blog tomato 1Diana Kennedy, an intrepid chronicler of Mexican cuisine, describes cuatomates as “very small cherry tomatoes with an intense flavor and enormous amount of tiny seeds.”  A potently flavored, tiny green tomatillo variety “grows wild in [Mexican] cornfields.”[1]

Wild, obscure tomatoes—ones you’ve never seen nor tasted—represent the tomato’s intellectual property asset future, in the form of valuable plant patents, closely held trade secrets and memorable trademarks.  Their genomic structures tell a fascinating, if indirect story of conquest and domestication.

Successful plant breeding demands genetic variability.   While the tomatoes we know appear to come in all kinds of fancy heirloom shapes and colors, their decoded genomes speak of genetic bottlenecks, of roadblocks to tomato plant improvements.

Of course, the best bred tomato falls flat without economic demand.  The halting reception this novel fruit qua vegetable received during the Age of Exploration ironically mimics the marketing fate GMO tomatoes face today.  Remember Calgene’s FlavrSavr tomato—the epic commercial dud of the 1990s?

This post examines the prospects for inventing and branding new tomato cultivars in light of a depleted, domesticated genome.

Tomato Domestication Syndrome

The domesticated tomato’s precursor “still grows wild in coastal deserts and Andean foothills of Ecuador and northern Peru. Inauspicious and easily overlooked, S. pimpinellifolium fruits are the size of large garden peas.”[2]  How did such tiny wild tomatoes (just 1 cm in diameter) balloon into the beefsteak tomatoes we relish in a Caprese salad?

Domestication of plants triggers a range of traits that distinguish them from their wild ancestors.[3]  Generally speaking, domesticated plants differ in three basic ways:

  • More compact growth habits.
  • Reduction and loss of seed dispersal and dormancy.
  • Gigantism and increased morphological diversity in the consumed portion of the plant.

Collectively, these traits are known the “domestication syndrome.”[4]  Studies reveal that the “traits that distinguish crop plants from their wild relatives are often controlled by a relatively small number of [genetic] loci with effects of unequal magnitude.”[5]

Classic Arc of Novel Food Acceptance

During the (often horrifying) Age of Conquest, Spanish explorers observed the Amerindians would easily forego meat and “most content themselves with some tortillas spread with a chili sauce to which they usually add the fruit of a certain species of solanum called tomamo.[6]

Although Spanish conquistadores brought this strange fruit back to Europe in the early 1500s, they shunned it.  They feared consuming New World foods would turn them into emasculated, “phlegmatic, beardless Amerindians.”[7]  They much preferred a steady Iberian diet of meat, wine, olive oil and bread.

European herbalists soon classified tomatoes in the Solanaceae or “nightshade” family of fruits and vegetables that include eggplants, potatoes and chili peppers.  At first, tomatoes were considered a decorative fruit—not to be eaten.  The tomato’s physical likeness with its poisonous “bittersweet nightshade” relative, Solanum dulcamara,[8] cautioned against ingestion.  One British herbalist described tomato plants to be “of ranke and stinking savour.”[9]

blogtomato 2

The first tomato described by an Italian botanist in 1544 is a yellow-fruited variety he called mala aurea, or “golden apples.”[10]  The name stuck in Italy.  The first documented tomato recipe, spaghetti con salsa di pomodoro, appears in a 1692 cookbook published in Naples.  Translated, pomodoro means “apple of gold.”  The symbolic imagery suggests a medieval conundrum: eating tomatoes could lead to tragic death and metaphorical expulsion from an Edenic garden.

The “Doctrine of Signatures” offered the wary European consumer with a countervailing, positive tomato association.  This ancient notion contends that a plant’s medicinal qualities can be ascertained by external appearance.  Hence, a walnut becomes the “brain” food it resembles.  A sliced-opened beefsteak tomato looks vaguely like the four chambers of the heart.

Distilled, novel food acceptance—like that of the tomato—tends to occur in the following stages:

Novel Food Acceptance Patterns Tomatoes Enter Mainstream American Diets

New foods are at first warily shunned and scorned as impure or unhealthy; this natural reaction may be explained by moral foundations psychology and our innate, Darwinian need for assurances of food safety and sanctity.

 

Budding entrepreneurs stage public tomato eating demonstrations to defuse concerns that it is poisonous.

 

Promoters offer free samples, celebrity testimonials, extravagant health claims and favorite recipes.

 

Hucksters promote medicinal tomato cure-alls; 19th century statesmen endorse tomato farming and consumption; immigrant tomato recipes become ingrained in American food culture.

 

Market forces and subsistence needs encourage novel food production and consumption.

New 19th century canning technologies transform tomatoes into a Civil War staple food and favorite among returning veterans; tomatoes grow in disparate climates.

