• Prominently-displayed bold-type boxed warnings on the principle display panel of foods and beverages with specific warnings depending on the product’s nutritional profile. For example, for sugar-sweetened beverages, the warning must state as follows:

• Investigation by the National Institutes of Health (NIH) into the dangers associated with “ultra-processed foods”.
• Development of a national campaign for education and awareness through the Centers for Disease Control and Prevention (CDC).

As written, the Act includes significant advertising prohibitions as well, such as the following:

• Prohibit advertising of “junk food”, defined as products subject to warning label requirements per the Act, in a manner directed toward children.
• Prohibit advertising of “junk food” to the general population without including the relevant mandatory health or nutrient label warnings, as described above.

Violation of this prohibition will be treated as a rule violation under the Federal Trade Commission Act, meaning that the FTC could pursue civil penalties for first time offenders.

There will undoubtedly be much discussion among consumer brands as to how best to respond to the Act. As our readers may know, several of the nation’s largest food and beverage companies committed years ago to an industry self-regulation initiative called the Children’s Food and Beverage Advertising Initiative, which restricted advertising directed at children 12 years and under for foods meeting certain nutritional criteria. Further, many of these same companies already use “Facts Up Front” - a front-of-pack labeling disclosure to provide specific nutritional information, as shown below.

Will taking the next step and expressly telling the consumer that a particular product may contribute to obesity, diabetes, and tooth decay make a difference? We may find out.

It is not a stretch to assert that Spencer Sheehan has achieved notoriety for his prolific filing of consumer class actions. He is referred to by some as the “Vanilla Vigilante”—an apt moniker derived from suing manufacturers claiming products are made with vanilla when in reality they contain artificial flavoring. According to a recent New Yorker profile, Sheehan’s firm has filed over 500 similar class action lawsuits. But as Sheehan has recently discovered, when alleging labels are not true and that consumers would be misled, especially in the volume that Sheehan has done, courts are particularly vigilant that allegations are substantiated.

A recent plaintiff represented by Sheehan alleged that Starbucks, by marketing one of its coffees as “French Roast Ground 100% Arabica Coffee,” misrepresented that its coffee was without additives such as potassium. The Court found the plaintiff's claim was groundless. While the complaint cited to “reports based on laboratory analysis,” the sources of the report were found to be a New York Post article and a “study [that] appeared to be an advertisement,” as well as Sheehan’s own investigation completed after the complaint was filed. Moreover, even if the plaintiff had alleged evidence of a higher potassium content, the Court found that no reasonable consumer would take "100% Arabica Coffee" to mean anything other than that its beans are from an Arabica coffee plant.

The Court not only dismissed the claim, but it also sanctioned Sheehan for filing frivolous claims. The 18 actions Sheehan filed in the Northern District of New York since 2021—all of which stalled at the motion to dismiss phase—may have been top of mind for the Court.

Sheehan's own words from the past were also cited in the Court’s opinion. A prior defendant company filed an amicus brief describing a separate lawsuit Sheehan filed, where in response to a threatened motion for sanctions, Sheehan stated, "So go file your rule 11 motion [sic] I hear such sanction threats from people like you all day long."

Citing the number of failed lawsuits Sheehan filed in the District, along with the lack of substantiation for the claims against Starbucks and the faulty theory at the heart of the case, the Judge ultimately sanctioned Sheehan and held him in civil contempt of court.

Regarding product and facility registration and listing, in question-and-answer format, the draft guidance addresses a range of topics, including:

• Definitions
• Who registers and submits product listings
• What information is submitted to register and list
• Will the information submitted be public
• How and when stakeholders register and list
• Treatment of cosmetic products that are also drugs
• Fees

The draft guidance is open for comment until September 7^th. Previous voluntary facility registrations will not be considered adequate to comply with the mandatory registration and listing requirement. FDA expects to have an electronic portal available in October 2023 along with a paper registration option.

