The Origins and Current Legal Status of “Natural” and “Organic” Food Labels
The cook plays an important part in the nourishability of food. Meals which are lovingly prepared with a profound desire for the welfare of the eater always benefit the body and mind more than do meals which are commercially prepared, or which have been prepared by someone who is indifferent to or dislikes the proposed eater. No one should cook when in a state of indifference, agitation, sorrow or anger.
From The Hidden Secret of Ayurveda, by Dr. Robert E. Svoboda
The most famous gastronome of them all, Anthelme Brillat-Savarin, wrote in Physiologie du Gout, ou Meditations de Gastronomie Transcendante (1826): “Dis-moi ce que tu manges, je te dirai ce que tu es.”: “Tell me what you eat and I will tell you what you are.” For some, such as Adelle Davis — Time magazine characterized her as “the high priestess of a new nutrition religion” in December 1972 — the consequences of our food choices are stark: “As I see it, every day you do one of two things: build health or produce disease.”
How do we know if we are supposedly building health, rather than unwittingly producing disease by what we consume? We resolve what economists call “informational asymmetry” by relying on food labels, brands and trademarks to confirm the authenticity and quality of our foodstuffs. But making “correct” food choices can be daunting and baffling. In her groundbreaking book, What to Eat, Dr. Marion Nestle estimates that there are around 320,000 food and beverage products available in the United States; and that the average supermarket stocks about 30,000 to 40,000 of them. While we may not understand the true origins or makeup of what we put on our tables, most baby-boomers can tell you in a heartbeat that Rice Krispies go “snap, crackle and pop,” Lucky Charms are “magically delicious,” and Wonder Bread helps “build strong bodies in 8 ways.”
Two of the most symbolic words in food promotion nowadays are “organic” and “natural.” Generally defined, “natural” means “present in or produced by nature” and is not something “altered, treated or disguised,” but rather “faithfully represents nature or life.” “Organic,” in its most abstract sense, means “simple, healthful, and close to nature.” Both words hearken back to a pre-industrial age and share Edenic, utopian connotations. They imply a general distrust of chemical engineering and manufacturing processes. If we are what we eat, are we not closer to “nature” if we incorporate natural and organic foods into our diet? That is the compelling allure and implicit bargain of consuming organic and natural foods.
Depicting the source of food as emanating from a “natural” source and setting is a longstanding tradition among food purveyors. It is intended to alleviate and relieve the anxiety of a successive number of American generations who have lost—as a function of industrial revolutions — any meaningful, day-to-day connection with food production and processing.
The “organic” label is of more recent vintage and is the product of its own countercultural revolution. Its prominence in grocery store aisles reflects a cultural repulsion against factory farms and their reliance on chemical, biological and other industrial solutions to the myriad challenges posed by growing crops and raising animals for safe human consumption. Once avant-garde, the “organic” food movement became mainstream after passage of the federal Organic Food Production Act of 1990.
Feeling ethical and savvy about our food choices does not come cheaply. Organic and sustainable meats, fruits and vegetables tend to cost substantially more than their “conventional” (read here, industrially farmed or produced) counterparts. Whether or not organic food tastes better or is more nutritious for us, consumer studies show that consumer expectations created by a mere logo or words themselves affect subsequent flavor perceptions. In other words, natural or organic food may taste better in part simply because we think that natural or organic food should taste better.
In order to whet and satisfy consumer expectations and desires, tremendous marketing value clearly inheres in the presentation of food as “organic” or “natural.” This article traces the evolution of these two words in their historical context and analyzes how federal and state laws now define and regulate their commercial usage.
Once We Were All Natural and Organic “Locavores”
The ascendency of “organic” and “natural” as preferred food descriptors is a relatively recent phenomenon in human history. Before the first industrial revolution, there would be little or no point in labeling food as either organic or natural. These two words only took on meaning when we became largely divorced from the mechanics of food production and in the advent of chemical fertilizers and pesticides, industrial farming and food processing techniques. A tipping point may well have passed in 1920 when urban populations first exceeded rural populations in the United States.
The names “organic” and “natural” are classically paired with bucolic images of rolling green pastures and animals grazing in free-range fashion. The scenes represent a nostalgic vision of the family farm. That hypothetical locale is the reigning mental image of a “natural” food source. Norman Rockwell’s iconic painting, Norman Rockwell Visits the County Agent, depicts the comforting and romantic symbolism of the family farm. It captures the essence of what Americans may prefer to believe is the “natural” provenance of their daily sustenance.
Industrial farming realities outstripped family farm nostalgia some time ago. In Kitchen Literacy: How We Lost Knowledge of Where Food Comes From and Why We Need to Get It Back (2008), Ann Vileisis recounts how the American populace became disconnected from food production and distribution. Vileisis charts the “foodshed” of Martha Ballard in 1790. Ballard epitomizes what we now classify as a “locavore,” i.e., one who relies on neighborhood food resources for sustenance.
In a Kitchen Literacy chapter entitled “A Meal by Martha,” a colonial America dinner table is set:
In the center of a wooden table on a pewter platter sat a baked leg of lamb. One earthenware bowl held a heap of steaming, fresh string beans, while another contained sliced cucumbers, likely drizzled with vinegar. The table was plain, but the savory smell of the roast meat made mouths water and elevated this meal, like many simple meals, to a humbly exceptional status.
At the time, it was ordinary, but in retrospect, it seems utterly distinctive: everyone sitting at the table knew exactly where the foods came from. The lamb came from a nearby farm, while the string beans and cucumbers came from a garden just down a path out the kitchen door. 
Daily life in the 1790s represents a baseline for evaluating the evolution of “natural” and “organic” food labels. While some would argue that the very act of farming itself is not “natural” — involving a wholesale transformation of land and destruction of nature — it does depend on nature’s rhythms. As Ann Vileisis posits, being subjected to the seasonal cycles and the whims of nature is what really defines preindustrial food production as “natural”:
It was this aspect of farming that was most tangible to preindustrial Americans whose lives were tied so closely to the cycles of seasons and the whims of nature. The idea that farms and gardens could be anything other than part of the natural realm was to them unthinkable.
Farming in the 1790s equally qualifies as “organic.” Dealing with weeds and pests required vigilance and brute force labor in the absence of chemical herbicides and pesticides:
Weeds demanded perseverance and had to be pulled — and pulled—until the desired seedlings gained a clear advantage. After one spell when Martha was gone from home for a week delivering babies, she came back to find her garden overrun. “The weeds almost gained mastery,” she wrote in her diary, but over the course of the next week, with diligence and muscle, she managed to wrest “mastery” back from the unwanted plants. * * * .
