Book Review by Sapphire Ng
Copyright December 2014
Food Law and Regulation for Non-Lawyers is a phenomenal textbook introducing students to the fundamentals of U.S. food law, its associated legislations and local enforcement agencies. Its contents is aptly and functionally structured to target “non-lawyers,” both American food practitioners, and academics intrigued by the legal functions of the industry.
Most fascinating, and qualifyingly the most practical, pieces of knowledge the reader stands to gain from the text, owes to the strategic inclusion of original, and incredibly detailed, letters penned by the US Food and Drug Administration (FDA)—one of the primary food enforcement agencies in the country—as addressed to specific companies deemed to have committed violations. Interestingly, the reader gets to read a warning letter the FDA issued to General Mills pertaining to the misbranding and mislabeling of a Cheerios product; the FDA alleged that the company made “unauthorized health claims,” and illegitimately promoted its Cheerios as “a drug” intended for “preventing, mitigating, and treating the disease hypercholesterolemia.”
The reader is given the precious opportunity to learn from the mistakes of others. In another case, the FDA and the FTC co-wrote a warning letter addressed to Vitalmax Vitamins; the facility was cautioned against illegal marketing of its product “intended to diagnose, mitigate, prevent, treat or cure the Flu Virus,” especially without FDA approval. In another very interesting instance, a highly insightful and lucid letter was sent to Breathable Foods, Inc. regarding the product AeroShot; the product is misbranded, triggered safety concerns, and was associated with contradictory labeling messages.
Incredibly instructive and illuminative judicial opinions included in the textbook represents yet another element contributing to the text's excellence. The target audience of “non-lawyers” will appreciate the insertions of such materials from primary sources. The United States v. 1232 Cases of American Beauty Brand Oysters case, for example, clearly illustrated the concept of “non-added” substances; the court opinion lucidly provided the reasoning that led shell fragments in canned oysters to be considered “non-added,” and thus subject to the “ordinarily injurious” standard.
In yet more examples delivering a highly cherished and unique educational experience to the individual reader, are two misbranding cases, United States v. An Article of Food...Nuclomin and Vitasafe 1964. The Nuclomin case involved contentious ingredients like choline, inositol, and p-aminobenzoic acid (PABA) alleged to be “misleading nutritional information,” whilst multiple ingredients in the Vitasafe product, such as rutin, sulfur, lemon bioflavonoid, and monopotassium glutamate, contain “no nutritional value at all.” The Vitasafe product was also condemned for ludicrous claims as an “adequate and effective treatment” for an extensive range of conditions including “nervous disorders,” “impairment of memory,” “defective calcification of the bones,” “dermatitis,” “depression,” and more. In another excellent instance, examination of the Dotterweich Doctrine—“an absolute liability doctrine”—was further reinforced with substantial material on the United States v. Dotterweich case, to which the doctrine was derived.
The textbook is indeed a treasure trove of citations of a myriad of other highly instructive cases. The United States v. Thirftmart, Inc. case was cited to explicate the inability to negate the validity of the administrative consent-waiver, of relinquishing the right to “raise a Fourth Amendment challenge” with any reasonable “manifestation of assent” to an inspection, “no matter how casual.” The Kordel v. United States case interestingly showed the ability for a written material to qualify as “labeling” with a mere “textual relationship” between the material and the product in question. On the other hand, the United States v. 250 Jars 'Cal's Tupelo Blossom U.S. Fancy Pure Honey' case was introduced as “one of the first cases to consider what constituted labeling.”
The textbook does contain an appropriate sampling of legal cases that provide a balanced perspective to the narrative; botched lawsuits filed by the FDA are highlighted. In one such case, 29 Cartons, the court accused the FDA's interpretation of the Amendment as “nonsensical;” black currant oil sold in “capsule form” fails to be considered an “unapproved food additive,” due to the product lacking “more than one ingredient.”
Many other fascinating cases include United States v. Anderson Seafoods Inc. which illustrates the definition of “added” substances through the levels of mercury in fish; the extensively detailed Monsanto Co. v. Kennedy case which discussion revolves around a specific food additive, acrylonitrile copolymer, used to fabricate unbreakable beverage containers; Alliance I, and Alliance II which interestingly dealt with the revision of disclaimers; and the Colonnade, Biswell, and Barlow's cases which significance and influence to the FDA, or lack thereof, was explored.
