In September 2017, Laura,1 53, was on her third battle with Clostridium Difficile (c-diff.), a bacterium that causes gastrointestinal disturbances and potentially deadly inflammation of the gastrointestinal tract.2 She had tried the first line medication, metronidazole, which had worked for her previously, but it seemed to no longer be effective. Now she was having inconsistent results with the second line medication, vancomycin.3 After Laura kept a food diary for a few weeks documenting what she ate each day and rating her symptoms for that day, the doctor identified certain categories of processed foods that seemed to affect Laura’s responsiveness to her medication. On a more restrictive diet, Laura found that her body responded to the vancomycin and she is now in remission. Unbeknownst to Laura, the processed foods she removed from her diet contained a substance, invisible on the ingredient list, which enhances the virulence of c-diff.
Food choice is a decision to allow something to enter one’s body, but this decision is affected by more than just taste preferences. People managing preexisting medical conditions or those who take medications may have to avoid certain substances. Food ingredients have been linked to changes in gut bacteria, elevated risk for insulin resistance, weight gain,4 and even disruption of hormone function.5 Additionally, millions of Americans live with some form of a food sensitivity.6 An allergy or intolerance means that some ingredients can cause mild to potentially fatal bodily responses.7 Individuals that follow the latest scientific data of foods’ effect on the human body may prefer to avoid certain preservatives, fake sugars, and flavorants.
Food choice decisions should be an informed decision considering all of the ingredients. But current food labeling laws leave too many gaps in the ingredient listing to be fully informed. Food labeling laws encourage food manufacturers to list substances under generic category names, cloaking a variety of substances that consumers may wish to avoid for various reasons. For instance, Laura did not know that her restrictive diet made the vancomycin work better because she was avoiding trehalose, a sweetener that can appear in the ingredients of processed foods as “natural flavoring”8 and which encourages hypervirulence of c-diff. in suffering patients.9 But Laura, and c-diff. sufferers in general, are not alone in struggling with ingredients that are being hidden by the generic ingredient categories on food labels.
These generic ingredient categories originate in the Federal Food, Drug, and Cosmetics Act (FDCA), which defines misbranded or adulterated foods.10 The statute and subsequent Food and Drug Administration (FDA) regulations create hiding places for certain substances.11 This creates labeling discretion that manufacturers can take advantage of. The collective result is that consumers of processed foods are unwittingly assuming the risk of exposure to unknown substances.
Part I-A of this article describes how the legal framework for ingredient labeling provides gaps that enable ingredients to be hidden. Part I-B discusses which ingredients can legally be used in food manufacturing. Part II-A provides some examples of the issues these gaps have created and Part II-B considers some labeling mechanisms that legislature and manufacturers have developed to cope with public concerns. Part III-A recommends that all food manufacturers should be required to disclose all ingredients. Part III-B will briefly introduce the problem of trade secrets that may affect such disclosure.
Part I-A: Misbranding and Gaps in the Labeling Framework
Section 403 (i) of the FDCA, codified in 21 U.S.C. § 343, deems a food product misbranded unless all ingredients on the product label are listed by their common or usual name.12 The stated goal of this system is to allow consumers to pick and choose which ingredients they would like to consume.13 To avoid being misbranded, processed foods must comply with the following labeling mandate if they are:
fabricated from two or more ingredients, the common or usual name of each such ingredient [should appear on the label]. . . except that spices, flavorings, and colors . . . unless sold as spices, flavorings, or such colors, may be designated as spices, flavorings, and colorings without naming each.14
This section seems to require disclosure of all of the ingredients in food. But there are ambiguities within this mandate with the phrase “spices, flavorings . . . may be designated . . . without naming each.”
This “spices, flavoring” exception provides a broad ingredient labeling loophole. The FDA outlines very specific regulations for labeling ingredients.15 Requirements such as putting the ingredients in descending order by quantity and how to name ingredients seem intended to provide consumers with a precise understanding of what ingredients they are consuming and how much of each.16 But a quick glance at the various definitions and regulations involved with the words “spices”17 and “flavorings”18 tells a very different story. For example, 21 C.F.R. 101.22 lists two types of flavorings, natural and artificial.19 “Natural flavoring” can refer to any substance derived from:
the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in [other sections of the regulation].20
The expansiveness of this definition includes multiple methods for obtaining a flavoring component from multiple categories of “natural” sources. However, once the substance has been derived by one of these processes, the resulting flavor is often anything but natural.21 These separation processes tend to require the force and combination of several chemicals.22 The resulting flavor is a mixture of some component of the original natural source and a collection of chemical residue.23 Therefore, an ingredient that may originate from a source the FDA has designated as “natural” may be a completely unrecognizable chemically altered ingredient.24 Yet the whole mixture will appear on the food label as “natural flavors.”
Natural flavor is one of the top five most common ingredients in manufactured food products.25 One study estimated some “natural flavors” can consist of as many as 250 chemicals in addition to the derivative from the “natural” source.26 But when consumers read “natural flavor” on the ingredients list, they are likely to believe that this merely refers to some wholesome, chemical-free flavors.