To control insect pests, many gardeners let chickens and ducks range freely among the plants during the day, or they might lay down a wilted cabbage lead or an old shingle, and then squash all of the bugs hiding under it early the next morning. Picking bugs was a job that often fell to children. For bad infestations, some gardeners applied repellent concoctions made from black walnut or tobacco leaves.
The commonplace methods described for controlling weeds and pests in preindustrial America would now be recognized as organic farming techniques.
Industrial Food Processing and Marketing Deception Comes of Age
Two of the most significant impacts of food processing in the 19th century were the invention of canned food and “margarine,” a cheap substitute for and imitation of butter. Both inventions were rooted in chemical engineering advances in France and Germany.
Canning food first developed as a means to feed Napoleon’s armies. That technology came to the United States by the 1820s. Both the California Gold Rush and the Civil War created market niches for “hermetically sealed foods.”
In the 1860s, Emperor Napoleon III offered a prize to the person who could produce an edible fat substitute for butter. In response, “Hippolyte Mege-Mouries, a French chemist, created oleomargarine, a combination of clarified beef fat, water, and a bit of tributyrin — a milk fat—to give it a buttery taste.” Mege-Mouries called it oleomargarine after margaric acid, a fatty acid.
Eventually, margarine would be made out of vegetable oils instead of beef fat; but it would take advances in chemical engineering — the process of hydrogenation — “to convert liquid vegetable oils into a semisolid product.” Many inventors sought and received U.S. patents for their margarine formulations and processing techniques and for techniques to simulate butter color and flavor.
A desire to find a cheap substitute for butter spawned the epic marketing and political food battle of the 19th and 20th centuries. Palming off margarine as butter became rampant immediately upon margarine’s introduction into the U.S. consumer marketplace in the 1870s. Margarine production produced a white product, so one relatively easy way to prevent it from competing more directly with butter was to prevent it from being colored yellow.
Dairy producing states soon passed laws prohibiting the sale of yellow-colored margarine. The marketing deception nevertheless continued and led to the enactment of federal taxation in 1886 (and later in 1902) on manufacturers, wholesalers and retailers selling white and yellow oleomargarine. The taxes were set much higher on yellow oleomargarine. Those desiring to serve yellow margarine would purchase yellow coloring agents separately and then mix it with white margarine at home. This was a time-consuming and arduous task for homemakers.
Margarine manufacturers and distributors were quick to assert that it was just as nutritious as butter. That representation lacked a valid scientific basis and eventually would be thoroughly discredited. A compulsion to promote product consumption through health claims permeates the food and dietary supplement market to this day.
Canned foods and the desire to imitate butter exposed the limitation of the human senses in deciding what foodstuffs to purchase. Sight supplanted smell and touch as an arbiter of food quality. Offering a pleasing appearance for food products became a paramount marketing concern. The content of labels became a surrogate means for evaluating food quality.
In order to assuage consumer anxieties about the source of their food, producers adopted bucolic images of nature for their can labels. These early canned food labels often emphasize the purity, cleanliness and geographic source of the food. Some early 20th century examples show how food purveyors portrayed the source of food as originating from an unpolluted, untrammeled, preindustrial “natural” locale:
The desire to depict lush nature as the source of food produce was not universal, however. One California canned fruit label shows how even black belching smokestacks could serve as a symbol of industrial progress:
Passage of the Federal “Pure Food Law” in 1906
Regulating the health and welfare of U.S. citizens is generally considered to be the province of state, not federal law. Upton Sinclair’s muck-raking novel, The Jungle, almost singlehandedly changed that food regulatory landscape. First published in 1905 in serial form in the socialist newspaper Appeal to Reason, the novel exposed the unsanitary condition of Chicago meatpacking plants. It shocked readers with its scenes of workers falling into rendering vats and being ground up with animal fats to form “Durham’s Pure Leaf Lard.” This touched the raw nerve of a basic human taboo: cannibalism.
The Jungle’s exposé provide an impetus for the passage of the Federal Food and Drugs Act of 1906 and the Federal Meat Inspection Act of 1906. The former became popularly known as the Pure Food Act and sometimes as the “Wiley pure food law” in tribute to the chief proponent of the legislation, Dr. Harvey W. Wiley. This new federal law focused on adulteration and misbranding of food. The word “pure” is used in its sense of food being “free from adulterants or impurities,” rather than having “a homogeneous or uniform composition.” The 1906 Act’s use of the word “pure” — not defined in the text of the Act—underscores a deep suspicion of how the industrial revolution had been altering the very composition of food placed on the table. The 1906 Act does not mention “natural” or “organic” food.
100,000,000 Guinea Pigs
Perceived deficiencies in the scope and enforcement of the Pure Food Act of 1906 are recounted in a wildly popular book in the 1930s entitled 100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics, by Arthur Kallet and F.J. Schlink. First published in 1933, it was already in its thirtieth printing by 1935. The opening chapter is “The Great American Guinea Pig” and relates that:
In the magazines, in the newspapers, over the radio, a terrific verbal barrage has been laid down on a hundred million Americans, first, to set in motion a host of fears about their health, their stomachs, their bowels, their teeth, their throats, their looks; second, to persuade them that only by eating, drinking, gargling, brushing, or smearing with Smith’s Whole Vitamin Breakfast Food, Jones’ Yeast Cubes, Blue Giant Apples, Prussian Salts, Listroboris Mouthwash, Grandpa’s Wonder Toothpaste, and a thousand and one other foods, drinks, gargles and pastes, can they either postpone the onset of disease, of social ostracism, of business failure, or recover from ailments, physical or social, already contracted.
The reference to guinea pigs reflects a basic human conundrum. We have been creating new and varied things to eat since the dawn of mankind. We like to experiment with our diets. Each of us is our own “control group” in deciding what we desire and choose to ingest. What role should government play in regulating our food choices?
In June 1938, the Federal Food, Drug and Cosmetics Act (“FDCA”) repealed much of the former Pure Food Act and created a more detailed regulatory scheme. It carried forward the 1906 Act’s emphasis on outlawing adulteration and misbranding of food. The operative paradigm of the FDCA is to provide consumers with food content information and let them decide whether the food is appropriate for them to eat.