Other December 2023 Deadlines

Stakeholders will recall that several provisions in MoCRA have one-year deadlines, making December 29, 2023 a key date. In addition to establishment registration and product listing (§607), these include:

• Adverse event recordkeeping and reporting (§605) – Every responsible person must maintain records of all adverse events associated with any of its cosmetic products for six years. Serious adverse event reports must be submitted to FDA (along with retail packaging of the product at-issue) within 15 business days after receipt of same.
• Safety substantiation (§608) – Responsible persons must ensure, and maintain documentation of, “adequate substantiation of safety” for each cosmetic product it distributes/manufactures.

Additional information regarding MoCRA’s requirements is available here.

The proposed rule came just one day after the FTC’s release of updated Endorsement Guides, which we reviewed here. As currently drafted, the proposed rule would prohibit:

• Fake or false reviews and testimonials, which are defined to include reviews by reviewers who do not exist, did not use the product or service, or that materially misrepresent their experience with the product or service;
• Repurposing consumer reviews written for one product so that they appear for a “substantially different” product;
• Compensating or otherwise incentivizing or conditioning consumer reviews, whether positive or negative;
• Posting reviews by employees or “insiders” without disclosures regarding their material connection to the company;
• Creating seemingly “independent” review websites that are in fact controlled by the company and are not truly independent;
• Suppressing negative reviews, including by “unjustified” legal threats or “false accusations” or by declining to post negative reviews for a product or service unless for a specified reason unrelated to the negative nature of the review; and
• Selling, distributing, purchasing, or procuring “fake indicators” that misrepresent social media influence.

Many of these practices are already addressed in the FTC’s recently updated Endorsement Guides. Many are also listed in the Commission’s Notice of Penalty Offense letters on endorsements sent to over 700 companies last year, which we discussed here. For those practices that have long been considered deceptive, the proposed rule is clearly intended to open a path to consumer redress and civil penalties.

In other ways, however, the FTC is not just looking to authorize new remedies but also to substantively move the needle on the current legal standard. These efforts raise a host of issues and questions ripe for comment by interested parties, including:

• Should companies be liable for civil penalties based on a negligence theory and is the FTC authorized to do so under their Magnuson-Moss rulemaking authority? The proposed rule draws on concepts of negligence and third-party liability to propose that businesses will be liable directly if they disseminate or cause to be disseminated deceptive reviews (e.g., ones that materially misrepresent the testimonialist’s experience or that fail to disclose the relationship between the business and the testimonialist) if they “knew or should have known” of the facts giving rise to the deception. This new standard raises a number of important questions, which the FTC to its credit specifically seeks input on. Even assuming the FTC is authorized to seek civil penalties based on such a standard, what would this mean in practice for companies when they oversee and review reviews, and how would they show that they “should not have known” about a particular fact.
• What is a “substantially different” product for the purposes of the rule’s prohibition against “review repurposing”? Under the proposed rule, companies may not repurpose consumer reviews from one product and apply it to a “substantially different” product, which is defined as one that “differs from another product in one or more material attributes other than color, size, count, or flavor.” But the proposed rule does not specify which attributes might not be “material” for purposes of review repurposing other than color, size, count or flavor, nor does it consider that other product attributes – similar to flavor – could hinge on consumers’ subjective preferences. For example, what about a cleaning spray that comes in different fragrances? Or the same exact shirt featuring a V-neck and a boat neck? What about a supplement that comes in gummy form and tablet form, where all active ingredients are the same? The agency also does not take into account the benefit consumers experience when viewing different product options listed on the same product page.
• How far-reaching is the prohibition against characterizing reviews as “independent” on company-controlled websites? Proposed section 465.6 would authorize civil penalties where a business “represent[s], expressly or by implication, that a website, organization, or entity that it controls, owns, or operates provides independent reviews or opinions about a category of businesses, products, or services including the business or one or more of its products or services.” While staff’s intent appears to be to prohibit companies from misrepresenting the purported independence of a company-controlled review site, in practice, the language of the proposed rule would prohibit companies from representing that any consumer reviews or opinions featured on their own sites are independent, even if they are.