Further, the definition for “natural flavors” includes fruit and vegetable juices, meat, and dairy products.27 While it may seem like splitting hairs, it is important to note that fruit and vegetable juices, meat, and dairy products are themselves already processed substances from produce and animals. This leaves even more room for unknown ingredients to be incorporated into the manufactured foods undisclosed to consumers, such as the preservatives utilized to maintain the juices until it is utilized as a flavoring component.
Similar issues of nondisclosure arise with the definitions of artificial flavors28 and spices.29 The flavoring and spices ingredient labeling categories create generic labeling terms that can encompass many types of chemicals and ingredients.
Part I-B: Adulteration and the GRAS Exception to the Food Additives Rule
According to section 402 of the FDCA, food is considered to be adulterated if it has an added substance that “may render it injurious to health” or for incidentally containing a substance not specifically added by the food manufacturer in a quantity that “ordinarily render[s] it injurious to health.”30 Congress enacted an amendment to the FDCA in 1958 known as the Food Additives Amendment (FAA) to respond to rising consumer concerns about the chemicals that were being added to food.31 The amendment aimed to regulate food additives to force substances to be adequately tested to demonstrate their safety.32
Food additives are any substances added to a food product to alter the characteristics of the food.33 The FAA creates the presumption that food additives are unsafe and adulterated.34 To rebut this presumption, food additives can still be used in food manufacturing after they are subjected to the FDA’s premarket approval process.35 For premarket approval, ingredient manufacturers must file a food additive petition pursuant to 21 U.S.C. § 348.36 A food additive petition is time-consuming and expensive for manufacturers to file as it requires full FDA notice and rulemaking with comment.37 If a substance is present in a food product without an approved food additives petition the product is considered adulterated and illegal to sell in interstate commerce.38
However, there are several exceptions to the food additives definition.39 One is for substances that have a legacy presumption of safety from their consistent usage in food prior to January 1, 1958 (such as salt and sugar).40 The concerning exception to the food additives rule is the ironically titled “generally recognized as safe” (GRAS) exception.41
As the name implies, the GRAS exception is designed to allow ingredients that have been well studied via proper scientific testing by qualified experts to not be adulterated and skip the hassle of food additive petitions.42 The FDA does not need to rigorously test substances that are already known to be scientifically sound as food ingredients. Such ingredients need not endure any further pre-market testing before appearing in food products.
The GRAS exception’s ability to avoid filing a food additive petition has become the preferred mechanism for putting ingredients onto the market. The problem with this mechanism is that there is no one overseeing the GRAS status determination; manufacturers are responsible for determining the GRAS status of their chemical ingredients privately.43
A system of self-determining by private manufacturers ignores the fact that the GRAS exception was built on the idea of publicly available scientific knowledge showing that a substance was generally known to be safe.44 The FDA has noted that GRAS-exempt ingredients are supposed to be based on the equivalent amount of scientific evidence as would have been required for a food additive petition.45 However, it is presumed that there may be thousands46 of substances used in foods under the GRAS exception without any publicly available scientific data.47
In August 2016, the FDA promulgated a final rule to provide a voluntary system of reporting self-determined GRAS status to obtain FDA approval of the GRAS determination via a GRAS notification petition.48 This offers a benefit to ingredient manufacturers that want to sell their ingredients to food manufacturers by providing a way to declare and market their ingredients as GRAS. Manufacturers can choose to submit paperwork to the FDA to inform the agency of their GRAS determinations.49 If the FDA approves the GRAS notification petition, or a manufacturer’s documentation of its research methods for testing the safety of the ingredient, the FDA will issue a “no questions” letter to declare that the FDA approves the research methods and documentation of the manufacturer.50 This system, however, is voluntary and there is no incentive for food manufacturers to reveal their actual ingredients and recipes; it merely provides a mechanism for improving the marketability of substances that have been properly determined to be safe for ingredient manufacturers. Being that it is not mandatory to have a “no questions” letter to market food products, food manufacturers that have not properly tested the safety of their ingredients are still permitted to sell products that may contain inadequately tested or untested ingredients.51 There is presently no way to know how many food manufacturers are self-determining the safety of their own ingredients without publicly available research.52
Private research organizations have tried to determine what chemicals are actually in food products via undisclosed GRAS determinations.53 In 2014, the National Resource Defense Council (NRDC), a nonprofit environmental advocacy group, discovered 275 self-determined GRAS chemicals utilized in food.54 But the NRDC estimates this is just the “tip of the iceberg” with potentially thousands of unknown substances in foods.55 The NRDC’s research revealed that manufacturers chose to keep their GRAS determinations undisclosed for reasons such as wanting to avoid making GRAS determinations easier for competitors, misunderstanding the law of what was required to market their substance, and wanting to evade the requirements of other statutes.56
The FDA has not set standards for manufacturers regarding managing these biases and self-interest concerns when making their own GRAS self-determinations.57 Without any quality control system in place, there is little reassurance for consumers that manufacturers have devoted the proper time and funding necessary to thoroughly research the safety of a substance. Very little, if any, information is known about the research methodologies of food manufacturers that make their own GRAS determinations and keep the substances private for trade secret purposes.
