FDA Dietary Supplement Ingredient Advisory List
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[March 1, 2023] -- A California federal judge on Tuesday rejected Bayer's bid to escape a proposed consumer class action alleging the pharmaceutical giant falsely labeled multivitamins containing synthetic ingredients as "natural," saying it is plausible a reasonable consumer could be deceived.
Beyond Meat is Not Beyond Lying
[July 15, 2022] -- One of the fastest growing areas in the food and beverage industry is meat originating from someting other than animals. Beyond Meat is a leading producer of plant-based meat alternatives. Beyond Meat, like other such businesses, touts the health and environmental benefits of its products in its advertising.
Unsurprisingly, animal-based meat companies have repeatedly expressed skepticism over those cloans. Now add a group of consumers to the body of skeptics.
In order to determine the actual value of a product like Beyond Meat, one needs to know the actual amount of protein one is obtaining. Even vegans who now can eat "meat" want to know they are getting value for their money. Eating a chemical soup is pointless if it contains less protein than is advertised for more money than other sources.
On May 31, a group of consumers filed a complaint for damages, alleging Beyond MEat has committed unjust business practices by misrepresenting the nutritional benefits found (or not found) in its products.
Just a day after, Beyond Meat and its CEO Ethan Brown has been hit with another civil complaint brought by competittor Don Lee Farms claiming the protein value is overstated by up to 30%, based upon testing.
Reef Friendly is Likely Not Puffery
(March 31, 2022) -- Kroger, the supermarket chain, sells a store brand of sunscreen that is labeled as "reef friendly." A consumer sued Kroger, as well as the manufacturer of the sunscreen, Fruit of the Earth, alleging that the "reef friendly" claim is false and misleading because the product sunscreen contains various chemical ingredients that are not, in fact, safe for reefs.
Kroger moved to dismiss the lawsuit on the grounds that the "reef friendly" claim is mere puffery. Puffery is generally considered to be a subjective, exaggerated, statement of opinion, that is not provable or disprovable, and which consumers would not rely on when making a purchasing decision. (We blog about puffery cases all the time -- such as whether statements such as "free range," "slightly sweet," "therapeutic-grade," and "gently removes makeup" are puffery.)
Not surprisingly, the court denied Kroger's motion to dismiss, holding that the company had failed to demonstrate, at least at this stage in the litigation, that the "reef friendly" statement is "too generalized, vague, subjective, and/or constitute exaggerated boasting, such that a consumer cannot reasonably rely on the claim."
The court distinguished other cases where "friendly" claims -- "user-friendly" waterproofing products and "pet friendly" bamboo flooring -- were held to be puffery. The court explained, "Where a reasonable inference exists that consumers may be looking for sunscreen products that are not damaging to reefs, however, 'reef friendly' may reasonably be understood as implying defendants' products meet those criteria."
What seemed to really drive the court's decision, however, was existing FTC guidance and California law on environmental marketing claims. The court pointed to the fact that the FTC's Green Guides called out "Eco-Friendly" as a potentially misleading claim, noting that the Green Guides advise that, "Unqualified general benefit claims . . . likely convey that the product . . . has specific and far-reaching environmental benefits and may convey that the item . . . has no negative environmental impact." The court also relied on the fact that, under California law, statements that a product is "ecologically friendly," "earth friendly," and "environmentally friendly" mean that the product "is not harmful to, or is beneficial to, the natural environment." The court concluded that FTC guidance and California law "undermine any argument that 'reef friendly' can be dismissed as mere puffery."
White v. The Kroger Co., 2022 WL 888657 (N.D. Cal. 2022).
"Where a reasonable inference exists that consumers may be looking for sunscreen products that are not damaging to reefs, however, 'reef friendly' may reasonably be understood as implying defendants' products meet those criteria"
Kratom is Still Banned in the U.S.