When the FDCA was enacted in 1938, it too did not define what constitutes “natural” or “organic” food. It defines the word “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles use for the components of any such article.” “Processed food,” in turn, “means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.”
The FDCA distinguishes food from drugs. A drug includes “articles intended for use in the diagnoses, cure, mitigation, treatment, or prevention of disease in man or other animals” as well as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” When food producers make unsubstantiated health claims to promote their food products, they risk having their food categorized as an unapproved, hence unlawful new “drug.”
Passage of the FDCA solidified the paramount role for the federal government in regulating commerce in food. In construing the scope of its provisions, the United States Supreme Court characterized the purpose of these federal food enactments as a necessary response to modern industrialization. The consumer’s physical separation from the source or content of packaged food created a need for laws against adulteration that could not be discerned and disclosure of product constituents. Supreme Court cases encouraged a liberal application of FDCA provisions in order to comply with Congressional intent:
By the Act of 1906 … as successively strengthened, Congress exerted its power to keep impure and adulterated foods and drugs out of the channels of commerce. The purposes of this legislation, as we have said, “touch phases of lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.”
The role of state laws in regulating food content and safety dwindled after the passage of the FDCA. Under the principle of federal preemption, state laws and regulations governing food would have to give way to federal law if they conflicted. Further, under the primary jurisdiction doctrine, courts could dismiss a case if a judge believed that the issue under review may or should be addressed and resolved by the federal Food and Drug Administration in the first instance.
Historically, the FDA’s response to food safety issues has been reactionary rather than proactive. New foods must be proved to be unsafe, rather than safe, for human consumption. In this sense, the operative standard is really “buyers beware.” The introduction of genetically modified organisms (“GMO”) into the food chain is a controversial case in point:
Genetically engineered foods saturate our diet today. In the US alone, over 80% of all processed foods contain them. Others include grains like rice, corn and wheat; legumes like soybeans and soy products; vegetable oils, soft drinks; salad dressings; vegetables and fruits; dairy products including eggs; meat, chicken, pork and other animal products; and even infant formula plus a vast array of hidden additives and ingredients in processed foods (like in tomato sauce, ice cream, margarine and peanut butter). Consumers don’t know what they’re eating because labeling is prohibited, yet the danger is clear. Independently conducted studies show the more of these foods we eat, the greater the potential harm to our health.
Today, consumers are kept in the dark and are part of an uncontrolled, unregulated mass human experiment the results of which are unknown. Yet, the risks are enormous, it will take years to learn them, and when we finally know it’ll be too late to reverse the damage if it’s proved conclusively that genetically engineered foods harm human health as growing numbers of independent experts believe.
Whether or not health fears regarding GMO foods are justified, the same apprehension about the adulterated of food expressed in 100,000,000 Guinea Pigs in 1933 rings true today:
In considering these adulterations and their probable safety, we must consider that the human stomach evolved in a world stocked with game, eggs, milk, fruits, berries, cereals, and seeds, vegetables, and a very limited supply of natural sweets like honey—no sulphur dioxide, no sulphate of soda, no glucose, no alum, no aniline dyes, no benzoate of soda, no liquid, “artificial smoke” for curing ham and bacon, no frozen meats or eggs, or bleached or denatured flour. The only race of beings that can successfully live and breed on adulterated and sophisticated products is one which has spent its period of evolution in a chemical plant and fed from among dye vats, crucibles, acid carboys, desiccators, stills, and sulphurizers. And we who now live on this planet are not that race.
The anxiety about eating food that may be toxic to our health reinforces a consumer desire to only consume “natural” and “organic” foods. Presumably, only such foods enjoy the historical track record of being healthy and safe to consume (putting aside the grave risks of salmonella, listeria and E. coli contamination and the like in processing food from farm to table).
The desire to only eat “healthy” food perhaps can become obsessive and even lead to a condition some in the psychological community have termed “orthorexia nervosa.” However, that eating disorder is not recognized as a mental disorder by the American Psychiatric Association, nor is it included in the Diagnostic and Statistical Manual for Mental Disorders IV (2006). Those afflicted with orthorexia nervosa purportedly become fixated on “righteous eating” and set rigid rules about avoiding certain foods. As one author put it, these “dietary restrictions commonly cause sufferers to feel proud of their ‘virtuous’ behavior even if it means that eating becomes so stressful their personal relationships can come under pressure and they become socially isolated.” This may well be just another instance of “therapy” terminology permeating discourse of all subjects in American culture. The attitudes described as indicative of a possible eating disorder are equally consistent with taking a highly ethical, moral and political stand with respect to one’s food consumption.
“Tuesday is Soylent Green Day” and the Growth of an Organic Food Movement
To better grasp and understand the passionate roots of the “organic” food movement, a brief foray into American popular culture is illuminating. 1973 was a watershed year. President Richard Nixon proclaimed that “peace with honor” would soon be at hand. With the Vietnam War no longer a focal point for the “protest” movement, the country’s attention turned back to a litany of ecological calamities recounted so vividly by Rachel Carson in Silent Spring (1962). E. F. “Fritz” “Schumacher’s book Small is Beautiful: Economics as if People Mattered was published and would become a best seller.
Soylent Green hit the silver screen in 1973. Set in the year 2022 in New York City, it portrays the culmination of our Earth’s degradation. Store shelves and cupboards are bare and empty. Overpopulation is rampant. People sleep in stairwells, dress in Soviet-style peasant garb, and mill about listlessly in automaton fashion. Fresh fruits and vegetables and Grade A cuts of meat no longer exist for the masses; only the wealthy elite can get their hands on them.
The populace instead consumes food wafers manufactured by the Soylent Corporation. Soylent Red and Soylent Yellow are advertised as “high energy vegetable concentrates.” A newer and much more popular foodstuff is Soylent Green, supposedly produced from “high-energy plankton.”
Tuesdays are Soylent Green days and New Yorkers queue up for their wafer rations. When those waiting in line all day are denied their aliquot portions of Soylent Green, riots break out. Huge front end loading bulldozers emerge to scoop up protestors, dump them into police trucks and cart them away, like so much street detritus.
Assisted suicide becomes a desirable way to end one’s miserable existence in these end times. At the government-run euthanasia facilities, it is called “going home.” After selecting a lighting scheme and choosing the music you wish to hear as you die, you are escorted to a private room and bed by employees dressed in vaguely religious vestments. In Socratic fashion, you drink a poisonous concoction, lie down on a comfortable bed, and then spend your final twenty minutes of life witnessing — in IMAX-panoramic fashion — scenes of a pristine Earth where streams and rivers run free and the deer and antelope play.