Additionally, the FDA seems unphased when ingredient manufacturers withdraw their GRAS notifications petitions.58 If a manufacturer realizes in the middle of a GRAS notification petition that the FDA is likely to reject its research methodologies and withdraws its petition, the public might expect that the FDA would demand that these manufacturers recall all food products containing these poorly researched ingredients immediately. However, the FDA makes no effort to remove such substances from the market nor asks any questions as to why the manufacturer decided to revoke the application before the FDA could complete reviewing it.59 There is not even an effort to remove food products from the market that contain substances that the FDA specifically refused to approve for human consumption.60
For example, the key ingredient in the now popular “Impossible Burger” contains soy leghemoglobin.61 When the Impossible Burger’s manufacturer, Impossible Foods, voluntarily submitted its petition to obtain GRAS approval for soy leghemoglobin, the FDA rejected it.62 The FDA decided against declaring soy leghemoglobin as GRAS because it felt the research conducted to determine its safety was insufficient to determine that the substance is not an allergen.63 If the FDA could not declare the ingredient as GRAS because the research methods were insufficient, which therefore disqualifies the ingredient from being deemed GRAS, this should constitute the ingredient a food additive.64 And having an unapproved food additive in a marketed food product in interstate commerce constitutes adulteration.65 Yet the Impossible Burger remains on the market. The GRAS exception has overtaken the food additives rule.
For known controversial GRAS substances, the FDA has regulations for filing a petition to have these substances reevaluated and potentially removed from the market.66 The FDA does not provide information on what standard it uses or what factors will be considered in evaluating the information surrounding controversial ingredients.67 When the FDA rejects such a petition it cites a “disagreement with the petitioner’s scientific basis.”68 It can take years for the FDA to finish its evaluation once a petition is filed.69 For instance, the Center for Science in the Public Interest’s70 petition for revoking GRAS status of partially hydrogenated oils (PHOs or Trans Fat) which was filed in 2004, was finally granted in 2015.71 However, even once the GRAS status of PHOs was revoked, manufacturers were permitted to continue manufacturing products containing PHOs until June 2018, and these products could remain on store shelves until January 2020.72 This is concerning because a five-year delay in the removal of a substance that the FDA has determined is not safe means five years of continued consumer exposure to a substance that should not have been in food. Consumption of PHOs can risk the development of a chronic condition or illness, like obesity or type 2 diabetes, over a long period of time.73
However, consumers can only file petitions for the FDA to investigate the GRAS status of substances that they are aware are present in the food products. For undisclosed GRAS determinations hidden under the spices or flavorings74 categories, consumers can merely hope that manufacturers do not act out of self-interest and are actually conducting “no questions letter”-worthy research.
Part II-A: Problems with Undisclosed Ingredients and Efforts to Address Some of These Issues
These ingredient-labeling gaps are problematic as they remove consumers’ control over what they are consuming. The spices and flavoring categories can mask thousands of different ingredients and chemicals, which may cause consumers to struggle to avoid substances that they may want or need to avoid.
Examples of How Not Knowing the Ingredients of Food Can be Problematic
It is impossible to list all of the controversial substances that can be hidden within ingredient categories. Below are several examples of hidden substances and the problems they may cause.75
Trehalose76 received a “no questions” letter from the FDA regarding its manufacturer’s GRAS determination on October 5, 2000.77 In May 2017, Nagase America LLC, a U.S. manufacturer of trehalose, announced that trehalose now fits the ingredient labeling requirements of “natural flavoring.”78 But research published in January 2018 shows that trehalose is linked to a rise in the occurrence of c-diff.,79 a bacterial infection that used to appear mainly in older individuals that is caused by long-term courses of antibiotics and by stays in medical care facilities.80 The Mayo Clinic notes that there has been an uptick in a particularly aggressive strain of c-diff. since 2000, when trehalose was commercially introduced into the American diet.81 Trehalose significantly improves the virulence of two resistant strains of c-diff., raising the risk of healthy individuals developing this potentially deadly infection.82 Additionally, consumption of trehalose aggravates the severity of the symptoms of individuals already struggling with c-diff.83 Considering the high recurrence rate of c-diff.,84 individuals who have had or are presently suffering from c-diff. would be wise to avoid consuming trehalose. However, trehalose is often not explicitly listed in the ingredients and instead hidden as natural flavoring.