 

Time passes and no one gets demonstrably ill.

 

Economic adulteration, however, continues to defraud consumers who cannot ascertain the quality of canned foods.

 

 

A nostalgic feedback loop ensues. Past consumption experiences are romanticized and pleasing images portray the novel foodstuff. (As the mouth is the portal to the self, consumers seek emotional bonding with the foods they ingest.)

 

A resurgent Doctrine of Signatures[11] encourages tomato consumption as “heart healthy” and indeed, a “reduced risk of heart disease is an area of health benefits in which tomatoes truly excel.”[12]

Phenotype = Genotype + Environment

To understand the tomato’s intellectual property prospects, some basic plant breeding terminology is helpful.

A phenotype is the composite of observable characteristics or traits in a plant.  In the basic plant breeding equation, a plant’s phenotype is the result of the organism’s expression of its genetic code—its genotype—in conjunction with the influence of environmental factors.

Historical evidence shows that Mesoamerican farmers domesticated the earliest forms of tomatoes that, in turn, had originated somewhere in the Andean region of South America.  They exercised a form of plant breeding summed up as “crossing the best with best and hoping for the best.”[13]  The tremendous increase in the tomato size arose from this trial and error technique.[14]

In this process, yet another form of tomato emerged.  Landrace varieties are cultivated plants that have adapted to specific, local environmental conditions, perhaps hundreds or even thousands of years ago.

An Evolving Tomato Genome

While plant patenting laws operate at the observational, phenotype level—requiring new, distinct and stable varieties of plants for patentability purposes—trait inheritance evolves genomically:

Genomes evolve by duplication of genes, chromosomes or whole genomes, by various rearrangements, insertions of organellar, bacterial or viral DNA that are part of horizontal gene transfer (HGT), (micro)satellite expansions, transposable element insertions and other processes.

A major part of the nuclear genome of most plants is represented by repetitive DNA elements; these elements contribute to the higher evolutionary dynamics of genomes, while genes represent slowly evolving (conservative) genetic units.

Perhaps, the most distinctive feature of angiosperm [flowering plants] is the large amount of genome duplication, i.e., polyploidization [containing more than two homologous sets of chromosomes].

Higher repetitive DNA turnover, repeated polyploidizations and subsequent gene losses lead to a much more rapid structural changes of plant genomes when compared to vertebrates, where gene order conservation is evident event after hundreds of millions of years of divergence.[15]

The sheer geographic distance between the original “wild” tomatoes in South America and their domesticated counterparts in Mexico (and later in Europe and North America) means that tomato genomes diverged a long time ago.

Compared with the rich reservoir in wild species, the cultivated tomato is genetically poor.  It is estimated that the genomes of tomato cultivars contain [less than] 5% of the genetic variation of their wild relatives.

Tomato domestication experienced a severe genetic bottleneck as the crop was carried from the Andes to Central America and from there to Europe.  The initial domestication process was, in part, reached by selecting preferred genotypes in the existing germplasm.[16]

Reinventing the 21st Century Tomato

Charles Rick

During the 20th century, Charles Rick would become the tomato’s most important scientist and plant breeder.  Described as a cross between a Charles Darwin and an Indiana Jones, Rick traveled through the Andean region of South America collecting wild relatives of the domesticated tomatoes.  “As early as 1953, Rick showed that crosses between wild species and their cultivated relatives could reveal novel genetic variations of potential use in agriculture.”[17]

Rick’s astonishingly valuable collection of tomato germplasm is now maintained at the C.M. Rick Genetic Resource Center of the University of California, at Davis:

The Rick Center acts like a lending library, nurturing and preserving its 3,600-specimen collection but also making it readily available to scholars and plant breeders worldwide who want to “check out” seeds for their own experiments.  Today, those seeds are kept in a vault that resembles a restaurant’s walk-in refrigerator.

But the Rick collection is not really about taste. Domestic tomatoes had virtually no innate resistance to common tomato diseases and pests until breeders [like Rick] began crossing them with wild species in the 1940s. . . . . Wild tomatoes, on the other hand, are more robust.  “We know of at least forty-four pathogens for which resistance has been found in wild species.”

The possibilities of using wild traits to improve cultivated tomatoes seem almost limitless.  Some wild species grow at chilly altitudes thirty-five hundred meters up the in the Andes, tolerating low temperatures that would cause other tomatoes to shrivel and die.  Others thrive in humid rainforests.  A few can eke out an existence in the desert.[18]

Crosses between wild and cultivated species of tomatoes can generate an array of novel genetic variation in their offspring.  Breeding “from wild species via interspecific crosses followed by many backcrosses to cultivated tomatoes can lead to the transfer of favorable attributes” in the resulting tomato variety.[19]  This is known as “wild introgression” plant breeding.