Unbeknownst to everyone except for some high-level executives of the Soylent Corporation and a small group of intellectuals (who meet in a library of old books called the “supreme exchange”), the world’s plankton population had collapsed. To remedy this, the Soylent Corporation began using cadavers from the euthanasia centers as the protein ingredient for the popular Soylent Green.
When the protagonist of the film — a police detective named Robert Thorn (played by Charlton Heston)—confirms this fact for himself, he becomes the film’s “prophet of doom.” Having stripped the Earth of its natural resources through pollution and overpopulation, man is now cannibalizing man. In the final scenes of the film, he screams out to anyone who will listen that the Soylent Corporation “raises humans like cattle” and that “Soylent Green is people.”
With its taboo theme of cannibalism — akin to that exposed in The Jungle in 1906 — and portrayal of massive environmental degradation, Soylent Green serves as a stark counterpoint to the hopes and dreams of a nascent organic food movement. Small groups began to coalesce around the idea of returning to organic cultivation methods. They collectively decided to wean themselves off industrialized farming methods and its overwhelming reliance on the use of pesticides, herbicides, fungicides and petroleum-based fertilizers. Taste and health drove their decisions to “return to the earth.”
Wendell Berry would fuel the collective disgust of the “anti-establishment” with industrial scale farming methods at the 1974 World’s Fair in Spokane, Washington. His speech during an “Agriculture for a Small Planet” symposium rocked the house. He bemoaned the loss of small farm culture and declared a Declaration of Independence from conventional agricultural methods. He tapped into an intense distrust of science and the “military-industrial complex,” which gave us such chemical defoliants as Agent Orange, by stating that “one of the miracles of science is that the germs that used to be in our food have been replaced by poisons.”
Originally considered to be made up of “farmers on the fringes,” a number of these groups are now largely responsible for certifying that the food we purchase and consume is “organic.” A case in point is the formation of the “Tilth Producer’s Cooperative.” On grainy archive photos taken in August 1977, Becky Deryckx is sitting on top of a 1947 Farmall A tractor. Gathered around Becky are 70 or so people dressed mostly in plaid flannel shirts and jeans. They are a youngish, scruffy-looking group. Their hair is long and in braids or ponytails or covered by handkerchiefs.
They all migrate to the Pragtree Farm near Arlington, Washington, to discuss a new/old way to approach farming and food production. Becky explains how the word “tilth” refers to the quality of the soil; and, in an older sense of the word, also describes the cultivation of knowledge and wisdom. Perhaps without even realizing it, they are launching what would become the most influential organic food organization in the United States.
To capture the flavor of what these organic pioneers were up against, put yourself in Patrick Langon’s shoes for a moment. It is Sunday morning in early June 1973. You own a small three acre farm near Yakima, Washington. You are up early irrigating your crop of organic tomatoes, beans, garlic, cucumbers and Jerusalem artichokes. You intend to bring them to market as rare organic produce. You happen to be the president of the Northwest Organic Food Producers Association (“NOFPA”). Your neighbors, the Thalheimers, however, are not. They raise potatoes on their farm in conventional fashion.
Overhead, you hear and then see a helicopter coming toward you. It is spraying chemical pesticides over the Thalheimer’s farm. You later learn they are Thiodan® — to control against a Colorado beetle infestation—and (the now banned) Guthion. The pilot doesn’t seem to see you and before you know it, a chemical mist blankets you from head to toe. The material safety data sheet for Thiodan warns that it “is highly toxic if absorbed through the skin or inhaled.” Symptoms include headache, weakness, abdominal cramps, nausea, excessive salivation, perspiration, blurred vision, tearing, pin-point pupils, convulsions, tremor and coma.
The pilot sprays all of your carefully tended rows of sprouting plants. Your wife Dorothy laments, “it has reached the point of insanity,” referring to indiscriminate spraying of herbicides and pesticides in the Yakima Valley. As she puts it, “anyone can drive down this valley early any morning and see what utter disregard the crop dusters have for one and all.”
Your entire organic crop is ruined. Pursuant to NOFPA bylaws, no member can market foods or advertise food as organic if laboratory tests on the finished crop show the presence of more than ten percent (10%) of the maximum pesticide residue tolerances allowable by the Food and Drug Administration.
The Seemingly Innocuous Passage of Washington State’s Organic Food Law in 1985
You know I love that organic cooking
I always ask for more
And they call me Mr. Natural
On down to the health food store
I only eat good sea salt
White sugar don’t touch my lips
And my friends are always begging me
To take them on macrobiotic trips
Yes, they are
Oh, but at night I stake out my strong box
That I keep under lock and key
And I take it off to my closet
Where nobody else can see
I open that door so slowly
Take a peek up north and south
Then I pull out a Hostess Twinkie
And I pop it in my mouth
Junk Food Junkie, by Larry Croce
Larry Croce’s novelty song Junk Food Junkie captured the schizophrenic national mood regarding the consumption of organic food. It reached No. 9 on the Billboard charts in February 1976. It was easy to dismiss the desire for organic food as a cause célèbre of a harmless counterculture “hippie” fringe group.
An atmospheric feeling of “let’s throw them a bone” animates the discussion of Washington legislators regarding SHB 297, a bill “establishing standards for organic food products.” The following legislative colloquy regarding a one year transition period for not using pesticides is instructive:
Senator Hansen: “…Personally, I’m not going out to try and raise organic foods, but there are people out there who are serious about it and they have all agreed to this termination [regarding how much time it will take for agricultural lands to be deemed organic after prior use of pesticides], so why should I take opposition to it if they’ve agreed to it?
Senator Rasmussen: “What you’re saying it that it doesn’t make a bit of difference whether it’s organic or not, but we should pass the bill, maybe?”
Senator Hansen: “If it makes them feel better, as far as I’m concerned, if this achieves their goals, then why should I take objection to it.”
Senator Rasmussen: “Thank you, Senator Hansen. It has been an advantage to have a farmer here that knows organic foods.”