In addition to these specific issues related to proposed requirements, there are the general questions as to whether a rule is necessary in the first place. As many will remember, the NPRM was preceded by an ANPR in October 2022, in which the agency announced its intent to explore rulemaking in this space. At that time, former Commissioner Wilson – the sole “no” vote on issuing the ANPR – noted that “the harm that results from the deception at issue is speculative in nature” and opined that “the Commission already has a multi-pronged strategy in place to combat [deceptive endorsements or fake reviews].” In her view, “churning out another proposed rule” downplays the impact of other enforcement tools and unnecessarily diverts already-strained staff resources.

The comment period for the NPRM will run for 60 days following the publication of the proposed rule in the Federal Register, and we encourage stakeholders to submit comments addressing the above-mentioned topics and any other areas of concern.

In its preamble to the final rule, FSIS indicated its intention to conduct meetings and webinars on the final rule in advance of its effective date to facilitate compliance. Specifically, FSIS stated that it would provide examples of notices to be used at the point-of-purchase (POP) which would satisfy the labeling mandates for single-ingredient raw meats and also include examples of acceptable labels for ground or chopped products. The agency noted that it had provided such guidance, and additionally held numerous public meetings to answer questions about the rule’s requirements.

However, in their August 12, 2011 letter to the FSIS, eight trade associations cited the agency’s delay of one or two months in making such information available as the basis for their request that FSIS exercise enforcement discretion for a six month period following January 1, 2012, the rule’s initial effective date. While FSIS conceded some delay, it noted that postponing the regulation’s effective date two months would provide ample time for industry to ready for compliance. FSIS indicated that it could provide approval of any labels submitted prior to January 1, 2012 before the regulations became effective. Additionally, the agency explained that it would continue to conduct education and outreach activities to assist in compliance in advance of the new March 1, 2012 effective date.

The notice was published in the Federal Register on December 9, 2011 and is available here.

This post was written by Sarah Roller and Donnelly McDowell.

According to FDA, research findings on the effects of comparative versus noncomparative ads on purchase intentions indicate that comparative ads result in greater purchase intentions than noncomparative ads. Given the prevalence of comparative advertising, "FDA is embarking on the proposed research to ensure that it has adequate information to assess whether prescription drug comparative DTC ads provide truthful and nonmisleading information to consumers."

Through the study FDA “aims to investigate how consumers interpret and react to DTC comparative drug ads.” The two-phase study will explore drug efficacy comparisons and other evidence-based comparisons, such as dosing, mechanism of action, and indication. The goal of Phase I is to (1) explore how consumers understand and interpret print and broadcast ads that explicitly compare the efficacy of two similar drugs; and (2) learn whether named comparisons are more likely than unnamed comparisons to promote accurate recall, comprehension, and perceptions. The goal of Phase II is to (1) determine if consumers infer that one drug is better or more effective than another from ads that include different types of drug label comparisons (i.e., indication, dosing, mechanism of action, drug risk), and (2) if consumers consider switching medications based on these comparisons in advertisements.

FDA also intends to apply existing comparative literature to DTC advertising, beginning with a large compendium of information on the comparative effectiveness of medical treatments in 14 priority medical conditions (including arthritis, cancer, dementia, depression, diabetes, and substance abuse). The compendium is being secured by the Agency for Healthcare Research and Quality, which also is funding a set of CHOICE (Clinical and Health Outcomes Initiative in Comparative Effectiveness) studies designed to explore comparative effectiveness.

More information regarding FDA's proposal can be found here.