FDA has warned consumers for years against using products containing Mitragyna speciosa, a plant from Southeast Asia that is commonly known as kratom, or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, which affect the same opioid brain receptors as morphine. Since identifying kratom on an import alert for unapproved drugs in 2012 and on a second import alert for kratom-containing dietary supplements and bulk dietary ingredients in February 2014, FDA has taken numerous enforcement actions.
Most recently, on May 21, 2021, FDA announced the seizure of approximately $1.3 million worth of products including over 34,000 kilograms of bulk kratom and more than 207,000 units of dietary supplements containing kratom with the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo manufactured by Atofil, LLC located in Fort Myers, Florida.
The latest activity shows that FDA remains ready to initiate enforcement action against supplements that are believed to pose safety risks.
Orange Book Transparency Act Signed
On January 5, 2021, the President signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act of 2020 clarifies information related to patent listing and the types of patents that should be listed in the Orange Book. The Act also requires that NDA holders notify FDA within 14 days of a final decision if an Orange-Book listed patent is invalidated by the PTAB or a court, and that, FDA remove or amend the patent information in the Orange Book in accordance with the decision, but not before the expiration of any 180-day exclusivity period that relies on a paragraph IV certification that such patent is invalid.
An earlier version of the Orange Book Transparency Act of 2020 was passed unanimously by the House of Representatives in May 2019. The Senate unanimously passed an amended version on December 7, 2020, which was approved by the House on December 10, 2020 and sent to the President on December 24, 2020.
5-Hour Energy Again Penalized for False Advertising
On March 18, 2019, the Washington Court of Appeals upheld a trial court’s decision that three advertising campaigns for 5-Hour Energy® made by Living Essentials, LLP and Innovative Ventures, LLP (collectively, Living Essentials) violated the Washington Consumer Protection Act (CPA) by making deceptive advertising claims.
Living Essentials makes and markets the energy drink 5-Hour Energy®. The three advertising claims at issue involve claims about the efficacy of the drink. Living Essentials claimed or implied that: (1) 5-Hour Energy® was “Superior to Coffee” (Superior to Coffee claim); (2) decaf 5-Hour Energy® was effective “for hours” (Decaf claim); and (3) 73 percent of doctors would recommend 5-Hour Energy® (Ask Your Doctor claim). The trial court found all three advertising claims in violation of the CPA. It also assessed a civil penalty against Living Essentials of $2,183,747 and awarded the State $1,886,866.71 in attorney fees and $209,125.92 in costs. The court of appeals affirmed.
Living Essentials argued on appeal that the trial court (1) erred by adopting the Federal Trade Commission’s (FTC) prior substantiation doctrine; (2) that the prior substantiation doctrine violates article I, section 5 of the Washington State Constitution and the First Amendment to the United States Constitution; (3) that Living Essentials’ claims were mere puffery which did not require substantiation; (4) the trial court applied the wrong standard for necessary substantiation; and (5) the trial court erred in concluding that Living Essentials’ Ask Your Doctor claim was deceptive. Living Essentials also challenged the trial court’s penalty and award of attorney fees.
With reference to Living Essential’s first two arguments surrounding the prior substantiation doctrine, the court of appeals was unconvinced. The issue of prior substantiation is an important one to understand for those in the product advertising space, so we take the opportunity here to provide further context. Section 5 of the Federal Trade Commission Act (FTCA) declares “unfair or deceptive acts or practices in or affecting commerce” to be unlawful (15 USC § 45(a)(1)). The FTC Policy Statement Regarding Advertising Substantiation affirms that advertisers “must have a reasonable basis for advertising claims before they are disseminated.” The reasonable basis doctrine requires that firms have substantiation prior to disseminating a claim. Where an advertiser does not have the adequate substantiation for a claim, it necessarily lacks any reasonable basis for the unsubstantiated claim and it accordingly is deceptive.
