Category Archives: Natural Claims

Consumer Reports Petitions FDA/USDA to “Prohibit the Use of the ‘Natural’ Label on Food”

Consumer Reports is sponsoring a petition to the FDA and USDA to prohibit use of “natural labeling” on food products.  Consumer Reports believes such labeling is misleading because it is used on products that most consumers would not view as “natural.”

Even though the Food and Drug Administration does not object to the use of the term “natural” if “nothing artificial or synthetic” is added, there’s no definition for the term, which essentially means no regulation and no oversight.  As a result, “natural” processed foods can include ingredients from nature that are processed into artificial ingredients and may also come from plants grown with toxic pesticides, bioengineered seeds, and chemicals processed with synthetic solvents.  Meat labeled as “natural” can come from animals that were raised with daily doses of antibiotics and other drugs, given artificial growth hormones, fed genetically engineered soy and corn feed and other artificial ingredients and continually confined indoors.

Consumer Reports then cites the results of a recent consumer survey which suggests that most consumers view the “natural” label as excluding the foregoing practices and ingredients.   Thus, “[t]oo many people believe they’re avoiding toxic pesticides, artificial growth hormones, and GMOs when they buy food labeled ‘natural.’”

The petition therefore urges (a) the USDA to add the following section to 9 CFR 412.1: “The term “natural” may not be used on labeling for meat products and poultry products” and (b) the FDA to add the following section under 21 CFR 101 General Provision for Food Labeling: “The term ‘natural,’ or any derivation of the term, such as ‘naturally grown,’ ‘naturally sourced,’ or ‘from nature,’ is vague and misleading and should not be used.”

Consumer Reports certainly has a point.  There is no question that the term “natural” is vague and subject to different interpretations.  And there are certainly food products with questionable “natural” claims when compared to the expectations of a reasonable consumer.   Moreover, as I wrote in January, the FDA has no interest in crafting a formal definition of the term “natural.”  It recognizes that such a task means traveling down the proverbial rabbit hole in a potentially vain effort to  issue a regulation or formal guidance on this amorphous term.  It noted that engaging in this process requires it to consider, among other things, “relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods); the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation); and any strictures flowing from the First Amendment.”  (Emphasis added)

The Consumer Reports’ petition seeks to avoid these complications by simply banning all uses of “natural” labeling.  But this approach tosses the baby out with the bath water.  Specifically, banning all uses of “natural” precludes uses of “natural” in cases where it is plainly not false or misleading.  In this regard, the petition also appears to bar all uses of the term, no matter how narrowly drawn.  These points raise First Amendment concerns and concerns about the regulatory authority for the proposed regulations.  Notably, if the petition sought to prohibit natural labeling only as to certain types of food products, ingredients, technologies and/or processes, then it would be creating a de facto definition of natural that brings with it all the complications the FDA wants to avoid.

In light of the foregoing, I doubt the FDA or USDA will view this petition any differently than petitions asking for a formal definition of “natural.”  As I told NPR,  “[t]his is not a health or safety issue for them” and not high on the agency’s list of priorities.”

FDA Declines Courts’ Requests to Determine if GMO’s Allowed in “Natural” Products

The FDA has declined the referral requests from three U.S. District Courts seeking to have the FDA pronounce on whether “GMO ingredients may be used on food products labeled as “natural” or “all natural.”   The three cases are Cox v. Gruma Corp., 4:12-cv-6502 (N.D. Cal.), Barnes v. Campbell Soup Co. 3:12-cv-05185 (N.D. Cal.) and In Re General Mills, Inc. Kix Cereal Litigation, 2:12-cv-00249 (D. N.J.).

The FDA explained its rationale as follows in a January 6, 2014 letter to the three relevant judges signed by Leslie Kux, Assistant Commissioner for Policy:

FDA has not promulgated a formal definition of the term “natural” with respect to foods.  The agency has, however, stated that its policy regarding the use of the term “natural” on food labeling means 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 normally be expected to be in the food.”   See 58 Fed. Reg. 2302, 2407 (1993).