Genome Editing and Plant Breeding Bandwagons

In one way or another, all plant breeding techniques hearken back to Experiments in Plant Breeding, Gregor Mendel’s 1866 groundbreaking article (ignored at first and rediscovered 34 years later).

By the latter 20th century, plant breeders applied increasingly sophisticated biotechnology tools to “improve” the tomato.  Goals included breeding for “yield in the 1970s, for shelf life in the 1980s, for taste in the 1990s, and for nutritional quality currently.”[20]

The first transgenic tomato, Calgene’s Flavr Savr tomato, relied on recombinant DNA techniques to extend the shelf life of tomatoes by inhibiting an enzyme involved in fruit softening.  The Flavr Savr tomato had some initial market success in the mid-1990s, then flopped.  Its developers chose a tomato intended for the food processing market as the target cultivar, rather than a tomato grown for fresh food markets.  Apparently, the resulting GMO tomato had very little flavor worth saving.  It found its best use in the tomato processing market, but consumers rebelled against the GMO provenance.[21]

In contrast to recombinant DNA technology—in which foreign genes are inserted into a target host—a new wave of plant breeding relies on genomic editing tools, such as the CRISPR/Cas9 system. In broad terms:

Genome editing focuses on the G component of P = G +E [i.e., that phenotype value (P) is the sum of genetic (G) and environmental effects (E)], and it represents an infinitely more precise form of mutation breeding.  Genome editing allows changes in targeted DNA sequences, with the edits involving the deletion, substitution, or addition of one or more bases.

[G]enome editing requires prior information on gene identity and function and leads only to targeted mutations.  In practice, however, the plant regeneration process after genome editing may lead to unwanted somaclonal variation in the target cultivar.  Genome editing may be particularly valuable in plant species for which backcrossing (to introgress favorable alleles) is impractical due to a long generation interval or infeasible to a heterozygous recurrent parent.

[G]enome editing will be most useful in the same situations where linkage mapping of QTL [quantitative trait loci] is most useful: for traits that have major QTL or major genes.  For such traits, such as disease resistance or flowering date, changes in the known underlying genes can be directly made via genome editing.  These changes will involve loss-of-function mutations or gain-of-function mutations equivalent to naturally occurring mutations with known effects, or novel mutations that need to be characterized via phenotypic screening.

The many genes affecting a trait such as yield in elite germplasm remain largely unknown even after whole genomes have been sequenced.[22]

While this description of genome editing may read somewhat like Greek, the most important finding is that “most quantitative [plant] traits are controlled by a large number of small effect genes ‘locked away in low-recombinant regions,’ presenting challenges in (even) sequenced and highly genotyped association mapping panels.”[23]

In other words, even though genomic editing is the latest and greatest biotech bandwagon, its technical shortcomings will also confound the plant breeding industry.

Wild” Tomatoes are Not Patentable

U.S. plant patenting laws, 35 U.S.C. §§ 161-164, protect new and distinct varieties of “asexually reproduced” plants other than those “found in an uncultivated state.” More generally, U.S. utility patents, among other things, cover new and useful “compositions of matter, or any new and useful improvement thereof.” 35 U.S.C. § 101. In addition, the Plant Variety Protection Act offers patent-like protections for new, distinct, uniform and stable sexually reproduced plant varieties. 7 U.S.C. §§ 2321-2582.

Plant explorers will find no solace in U.S. plant patent laws—since plants discovered in the wild are not patentable.  A recent Federal Circuit decision discussing plant patenting, In re Beineke (2012), stands for the proposition that:

[T]wo things [are] necessary for an applicant to obtain plant patent protection: (1) the plant must have been created in its inception by human activity, i.e., it must be the result of plant breeding or other agricultural or horticultural efforts; and (2) the plant must have been created by the “inventor,” i.e., the person seeking the patent must have contributed to the creation of the plant in addition to having appreciated its uniqueness and asexually reproduced it.[24]

Although plants found in the wild are not patentable, their progeny may be.  These plant patenting activities appear relatively immune from a line of attack generated by the recent Myriad/Mayo Supreme Court cases—i.e., that naturally occurring DNA segments constitute unpatentable products of nature. [25]  The Plant Patent Act of 1930 altered former law rejecting plant inventions as unpatentable “laws of nature.”  The same can be said for the Plant Variety Protection Act.

Standard utility patent applications, however, may present separate patenting difficulties.  If the utility patent claims seek to cover naturally occurring genomic sequences, new plant variety patents may be subject to Mayo/Myriad-based rejections.