Living Essentials argued that the trial court erred by relying on the FTC’s prior substantiation doctrine, effectively creating a new per se unfair trade practice. The court of appeals disagreed, finding that the trial court, although was appropriately guided by the FTC’s prior substantiation doctrine, had specifically declined to rely only on prior substantiation and did not adopt it as a per se violation of the CPA. As for Living Essential’s argument that the application of the prior substantiation doctrine was contrary to article I, section 5 of the Washington Constitution and the First Amendment to the United States Constitution, the court of appeals were equally unconvinced.
Living Essential’s third appeal argument was that substantiation was not necessary because the Superior to Coffee and Decaf Claims were “mere puffery” and therefore not actionable under the CPA. The FTC Policy Statement on Deception states that the FTC “generally will not bring advertising cases based on subjective claims… [or] cases involving obviously exaggerated or puffing representations, i.e., those that the ordinary consumers do not take seriously.” The court of appeals found that because the advertised claims about 5-Hour Energy® were factual representations capable of being tested, they were not mere puffery.
The court of appeals did agree with Living Essential’s argument that the trial court erred in applying the FTC substantiation standard for claims that “relate to consumer health.” The FTC defines a health claim as a “representation about the relationship between a nutrient and a disease or health-related condition.” When an advertisement alleges that a product has a relationship to a disease or health-related condition, FTC requires substantiation with “competent and reliable scientific evidence.” The court of appeals acknowledged that although 5-Hour Energy® is a dietary supplement, the advertising claims were not health claims. Dietary supplements can make structure/function claims, which are distinct from health claims, that describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body. Such claims are not subject to a high standard of substantiation, but do need a reasonable basis to be made. Since the claims for 5-Hour Energy® were not health claims, the court of appeals agreed with Living Essentials that the applicable standard was not competent and reliable scientific evidence.
Nevertheless, the court of appeals found, based on their independent review of the record and evidence, that reversal was not warranted. The court of appeals agreed with the trial court that there was insufficient substantiation as no person with science training had evaluated the claims. The court pointedly stated, “asking an advertising director who lacks any scientific or medical training to conduct internet research is [not] adequate substantiation.”
Finally, Living Essentials argued that the trial court erred in determining that its Ask Your Doctor claim was deceptive. To note, the trial court found that, although the words in the Ask Your Doctor advertisement were literally true, the net impression was deceptive. The net impression was that 73 percent of doctors had specifically recommended 5-Hour Energy® as a health and safe dietary supplement. The trial court found that the surveys Living Essentials used were specifically designed to elicit certain responses from the doctors and that the statistics were presented in a way that would lead a reasonable viewer to believe that 73 percent of 3,000 surveyed would recommend the product, when in fact it was 73 percent of 503 doctors. The court of appeals states, based on the FTC Policy Statement on Deception, that the key question for the trial court was what the reasonable consumer would have taken away from the advertisement. The court of appeals agreed with the trial court’s conclusion that the reasonable consumer would have been misled by the Ask Your Doctor Claim.
The court of appeals upheld the trial court’s assessment of a hefty $2,183,747 civil penalty against Living Essentials and award to the State of $1,886,866.71 in attorney fees and $209,125.92 in costs. Product advertisers should pay special attention to the lessons this case illustrates by ensuring adequate prior substantiation of claims in advertisements, especially if those claims are about diseases or health-related conditions. Advertisers should not only review explicit claims, but consider any implied claims that the advertisement may make or the net impression of a claim. Spending the time to adequately substantiate claims prior to advertising may make all the difference, especially when the alternative may be facing millions of dollars in penalties and fees.
Courtesy of: McDermott Will & Emery - Marc Sorini and Gugan Kaur
Missouri bans non-meat labeling as meat and is sued of course.
10-15-18 -- Missouri recently became the first state in the union to enact a ban on labeling products as "meat" unless they are "derived from harvested product livestock or poultry." But the company that makes Tofurky has already filed suit in federal court to challenge the new law's constitutionality, says James Lawrence of Michael Best & Friedrich LLP.