The committee report for SHB 297 summarized the proposed legislation as precluding a producer or vendor from selling or offering to sell any food product with the representation that the product is an organic food if the producer or vendor knows, or has reason to know, that the food was grown or raised with any of the following substances:
- Fertilizers by excluding manure and other natural fertilizers;
- Manufactured pesticides, hormones, antibiotics, or growth stimulants;
- Arsenicals, i.e., a drug or preparation containing arsenic; or
- Similar substances listed by the Department of Agriculture.
The SHB 297 Committee Report (“Report”) notes that the Director of Agriculture has administrative power to enforce the Act through injunctive relief and civil fines. Importantly, the Report states that a “violation of these requirements regarding organic food also constitutes a violation of the provisions of the Consumer Protection Act which declares unfair methods of competition and unfair or deceptive acts or practices in the conduct of trade or commerce to be unlawful.” The Report reiterates that the Consumer Protection Act “permits the court to award attorney’s fees and damages in an amount not exceeding three times actual damages in certain circumstances.” Both the House and Senate passed SHB 297 and it is now codified as RCW Ch. 15.86.
Alaska and Oregon also enacted organic food legislation. Oregon followed a different tack in enacting its organic food law in 1989. Like most other state organic food laws—with the notable exceptions of Washington and Alaska — Oregon’s short-lived law did not provide private individuals with a right to sue for organic certification violations. Former ORS § 616.900 imposed only civil penalties that were to be enforced by the Director of Agriculture. All in all, 29 states enacted some form of organic food law.
Federal Organic Food Laws Trump State Laws
The growing patchwork of state organic food laws led to calls for the enactment of a uniform federal law governing organic food production and promotion. This ultimately culminated in the passage of the federal Organic Food Production Act of 1990. It was promulgated in order to (1) “establish national standards governing the marketing” of organically produced agricultural products, (2) “assure consumers that organically produced products meet a consistent standard,” and (3) “facilitate interstate commerce in fresh and processed food that is organically produced.”
Under the regulatory authority granted by the Act, the United States Department of Agriculture (“USDA”) established a National Organic Program of approved and prohibited substances for the production and handling of organic products which went into effect in 2002. Certified compliance with the USDA allows an organic producer or processor to use the USDA’s green organic seal. That seal is now the ubiquitous symbol of organic food.
Under the federal Act, both states and private organizations can serve as organic certifying agents. State certification programs may “contain more restrictive requirements governing the organic certification of farms and handling operations,” but any additional requirements shall further “the purposes of” and not “be inconsistent with” the federal organic products legislation. Pursuant to the Act, both the Washington State Department of Agriculture (“WSDA”) and Oregon Tilth, Inc., headquartered in Corvallis, Oregon, are now accredited certifying agents. Those meeting WSDA or Oregon Tilth organic certification requirements are permitted to affix their respective individual logos to their food products.
A key dividing point between federal and state regulation of organic food products is whether individual consumers and product competitors are entitled to bring private lawsuits against those who violate the guarantees wrapped up in an organic food logo. Federal law includes no private right of action for aggrieved consumers. It instead relies on a host of civil penalties and decertification remedies as enforcement mechanisms. Alaska and Washington organic food laws specifically allow individuals to file consumer protection act claims against those who violate organic food certification standards. (In contrast, Oregon law is silent on this point.)
The availability of consumer protection act claims and remedies should provide financial incentives for pursuing class action litigation on behalf of consumers harmed by false or misleading organic food representations. Prevailing parties can recover attorneys’ fees and potentially, exemplary damages. Recovery of “emotional distress” and “mental anguish” damages can present difficult claim and proof issues, since consumer protection act claims limit a damages recovery to injuries to one’s business or property.
Recovering the amount paid for food products whose organic or natural representations are false or misleading involves a relatively straightforward damages analysis. The more intractable claim and proof issues arise from an aggrieved purchaser’s disappointment and emotional response to consuming food that may well violate one’s moral or ethical beliefs. Courts have a difficult time evaluating such damage claims. Loss of enjoyment of food can be recoverable as “hedonic” damages in personal injury cases. Plaintiffs will need to allege state law tort claims for mental anguish and emotional distress to seek such damages. These types of personal injury claims are not generally amenable to class action resolution since they raise issues of fact peculiar to each claimant.
Defendants targeted in Washington and Alaska organic food class actions may argue that private state law claims are preempted as “inconsistent” with the purposes of federal organic food legislation. There is no controlling case law on this point. More generally, the leading case confronting “organic” federal preemption issues is In re Aurora Dairy Corp. Organic Milk Marketing and Sales Practices Litigation. The case concerned whether milk produced from Aurora Dairy Corporation’s dairy farm was properly certified and labeled as “organic.” Various class action plaintiffs sued Aurora, the organic certifying agent (“QAI, Inc.”), and retailers selling the milk, including Costco, Safeway, Target and Wild Oats Markets. These retail stores sold Aurora milk under their own private labels.
The plaintiffs contended that Aurora’s milk was not organic and that the defendants made other misleading representations violating state consumer protection laws. For example, several cartons “featured depictions of pastoral scenes with cows grazing in pastures, and advertised the idyllic conditions under which the dairy cows lived.” In an article appearing in Costco Connection magazine, the company represented that the “cows on the farm have quite the life. They feed on a balanced vegan diet and have access to organic pastures for grazing.”
The Aurora federal appeals court held that the plaintiffs’ state law claims based on the “organic” food certification and label themselves were preempted by Organic Food Production Act of 1990 and its regulations, promulgated as the National Organic Program (“NOP”).
The Aurora appeals court determined the state law consumer protection act claims based on the following types of representations were not preempted:
The class plaintiffs alleged Aurora engaged in deceptive advertising practices, by, among other things, “misrepresenting the manner in which its dairy cows were raised and fed,” and “suppressing or omitting material facts regarding the production of its ‘organic’ milk or milk products, specifically that … the dairy cows were not raised at pasture.” This claim sufficiently states a cause of action at this stage of the proceedings.
The key to avoiding federal preemption in misrepresentation in cases regarding “organic” food is not relying on violations of federal NOP certification process in framing complaint allegations. The Aurora appeals court decided that:
To the extent the class plaintiffs, relying on state consumer protection or tort law, seek to set aside Aurora’s [organic]certification, or seek damages from any party for Aurora’s milk being labeled as organic in accordance with the certification, we hold that state law conflicts with federal law and should be preempted. Accordingly, we affirm the dismissal of the class plaintiffs’ claims based on Aurora’s and the retailers’ marketing, representing, and selling milk as organic when, allegedly, it was not.