If FDA were inclined to revoke, amend, or add to this policy, we would likely embark on a public process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change; we would not do so in the context of litigation between private parties.  Issuance of a regulation or guidance document allows an agency to obtain data, information, and views from all stakeholders wishing to engage on an issue.  ….
 [In addition,] [a]ny definition of “natural” on food labeling has implications well beyond the the narrow scope of genetically engineered food ingredients about which the Court’s referral pertains.   For example, if the agencies were to define the term, they would likely need to consider among other things: relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods); the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation); and any strictures flowing from the First Amendment.  Thus, even if we were to embark on a public process to define “natural” in the context of food labeling, there is no assurance that we would revoke, amend, or add to the current policy, or develop any definition at all.
In other words, the FDA is keenly aware that an effort to craft a comprehensive definition of “natural” necessarily opens the door to an array of issues and interest groups that would complicate an already complex process.  Thus, the FDA concluded by observing that its current priorities are public health and safety matters, including developing regulations relating to the Food Safety and Modernization Act and the Patient Protection and Affordable Health Care Act.
The FDA’s response is not necessarily a rejection of the GMA’s recent request to have the FDA define natural (as set forth in my prior post).   Rather, the FDA is noting to these courts that the rule-making process would take years, that it is not inclined to start that process now, and that it would not engage in this process in the context of litigation.

Update: Judge Stays Class Action Suit Pending FDA Determination on Whether GMO Ingredients Can Be Labeled “All Natural”

Last month I wrote about the Court’s preliminary ruling in the class action  lawsuit targeting Gruma Corporation with respect to labeling its Mission® tortilla chips as “All Natural” despite the presumable presence of GMO corn.   The court stated its view that deference to the FDA appeared to be the appropriate course in light of the primary jurisdiction doctrine but allowed supplemental briefing before it rendered a final ruling.

On July 11, the Court that ruling final, noting a “gaping hole” in the FDA’s regulations.  On the one hand, the FDA has reaffirmed “its decision to not require special labeling of all bioengineered foods.”   But on the other hand, “[w]ith respect to the use of the term ‘natural’ on food labels, the agency has published non-binding guidance defining that term to mean 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.'”  Thus, “the FDA has not addressed, even informally, the question of whether foods containing GMO or bioengineered ingredients may be labeled ‘natural’ or ‘all natural,’ or whether GMO or bioengineered ingredients would be considered ‘artificial or synthetic.’”

In other words, “there is no direct regulation by the FDA of the term ‘natural,’ nor any requirement that a company disclose on a food product’s label whether it contains GMOs.”   Significantly, for purposes of the primary jurisdiction doctrine, the Court found that the FDCA and NLEA unquestionably and squarely give the FDA authority to determine whether food labels may properly state that GMO products can be labeled “all natural.”

Accordingly, the Court referred to “the FDA, for an administrative determination, the question of whether and under what circumstances food products containing ingredients produced using bioengineered seed may or may not be labeled ‘Natural’ or ‘All Natural’ or ‘100% Natural.’”   The case was stayed for six months with the potential for additional extensions of time based on good cause, including an indication from the FDA that it intends to resolve this issue.

Courts Continue to Struggle Over “All Natural” Claims for GMO Ingredients

With my trial over, I can again focus on this blog.  Sorry for the lack of recent updates.

Some interesting news in the putative class action lawsuit in which Gruma Corporation is charged with falsely and misleadingly labeling its Mission® tortilla chips as “All Natural” because they contain GMOs in the form of corn.  On April 10, 2013, Gruma moved to dismiss based on, among other things, the primary jurisdiction doctrine, arguing that the Court should defer to the FDA based on its “unique expertise and resources suited to resolving the issues presented by Plaintiff’s claims.”  As framed by Gruma:

[R]egulation of foods derived from bioengineered plants, including the labeling of those foods, is a matter in which the FDA has experience, specialized resources, and enforcement methods not available to courts.  The agency also has extensive experience with the definition of “natural.”  The issues raised by Plaintiff’s claims thus come within two spheres of FDA regulation and enforcement activity.  At the same time, however, the agency has not as yet explicitly articulated rules governing the intersection of those two spheres.  This case consequently falls squarely within the primary jurisdiction doctrine, which “allows courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency.”