UPDATE 06/01/2021: 13 states have now passed similar laws. In Missouri, the court found that the plaintiffs did not successfully show a likelihood of success on the merits, and the court denied the preliminary injunction.[2] The language of Missouri’s statute mirrors Texas’s proposed language in that it bans “misrepresenting” products as meat.
In contrast, the court granted a similar injunction in Arkansas because the statute banned “representing” products as meat.[3]
The ACLU appealed on behalf of the plaintiffs the denial of the preliminary injunction in Missouri to the Eighth Circuit. On March 29, 2021, the Eighth Circuit affirmed the District Court’s ruling, finding that the original plaintiffs did not have the substantial likelihood of success on the merits of their claim.[4]
[1] “Truth in Labeling Laws(uits),” The National Agricultural Law Center (12/10/2020) ruth-in-Labeling LawsT updated 4/26/2021.
[2] Turtle Island Foods, SPC v. Thompson, 425 F.Supp.3d 1131 (W.D. Mo. 2019).
[3] Turtle Island Foods, SPC v. Soman, 424 F.Supp.3d 552 (E.D. Ark. 2019).
[4] Turtle Island Foods, SPC v. Thompson, 992 F.3d 694 (8th Cir. 2021).
FDA Issues Food Facility Registration Small Entity Compliance Guide
06-01-18 -- FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. While the registration requirement has been in effect since 2003, the requirements were revised under the Food Safety and Modernization Act (FSMA).
Food Safety Management Systems required
Everyone running a food business is legally required to have an approved written food safety management system in place to comply with the law and to help ensure food is safe for customers to eat.
It’s recommended that the Hazard Analysis and Critical Control Point (HACCP) is used to help food business operators assess how they handle food and introduce procedures to make sure the food produced is safe to eat.
It is a legal requirement to write down your hazard analysis to show you have identified and controlled hazards. The level of documentation required will depend on the nature and size of your business.
Enforcement officers in routine inspections, annual audits and unannounced visits will check and assess the hazard analysis.
If found lacking they can take action to reduce the Food Hygiene Rating of the business, serve hygiene improvement notices or close the premises immediately (formally or by voluntary agreement). Last year Wahaca faced a number of temporary closures when it experienced an outbreak of the Norovirus.
In serious situations the business owners can be cautioned or prosecuted leading to six figure fines.
It’s clear from the disciplinary actions if not the reputational damage that food safety and hygiene must not be taken lightly. If in doubt, we recommend having your practices and procedures reviewed to ensure compliance.
Pitmans Law - Alan Davies
Federal Circuit Nixes Bayer's ED Drug Patent
On Wednesday Nov. 1, 2017 the Federal Circuit ruled that a Bayer patent on the erectile dysfunction drug Staxyn is invalid as obvious, handing a win to generics maker Teva with a strongly worded finding that a Delaware federal judge “clearly erred” when he found that the patent was not invalid.
U.S. District Court issues important decision on dietary supplement law
On April 18, 2017, Judge Michael Vasquez granted summary judgment to Bayer in a consumer class action over its probiotic dietary supplement Phillips’ Colon Health. In re Bayer Phillips’ Colon Health Probiotics Sales Practices Litigation, No. 11-03017 (D. NJ). This important decision should help rein in the onslaught of lawsuits that improperly target dietary supplements.
First, the Court’s decision reinforces that dietary supplements are not regulated as drugs, and structure function claims need not be supported by randomized controlled clinical trials (RCTs).
Second, the opinion makes clear that private consumer class actions cannot be premised on a “lack of substantiation” theory.
RCTs Are Not Required
Recognizing the many health benefits of dietary supplements, Congress enacted the Dietary Supplement Health and Education Act of 1994 (DSHEA) to ensure that supplements can be marketed and sold without following the stringent requirements imposed on prescription drugs. In April 2001, the Federal Trade Commission (FTC) promulgated guidance stating that the relevant standard for dietary supplements is “competent and reliable scientific evidence.”
