Update on BPA Regulation

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.

FDA Will Continue to Study the Safety of 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.

Upcoming Deadline for FDA to Decide Whether to Ban BPA

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.  

Bottled Water Association Sues Over Water Bottle Ads

The International Bottled Water Association (IBWA) is taking aim at an advertising campaign for Eco Canteen stainless steel water bottles, claiming the ads wrongly suggest that plastic water bottles are unhealthy and unsafe.

In a lawsuit filed in the U.S. District Court for the Western District of North Carolina, IBWA claims that Eco Canteen’s television ads and content on various Eco Canteen websites deceive the public into believing that single-serve and reusable plastic water bottles constitute a safety and health risk to consumers. Among other things, IBWA’s lawsuit alleges that some of Eco Canteen’s ads have:

  • Improperly linked plastic water bottles to breast and prostate cancer and stated that plastic water bottles “could be poisoning you and your family”;
     
  • Matched images of single-serve plastic water bottles with Eco Canteen’s claims “relating to an organic compound called Bisphenol A (BPA) with the intent to confuse consumers into believing that single-serve bottles also contain BPA even though they do not”;
     
  • Conveyed false and misleading information regarding the alleged health risks of BPA; and
     
  • Suggested that exposing certain water bottles to warm temperatures can lead to leaching of chemicals.
     

IBWA brings two claims against Eco Canteen: (i) a false advertising claim under the Lanham Act, 15 U.S.C. § 1125; and (ii) an unfair competition claim under North Carolina law. A copy of the complaint (including exhibits showing some of the Eco Canteen ads about which IBWA complains) is available here.