Subsequently, on June 7, 2013, District Court Judge Yvonne Gonzalez Rogers issued a “tentative ruling” in favor of Gruma based on primary jurisdiction with the parties still having the opportunity to present oral argument.  The tentative ruling observed that:

[T]he parties appear to be in agreement that the FDA has not addressed, even informally, the question of whether foods containing GMO or bioengineered ingredients may be labeled “natural” or “all natural,” or whether GMO or bioengineered ingredients would be considered “artificial or synthetic.”  Thus, as Plaintiff concedes, “[t]he [First Amended Complaint] identifies a gaping hole in the current regulatory landscape for ‘natural’ claims and GMOs, laying out how there is no direct regulation by the FDA of the term ‘natural,’ nor any requirement that a company disclose on a food product’s label whether it contains GMOs.”

The court thus noted that deference to the FDA appeared to be the appropriate course.   After oral argument on June 11th, however, the court ordered supplemental briefing before it rendered a final ruling.

The court’s inclination to defer to the FDA, however, is continued evidence that courts realize they are ill equipped to make what is ultimately a policy-based determination on whether GMO ingrediants are “natural.”

Judge Dismisses AriZona “All Natural” Lawsuit

Three years ago, AriZona Beverage Co. was hit with a class action lawsuit challenging its marketing and selling of iced tea beverages labeled “All Natural,” “100% Natural,” and “Natural” because they contain high fructose corn syrup (HFCS) and citric acid — which are allegedly artificial and man-made.   Class certification was allowed under Rule 23(b)(2) for purposes of injunctive 
and declaratory relief.  But on March 28, 2013,  U.S. District Court Judge Seeborg (N.D. Cal.)  granted AriZona’s renewed motion for summary judgment and class decertification.

Earlier in the case, plaintiffs had argued that it would “have experts that will line up and they’ll be able to show, pursuant to FDA regulation, that this is a chemical process, it’s not a biological process.”  But in response to the summary judgment motion, they simply asked the Court to “take judicial notice of United States Patent law” and rule that that HFCS is not natural because patents have been issued for the process of producing it.  In a significant retort, the Court noted:

[Plaintiffs’] argument is that if HFCS were a naturally occurring substance such as “a new mineral discovered in the earth or a new plant found in the wild” it would not be patentable.  ….  “United States Patent law” is not a proper subject of judicial notice under Federal Rule of Evidence 201 and the request is denied.  Plaintiff’s request is properly characterized as an argument that HFCS is not natural as a matter of law.  But plaintiffs have cited no legal authority supporting their contention that if the process to produce an ingredient is patented, that fact, in and of itself, automatically renders it artificial.  This is merely an extension of their rhetoric that HFCS is artificial because it “cannot be grown in a garden or field, it cannot be plucked from a tree, and it cannot be found in the oceans or seas of this planet.”  ….  In the face of a motion for summary judgment, rhetoric is no substitute for evidence.

The Court then turned to the issue of whether the labels may nevertheless be misleading because AriZona admitted it changed its labels to add the language “All Natural Tea,” “No Preservatives,” “No Artificial Color,” and “No Artificial Flavor” because some customers were confused by the terms 100% natural and asked “100% natural what?”  Plaintiffs argued that this was an admission that the labels were confusing.  The Court rejected that argument, noting that this “admission” simply indicated that “everything in” the beverages is natural, and “that defendants included the additional claims on the labels specifying that they contain all natural tea without preservatives, artificial color, and artificial flavor to clarify that to confused customers.”