For purposes of the GAO evaluation and report, the GAO defined economic adulteration as “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e. economic gain.” The GAO study highlighted two specific cases of economic adulteration as indicators of the need for stronger policies to prevent economic adulteration of FDA regulated products. First, in 2007, vegetable protein products were found to contain melamine and cyanuric acid, industrial chemicals, in order to give the products an appearance of a higher protein content. The protein products were subsequently used in pet food and caused an unknown number of illnesses and deaths to dogs and cats. Notably, the melamine contamination case helped to inspire a number of food safety policy reforms, including the enactment of the Food Safety Modernization Act on January 4, 2011, which includes mandatory HACCP-type preventive controls and establishes new safeguards to prevent intentional adulteration of food products. The second case occurred in 2008, and involved the blood thinner known as heparin, which was found to contain oversulfated chondroitin sulfate, a toxic contaminant which was later linked to multiple human illnesses and deaths.

Both of the economic adulteration cases addressed in the GAO report involved products that were imported from China to the United States. The GAO report cites increased globalization as a key factor contributing to the increased risk of economic adulteration in FDA regulated products. According to FDA documents, 10 to 15 percent of all food, 80 percent of all pharmaceutical ingredients, 40 percent of finished drugs and half of all medical devices used in the United States are imported. With these numbers expected to continue to rise, the FDA Commissioner has suggested that the FDA may need to fundamentally alter the process by which it monitors safety and quality of food and medical products. The report also references an increase in supply chain complexity as one factor complicating the regulation of economic adulteration. As products may travel through many countries for manufacturing and processing before ultimately reaching the United States, it becomes increasingly difficult to trace an ingredient back to the original source.

While the Federal Food, Drug & Cosmetic Act prohibits the introduction of any adulterated food, drug or medical device into interstate commerce, it does not distinguish between ordinary adulteration and economically motivated adulteration. Among other things, a food is adulterated if it contains any poisonous or deleterious substance which may render it injurious to health or if any valuable constituent has been omitted, or if any damage or inferiority has been concealed.

The GAO interviewed a number of FDA officials in the course of its study and noted that the FDA currently addresses economic adulteration as part of broader efforts to combat adulteration generally. These efforts include using publicly available data to target products at risk for adulteration as part of the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT), sharing data with other federal and state agencies with authority over pet food to monitor outbreaks of illness in animals, and implementing a program allowing certain drug companies to import products on an expedited basis upon meeting certain criteria for safety.

While FDA has taken some steps specific to economic adulteration, the report found that the FDA missed opportunities for coordination and communication which would make those efforts more successful. For instance, the FDA’s Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) both developed models to determine which human foods and drugs were at the greatest risk for economic adulteration, but did not adequately coordinate efforts or share valuable information with the other.

The report provides three broad recommendations to the FDA in order to address economic adulteration:

• Adopt a working definition of economic adulteration as done in May 2009;
• Provide written guidance to agency centers and offices on the means of addressing economic adulteration; and
• Enhance communication and coordination of agency efforts on economic adulteration.

The GAO report is available here.

This post was written by Sarah Roller and Donnelly McDowell.

The law prohibits USDA from implementing several prominent provisions from the proposed rule, including the proposed limits on servings of starchy vegetables such as potatoes, the long-term sodium reduction requirements, the increase in servings of whole grain foods for breakfast and lunch, and certain proposed vegetable serving requirements.

The USDA proposal would represent a substantial shift in the nutritional composition and quantity of a number of food items and would have far-reaching implications for companies that make or market food products for use in school breakfast or lunch programs. Please see Kelley Drye’s February 2, 2011 Client Advisory for more information on the USDA proposal.

This blog post was written by Sarah Roller.

The Act would require genetically engineered or modified foods or foods containing genetically engineered ingredients to be clearly labeled as containing genetically engineered material in a manner similar to nutrition information labeling. The Committee describes genetically engineered food as "[a] plant or meat product that has had its DNA artificially altered in a lab with genes from other plants, animals, viruses, or bacteria, in order to produce foreign compounds in that food." The FDA currently does not require genetically engineered foods or foods that contain genetically engineered ingredients to bear labeling regarding genetic modification.