Some hidden ingredients can affect how medications interact in the body and should be avoided by affected individuals. The expression and absorption of the medication can be altered by other substances in the body.85 Doctors or pharmacists typically notify patients of these interactions to avoid harm from the medication. However, patients cannot avoid what they do not realize they are consuming. Grapefruit, for instance, is often hidden under a generic food label category in foods such as soft drinks.86 Yet this fruit and its extracts are associated with a wide range of medication interactions. Chemicals in grapefruit interact with the enzymes in one’s intestines and can affect the breakdown of medications, causing an individual to absorb too much or too little of the medication.87 This can put an individual at risk of experiencing toxicity from overabsorption of the medication or the consequences of under-absorption of the medication.88 Medication interactions with grapefruit derivatives have been found with individuals taking immunosuppressants, such as transplant patients,89 as well as individuals taking blood pressure medications, cholesterol medications,90 and even birth control pills.91
Monosodium glutamate (MSG) is one of the longest-running food labeling controversies in the United States, with arguments against this ingredient starting as early as the 1960s and continuing to the present.92 Some people have complained of a sensitivity to MSG, resulting in a collection of mild to moderate symptoms, such as triggering skin disorders.93 Other research has tied MSG to more severe ailments, including causing blindness and neurological issues.94 The FDA has only recognized that MSG can trigger migraines.95 While MSG is now required to be listed as an ingredient on the label of foods that contain it,96 manufacturers seem to have discovered a loophole.97 Glutamates do not have to be declared on ingredient labels despite being chemically identical to MSG.98 Glutamates can be disguised under the phrase “natural flavoring” in the ingredients and therefore hide from consumers who actively seek to avoid MSG.99 Manufacturers have argued that glutamates should not be required on the ingredients label because they naturally occur in other foods.100 A proposed rule sought to have glutamates removed from the flavoring exception, as was done with MSG, which would require manufacturers to declare the presence of glutamates on the label. Unfortunately, this consideration ended in 2003 when the FDA formally withdrew the proposed rule.101
Dietary Restriction Preferences
Voluntary dietary restrictions are at issue as well if individuals cannot know which ingredients they are consuming. For instance, natural flavoring can encompass products of animal origin.102 This is problematic for individuals who choose to avoid the consumption of foods that utilize animal products. Vegans, for example, would likely prefer to avoid products containing castoreum, a secretion from the castor sacs of beavers103 that can be used as a flavor enhancer in strawberry and raspberry flavored snacks.104 However, castoreum fits neatly into the requirements for being listed as a natural flavor on the food label ingredients, making it difficult to identify its presence in a product.105 This concern may also arise for people with religious dietary restrictions, such as those following the rules of Halal and Kosher.106 While there are no health consequences to misleading someone into consuming products in violation of his or her dietary restriction preferences, there are ethical and autonomy issues with deceptive ingredient naming practices.
Part II-B: Efforts to Identify Problematic Hidden Ingredients
The current labeling statutes and regulations allow manufacturers to hide the above substances and many others from consumers. While such practices have often been justified by claims of avoiding consumer confusion, trade secrets, and limitations of labeling space,107 there have been some attempts to provide consumers with accurate information about certain ingredients.
Mandatory Allergen Labeling
In 2004, Congress passed The Food Allergen Labeling and Consumer Protection Act (FALCPA).108 FALCPA covers eight common allergens: “milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.”109 According to FALCPA, such ingredients must either be listed independently by their name in the ingredients list or a statement must appear underneath the ingredient list stating that the product contains this allergen.110
While this is a limited acknowledgment of individuals suffering from food sensitivities, it is a step in the right direction. A substance derived from peanuts can be merely flavoring to one individual but lethal to another. However, more is needed to address the vast array of documented food sensitivities, considering the over 160 known allergens.111 Additionally, in rare instances medical professionals discover that typically safe substances can cause dangerous allergic reactions.112 Individuals who know they have uncommon food sensitivities should be equally able to determine whether or not a food product will trigger a negative physiological response. Spices in general are considered to be an uncommon source of anaphylactic allergic responses.113 For example, in 2018 a woman unexpectedly had an anaphylactic response to undisclosed coriander in her beer.114 Coriander often appears as merely “spices” on nutrition ingredient labeling, which could make it difficult for this woman or those similarly situated to detect the triggering ingredient when making food choices.115 Further, there may be food sensitivities to substances that are unknown because of the deleterious combination of the loopholes in food ingredient labeling laws and GRAS self-determinations.
Manufacturers have started to take the initiative to voluntarily label their products as being free of substances that the public has deemed concerning. Recombinant bovine somatotropin, or rBST, is a controversial artificial hormone given to cows to increase their milk production.116 Genetically modified organisms, known as GMOs, are genetically altered crops, which despite being scientifically shown to be safe, remain controversial.117 Substances like gluten, rBST, and GMOs are often mentioned on packaging for products that do not contain them. Such declarations aid consumers that are trying to avoid these substances.
While approximately three million Americans live with celiac disease and 18 million live with gluten sensitivity,118 it was not until August 2013 that the FDA announced its rule to standardize what the phrase “gluten free” would mean when written on the label.119 However, the labeling is entirely voluntary; consumers must look for the “gluten free” label or else assume that the product may contain hidden gluten. Similar labeling appears on milk that is rBST free, as well as products that are non-GMO, certified vegan, organic, and the like.