In this regard, an analysis of patent claims in human biomedicine vs. crop-based agriculture reveals a substantive overlap in claimed genome sequences.  “Such practice could, in principle, raise infringement concerns—for example, if an agribusiness and a medical diagnostic company use the same DNA primers for polymerase chain reaction-based genetic testing.”[26]

If the Mayo/Myriad case holdings operate as a brake on plant patent activities at the genomic level, one can anticipate that agribusinesses and other plant patent inventors will guard their plant-based innovations under a reinvigorated trade secrets law, now federalized per the “Defend Trade Secrets Act of 2016.[27]

Genome Edited Plants Evade Regulatory Scrutiny

Genetically engineered (GE) plants are presumptively subject to a convoluted array of federal regulatory oversight by the Food and Drug Administration, the Environmental Protection Agency, and the United States Department of Agriculture.  Generally speaking, the FDA established a voluntary structure for GE plant producers to consult with the FDA before marketing these products.

Much of this regulatory structure—developed in the mid-1980s—is premised on theoretical “plant pests” and recombinant DNA techniques involving foreign gene insertion.

The USDA regulatory process for GE crops is triggered by the use of “plant pests” in any portion of the modification process or the derived potential of the GE crop to behave as plant pests.  In practice, the routine use of pest-derived genetic components triggers a de facto process-based regulatory regime by the USDA’s inspection service, APHIS [Animal and Plant Health Inspection Service].[28]

This regulatory framework focuses on transgenic biotechnology tools—now a fading, late 20th century bandwagon.  Genome editing tools tend not to trigger this GE food regulatory regime.  When requested to opine on genome editing tools, APHIS determined that genome editing technologies create two potential classes of products:

(i) those in which endogenous genetic material is removed (targeted deletions); and (ii) those in which precise sequence changes are introduced by using specific template oligonucleotides (targeted substitutions and insertions).

APHIS [states] that products resulting from targeted deletions would, in most cases, not be regulated because no new genetic material is integrated into the recipient genome, and the engineered nucleases did not originate from plant pests.  The second class of products (targeted substitutions and insertions) would need to be reviewed on a case-to-case basis to assess the inserted trait and determine regulatory status.[29]

Based on this dichotomy, genome editing appears to sidestep US regulatory oversight.  While this may be a policy loophole, there may be little impetus to expand bureaucratic review of genome edited plant food products when a sufficiently large body of scientific literature on GE traits already shows that “DNA modification per se is not inherently unsafe or a threat to the environment.”[30]

Guacamole Con Tomate Verde

You need not be a wild plant explorer to experience unusual tomato flavors.  Green tomatillos are more widely available in American grocery store shelves nowadays.  Their paper husks and sticky skin may be off-putting, but these are small bothers in a quest for sublime taste.

To mix up your standard guacamole recipe, try Diana Kennedy’s recipe for guacamole con tomate verde.[31]  After you’ve ground white onions, serrano chilies, cilantro and broiled tomatillos (preferably with a mortar and pestle), you mash—never machine blend!—avocadoes into this mixture.  Voilà, your taste buds will be transported to the state of Mexico bordering on Morelos, where this recipe originated perhaps eons ago.

_______________________________

* The opening photograph of tomatoes included in the Earth & Table version of this article is licensed under the GNU Free Documentation License, Version 1.2. For photographer information, see https://commons.wikimedia.org/wiki/User:Berrucomons.

[1] D. Kennedy, The Essential Cuisines of Mexico (2000), at 490-91.

[2] B. Estabrook. Tomatoland: How Modern Industrial Agriculture Destroyed Our Most Alluring Fruit (2011), at 3.

[3] Y. Bau and P. Lindhout, “Domestication and Breeding of Tomatoes: What Have We Gained and What Can We Gain in the Future,” 100 Annals of Botany 1085, 1086 (August 2008).

[4] Id.

[5] Id.

[6] R. Earle, The Body of the Conquistador: Food, Race and the Colonial Experience in Spanish America, 1492-1700 (2012), at 42.

[7] Id. at 52

[8] Photograph in the Earth & Table blog post version by Guido Gerding, https://commons.wikimedia.org/w/index.php?curid=1037325.

[9] A.F. Smith, The Tomato in America: Early History, Culture, and Cookery (1994), at 17.

[10] C. Wright, A Mediterranean Feast: The Story of the Birth of the Celebrated Cuisines of the Mediterranean, from the Merchants of Venice to the Barbary Corsairs (1999), at 32.

[11] See, e.g., http://herbs.lovetoknow.com/doctrine-signatures.

[12] See http://www.whfoods.com/genpage.php?tname=foodspice&dbid=44 (World’s Healthiest Food website page devoted to tomatoes).

[13] G. Acquaah, Principles of Plant Genetics and Breeding (2d ed. 2012), at 7.

[14] See n. 2, at 4.

[15] P. Smykal, et al., “From Mendel’s discovery on pea to today’s plant genetics and breeding,” 129 Theoretical and Applied Genetics, 2267, 2271-72 (2016) (citations omitted and text formatting altered for readability).