As expected, the material in the textbook is predominantly anchored upon the FDA and the United States Department of Agriculture (USDA)—the other pertinent US food enforcement agency—otherwise referred to interchangeably with the US Department of Agriculture's Food Safety Inspection Service (FSIS), the USDA's inspection arm.
The textbook comprehensively examined the jurisdictions of the FDA versus the USDA on food products at the outset, and which is additionally excellently encapsulated in Table 1.1. The agencies' antithetical inspection models were also examined; the FDA noted for its “postmarket surveillance” model, random inspections, aimed at removing “problematic products from the market,” as opposed to the USDA's “premarket approvals” strategy, coupled with a continuous mandatory inspection model, focused on preventing “contaminated” products from reaching the market.
The diverging enforcement actions of the FDA versus the USDA/FSIS are also commendably explored. The FDA enjoy the options of “seizures and administrative detentions, recalls, import refusals and alerts, restraining order and injunctions, and suspension of facility registration,” while the FSIS opts for regulatory control action, withholding action, or suspension. Examples of further elaboration of the individual enforcement actions include the availability for a recall to be classified as Classes I, II, or III; of a seizure and an administrative detention differing in terms of the need for obtaining a court order; and separate circumstances that permit the ordering of a withholding action or a suspension depending upon whether notification is, or is not, provided.
Important legislations most predominantly covered and referenced include the Food Drug and Cosmetic Act (FD&C), and the Food Safety Modernization Act (FSMA). The seven FSMA rules are systematically listed and very briefly described; the rules of Produce Safety Rule, Human Food Preventative Controls, Foreign Supplier Verification Program (FSVP), Intentional Adulteration of Food, and more. The Nutrition Labeling and Education Act (NLEA), in the context of misbranding, is another example amongst the myriad other legislations mentioned in the text.
The two major prohibited acts under US food law—adulteration and misbranding—are dealt with meticulously in their separate chapters, whilst the concept of food additives is also addressed individually in another later chapter. Several types of adulteration—economic adulteration, indirect adulteration, and intentional adulteration—were explored. Under the umbrella of misbranding, three primary types of claims—nutrient content claims, health claims, and structure/function claims—and other notions such as allergen labeling and the Country of Origin Labeling (COOL) requirement are surveyed. In the food additives chapter, the most essential concept, and most sizably covered, appeared to be the notion of Generally Recognized as Safe, the GRAS exemption; the classification of GRAS was discussed, in addition to case studies on substances revoked of the GRAS status, for example, partially hydrogenated oils (PHOs).
The textbook contains an abundance of highly valuable information. The Delaney Clauses—“prohibitory provisos aimed at carcinogens”—is an idea relatively frequently referenced in the text; one such allusion noted the Delaney Clause as being credited for the banning of a substance previously enjoyed a place on the FDA's GRAS list, the cyclamate salts. Another important idea highlighted is the “Pathogen Reduction/Hazard Analysis and Critical Control Point System” (HACCP)—“the industry standard for FSIS inspections.”
Select pieces of information will appear to be more directly relevant to food professionals currently working in the industry. Form 482 and Form 483 “Inspectional Observations” are said to be ubiquitous aspects of FDA inspections; Good Manufacturing Practices (GMPs) ought to be closely adhered to; of complying to mandates demanding the creation of Food Defense Plans meant to “mitigate risk of intentional adulteration;” of equipping oneself with the awareness of certain basic required components of food additive petitions and color additive petitions; and for those in the energy drinks business, of not erroneously misrepresenting the “liquid dietary supplements” as “conventional food.”
Information on constitutional and statutory challenges available are decently dealt with in the text. Allegations of misbranding, regulatory mandated disclosures, or restrictions of free speech on product labels, can be challenged with the First Amendment “right to free speech and the consumers freedom of choice;” the constitutionality of warrantless searches can be challenged with the Fourth Amendment; and inspections and enforcement actions can be countered with the statutory, “arbitrary and capricious” challenge raised under the Administrative Procedures Act (APA).
The most engaging “Comparative Law” sections in the text pertain to those identifying Japanese examples, which most significantly differ from the US. It was definitely eye-opening to learn that the Japanese list of currently 25 allergens, is more than 3 times the US designation of a mere 8 food or food groups determined as “major allergens.” There was also tremendous disparity between the US and Japan with regards to inspection models—“the Japanese Health Ministry estimates its test sample from over 10% of its imports,” whilst the FDA does so on “less than 1% of its imports.” In the “Comparative Law” section in chapter 5, it was certainly a pleasant surprise to have one's expectations surpassed, to see the inclusion of a highly visual and attention-grabbing diagram on the “overview of Japanese supplement classification system.”