This voluntary labeling system is helpful for individuals with various dietary concerns but it shows the flaws in the United States’ food labeling system in several ways. First, in order for a substance to be acknowledged on the label on products that do not contain it, the substance must have gained enough public attention and concern to incentivize manufacturers to label. Less common or rare sensitivities, even potentially fatal allergens, are unlikely to be afforded space on the label since they receive less public attention. Second, food packaging has a limited amount of space. As companies add more labels, food packaging may start to run out of room, which could affect whether a manufacturer decides to add a voluntary label. Lastly, with unknown, potentially untested GRAS substances in processed foods, people may be suffering from food sensitivity reactions that they will never be able to identify. If people do not realize they are suffering digestive issues or headaches from a chemical they are unaware they are consuming, they cannot complain to manufacturers about wanting to avoid this substance. This voluntary labeling system can only reassure individuals who know the identity of the substance that is causing them harm. For instance, prior to 2018, individuals struggling with c-diff. did not even know they should be fighting to have trehalose listed on the label.
Part III-A: Solutions
To resolve the aforementioned problems associated with current food labeling regulations, Congress should amend the FDCA’s provision on misbranding, 21 U.S.C.S. § 343(i), and the FDA should amend 21 C.F.R. 101.22 to require disclosure of all flavoring and spice ingredients to protect consumers more adequately.120 Broad ingredient categories such as natural flavoring,121 artificial flavoring,122 and spices123 prevent consumers from knowing what they are purchasing and consuming. Regardless of the source of the substance, or the process utilized to obtain the substance, consumers should be afforded the autonomy to decide what ingredients they wish to consume. This is especially true due to the deficiencies in the food additive laws, and the GRAS exception, which lead to safety concerns. The possibility that a substance may be uniquely harmful to one person and not another goes against having generalized labeling schemes that prevent individuals from making properly informed decisions for themselves. Congress will also need to reconsider and possibly revise the statutory protections to trade secrets written into the FDCA’s food additives provision.124
Note that not all ingredients need to be listed on the packaging label itself. In the event that natural or artificial flavoring, or spices, mask hundreds of chemicals, manufacturers should be required to provide the full listing of ingredients on their website; the ingredients list should denote that these generic label ingredient terms can be further defined on the manufacturer’s website. This system reduces consumer confusion by not providing a deluge of information on the nutrition facts label while still addressing the dietary and autonomy concerns of the consumer. It would also avoid the ingredient list covering the entire external product packing. This online availability would balance the needs of the consumer and the food manufacturer.
Such a system would allow consumers to protect themselves from food sensitivities, health concerns, and dietary restrictions. Individuals who experience a reaction to certain foods may be able to use the process of elimination to determine which chemicals cause their reaction. Likewise, health conscious individuals that read scientific data to consider what substances they wish to avoid in their diet, or individuals who know they have an elevated risk for developing a chronic disease, can more adequately screen their food choices. In the event that there is no scientific data available for a particular substance, consumers will be able to decide for themselves whether they wish to consume foods containing this novel substance.
Moreover, full disclosure eases the GRAS problem by providing consumers the option to decide for themselves if they believe that enough reliable information supports the safety of a substance. Transparency in the food ingredients market may proliferate scientific research on new substances, furthering our understanding of how they interact with the human body. Furthermore, this would mediate the FDA’s struggle to keep up with available scientific data. If consumers are on notice of what they are consuming, the burden can be shifted to consumers to make informed decisions for themselves. Lastly, such a system would incentivize manufacturers to reassess their food processing strategies. Consumer backlash alone over the usage of scientifically questionable ingredients may prove to be an effective form of ingredient regulation all by itself.
Part III-B: The Trade Secrets Issue
Proposing new legislation, however, requires considering its interaction with other laws. The solution proposed in this article is encumbered by the clash of trade secret law and the government’s police power. Protection of trade secrets from public disclosure is codified within the food additives definition in the FDCA.125 Scholars have tried to define trade secrets as “any formula, pattern, device or compilation of information which is used in one’s business, and which gives him an opportunity to obtain an advantage over competition.”126 But in order to qualify as a trade secret, the information must be kept a secret.127 Trade secrets allow the owners to profit from their innovation and get returns on their “reasonable investment-backed expectation.” They also reward efficiency and grant a competitive edge.128
But in food manufacturing, trade secrets hide information from consumers and tie the metaphorical hands of the FDA to regulate the ingredients added to food. In fact, the very notion of trade secrets is in direct conflict with the rationale behind GRAS substances. How can a self-determined secret substance be generally recognized as safe if it actually unheard of? As noted above, the protection of trade secrets in the FDCA may need to be revisited and revised. This clash between trade secrets and food labeling laws is a problem that needs to be addressed.129
The current system of food regulation in the United States does not adequately protect consumers due to the discretion and secrecy afforded to food manufacturers. GRAS self-determinations and food labeling categories leave consumers ingesting unknown substances that they may have decided against eating if they were offered the right to make a properly informed decision for themselves. Legislation should be enacted to revoke the current food label categories that provide hiding places for unknown food and chemical ingredients. Congress should reconsider the system that requires consumers to individually carry the burden of protecting themselves by abstaining from processed foods.