The full text of the Act, as submitted to the California Attorney General on November 9, 2011 is available here.

In the AcneApp case, the defendants claimed that their apps could treat acne with colored lights emitted from a mobile device. To support the claim, the AcneApp marketers relied on a study published by the British Journal of Dermatology, claiming that the study showed blue and red light treatments eliminated p-bacteria (a major cause of acne) and reduced skin blemishes. The FTC determined that AcneApp falsely claimed that the British Journal of Dermatology study proves that red and blue light therapy is an effective acne treatment.

The FTC order prohibits Acne Pwner and AcneApp “from making acne-treatment claims about their mobile apps and other medical devices” without at least two adequate and well controlled human clinical studies. The requirement for two clinical studies is the same standard that the FTC applied in recent settlements with a dietary supplement manufacturer over weight loss claims for its dietary supplements, and with a food marketer over its claims that one of its products reduced the duration of acute diarrhea and reduced school absences. In another recent settlement, FTC ordered Reebok to provide one clinical study to substantiate fitness claims for its toning shoes.

The marketers of Acne Pwner and AcneApp were also ordered to pay the FTC $1,700 and $14,294, respectively.

This blog post was written by Alysa Hutnik and Sarah Roller.

• Federal agencies should use the IOM Committee’s recommendations to develop a single, simple front-of-package nutrition rating system with symbols that graphically convey calorie information and a “point” value showing whether nutrients of concern (i.e., saturated and trans fat, sodium, and added sugars) are below threshold levels (as established by the Food and Drug Administration (“FDA”) and other federal agencies); and
• The front-of-package system developed by federal agencies should apply to all food and beverage products and replace any other symbol currently being used on the front of packaging.

More information regarding the IOM Committee’s report can be found in Kelley Drye and Warren’s October 24, 2011 Client Advisory.

On August 18, 2011 the FTC issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Commission's review of the costs, benefits, necessity, and regulatory and economic implications of its “Retail Food Store Advertising and Marketing Practices” rule, commonly called the “Unavailability Rule,” 16 C.F.R. Part 424.

Currently, the Unavailability Rule states that it is an unfair or deceptive act or practice for “retail food stores” to advertise “food, grocery products or other merchandise” at a stated price if those stores do not have the advertised products in stock and readily available to consumers during the effective period of the advertisement. The Rule includes a provision that permits stores that do not have the advertised products in stock and readily available to comply with the Rule if “the advertisement clearly and adequately discloses that supplies of the advertised products are limited or the advertised products are available only at some outlets.” In addition, the rule provides that it would not be a rule violation if: (1) The store ordered the advertised products in adequate time for delivery in quantities sufficient to meet reasonably anticipated demand; (2) the store offers a “rain check” for the advertised products; (3) the store offers a comparable product at the advertised price reduction; or (4) the store offers other compensation at least equal to the advertised value.

According to the ANPR, “the Commission now solicits comments on, among other things, the economic impact of, and the continuing need for, the Unavailability Rule; the benefits of the Rule to consumers purchasing products at retail food stores; and the burdens the Rule places on firms subject to this requirement.” The Commission also is considering whether to broaden the Rule to include stores not currently covered, such as drugstores, department stores, and electronic retailers. Comments can be filed online or on paper and must be received by the FTC on or before October 19, 2011.

The federal preemption decision is helpful to generic drug manufacturers, and the ruling has broader implications for companies that confront conflicts between the requirements imposed by federal versus state law. Click here for more information about this case.