The clear organization and presentation of information in various diagrams in the textbook is worth a mention. A diagram in particular, was observed to help immensely in information retention, specifically the “adulteration framework” in Fig. 3.4. The diagram effectively summarized and laid out salient points which are previously discussed and somewhat “buried” within the preceding paragraphs.
The book contains the occasional instance of significantly detailed charts, which complexity might or might not be appreciated by the individual reader. A relatively long chart documented “color additives approved for use in human food,” recording for example, annatto extract, cochineal extract, FD&C Blue No. 1, and Citrus Red No. 2. Another shorter chart indicated precise irradiation limitations for specific uses.
Some portions of the textbook are notably more accessible than others, in both positive and negative ways. The only—thankfully—and most layman section, geared towards providing advice to the reader is “How to Respond to a Form 483,” which speaks of dropping “the anger-first response” and to avoid “playing dumb.” In other instances, though written and structured in the manner of legal speak, a section titled, “How to Name Sherbet” in chapter 4 remains highly understandable to the general reader; and “Section 109.30 Tolerances for polychlorinated biphenyls (PCB's)” noteworthily highlights favorably practicable information.
The textbook appears to successfully cater to a relatively wide audience; the book gets progressively more difficult as one proceeds further along. The range of material and the varying difficulty levels seem to be able to satisfy “non-lawyers” intending to learn the very fundamentals of US food law, and also the more ambitious who prefer more challenging and in-depth examinations into the law. A zealous learner may appreciate the introduction of for example, the theory of res ipsa loquitor in the last chapter, which decidedly seems more alien or more baffling compared to material in the rest of the book.
The greatest and most unfortunate flaw of the textbook is that it is poorly edited; the abundance of spelling and grammar errors throughout the entire book appeared unprecedented for such scholarly text. Naturally, the overall pleasantness of the reading experience is greatly diminished owing to the relentless appearance of seemingly innocuous mistakes; the impression of credibility and professionality of the text also takes a dramatic hit.
The Colonnade Catering Corp. v. United States case was misspelled in the heading of the subsection 2.4.6 as “Collonade;” more than merely a few instances, “bringing” was spelt as “brining”—in chapter 7, a sentence went, “There are constraints on brining labeling lawsuits using State law,” and under subsection 7.3, the start of the first paragraph went, “The discussion thus far focused on corporate responsibility to individuals brining a lawsuit”—; it was rather infuriating to come across errors such as this, “Police pursued an professional investigation;” or other unjustifiable spelling errors such as in the following sentence, “To prove negligence, plaintiffs must chow causation...” In another instance, a case was brought against Pinnacle for “its blueberry waffles made suing blueberry bits.”
Examples of grammar errors include the following: “it also shifted the paradigm to reactive and enforcement based to proactive and pre market oriented,” in chapter 3; “nearly any written materially associated with a food product can be captured under Section 201(k),” in chapter 4; and in chapter 6, “In section 402(a)(7) intentionally irradiation is added to the acts that constitute adulteration”—the concept of “intentional irradiation” was referred to as “intentionally irradiation.” An instance of a punctuation error resulted in a vastly different meaning being construed from what was originally intended; a sentence in the subsection, “Interstate Commerce Presumption,” in chapter 2, went, “Rather than allowing every producer to raise a constitutional challenge questioning the FDA's authority to regulate Congress, passed a statutory presumption in Section 379a.”
In a separate juncture, the textbook could be potentially improved by incorporating more details and elaboration comparable to the way other themes are handled in the text. The subject of ice in the subsection 5.3.3 “Water and Ice” under 5.3 “Other Areas of Specialized Regulations” was dealt with in a manner so cursory that the reader is unable to take away any sort of learning point, nor seize any chance to foster a greater understanding of related information. A solitary, and not self-explanatory paragraph about ice went, “Packaged ice is also regulated by the FDA. Unlike bottled water ice is subject to the GMP requirements of Part 110 conventional for human food rather than Part 129. There are also labeling requirements and exemptions for small producers.”
Disclaimer: I received a complimentary copy of this book from Springer in return for this review.