This article was originally written as an independent study with Professor Clare Huntington, Esq. The author wishes to thank Professor Huntington for her valuable guidance.
- Name changed for anonymity.
- C. Difficile Infection, Mayo Clinic (Jan. 4, 2020), https://www.mayoclinic.org/diseases-conditions/c-difficile/symptoms-causes/syc-20351691.
- The 2018 guidelines on the management of c-diff. recommend utilizing vancomycin as the first line medication for adult patients. See Ng, K., Updates in the Management of Clostridium difficile for Adults, U.S. Pharmacist (Apr. 19, 2019), https://www.uspharmacist.com/article/updates-in-the-management-of-clostridium-difficile-for-adults.
- West, H., Do Artificial Sweeteners Harm Your Good Gut Bacteria?, HEALTHLINE (Sept. 13, 2017), https://www.healthline.com/nutrition/artificial-sweeteners-and-gut-bacteria.
- Chu, W., Food Preservatives May Disrupt Appetite Hormone Function, Study Claims, Food Navigator (Aug. 10, 2017), https://www.foodnavigator.com/Article/2017/08/11/Food-preservatives-may-disrupt-appetite-hormone-function-study-claims.
- Derr, L., When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 Food Drug L.J. 65, 65 (2006).
- Moses, M., TREHA® Trehalose Available As A “Natural Flavor” Through Improved Production Process, Nagase Am., LLC. (May 10, 2017), https://nagaseamerica.com/news_release/treha-trehalose-available-as-a-natural-flavor-through-improved-production-process/.
- Collins, J., et al., Dietary Trehalose Enhances Virulence of Epidemic Clostridium Difficile, 553 Nature 291 (2018).
- 21 U.S.C.S. §§ 342–43 (2012).
- 21 U.S.C.S. § 343(i); 21 C.F.R. 101.22.
- 21 C.F.R. 101.4 (2019).
- 21 C.F.R. 101.22(a)(2) (2016).
- Id. at (a)(1) & (3).
- 21 C.F.R. 101.22.
- Id. at (a)(3).
- Goodman, M., The "Natural" vs. "Natural Flavors" Conflict in Food Labeling: A Regulatory Viewpoint, 72 Food Drug L.J. 78, 80 (2017).
- Andrews, D., Synthetic ingredients in Natural Flavors and Natural Flavors in Artificial flavors, EWG Food Scores (Oct. 27, 2014), https://www.ewg.org/foodscores/content/natural-vs-artificial-flavors/.
- Goodman, supra n. 21, at 80.
- 21 C.F.R. 101.22 (a)(3).
- Id. at (a)(1).
- Id. at (a)(2).
- 21 U.S.C. § 342(a)(1) (2018).
- Dragich, M., GRAS-Fed Americans: Sick of Lax Regulation of Food Additives, 49 Ind. L. Rev. 305, 306–07 (2016).
- See Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (codified as amended in scattered sections of 21 U.S.C.S. § 348 (2018)).
- Dragich, supra n. 31, at 306–07.
- Id.; see also 21 U.S.C.S. § 348.
- Id. at (h)(2)(A).
- Dragich, supra n.31, at 315.
- 21 U.S.C.S. § 348.
- Food Additives Status List, U.S. Food & Drug Admin. (last updated Oct. 24, 2019), https://www.fda.gov/food/food-additives-petitions/food-additive-status-list.
- 21 U.S.C. § 321(s) (excluding from the food additive definition: pesticide chemical residue, pesticides, color additives, legacy substances included prior to the 1958 FDCA amendment, the Poultry Products Inspection Act, the Meat Inspection Act of March 4, 1907, new animal drugs, and ingredients for dietary supplements).
- Dragich, supra n. 31, at 316.
- 21 U.S.C. § 321(s) (“if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures . . . to be safe under the conditions of its intended use”).
- Dragich, supra n. 31, at 316.
- Beyranevand, L., Conference on Agriculture and Food Systems: September 28, 2012: Generally Recognized as Safe?: Analyzing Flaws in the FDA's Approach to GRAS Additives, 37 Vt. L. Rev. 887, 906-07 (2013).
- Scrufari, C., Substances Generally Recognized as Safe — Until They're Not: Challenges in Protecting the Food Supply in a Processed World, 36 Stan. Envtl. L.J. 219, 231 (2017).
- Id. at 234.
- Arnold, M., How The 'Impossible Burger' Revealed Some Disturbing FDA Practices, Forbes (Aug. 31, 2017), https://www.forbes.com/sites/quora/2017/08/31/how-the-impossible-burger-revealed-some-disturbing-fda-practices/#6f804ad26aa9.
- See Neltner, T. & Maffini, M., Generally Recognized as Secret: Chemicals Added to Food in the United States, NRDC Report 3–4 (April 2014), http://www.nrdc.org/food/files/safety-loophole-for-chemicals-in-food-report.pdf [hereinafter Generally Recognized as Secret].
- Substances Generally Recognized as Safe, 81 Fed. Reg. 54960 (Aug. 17, 2016).