Next, the Court also noted that “plaintiffs have no evidence to support their prayer for restitution and disgorgement” and did not “offer not a scintilla of evidence from which a finder of fact could determine the amount of restitution or disgorgement to which plaintiffs might be entitled if this case were to proceed to trial.”

Finally, the Court sternly criticized plaintiffs’ counsel in the context of decertifying the class, noting that they had “been dilatory and has failed to prosecute this action adequately.”

Please see complete ruling here.

“GMO Inside” Campaign Launched As Flow of “Natural” Class Action Lawsuits Continues

Voters may have defeated Prop 37, which would have required the labeling of foods with GMO ingredients, but the issue of GMO ingredients is definitely not going away.  Two days after the election, supporters of Prop 37 launched GMO Inside, a coalition dedicated to help consumers identify GMO ingredients in their foods.  Members of GMO Inside’s steering committee include Food Democracy Now!, Green America, Institute for Responsible Technology, Foodbabe, Nature’s Path and Nutiva.  The press release announcing the coalition included the following statement:

“Corporations may have misled voters in California about GMOs, but they can’t change the fact that over 90 percent of Americans support the labeling of foods with genetically engineered ingredients,” said Alisa Gravitz, CEO of Green America.  “The GMO Inside campaign will make it possible for all Americans to find GMOs in the food products in their homes and communities, label them, and switch to non-GMO foods instead.  The campaign will show corporations that people will not complacently serve as lab rats for the testing of genetically engineered foods.”

Food companies were also reminded last week that litigation is a key tool of anti-GMO advocates by the filing of yet another class action complaint alleging that a product touted as “natural” is deceptively labeled because it is made with GMO ingredients.  This time, Pepperidge Farm, Inc. (owned by Campbell Soup, Co.) is the target of a putative class action suit filed in federal court in Colorado alleging that Pepperidge Farm “has mistakenly or misleadingly represented that its Cheddar Goldfish crackers … are ‘Natural,’ when in fact, they are not, because they contain Genetically Modified Organisms … in the form of soy and/or soy derivatives.”   See the entire complaint here.

As the above image shows, however, the product is not described as “All Natural” or “100% Natural” and its “Natural” claim is somewhat qualified by the “No Artificial Preservatives” statement.  A key issue will thus be whether a reasonable consumer perceives this language as a qualification or instead views “Natural” in this context as synonymous with “100% Natural.”

Nestlé Sued For Allegedly Misrepresenting “Spring” Water Sold in 5-Gallon Jugs

Nestlé is being sued for allegedly misrepresenting municipally-sourced water as naturally, spring-sourced in 5-gallon jugs of Ice Mountain Water used for office dispensers.  The complaint notes that bottled water often comes from municipal sources (i.e. taps) and alleges that bottled water from special sources such as a spring commands a premium and stands out in a crowded marketplace.  Plaintiff — the Chicago Faucet Shoppe — purchased the 5-gallon jugs beginning in 2008 and alleges that during the entire time it believed it was purchasing spring-sourced water based on invoices stating “Ice Mountain® Natural Spring Water,” delivery trucks that included the “Ice Mountain Natural Spring Water” logo, and the overall marketing of the products, which stress natural spring sources for the water products.

As the above image illustrates, many ICE MOUNTAIN water products include the text “100% Natural Spring Water” the 5-gallon jug is offered in “Spring,” “Drinking” and “Distilled” varieties, the later two of which may come from “well or municipal supply” according to this document.  Allegedly, though, this information does not appear on the 5-gallon jugs or the Ice Mountain Water website.

Initially filed in Illinois state court as a class action lawsuit on behalf of consumers in Illinois, Michigan, Minnesota, and Missouri, the case was removed to federal by Nestlé and is now pending in the Northern District of Illinois as The Chicago Faucet Shoppe, Inc. v. Nestlé Waters North America, Inc., Case No. 12-cv-08199.  See full complaint here.