Safe to Eat? States vs. Feds in the Food Dye Debate

by Candace Yamanishi*

There is a shifting sentiment against the use of synthetic food dyes in the US food supply. As citizen-led advocacy groups have been raising their voices about the health concerns of artificial food dyes, several states have introduced or passed legislation banning or limiting the use of certain synthetic food dyes in food products. These efforts reflect the growing concerns over links between artificial dyes (such as Red No. 3, Yellow No. 5, and others) and potential effects on children’s learning and attention, as well as possible risk of carcinogenic effects. These state-wide initiatives have now captured the attention of the federal government and the larger food industry as a whole. Since the U.S. Food and Drug Administration (FDA) maintains nationwide regulatory authority over food additives, a crucial question emerges: can state bans and restrictions on FDA approved food dyes stand, or will they be preempted by federal law?

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To Eat or Not to Eat: For Consumers in a City Without a Food Allergen Ordinance, The Choice Could Be Life or Death

by Melissa Deng*

For many of us without food allergies, we don’t think twice about choosing to dine at a restaurant or order take-out––often, the biggest concern is picking which restaurant you feel like eating at, what to order, and comparing costs.  But for individuals with food allergies, the choice between dining in and ordering out can mean life or death.  Even so, cities you might think are more “food allergy-friendly” like Los Angeles, which has a colloquial reputation for having a vibrant food scene, may not have an ordinance specifically governing food allergen training in restaurants––even while more than fifty percent of adults with food allergies and over forty percent of children with food allergies in the United States have experienced a severe food allergic reaction (of note is that emergency treatment for anaphylaxis resulting from a food allergic reaction increased by 377 percent between 2007 and 2016). 

What gives?  For starters, the restaurant industry is of course profit-driven, and restaurant associations have a significant impact on lobbying for or against legislation.  From an economic perspective, restaurant management might be wary of the increased costs an ordinance specifically mandating food allergen training would impose, compounded by the fact that the restaurant industry generally experiences high turnover (reportedly, there was a 28% average turnover rate for restaurants in LA last year).  From a legal perspective, restaurants might not want to face increased liability: with an ordinance that mandates training, plaintiffs can more easily make a prima facie case of negligence by showing that the restaurant’s conduct deviated from an established standard of care.  And from a psychological perspective, restaurant staff might have misconceptions about their role in preventing food allergic reactions (for example, believing that the onus falls solely on customers to order a dish that doesn’t have food allergens) and might not realize the potentially fatal consequences, such as anaphylaxis resulting from a food allergic reaction.   What this means is that consumers with food allergies are unfairly subjected to a burdensome and dangerous dining experience where each restaurant chooses which food allergen procedures to follow and to what degree. 

It is precisely this issue that drove us at the Resnick Center for Food Law & Policy, in collaboration with a professor and clinical immunologist at UCLA, to begin collecting both hospital-based and anecdotal evidence on instances of food-related anaphylaxis in the city, and pursuing the task of proposing a food allergy ordinance in the City of Los Angeles that will mandate a separate food allergen training for all restaurant employees in the city.  In the beginning stages of the project, we sought to answer two underlying questions: how do restaurants communicate allergen information to their consumers; and are they effectively training their personnel in allergen disclosure for menu labeling or food handling?

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In Search of Greener GRAS: How Regulatory Policy has Created the American Diet and How to Fix it

by Trey Catanzaro*

If you ask most Americans what food additives they may “generally recognize as safe,” it is highly unlikely that they would answer “propyl paraben” or “beta hydroxy acid.” Rather, they may say vinegar, olive oil, or black pepper. In fact, when asked about what “generally recognized as safe” means, a national poll found that 77 percent of respondents thought that standard meant the FDA has evaluated the product and determined it to be safe. However, under current FDA regulations, a company may self-determine whether its product is “generally recognized as safe” under FDA guidelines, and then bring it to market without even notifying the FDA as to its existence. In other words, there are currently thousands of chemicals in everyday food that the FDA has no clue even exist. As succinctly stated by the former Deputy Commissioner for Food at the FDA, “[w]e simply do not have the information to vouch for the safety of many of these chemicals.”

Most chemical additives enter the American food supply due to an exception in FDA pre-market review for ingredients that are generally recognized as safe (GRAS). In legislation drafted in 1958 to address the rising issue of additives in food, Congress specifically exempted certain ingredients which were “generally recognized . . . to be safe under the conditions of [their] intended use” from the definition of additives. Therefore, anything determined to be GRAS would not be subject to pre-market review and approval by the FDA. At the time of passing the amendment, the reasoning for the GRAS exemption was so that ingredients that had long been used in foods without apparent harmful effects, such as salt, sugar and other familiar substances, would not have to undergo extensive testing to be used in food products. However, the GRAS exemption continued to expand, eventually permitting companies to self-determine whether their ingredient was GRAS, and giving them the choice of whether or not to notify the FDA of their GRAS determination.

Under the present iteration of the rule, companies’ GRAS determinations are filled with a litany of conflicts of interest. Rather than relying on peer-reviewed data, companies often convene panels of experts to make a GRAS determination. These panels are frequently made up of the same small group of individuals who have made a career out of GRAS panel participation. To put this in perspective, a comprehensive study looked at convened GRAS determination panels from the year 2015 to 2020, and, out of the 732 panel positions available, there were a mere 7 individuals who filled 339 (46%) of these positions. Their determinations of safety are often never sent to the FDA for review. Further, even if a GRAS determination is sent to the FDA for notification, which is not required, and valid concerns are raised about the safety of the product, this does not always preclude the product from coming to market. Companies have the ability to voluntarily withdraw their petitions should they foresee unfavorable results from the FDA’s review. Therefore, after receiving health concerns from the FDA based on its review of a GRAS notification, the company may then withdraw its notification and continue to market the product. The FDA will then issue a letter of withdrawal without acknowledging the safety concerns raised during the review.

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