The FTC guidance makes clear that drug-level randomized clinical trials are not required. Instead, “competent and reliable scientific evidence” is a “flexible” standard and “[t]here is no fixed formula for the number or type of studies required.” Even “[r]esults obtained in animal and in vitro studies will . . . be examined, particularly where they are widely considered to be acceptable substitutes for human research or where human research is infeasible.” “[E]pidemiologic evidence may be an acceptable substitute for clinical data” in some circumstances.
In conflict with its own published guidance, however, the FTC and class action lawyers have brought a number of suits against dietary supplement companies on the grounds that the supplement claims are not supported by RCTs. Courts have rejected these attempts to ignore federal law. The most recent defeat for the FTC came in U.S. v. Bayer, where the Court denied the FTC’s attempt to demand drug-level clinical trials to support proper structure function claims for the same probiotic product, Phillips’ Colon Health. U.S. v. Bayer, No. 07-0001 (D.NJ).
Unfortunately, despite this defeat, the FTC continues to demand RCTs for dietary supplements. And, following that decision, an FTC attorney reportedly stated: “I don’t think [the US v. Bayer decision] was about whether you need clinical trials.”1 The most recent judicial decision makes clear that this statement is incorrect.
The Court in In re Bayer Phillips Colon Health reinforced that clinical trials are not required. The Court relied heavily on the FTC case (U.S. v. Bayer) and explained that the FTC opinion held that “RCTs are not required to meet the standard of ‘competent and reliable scientific evidence’” and that “dietary supplements do not” need to meet the “higher standard” that applies to drugs. Op. at 15. At bottom, the U.S. v. Bayer opinion means what it says: dietary supplements must be regulated as Congress intended. They are supplements, not drugs.
Private Plaintiffs Cannot Pursue a Lack of Substantiation Claim
The Court also closed the door to a claim favored by private plaintiffs — a “lack of substantiation” claim. Plaintiffs often sue manufacturers under state consumer fraud laws arguing that a particular food or supplement claim is not adequately substantiated by scientific evidence, where they cannot prove that the claim is scientifically false.
In In re Bayer Phillips Colon Health, the Court held that “[m]erely proving that the claims are unsubstantiated is insufficient.” Op. at 20. Rather, “a plaintiff must put forth affirmative evidence of falsity.” Op. at 19. Plaintiffs’ expert in this case testified that his only basis for saying that Bayer’s claims were false was that Bayer had no supportive RCT and that a number of existing RCTs did not show positive results. The Court rejected this testimony and explained that it “is nothing more than a lack-of-substantiation theory.” Op. at 24. The Court further described the expert’s opinion as “pure speculation” or an “educated guess,” both of which are wholly insufficient to survive summary judgment.
Plaintiffs around the country are pursuing similar claims based on a lack of substantiation theory and are tendering experts that apply the drug-level standard. Following the Phillips Colon Health case, courts should similarly reject these claims.
Ninth Circuit Court of Appeals Shuts Down Substantiation Claims
On April 21, 2017, the Ninth Circuit held that a district court in the Northern District of California “correctly concluded that California law does not provide for a private cause of action” for “lack of substantiation” claims under California’s Unfair Competition Law (UCL) (Cal. Bus. & Prof. Code § 17200, et seq.) and Consumers Legal Remedies Act (CLRA) (Cal. Civ. Code § 1750, et seq.).
Relevant Summary
In Kwan v. SanMedica Int’l, No. 15-15496, D.C. No. 3:14-cv-3287, Plaintiff alleged that SanMedica International falsely represented that its Human Growth Hormone (HGH) supplement provided a 682 percent mean increase in HGH levels. The district court granted SanMedica’s motion to dismiss, reasoning that it was based entirely on allegations that SanMedica’s representations lacked substantiation, for which there is no private cause of action. The district court instructed Plaintiff that if she chose to amend her complaint, she had to allege facts “affirmatively disproving” SanMedica’s representations.