The National Organic Program has its ardent critics. Ceding control over food quality and characteristics to faraway bureaucracies and the lobbyists of multinational corporations, organic purists argue, leads to watered-down, defanged organic food regulations. Arctic Organics — an Alaskan company that produces organic food but which eschews USDA organic certification — frames the issue this way:
Our philosophical aversion to being certified by the NOP [National Organic Program]is easily explained. The NOP is constantly pressured by large agribusinesses that spend enormous amounts of lobbying money to change standards so that they can take part in the success achieved through true organic production—including success in the marketplace which organic farmers have worked hard to accomplish over several decades. For example, under the NOP, it is now possible to feed nonorganic feed to livestock and sell the meat as “organic,” and poultry is no longer required to have access to the outdoors for foraging and exercise.
The growing “locavore” movement regards mass-produced food with disfavor and distrust. Federal regulation of organic foods can be viewed as an antithesis of locavore ideals. It opens up American markets to the importation of allegedly “organic” food in regions of the world (particularly China) where the organic inspection standards may be faulty or corrupt.
To summarize, in the space of about 40 years, organic food went from being a niche, specialty item produced by “farmers on the fringe” to its present status as well-recognized products subject to detailed federal and state law and regulations.
“Natural” Foods Follow a Different “Policy” Regulatory Path
In contrast to “organic” food, there are no binding federal regulations governing the use of “natural” food labels, only federally issued “policy” advice. The absence of federal regulation is significant because it undermines federal preemption and primary jurisdiction arguments in cases discussed in more detail below and opens the door to lawsuits based on state law.
The Federal Trade Commission (“FTC”) first attempted to define the term “natural” in the mid 1970s and concluded it was unable to establish a definition or meaning of the term in 1983. The FTC decided to pursue the issue on a case-by-case basis. A statement from the Chairman of the FTC observed that:
The proposed [abandoned]rule would also define “natural” foods as those with no artificial ingredients and only minimal processing. Quite aside from the significant difficulties that would be posed in enforcing this rule, a fundamental problem exists by virtue of the fact that the context in which “natural” is used determines its meaning. It is unlikely that consumers expect the same thing from a natural apple as they do natural ice cream. The proposed rule assumes, without any evidence, that “natural” means the same thing in every context. We should concentrate our resources on more serious consumer protection problems than whether a claim that “milk is natural” is deceptive.
Likewise, the FDA first attempted to define the term “natural” in 1989 and abandoned that effort in 1993. The FDA stated that it would maintain its policy of defining “natural” as meaning “that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.”
Like the FDA, the USDA has issued policy advice with respect to the use of the term “natural.” The USDA’s Food Standards and Labeling Policy Book informs the reader that the word “natural” may be used on labeling for meat and poultry products if (1) the product doesn’t contain any artificial flavor or flavoring, coloring ingredient or any other artificial or synthetic ingredient; and (2) the product and its ingredients are not more than minimally processed. With respect to what constitutes minimal processing, USDA policy relates in part that:
Minimal processing may include: (a) those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or (b) those processes which do not fundamentally alter the raw product and/or which only separate a whole, intact food into component parts, e.g., grinding meats, separating eggs into albumen and yolk, and pressing fruits to produce juices. Relatively severe processes, e.g., solvent extraction, acid hydrolysis, and chemical bleaching would clearly be considered more than minimal processing. …
All products claiming to be natural or a natural food product should be accompanied by a brief statement which explains what is meant by the term natural, i.e., that the product is a natural food product because it contains no artificial ingredients and is only minimally processed. The statement should appear directly beneath or beside all natural claims or, if elsewhere on the principal display panel; an asterisk should be used to tie the explanation to the claim.
In September 2009, the USDA’s Food Safety and Inspection Service issued an advance notice of proposed rulemaking on the use of the voluntary claim of “natural” in the labeling of meat and poultry products. No formal rulemaking has yet occurred in response to the FSIS notice. Earlier in 2009, the USDA also issued a voluntary standard for “naturally raised” livestock and meat marketing claims. Essentially, to make the “naturally raised” marketing claim, the meat and meat products must have been raised entirely without growth promotants, antibiotics (with some exceptions), and have never been fed animal by-products.
The absence of binding federal regulations governing the use of “natural” food representations, however, does not prevent the FDA from issuing “warning letters” to producers who misuse an “all-natural” representation. A November 2011 letter from the FDA to Alexia Foods is a prime example. It reads in part:
Your Alexia brand Roasted Red Potatoes & Baby Portabella Mushrooms product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)], which states that food shall be deemed to be misbranded if its labeling is false and misleading in any particular. The phrase “All Natural” appears at the top of the principal display panel on the label. The FDA considers use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic . . . has been included in, or has been added to, a food that would not normally be expected to be in the food.” [58 FR 2302, 2407, January 6, 1993].
Your Alexia brand Roasted Red Potatoes & Baby Portabella Mushrooms product contains disodium dihydrogen pyrophosphate, which is a synthetic chemical preservative. Because your products contain this synthetic ingredient, the use of the claim “All Natural” on this product label is false and misleading, and therefore your product is misbranded under section 403(a)(1) of the Act.
Despite its regulatory oversight, an FDA warning letter is not a “final agency action” as defined under the federal Administrative Procedures Act. Instead, it is a “tentative or interlocutory action” which does not constitute a final agency action. The non-binding nature of the warning letter means the target’s right to seek judicial review of the allegations is circumscribed and limited.
The absence of definitive federal law or regulations regarding proper use of “natural” food representations is a boon for state consumer protection act litigation. In recent years, a host of class action complaints have been filed against food producers regarding their use of the word
“natural” in product labels. For example, a recently filed class action complaint against Kashi Company, and Kellogg Company (which owns Kashi) alleges these defendants “inserted a spectacular array of unnaturally processed and synthetic ingredients to its so-called “all natural” products.” The complaint alleged that Kashi’s “All Natural” GoLean shakes are composed almost entirely of synthetic and unnaturally processed ingredients including sodium molybdate, phytonadione, sodium selenite, magnesium phosphate and a host of other ingredients that have been declared to be synthetic substances under federal regulations.
