair competition and consumer law. The district court had granted a motion to dismiss under Rule 12(b)(6), finding that statements on the label “were not likely to deceive a reasonable consumer, particularly given that the ingredient list was printed on the side of the box.”
Judge England distinguished Sugawara from Williams, writing that
while the challenged packaging contains the word “berries” it does so only in
conjunction with the descriptive term “crunch.” This Court is not aware of, nor has Plaintiff alleged the existence of, any actual fruit referred to as a “crunchberry.” Furthermore, the “Crunchberries” depicted on the PDP are round, crunchy, brightly- colored cereal balls, and the PDP clearly states both that the Product contains “sweetened corn & oat cereal” and that the cereal is “enlarged to show texture.” Thus, a reasonable consumer would not be deceived into believing that the Product in the instant case contained a fruit that does not exist.
Even lawsuits as unmerited as alleging that consumers believe Crunchberries grow on trees are expensive to deal with. As we said following the Williams decision, the sad state of affairs is that the only way manufacturers can mitigate against these types of putative class actions is to directly involve lawyers in the marketing and labeling process.
Bill Marler funded independent research at the University of Idaho to study the adequacy of cooking instructions found on the packaging on various retail brands of frozen ground beef patties. The research was published this month in Food Protection Trends.
The study found that three of the packages included cooking instructions that “would be inadequate to produce a safely cooked patty.” Most of the issues raised in the article center on the variability in cooking techniques, e.g., pan frying, using a propane grill, or preheating, and variability in cooking temperatures. Suggested solutions for improved cooking instructions are included in the study.
For food sellers trying to minimize or avoid claims, adequate cooking instructions are a good thing. Even if food-borne illness claims cannot be avoided, the scope of the claims and damages can be limited by providing adequate, "bullet-proof", cooking instructions.
Kudos to Bill Marler for “putting skin in the game” and funding this study.
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 that General Mills should file a new drug application with the FDA if it wants to keep making these claims on Cheerios boxes. The FDA also noted concerns with statements made on a General Mills-sponsored website regarding the benefits of eating whole grains.
The Wall Street Journal is reporting that a General Mills spokesperson said the company will work with the FDA to reach a resolution regarding Cheerios labeling.