- Scrufari, supra n. 44, at 235; 62 Fed. Reg. 18,938-01 (proposed Apr. 17, 1997) (to be codified at 21 C.F.R. pt. 170).
- Scrufari, supra n. 44, at 235; 81 Fed. Reg. 54960.
- Soroudi, R., Government Repudiation of Americans' Safety: A Call for Reformulation of FDA's GRAS Notification Program, 75 Food Drug L.J. 39, 50 (2020).
- See Generally Recognized as Secret, supra n. 47, at 3–4.
- Id. at 7–8.
- Neltner, T., et al., Conflicts Of Interest In Approvals of Additives To Food Determined To Be Generally Recognized As Safe, JAMA Network (Dec. 23, 2013), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1725123.
- Generally Recognized as Secret, supra n. 47, at 3–4.
- Arnold, supra n. 46.
- Strom, S., Impossible Burger’s ‘Secret Sauce’ Highlights Challenges of Food Tech, The New York Times (Aug. 8, 2017), https://www.nytimes.com/2017/08/08/business/impossible-burger-food-meat.html.
- 21 U.S.C. § 321(s).
- 21 U.S. Code § 348.
- 21 C.F.R. 10.30 (2016); 21 C.F.R. 170.38(b)(1) (2016).
- Scrufari, supra n. 44, at 241.
- Chen, B., et al., Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis, NCBI (May 12, 2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4865109/pdf/pone.0155259.pdf.
- FDA Urged to Require Restaurants to Disclose Use of Partially Hydrogenated Oils, Center for Science in the Public Interest (July 22, 2004), https://cspinet.org/new/200407221.html .
- Scrufari, supra n. 44, at 242.
- Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat), U.S. Food & Drug Admin. (last updated May 18, 2018), https://www.fda.gov/food/food-additives-petitions/final-determination-regarding-partially-hydrogenated-oils-removing-trans-fat.
- Dhaka, V., et al., Trans fats—sources, health risks and alternative approach - A review, 48(5) J. of Food Sci. Technol. 535 (October 2011), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551118/pdf/13197_2010_Article_225.pdf.
- 21 U.S.C.S. § 343.
- There is no complete listing of questionable substances, especially with the potential vastness of self-determined secret GRAS ingredients. However, some sources have tried to list problematic substances. See Just Say No to Natural and Artificial Flavors!!, Hemp USA https://hempusa.org/artificial-natural-flavorings-avoid/ (last visited Mar. 14, 2021); see also Scrufari, supra n. 44.
- Trehalose, Calorie Control Council, https://caloriecontrol.org/trehalose/ (last visited Mar. 14, 2021).
- Rulis, A., Agency Response Letter GRAS Notice, U.S. Food & Drug Admin. (Oct. 5, 2000), https://wayback.archive-it.org/7993/20171031033307/https:/www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm154119.htm.
- Moses, supra n. 8.
- Kociolek, L., The Role of Dietary Trehalose in the Clostridium difficile Epidemic, Infectious Disease Advisor (June 1, 2018), https://www.infectiousdiseaseadvisor.com/home/topics/gi-illness/clostridium-difficile/the-role-of-dietary-trehalose-in-the-clostridium-difficile-epidemic/.
- C. Difficile Infection, Mayo Clinic (June 26, 2019), https://www.mayoclinic.org/diseases-conditions/c-difficile/symptoms-causes/syc-20351691.
- Collins, J., et al., Dietary Trehalose Enhances Virulence of Epidemic Clostridium Difficile, 553 Nature 291 (2018).
- Collins, F., Has an Alternative to Table Sugar Contributed to the C. Diff. Epidemic?, NIH: Director’s Blog (Jan. 9, 2018), https://directorsblog.nih.gov/2018/01/09/has-a-sucrose-alternative-contributed-to-the-c-diff-epidemic/.
- Life After C. Diff, Ctrs. For Disease Control & Prevention, https://www.cdc.gov/cdiff/after.html (last updated Mar. 27, 2020) (finding one in six will experience a c. diff. recurrence within 2-8 weeks of recovering).
- Gilchrist, A., 5 Dangerous Food-Drug Interactions, Pharmacy Times (Sept. 17, 2015), https://www.pharmacytimes.com/news/5-dangerous-food-drug-interactions (noting several categories of ingredients that can lead to drug interactions such as calcium-rich products, sources of vitamin K, and pickled, cured, or fermented products).
- Auten, A., et al., Hidden Sources of Grapefruit in Beverages: Potential Interactions with Immunosuppressant Medications, 48 Hosp. Pharm. 489 (2013).
- Galan, N., Can Grapefruit Compromise Your Birth Control? Healthline (Feb. 2, 2016), https://www.healthline.com/health/birth-control/grapefruit-and-birth-control/.
- Auten, supra n. 86.
- Does Grapefruit Affect My Medicine?, NHS, https://www.nhs.uk/common-health-questions/medicines/does-grapefruit-affect-my-medicine/ (last reviewed 21 June, 2018).
- Galan, supra n. 87.