The Kashi case joins a growing list of state law class actions. A number of these cases raise the issue of whether high fructose corn syrup (“HFCS”) or other processed ingredients qualify as “natural” ingredients. See, e.g., Lockwood v. Conagra Foods, Inc. (allegation that defendant engaged in misleading conduct by advertising its “Healthy Choice’ pasta sauce as “all natural” when it in fact included HFCS); Astiana v. Ben & Jerry’s Homemade, Inc. (allegation that defendants misrepresented ice cream containing “Dutch” or “alkalized” cocoa as “all natural”); Ries v. Hornell Brewing Co. (allegation that AriZona Ice Tea bearing the words “100% All Natural” was misleading because the drink included HFCS).
Attempts by defendants to have these claims dismissed under the primary jurisdiction doctrine — so that the FDA can review the “all natural” food label claims — were initially persuasive to a number of federal district court judges. Such challenges have not been ultimately successful in resolving these cases, however. In one case where the “Is HFCS natural?” claim was stayed pursuant to the primary jurisdiction doctrine, the FDA informed the presiding judge that it would not make an administrative determination whether HFCS qualifies as a “natural” ingredient.” The FDA’s reasoning, in part, was as follows:
First, for the FDA to resolve whether HFCS qualifies as a “natural” ingredient in defendants’ beverages, in the absence of a pre-existing regulatory definition, the agency would expect to act in a transparent manner by engaging in a public proceeding to establish the meaning of this term. Given the issues involved, making such a determination without adequate public participation would raise questions about the fairness of FDA’s action. FDA’s experience with such proceedings is that they would take two to three years to complete. We recognize that such a timeframe would likely not be useful to the Court in resolving the current case.
Second, priority food safety and applied nutrition matters are currently fully occupying the resources that FDA has available for public proceedings on food matters. … Proceedings to define “natural” do not fit within these current priorities.
For the time being, there appears to be little bureaucratic appetite for issuing anything other than policy advice regarding use of “natural” in food promotion representations. The issue of when it is appropriate to label food as “natural” will continue to be litigated through false advertising and consumer protection act claims on a case-by-case basis. The risk of significant litigation exposure may temper the zeal of food producers and marketers to include the moniker “all natural” or portray misleading pastoral scenes on their brand labels.
Perceptions matter in choosing what to eat. If we believe our foodstuffs come from a natural or organic source, we intrinsically believe they will be better and more nutritious for us. The intense historical battle over whether margarine could be colored yellow to look like butter demonstrates the vital importance of appearances. During 1943 Congressional hearings on repealing the federal margarine tax, Elizabeth Schorske (representing the League of Women Shoppers) acknowledged that while adding color to margarine did not add any nutritive value, it does increase “the psychological goodness of it. I think you enjoy it more if it is colored. I know I do.” The same can be said of organic and natural foods. The emotive power of these two words ensures their continued vitality as descriptions of food quality.
 See generally, R. Deliza and H.J.H. MacFie, “The Generation of Sensory Expectations by External Cues and Its Effect on Sensory Perception and Hedonic Ratings: A Review,” 11 J. of Sensory Perceptions (1996), 103-128.
The number of studies seeking to determine whether organic food tastes better or is more nutritious is rapidly expanding. Unfortunately, the research methodologies employed in these studies generally rely on a limited set of variables as surrogates for determining what constitutes “good taste” or is deemed to be “nutritious.” Good taste is conflated into the presence (or not) of certain chemical compositions and nutrition is measured by the presence or absence of trace minerals. While these may be useful surrogates for analyzing nutrition, the academic challenge of the 21st century will be to study the complex physio-psycho-social interactions that appear to be much more explanatory of taste and nutrition. This will necessarily require a cross-disciplinary analysis involving the fields of physiology and psychology and even sociology.
 The author Michael Pollan is credited with making the term “locavore” a recognized food concept. His invaluable books explore our relationship to the production and consumption of food in many fascinating and subtle ways.
 When the name “oleomargarine” was first coined, the “oleo” prefix referred to the fact that margarine was being manufactured with beef fat. However, by the 1940s, much of oleomargarine was being manufactured with the use of vegetable oils, and technically, the “oleo” prefix did not apply. During Congressional hearings in the 1940s, legislators and witnesses began to use the words “oleomargarine” and “margarine” interchangeably.
 See, e.g., U.S. Patent No. 153,999, entitled “Improvement in Processes for Separating Oleomargarine and Stearine from Animal Fat” (issued on August 11, 1874); U.S. Patent No. 1,649,821, entitled “Powdered Butter Coloring for Butter and Oleomargarine” (issued on November 22, 1927); and U.S. Patent No. 3,940,504, entitled “Oleomargarine with Yellow Food Coloring” (issued on February 24, 1976).
The rapid increase in margarine consumption in place of butter in Denmark during World War I, for example, led to an epidemic of Vitamin A deficiency, which can result in such diseases as “night blindness” and corneal ulcers. Margarine producers then began fortifying it with Vitamin A. The following interchange during Congressional hearings in 1943 on whether to repeal the federal oleomargarine tax is illuminating:
Mr. Murray. I just want to call your attention to this: Up until 1938, not much of it [margarine]was fortified, or it was not fortified until 1938, to any great extent, and then anyone who has said that oleomargarine is as good as butter, was not making a scientifically accurate statement; that was not a scientific fact?
Dr. Gunderson. May we state it in terms of 1943, that in light of present knowledge and practice, this summary as I have read it, I think is a fair statement of the case.
Mr. Murray. In other words, the Oleomargarine Trust then up until 1938 was trying to tell the American public that oleo was as good as butter, and that was not the fact. It was not a scientific fact. * * * .
Vol 8, Legislative History of the Food, Drug and Cosmetic Act, p. 40 (accessed through http://heinonline.org).
See, e.g, United States v. Hohensee, 243 F.2d 367 (3rd Cir. 1957)(peppermint tea leaves and wheat germ oil were drugs when promoted to cure and prevent diseases); United States v. Vital Health Prods., Ltd., 786 F.Supp. 761, 772 (E.D. Wis. 1992), aff’d sub nom. United States v. Lebeau, 985 F.2d 563 (7th Cir. 1993)(“White Birch Mineral Water” and “Licorice Root Tea” reported to possess curative powers were drugs); Hanson v. United States, 417 F. Supp. 30, 34-35 (D. Minn. 1976)(extraction from the kernels of apricot pits marketed to treat cancer is a drug when “peddled for the intended uses set forth in the statute”); United States v. 250 Jars, etc., of U.S. Fancy Pure Honey, 218 F. Supp. 208 (E.D. Mich. 1963) aff’d, 344 F.2d 288 (6th Cir. 1965)(honey promoted as “a panacea for various diseases and ailments” is a drug; “The fact that the seized honey is a food cannot take it out of the statutory definition of the word ‘drug,’ since such honey was intended to be used in the capacity of a drug.”).