The USDA has jurisdiction over agricultural products and regulates the term “organic” as it applies to agricultural products through the National Organic Program (“NOP”). Consequently, the USDA has no statutory authority over the production and labeling of cosmetics that are not made up of agricultural ingredients or that do not claim to meet NOP organic standards. Cosmetics that contain or are made up of agricultural ingredients that satisfy NOP organic production, handling, processing, and labeling standards are, however, eligible for organic certification under USDA’s NOP regulations. Certification is based on the product’s organic content and other factors.
In contrast to the USDA’s organic standards, COPA applies to all cosmetics that are sold in California and are represented to be “organic” or contain organic ingredients, including those that contain no ingredients that are agricultural products. Thus, even if a cosmetic product is not within the USDA’s jurisdiction, sellers may still be liable under COPA for any representations that the product is organic. More specifically, COPA requires cosmetics that are sold, labeled, or represented as “organic,” or made with organic ingredients to contain at least 70% organically-produced ingredients. Multi-ingredient products containing less than 70% organically-produced ingredients may either identify each organically-produced ingredient in the ingredient statement, or display the total percentage of organic ingredients if they are so referenced in the label. Notably, any person may file a suit under the statute, and the statute does not require a plaintiff to demonstrate damages to obtain injunctive relief.

FDA and the Federal Trade Commission (FTC) have demonstrated interest in marketers' online content, including social media, as a means of investigating product claims. As social media proliferates, marketers of consumer health products should take specific steps to be sure that their companies' use of it does not raise red flags for regulators.

For more on this issue, see the Food and Drug Law Institute Update article, “FDA’s Policy on Social Media: Why It Matters for Marketers of OTC Drugs, Food, Dietary Supplements and Cosmetics.”

The proposed rule represents a substantial shift in the nutritional composition and quantity of a number of food items that make up current school breakfast and lunch meals and is likely to have far-reaching implications for companies that make or market food products for use in school breakfast or lunch programs. Affected companies are advised to evaluate the legal and business implications of the USDA proposal now, and bring issues and concerns to the attention of the appropriate policymakers, including by submitting written comments to USDA on or before the April 13, 2011 deadline.

See the Kelley Drye client advisory for more information, and please contact us if you have questions concerning the USDA proposal or other matters.

On October 26, 2010, the Institute of Medicine held the first meeting of its Phase II “Examination of Front-of-Package Nutrition Rating Systems and Symbols.” As discussed in our client advisory regarding IOM’s Report on Phase I of the “Examination of Front-of- Package Nutrition Rating Systems and Symbols,” Phase II will focus on consumer understanding and use of front-of-package systems and symbols. IOM is charged with considering which icons are the most effective with consumer audiences, developing conclusions about the systems and icons that best promote health and how to maximize their use, and assessing the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration (FDA).

The public portion of the meeting was divided into two sessions. Session I, entitled “"Recent Consumer Research on FOP Systems and Symbols,” included presentations on the effectiveness of front-of-package (FOP) systems and symbols by FDA, Yale University's Rudd Center on Food Policy and Obesity, the Grocery Manufacturers Association, and the International Food Information Council Foundation. Alan Levy, a Senior Scientist in the Office of Regulations and Policy at FDA’s Center for Food Safety and Nutrition (CFSAN), and Chung-Tung Joi, a supervisory consumer science specialist at CFSAN, presented on behalf of FDA.

Session II, entitled “Additional Research Issues," included presentations regarding "Health Literacy and Population Subgroups," which was addressed by Christina Zarcadoolas of Mt. Sinai School of Medicine, "Consumer Use of Back of Panel (NHANES analyses)," which was addressed by John Kozup of Villanova University, and the "Relationship of Labeling to Product Reformulation," which was addressed by Christina Johnson of the New York City Department of Health and Mental Hygiene.

The IOM workshop demonstrates that more research is necessary to identify the most effective FOP labeling system for the United States. During his remarks, Alan Levy noted that FDA would like to position FOP labeling to obtain an "iconic" status, where FOP labeling "causes people to think about nutrition." According to Levy, FDA would like FOP labeling to become a "brand" similar to the Nutrition Facts Panel, in which consumers “look to [FOP labeling] for key health information.” When asked FDA’s position on establishing a mandatory FOP labeling system, Levy stated that the Agency has not taken a position on whether FOP labeling should be mandatory, but noted that without a widely used system “that appears on both obviously good and obviously bad products,” it would be difficult for FOP labeling to “achieve the iconic status it needs to become the go to place” for helpful nutrition information.