[16] See n. 3, at 1086.

[17] S. Tanksley and G. Khush, “Charles Madera Rick 1915-2002,” Biographical Memoirs, Vol. 84 (2003), at 10, available online at https://www.nap.edu/read/10992/chapter/17.

[18] Id. at 13-16.

[19] See n. 13, at 56.

[20] See n. 3, at 1088.

[21] See n. 13, at 256.

[22] R. Bernardo, “Bandwagons I, too have known,” 129 Theoretical and Applied Genetics 2323 (2016), at 2329-30 (text formatting altered for readability).  The reference to “elite germplasm” in the quoted material refers to germplasm that is adapted (selectively bred) and optimized to new surroundings (i.e., environment).

[23] See n. 15, at 2270.

[24] In re Beineke, 690 F.3d 1344, 1348 (Fed. Cir. 2012).

[25] See Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66 (2012); Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___ (2013).

 [26] O. Jefferson, et al. “Gene patent practice across plant and human genomes,” 33 Nature Biotechnology 1033, 1035, 1037 (October 2015).

[27] See 18 U.S.C. § 1836(b)(1)(“An owner of a trade secret that is misappropriated may bring a civil action under this subsection if the trade secret is related to a product or service used in, or intended for use in, interstate or foreign commerce.”).

[28] A. Camacho, et al., “Genetically engineered crops that fly under the US regulatory radar,” 32 Nature Biotechnology No. 11 (November 2014), at 1088.

[29] Id. at 1089.

[30] Id. at 1091.

[31] See n. 1, at 351 (Diana Kennedy’s recipe for Guacamole con Tomate Verde).

blog post first pictureWhen Meriwether Lewis tasted his first roasted morsel of a fresh Chinook salmon at a Shoshone camp along the Lemhi River (in modern day Idaho), he ate it with “very good relish.”  It convinced him that “we were on the waters of the Pacific Ocean.”

For centuries, native tribes and later settlers in the Pacific Northwest have revered the Chinook (or King) salmon as an iconic symbol of life and regeneration.  Celilo Falls, along the Columbia River bordering Washington and Oregon, was once the greatest salmon fishing site in North America, and perhaps the world.

Some 200 years later, the Atlantic and Pacific salmon fisheries have merged in the form of the first transgenic salmon.  An AquAdvantage® salmon[1] is what you create when you take an Atlantic salmon and insert a Chinook salmon growth hormone gene and an ocean pout fish regulatory gene sequence into it through the use of recombinant DNA technology.  An AquAdvantage salmon can grow to market size in land-based tank farms in half the time of conventional salmon.  It is never, ever supposed to swim in either ocean.

Whether or not the AquAdvantage salmon achieves final regulatory approval and market acceptance, its current fate squarely pits the much vaunted concept of sustainability against the other two most heralded words in the modern food vocabulary, natural and organic.

This article provides a brief survey of how the FDA evaluates the food safety of transgenic animals as “new animal drugs.”  It then discusses an alternative, more rigorous means of assessing genetically altered animals as “food additives,” the analytical approach favored by Food & Water Watch in a recently filed FDA citizen’s petition.  It closes with an animal scientist’s perspective regarding the sustainability of transgenic animals as food sources. Continue Reading Transgenic Salmon: A Primer on FDA Food Safety Regulations

For centuries, we’ve ingested magic elixirs in pill and syrupy forms to cure whatever ails us and to ward off future illness.  Hard scientific evidence of efficacy may have been lacking for these nostrums, but lingering doubts fell sway to the testimonial charms and hard-sell tactics of proverbial snake oil salesmen.  Once operating door-to-door, these smiley faces are nowadays more likely to be wearing white lab coats in glossy advertorials. [1]

“Enough is Enough”

A recent headline-generating editorial in the Annals of Internal Medicine calls into doubt the health value of taking daily multivitamins and mineral supplements—the sacred cow of the over-the-counter pharmaceutical world; the pablum we mindlessly swallow believing it’s good for us.  

The Annals editorial authors proclaim: “Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements.”[2]  Their survey of study results concluded with this emphatic statement:

[W]e believe the case is closed—supplementing the diet of well-nourished adults with (most) mineral and vitamin supplements has no clear benefit and might even be harmful.  These vitamins should not be used for chronic disease prevention.  Enough is enough.