 S. Lendman, “Potential Health Hazards of Genetically Engineered Foods,” (dated February 22, 2008), Centre for Research on Globalization, accessed on 1/10/12 at http://www.globalresearch.ca/indix.php?context,+va&aid+8148.
A. Hill, “Healthy food obsession sparks rise in new eating disorder,” The Guardian/The Observer (August 15, 2009), accessed on 1/9/12 at http://www/guardian.co.uk/society/2009/aug/16/orthorexia-mential-health-eating-disorder.
 The name is an anagram, “soy” for “soybeans” and “lent” for “lentils.” The text description of Soylent Green is drawn from my recent viewing of the film and Wikipedia’s entry for the film, available at http://en.wikipedia.org/wiki/Soylent_Green.
 Dan Sullivan, “Time for Change: The Story of Tilth’s Remarkable Birth also Charts the Beginnings of the Sustainable Agricultural Movement,” Rodale Institute (January 27, 2005), available at http://www.newfarm.org/features/2005/0105/tilth/history.shtml.
 This narrative is based on the facts described in Langon v. Valicopters, Inc., 88 Wn.2d 855, 857, 567 P.2d 218 (1977) and “Langons Win Pesticide Case,” Tilth Producers Quarterly: A Journal of Organic and Sustainable Agriculture (Summer 1975).
“Guthion, also called azinphos-methyl, is an organophosphorous pesticide that was used on many crops, especially apples, pears, cherries, peaches, almonds, and cotton. Many of its former uses have been cancelled by the EPA, and its few remaining uses are currently in the process of being phased out.” From ToxFAQs, available at http://www.atsdr.cdc.gov/tfacts188.html#bookmark05 (accessed July 16, 2008). This website is maintained by the Agency for Toxic Substances and Disease Registry (“ATSDR”), which is part of the U.S. Department of Health and Human Services. According to the ATSDR, “Guthion interferes with the normal way that the nerves and brain function. Exposure to very high levels of Guthion for a short period in air, water, or food may cause difficulty breathing, chest tightness, vomiting, cramps, diarrhea, blurred vision, sweating, headaches, dizziness, loss of consciousness, and death. If persons who are exposed to high amounts of Guthion are rapidly given appropriate treatment, there may be no long-term harmful effects.” Id.
 The Organic Food Production Act of 1990 is codified at 7 U.S.C. § 6501 et seq. This Act required that the United States Department of Agriculture (“USDA”) develop national standards for organic products. Pursuant to this mandate, the National Organic Program (the “NOP”) instituted rules and regulations for organic food and its handling. The permitted use of the green USDA certification mark is regulated by the NOP.
 Under Washington’s “Organic Food Product” law, RCW 15.86.030, a producer, processor or handler shall not represent, sell, or offer for sale any food product with the representation that the product is an organic food if that person knows or has reason to know that the food has not been produced, processed or handled in accordance with standards established by the National Organic Program. A violation of RCW 15.86.030 constitutes “an unfair method of competition and unfair or deceptive act or practice” pursuant to RCW 19.86.023.
Similarly, a violation of Alaska’s organic food law, AS 17.06.010, is also an unfair and deceptive act pursuant to AS 45.50.471(47) and can give rise to a private cause of action pursuant to AS 45.50.531(a).
 See, e.g., RCW 19.86.080 (“Any person who is injured in his or her business or property by a violation [of Washington’s consumer protection act] … may bring a civil action in superior court to enjoin further violations, to recover the actual damages sustained by him or her, or both, together with the costs of the suit, including a reasonable attorney’s fee, and the court may in its discretion, increase the award of damages to an amount not to exceed three times the actual damages sustained …”; italics added).
“One does not need to be a gourmand or gourmet to conclude that the consumption of food and drink represents a not inconsiderable portion of man’s enjoyment of life. To be deprived of the capacity to enjoy flavorful dishes and palatable beverages is to be robbed of much of what goes into a rewarding existence because, with the ‘inner man’ satisfied, one can work with greater zest in the accomplishment of his chosen tasks and in making his contribution to the happiness of those dependent upon him and mankind in general. The defendant has lost much of the desire for the table because he can detect no difference in food. Whether it be the rarest delicacies or the commonest kind of provender which he eats, he tastes only sawdust.” Daugherty v. Erie R. Co., 403 Pa. 334, 340, 169 A.2d 549, 552 (1961).
The title to one article frames the issue: Is Your Organic Food Really Organic? (available at http://www.alternet.org/environment/94146/is_your_organic_food_really_organic). The article discusses the fact that 15 out of 30 federally accredited organic certifiers had been put on probation due to their shoddy certification practices, especially as they relate to food imported from China. The article notes, “Even if a Chinese inspector notices illegal pesticide use, he or she might feel pressured to stay silent,” says Dr. Robert E. Hegel, professor of Chinese and Comparative Literature at Washington University in St. Louis. “Everybody there is so proud of increased production that few people ask much about the farmer’s production methods,” he states. “And there’s no ‘organic’ food tradition in China.” According to Hegel, in China “everything was just ‘food’ and it was, until the 1950s, mostly ‘organic’ by our contemporary definitions—fertilized with human and animal waste, compost . . . and ashes.”
 USDA, Food Safety and Inspection Service (FSIS), Food Standards and Labeling Policy Book (revised for Web publication, August 2005). Note that the primary difference between FSIS meat labeling regulations and FDA food label regulations is that meat and poultry producers must submit their label claims to the FSIS before they can be marketed, whereas producers of other foods do not have to submit their labels to the FDA for pre-approval.
 Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939, 946 (E.D. Wis. 2008) (the opinions of the FDA officials who wrote the letter that the defendants’ products were misbranded were not final agency actions); Genendo Pharmaceutical v. Thompson, 308 F. Supp.2d 881, 885 (N.D. Ill. 2003)(statements of FDA officials in warning letter do not constitute final agency action).
 See Lockwood v. Conagra Foods, Inc., 597 F. Supp.2d 1028 (N.D. Cal. 2009); Astiana v. Ben & Jerry’s Homemade, Inc., 2011 WL 2111796 (N.D. Cal. 2011); Ries v. Hornell Brewing Co., 2010 WL 2943860 (N.D. Cal. 2010).