According to Christina Johnson of the New York City Department of Health and Mental Hygiene (NYC DHMH), the NYC DHMH believes that FDA should take an aggressive approach in establishing a FOP labeling system, and recommends, among other things, that FDA establish a mandatory FOP labeling system and a national nutrient database for food products to monitor compliance. The NYC DHMH also recommends use of a system that was not developed by industry.

In response to the disturbing rates of overweight, obesity, and diet-related chronic disease among Americans, Congress requested an Institute of Medicine (IOM) study that would examine “front-of-package” (FOP) nutrition labeling systems and symbols and the effects that FOP labeling could have on consumer food choices. With sponsorship from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), IOM launched the requested FOP labeling study to be conducted in two phases. On October 13, 2010, the results of the first phase of the IOM study (Phase I study) were published in a report entitled, “Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report” (Phase I Report).

The report concluded, among other things, that for FOP labeling systems to be helpful to consumers in making food choices that are consistent with the Dietary Guidelines for Americans, FOP labeling should focus on conveying a limited set of information concerning the nutrients that are most strongly linked to significant diet-related disease risks that affect the greatest number of Americans.

For more information, please see our advisory regarding the IOM study and related report.

The U.S. 8th Circuit Court of Appeals recently ruled that certain false advertising claims based on state consumer protection and anti-deception statutes were not preempted by the Organic Foods Production Act of 1990 (OFPA)— a federal Act that establishes national standards for the sale and labeling of organically produced agricultural products, and creates a certification program through which agricultural products may be certified to produce organic products. The court reversed and remanded the district court’s ruling that the false advertising claims were preempted by the OFPA, holding that, while claims challenging certification of a product as organic (e.g., alleging that a defendant’s products are falsely represented as organic when in fact the products were not organic), are preempted by the OFPA, false advertising claims challenging the facts underlying an organic certification (e.g., alleging that a defendant’s advertisements “misrepresent[] the manner in which its dairy cows were raised and fed,” and “suppress[ ] or omit[ ] material facts regarding the production of its ‘organic’ milk or milk products, specifically that . . . the dairy cows were not raised at pasture”) are not preempted by the OFPA.

As background, following a 2007 consent agreement between USDA and Aurora Dairy Corporation (Aurora) regarding Aurora’s violations of the OFPA and related implementing regulations, known as the National Organic Program (NOP), nineteen class action lawsuits were brought in federal district courts on behalf of organic milk consumers (class plaintiffs) against Aurora and various retailers, claiming violations of state law arising from Aurora’s alleged failure to comply with the OFFPA and the NOP. The U.S. Judicial Panel on Multi-District Litigation (JPMDL) consolidated these cases in the Eastern District of Missouri. In June 2009, the Eastern District court dismissed the case, finding the OFPA preempted all of the class plaintiffs claims.

The NARB shared NAD’s concern about implied claims conveyed by “more than 99% natural” insofar as consumers could understand it to mean that all or virtually all of Ideal’s sweetness comes from natural ingredients. The NARB’s decision, like NAD’s, relates the “natural” claim to the main product attribute, sweetness, rather than the natural or artificial classification of the ingredients that make up the finished product.

The FDA outlined its policy on use of “natural” in 1993 but has not officially defined the term. As use of “natural” claims have proliferated, scrutiny has increased as well. The makers of Snapple and AriZona Iced Tea have been the target of consumer class actions relating to claims that their products are “natural” despite containing high fructose corn syrup.

Advertisers need to be fully aware of the messages and risks created by use of the term “natural.” The Heartland decision demonstrates that the intended message is not always the only message. Further, advertisers can expect that a “natural” claim will draw not only the eyes of potential consumers but those of critics as well.