- Lavine, A., Monosodium Glutamate (MSG) and Food Labeling Regulations, 62 Food Drug L.J. 349, 349 (2007); see also Sammy, M., 5 FDA-Approved Food Additives With Brain-Damaging Effects, MDLinx (Feb. 7, 2020), https://www.mdlinx.com/article/5-fda-approved-food-additives-with-brain-damaging-effects/1CKUPqKCuQ2egrCNx38hyz.
- Id. at 362.
- Id. at 369.
- Id. at 359.
- Id. at 365.
- Id.; see also Questions and Answers on Monosodium Glutamate (MSG), U.S. Food & Drug Admin., https://www.fda.gov/food/food-additives-petitions/questions-and-answers-monosodium-glutamate-msg (last updated Jan. 4, 2018).
- Nelson, M., The Bizarre Truth About “Natural Flavors,” Branch Basics (Aug. 12, 2019), https://branchbasics.com/blog/the-bizarre-truth-about-natural-flavors/.
- Lavine, supra n. 92, at 370.
- Id. at 368; see also 68 Fed. Reg. 19766 (providing notice that the FDA formally withdrew proposed rules published in the Federal Register five years ago).
- 21 C.F.R. 101.22 (a)(3).
-  Natural Flavors & Castoreum, Gentle World (Nov. 10, 2010), http://gentleworld.org/the-gross-truth-about-natural-flavors/.
- 11 Disgusting “Natural” Ingredients in Your Food, Organics (Sept. 19, 2018), https://www.organics.org/11-disgusting-natural-ingredients-in-your-food/.
- Robicelli, A., What is castoreum, and why is it in my food?, The Takeout (Oct. 24, 2019), https://thetakeout.com/what-is-castoreum-in-food-vanilla-1839295396.
- Gagne, A., Eating According to Religious Practices: Kosher and Halal, Gordon Food Service, https://www.gfs.com/en-us/ideas/eating-according-religious-practices-kosher-and-halal (last visited Mar. 14, 2021).
- 56 Fed. Reg. 28592.
- 21 U.S.C. § 343(w).
- Horvath, J., How Can Better Food Labels Contribute to True Choice?, 13 Minn. J.L. Sci. & Tech. 359, 366 (2012).
- Can Spices Cause Allergic Reactions?, Am. Acad. of Allergy, Asthma, & Immunology, https://www.aaaai.org/conditions-and-treatments/library/allergy-library/spice-allergy (last updated Sept. 28, 2020).
- Can Spices Cause Allergic Reactions?, supra n. 112.
- Brussino, L., et al., Beer Anaphylaxis Due To Coriander As Hidden Allergen, BMJ (Aug. 8, 2018), https://pubmed.ncbi.nlm.nih.gov/30093499/.
- 21 C.F.R. 101.22(a)(2).
- Recombinant Bovine Growth Hormone, American Cancer Society, https://www.cancer.org/cancer/cancer-causes/recombinant-bovine-growth-hormone.html (last updated Sep. 10, 2014).
- Ferris, T., et al., Understanding the Biology Behind GMOs Can Help Consumers Evaluate GMO Safety, Mich. State Univ. Extension Agric. (Dec. 21, 2018), https://www.canr.msu.edu/news/understanding-the-biology-behind-gmos-can-help-consumers-evaluate-gmo-safety.
- Upton, J., Think You’re Sensitive to Gluten? Think Again, US News (June 11, 2015), https://health.usnews.com/health-news/blogs/eat-run/2015/06/11/think-youre-sensitive-to-gluten-think-again.
- 10 Fast Facts About the FDA Gluten-Free Labeling Rule, Celiac Disease Found. (Aug. 5, 2014), https://celiac.org/about-the-foundation/featured-news/2014/08/fda-gluten-free-food-labeling-information-page/.
- 21 U.S.C.S. § 343(i); 21 C.F.R. 101.22.
- 21 C.F.R. 101.22(a)(3).
- 21 C.F.R. 101.22(a)(1).
- 21 C.F.R. 101.22(a)(2).
- 21 U.S.C. § 348(h)(4).
- Gervin, D., You Can Stand Under My Umbrella: Weighing Trade Secret Protection Against the Need for Greater Transparency in Perfume and Fragranced Product Labeling, 15 J. Intell. Prop. L. 315, 321 (2008).
- Id. at 332.
- A full discussion of the problems with trade secrets in food labeling laws is outside the scope of this article.
About the Author
Raila Cinda Brejt is a third-year law student at Fordham University School of Law. Ms. Brejt is a runner-up in the 2020 American Bar Association Health Law Student Writing Competition. She has a Master’s Degree in School Guidance and Counseling K-12 from Steinhardt, New York University. Before starting law school, she taught Psychology and Health & Nutrition to high school students and worked as an administrator in a doctor’s office. The two experiences triggered her passion for food law regulations and their potential consequences. She hopes her article will bring greater awareness to the issues in food labeling laws and how they can affect individuals living with mild to severe food sensitivities and digestive disorders. She may be reached at Raila.Brejt@gmail.com.