Even worse, it turns out that consuming some vitamins or minerals in supplement form may be downright harmful.  The editorial further states that “[i]n conclusion, β-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful.  Other antioxidants, folic acid and B vitamins and multivitamins and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases.”[3]

Food vs. Dietary Supplements vs. Food Additives vs. Drugs

Dietary supplements occupy a curious nether world of regulation in the continuum that distinguishes “food”[4] on the one hand, and “food additives” and “drugs” on the other.  When marketers ascribe curative “healing” powers to food and dietary supplements—i.e., statutorily defined as vitamins, minerals, herbs or other botanical substances, amino acids or combinations or concentrates of these forgoing substances—an unsubstantiated choice of words regarding curative health benefits can instantly transform a food or dietary supplement into a “drug” under the Food, Drug and Cosmetic Act of 1938, as amended.[5]

The term “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” per 21 U.S.C. § 321(g)(1)(B).  A “drug” generally must undergo expensive randomized, double-blind testing to demonstrate efficacy before the drug can be sold to the public.[6]  A “food additive”—i.e., a substance which is expected to become a component of food or otherwise affect the characteristic of foods—can only be introduced into the market if the substance is generally recognized as safe by qualified scientific experts or has been commonly ingested in the food chain since prior to 1958.  Dietary supplements are specifically excluded from the definition of a “food additive.”[7]  Thus, dietary supplements do not have to undergo such pre-market testing before being ingested by the public.

The False Advertising Implications of the Annals Editorial

For vitamin and mineral supplement manufacturers, the Annals of Internal Medicine editorial throws down a gauntlet for false advertising litigation purposes.  Pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) [8], and its predecessor, the Nutrition Labeling and Education Act of 1990 (NLEA), a purveyor of a dietary supplement can claim “preventative” health benefits associated with its ingestion, such as describing (a) the role of the dietary supplement in addressing a nutritional deficiency, (b) how it affects the structure or function of our human anatomy, or (c) how it impacts our general well-being.  See 21 U.S.C § 343(r)(6).

Under the DSHEA, the FDA “may not establish maximum limits on the potency of any synthetic or natural vitamin or mineral within a food” and “may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the [FDA] determines is nutritionally rational or useful . . . .”  21 U.S.C.  §§ 350(a)(1)(A) and (a)(1)(B).

Whither the Scientific Substantiation
for Dietary Supplement Health Claims?

Whenever manufacturers or distributors tout “preventative” health claim benefits for ingesting a dietary supplement, they must have scientific substantiation that the claim is truthful and not misleading.  While the DSHEA does not define what constitutes proper or sufficient substantiation for dietary supplement health claims, the FDA and FTC generally require “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that [have] been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[9]

By way of example, even a casual review of Internet advertisements for beta-carotene shows that dietary supplement manufacturer health claims appear to be out of sync with an emerging scientific consensus that ingesting too much beta-carotene can be detrimental to your health and well-being.  For example, a website page for beta-carotene dietary supplements states that:

Beta-Carotene is a carotenoid that readily converts to vitamin A in your body when needed.**

Beta-Carotene supports eye health.**

Beta-Carotene supports antioxidant health and immune health by helping to fight free radicals.**

Beta Carotene is essential for healthy skin and hair.**

Unlike Beta-Carotene, fewer than 10% of other carotenoids convert into vitamin A.

This advertisement includes a disclaimer (marked by the double asterisks) that “These statements have not been evaluated by the Food and Drug Administration.  These products are not intended to diagnose, treat, cure or prevent any disease.” [10]

The beta-carotene advertisement does not include any disclaimer or qualification that would notify the consumer regarding the potential negative health implications of ingesting beta-carotene as a dietary supplement.  It implies that taking beta-carotene only brings health benefits as a universal good.  However, the scientific consensus regarding beta-carotene is best summarized as follows:

“There are many authorities – including the American Heart Association, the American Cancer Society, the World Cancer Research Institute in association with the American Institute for Cancer Research, and the World Health Organization’s International Agency for Research on Cancer – that recommend getting beta-carotene and other antioxidants from food instead of supplements, at least until research finds out whether supplements offer the same benefits.  Eating 5 servings of fruits and vegetables daily provides 6-8 mg of beta-carotene.”[11]

Because the scientific consensus undermines the asserted benefits of ingesting beta-carotene and other vitamins or minerals in supplement form, purveyors of dietary supplements may well soon find themselves named as defendants in false advertising claims brought by the FTC or by crafty class action plaintiffs.  False or misleading statements about dietary supplements can give rise to non-preempted, private rights of action under state unfair competition and deceptive trade practice laws.[12]

An analogous type of FDA-based false advertising claim is discussed in the Federal Circuit Court of Appeals decision in Allergan, Inc., et al. v. Athena Cosmetics, Inc., et al.  (decided on December 30, 2013).  Athena sells a “RevitaLash” line of products that contains a prostaglandin derivative as its active ingredient.  However, no new drug application had been submitted for this line of products.  The active ingredient in this product amounts to a “new drug” subject to FDA pre-market approval.  Athena violated FDA requirements by marketing and selling its “RevitaLash” line of products before undergoing that clearance/approval process.  Because California incorporates FDA laws into its Health Code, Athena’s FDA violation gave rise to a non-preempted, private right of action under California’s unfair competition laws.  Athena’s liability was so clear cut that it was liable for false advertising as a matter of law.

