General Publications January 12, 2015

“FDA Sets A High Bar When Considering Food Additive Bans,” Law360, January 12, 2015.

Extracted from Law360

At the end of 2014, the U.S. Food and Drug Administration was called upon to decide the fate of two common food additives, aspartame and bisphenol A, that had come under attack from consumer and environmental groups for their alleged health risks. After extensive inquiry into the scientific merit of these claims, the FDA declined to ban or limit current levels of these additives, employing a high bar for the reconsideration of the safety of additives.

The FDA commonly reviews requests for bans or limitations of various additives, and it is likely that the agency will continue to use such a high standard in future reviews. However, manufacturers of products regulated by the FDA should still take note of calls to ban or limit levels of additives, because if the agency does side with a challenger on a particular petition in the future, this action could have costly downstream effects within the food industry.

FDA Rejects Citizen Petition Call to Ban Aspartame

In November 2014, the FDA declined to ban aspartame, a popular sweetener additive first approved in 1981, stating that it had found no scientific evidence that the sweetener poses a health risk to consumers. The FDA issued its response following two citizen petitions that called on the agency to ban aspartame as a cancer-causing food additive.

The first petition was filed in 2002 by Betty Martini, founder of the consumer protection group Mission Possible International, and called on the FDA to recall aspartame as a “neurotoxic drug … masquerading as an additive.” The petition classified aspartame as a “dangerous chemical” and “poison” responsible for numerous health risks, including seizures, tumors and eye deterioration. The second petition was filed in 2009 by Paul Stoller, M.D., and asked the FDA to invoke the Delaney Amendment in revoking its approval of aspartame. The Delaney Amendment is a clause in the Food Additives Amendment of 1958 that prohibits the use of a substance as a food additive if it is found to cause cancer in man or animals or, after appropriate tests, found to induce cancer in man or animals. As noted in the legislative history of this clause and cited by the FDA, the safety demonstration requires proof of a reasonable certainty that no harm will result from use of the additive, but does not require proof beyond any possible doubt that harm will result.

The FDA denied the two citizen petitions after review of the scientific literature related to potential health risks of aspartame and additional limited data sets provided to the agency in petitions. The agency stated it has been monitoring the scientific evidence related to aspartame since the early 1970s and found no reason based on the data it reviewed to change its position concerning the safety of the sweetener. The FDA cited the lack of any “substantive scientific evidence demonstrating that aspartame’s use presents a public health risk or that this sweetener is adulterated or misbranded under the [Federal Food, Drug, and Cosmetic Act].” Also, while the FDA said it monitors adverse event reports it receives, the agency said it could not point to “an established mechanism that would explain how aspartame is associated with the reported adverse events.” Finally, the FDA specified that the safety of aspartame has been reviewed not only by the agency, but other “regulatory authorities” around the world, all of which have found that “aspartame is safe for the general population except for individuals with phenylketonuria” since phenylalanine is a component of aspartame.

FDA Declines to Take Action on Bisphenol A

Following the same protocol of its review of aspartame, the FDA similarly declined to ban bisphenol A (BPA), a chemical used in certain food packaging containers, such as the linings of food and beverage cans. For years, the FDA has received complaints from consumer health and protection groups, claiming that BPA is associated with various health risks, including heart disease. Further, several legislators in July 2014 sponsored the Ban Poisonous Additives Act in Congress, a bill that has been introduced in various forms over the past several years. If passed, the bill would have banned food and beverage containers with BPA from being sold unless affected companies obtained a waiver from the FDA.

The FDA has previously reviewed citizen petitions calling for a ban on BPA but, to date, has declined to act. In October 2008, the Natural Resources Defense Council filed a citizen petition requesting, inter alia, the prohibition of BPA in “human food and packaging.” The FDA denied this petition in March 2012, stating that “although FDA was not persuaded by the data and information in the [citizen] petition to initiate rulemaking to revoke the food additive approvals for BPA, FDA will continue in its broader and more comprehensive review of emerging data and information on BPA.” Note that the FDA has acknowledged that “[p]eople are exposed to low levels of BPA because, like many packaging components, very small amounts of BPA may migrate from the food packaging into foods or beverages.” Nonetheless, the FDA has found that its ongoing review of safety data continues to support this use of BPA in food containers and packaging.

During an extensive review of the scientific literature conducted in 2014, the FDA stated that it considered over 300 scientific studies in fields such as toxicology, analytical chemistry, endocrinology and epidemiology. In the FDA's review, it did not find “any information in the evaluated studies to prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.” However, the debate over the potential health risks of BPA continues today. Most recently, a Dec. 8, 2014, article in The New York Times reported on a new study published in a journal for the American Heart Association that found that BPA from a beverage can’s lining may “seep” into the liquid itself and “raise blood pressure within a few hours.” The FDA will likely continue to review new data as it becomes available regarding the safety of BPA.

Important: Stay Aware of Requests to Ban Additives

Given the FDA’s rejection of requests to ban both aspartame and bisphenol A, it follows that future requests to ban or limit the amount of additives in a particular product will be met with a high level of scrutiny and contemplation from the agency. The FDA takes matters of public health seriously, and it is clear that the agency regularly monitors the state of scientific literature on various additives and examines numerous mechanistic, toxicological and epidemiological studies in its reviews. While the FDA examines individual study data, the agency also looks to the totality of the scientific literature before making any decision.

Manufacturers should nevertheless pay attention to citizen petitions and legislative calls to ban or limit current levels of additives, as well as the state of the scientific literature related to the health risks of a particular additive contained within their products or packaging. If the FDA did decide to take action in the future and ban or limit a certain additive, that action could have the potential to necessitate major changes in the food industry, such as reformulation of products and packaging and identification and sourcing of alternative components or ingredients. In the process, there can be reputational risks to manage for both the product brands and company itself among loyal consumers and investors alike. Therefore, manufacturers should be actively engaged during the comment period following any regulatory notice or action to ban or limit an additive, especially if companies have their own safety data on file demonstrating no known harm for their additives or if removal of an additive could effectively remove their product as it is currently known from the marketplace.

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