It is important to take the Annals editorial with a grain of salt.  Its broadside against taking multivitamins itself deserves further qualification.  As Darya Rose—a self-described neuroscience PhDork and food and health writer—aptly observes in her excellent food blog, Summer Tomato, “I think they overstate the case against a basic multivitamin.  I can think of dozens of potential benefits they did not test for (e.g. immunity, fatigue, etc.), and very few of us can eat a perfectly balanced diet every single day.  I continue to recommend a food-based multivitamin . . . that does not contain megadoses of any single nutrient.”[13]

Conclusion

As some early DSHEA commentators foretold, distinguishing dietary supplement health claims “from ‘drug claims,’ which allege to diagnose, cure, mitigate or prevent a disease and thereby render the product a drug (and not a dietary supplement) poses one of the most difficult challenges for marketers of dietary supplements . . . .”[14]

With scientific substantiation eroding with respect to the supposed efficacy of ingesting certain vitamins and minerals, dietary supplement marketers are skating on very thin legal ice if they continue to advertise and promote the health benefits of taking certain vitamin and mineral supplements without including prominent disclaimers or qualifications regarding potential negative health implications.  Since the U.S. dietary supplement industry reached $28 billion in sales in 2010, this industry could serve as a deep pocket for funding the attorneys’ fees recoverable by pre

 


[1] The advertisement for “Mrs. Winslow’s Soothing Syrup” that appears at the beginning of this article on Lane Powell’s Earth and Table website is one of the most popular advertisements of the 19th and early 20th centuries.  These ads claimed that the syrup had “magical effects and medical virtues” and that Mrs. Winslow was an experienced nurse.  The syrup contained one grain of morphine per fluid ounce, and also sodium carbonate, spirits foeniculi, and aqua ammonia.  Kids who did not overdose on it often became addicted to morphine.  It was banned for sale in the U.S. in 1906.  See “Patent Medicines & Miracle Cures” (September 2011) available online at http://www.nycbar.org/library/featured-exhibitions/patent-medicines-and-miracle-cures.

[2] An article about this editorial can be found at http://disinfo.com/2013/12/enough-enough-stop-wasting-money-vitamin-mineral-supplements/.  The editorial article itself may be purchased from the website, http://annals.org.

[3] “Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements,” 159 Annals of Internal Medicine No. 12, pp. 850-51 (December 17, 2013).

[4] “Food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.  21 U.S.C. § 321(f).

[5] The complete definition of a “dietary supplement” is very detailed and set forth in 21 U.S.C. § 321(ff).

[6] Randomized, double-blind testing means that neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment.  Such testing seeks to prevent experimenter bias and placebo effects from subtly influencing experimental test results.

[7] See 21 U.S.C. § 321(s)(6).

[8] Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§ 321, et. seq.).

[9] See “Guidance for Industry Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act,” available online at http://tinyurl.com/lvmse2u

[12] A previous Earth and Table blog posts discusses the interplay between FDA regulations and California false advertising laws in more detail.  See P. Swanson, “Fruit Juice Misbranding Claims Lose Their Lanham Act Bite,” posted on June 11, 2012, http://www.earthandtablelawreporter.com/2012/06/11/the-ninth-circuit-takes-a-lanham-act-bite-out-of-fruit-juice-misbranding-lawsuits/#more-153.

[14] R. Pinco and T. Halpern, “Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After the Enactment of the Dietary Supplement Health and Education Act of 1994,” 54 Food and Drug Law Journal 567, 577 (1999).

Co-Authored by June K. Campbell and Paul D. Swanson

“There’s a Chinese restaurant on every block, and if you think mouths won’t water when you come strolling by, then you don’t know squat about Oriental cuisine.  They prize the taste of dog, friend.  The chefs round up strays and slaughter them in the alley right behind the kitchen—ten, twenty, thirty dogs a week.  They might pass them off as ducks and pigs on the menu, but the in-crowd knows what’s what, the gourmets aren’t fooled for a second.” — Willy G. Christmas talking to Mr. Bones, his dog, from the novel Timbuktu, by Paul Auster

Europe is abuzz with the horsemeat scandal.  After the Food Safety Authority of Ireland first discovered that a range of frozen beef products contained a large percentage of horse DNA, the story struck a viral nerve and spread like wildfire.

For consumers at the convoluted end of frozen food supply chains, the idea that you have been eating “Bessie” the horse probably comes as an emotional shock to the system.  It is yet another nagging reminder of how distant we are from our original sources of food and how easy it is to be fooled by food appearances and masked tastes.[1]

For the companies whose grocery store or packaged food brands are entangled in the horsemeat scandal, the damage to reputational interests can be profound.  Affected companies took public relations repair action first and terminated supply chain contracts in a peremptory fashion.  IKEA stopped serving its famous Swedish meatballs.  Burger King changed to a different supplier of burgers.  Tesco, a major European supermarket chain, dropped a major vendor after discovering its frozen spaghetti bolognese contained over 60% horsemeat. Continue Reading Why Does Food Mislabeling Outrage Consumers?

Food label lawsuits are often exercises in byzantine legal logic.  This is so because of the peculiar interplay between preemptive federal food labeling laws and regulations on the one hand and federal and state unfair competition and false advertising claims on the other.

The ability of individuals to pursue food mislabeling claims depends on whether allowing such claims to proceed would conflict with the purpose and intent of federal food labeling law and implementing regulations, such as those promulgated pursuant to the Food, Drug and Cosmetic Act of 1938 (“FDCA”) or the Nutrition Labeling and Education Act of 1990 (“NLEA”).  Those federal laws do not allow private lawsuits to enforce their provisions.

In Pom Wonderful v. The Coca-Cola Co., the Court of Appeals for the Ninth Circuit just eliminated a federal Lanham Act basis for pursuing food misbranding claims over regulated juice products.  This brief article examines the Pom case and what it means for the future of food label litigation.

The Nature of Pom’s Fruit Juice Label Claim

Pom contends that Coca-Cola’s labeling of its Minute Maid “Pomegranate Blueberry” juice label is misleading and deceptive because the juice product only contains 0.3% pomegranate juice, 0.2% blueberry juice (and 0.1% raspberry juice).  Most of the product consists of 99.4% apple and grape “filler” juices.  The brand label prominently displays the “Pomegranate Blueberry” name and features a colorful fruit vignette with a split ripe pomegranate, a sliced apple and a handful blueberries, raspberries and red grapes.  The label includes the legend “Pomegranate Blueberry Flavored Blend of 5 Juices.”  Although not at issue in the case, Minute Maid’s label also touts the fortified inclusion of an omega-3 fatty acid nutrient, DHA (docosahexaenoic acid), with the tag line of how its inclusion will “help nourish your brain.”

Continue Reading Fruit Juice Misbranding Claims Lose Their Lanham Act Bite

In 1969, the Archies combined granulated and aqueous forms of fructose and glucose in a bubblegum song called “Sugar, Sugar.”   It topped out at No. 1 in the U.S. Billboard Hot 100 charts.  The lyrics “Sugar / Oh, Honey, Honey / You are my candy girl, and you got me wanting you” lilted through and permeated the AM and FM airwaves.

In 2010, manufacturers of “high fructose corn syrup” (HFCS) sought to break down the FDA regulatory barriers that exist between granulated and aqueous forms of fructose and glucose—but their efforts would be met with much less glamorous success.  By then, HFCS had become a persona non grata among anxious consumers.  Scientific studies issued earlier in the decade had suggested a correlation between its overconsumption and the epidemic of bulging waistlines and type 2 diabetes spreading across the United States.

While those early studies would later be debunked, perceptions actually matter more than concrete reality when it comes to the very personal act of ingesting food.  That act is imbued (and fraught) with emotional and spiritual qualities that can readily override or distort facts.  Just as Morris—the world’s most finicky cat—would not deign to touch anything other than 9-Lives cat food, American consumers began to thumb their noses at food products incorporating HFCS.  While it is a useful and cost-effective sweetener for industrial food processing purposes, it could not rise above its bad rap.

We’d Rather Switch Than Fight

Once upon a time in advertising lore, Tareyton smokers “would rather fight than switch” their cigarette brands.  HFCS did not follow that playbook.  Instead of defending the words, “high fructose corn syrup,” HFCS manufacturers decided to change its product stripes altogether.  Following the age-old adage that if it “looks like a duck, quacks like a duck, it must be a duck,” the Corn Refiners Association (CRA) embarked on a $30 million dollar marketing campaign to convince wary American consumers that “HFCS is corn sugar,” that “HFCS is natural,” and that “sugar is sugar.”

By way of background, HFCS was first produced in Japan and entered the American food supply in the early 1970s.  Its name accurately describes its composition.  Unlike table sugar, which consists of 50% glucose and 50% fructose chemically bonded together, the main form of HFCS included in soft drinks is made from an enzymatic process that blends together 55% fructose and 45% glucose.  The distinction between sugar components being bonded versus blended creates potential implications for human digestion and metabolic fate purposes, but those distinctions appear to have been overplayed in early scientific studies leading to HFCS’s demonization.

Continue Reading The FDA Rejects Renaming of HFCS as “Corn Syrup”