Relying on the “firmly established law” in the California Court of Appeal’s decision in National Council Against Health Fraud, Inc., v. King Bio Pharmaceuticals, 107 Cal. App. 4th 1336 (2003), the Ninth Circuit affirmed.
Evaporated Cane Juice is NOT Juice
(06-06-2016) -- Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized FDA guidance on use of the term “evaporated cane juice” (“ECJ”) as an ingredient in food labels may change things.
Specifically:
FDA’s present view is that "such sweeteners should not be declared on food labels as ‘evaporated cane juice’ because that term does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups) . . . . Moreover, the use of ‘juice’ in the name of a product that is essentially sugar is confusingly similar to the more common use of the term ‘juice’ – ‘the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree’ (21 CFR 120.1(a)). Thus, the term ‘evaporated cane juice’ is false or misleading because it suggests that the sweetener is ‘juice’ or is made from ‘juice’ and does not reveal that its basic nature and characterizing properties are those of a sugar."
So what is FDA recommending to food companies? "Sweeteners derived from sugar cane should not be listed in the ingredient declaration by names such as ‘evaporated cane juice,’ which suggest that the ingredients are made from or contain fruit or vegetable ‘juice’ as defined in 21 CFR 120.1 . . . . [T]he common or usual name for the [evaporated cane juice] product should be or include ‘sugar’ . . . . FDA would not object to the addition of one or more truthful, non-misleading descriptors before the common or usual name ‘sugar.’"
Red Bull Does Not Give You Wings or More Caffeine Than a Cup of Coffee
Red Bull markets the product as providing more energy than a cup of coffee, despite the fact that a can of Red Bull provides roughly half the content of an equivalent sized cup of coffee. Add to this, a regular serving of Starbucks coffee costs just US$1.85, a marked difference in comparison to the exorbitant cost of a Red Bull can. The suit maintains, “even though there is a lack of genuine scientific support for a claim that Red Bull branded energy drinks provide any more benefit to a consumer than a cup of coffee, the Red Bull defendants persistently and pervasively market their product as a superior source of ‘energy’ worthy of a premium price over a cup of coffee or other sources of caffeine.” In evidence submitted by the plaintiffs, it was alleged that a 7 oz. cup of drip coffee contains approximately 115-175 milligrams of caffeine, while an 8.4 oz. can of Red Bull contains 80 milligrams of caffeine.
Given 75% of Red Bull’s value is estimated to be associated with its brand, the lawsuit was not a matter Red Bull took lightly, as evident from the US$13 million payout to which it has agreed to. US residents, who purchased a can of Red Bull in the last ten years, may be eligible for either a US$10 refund or a US$15 Red Bull product purchase. If it were me, I’d take my refund to Starbucks.
Coca Cola Sued Again Over Deceptive Simply Orange Advertising
Copycat lawsuits appear to be increasing in food labeling cases. The Coca-Cola Company (“Coca-Cola”) is the latest company to be targeted with a copycat suit in California. A putative class action, Phelps v. The Coca-Cola Co., No. BC547592, filed in Los Angeles Superior Court on June 3, 2014, alleges that Coca-Cola misleadingly promoted its Simply Orange brand juices as “fresh,” “100% Orange Juice,” and “100% Pure Squeezed,” when, according to the plaintiff, those juices are actually the product of a complex engineering process and use artificial flavoring.
More specifically, the named plaintiff, Gwen Phelps, alleges that Simply Orange juices are “engineered from multiple batches of oranges and orange products eight months to a year old with algorithms and flavor packs, concocted via an unnatural process.” Plaintiff claims that this process involves stripping the juice of its color and flavor, and then “adding back into the juice natural flavors and fragrances captured during squeezing,” along with “flavor packs” created by fragrance companies. She accuses Coca-Cola of concealing its use of this process and of misleading her and others into purchasing Simply Orange products. Plaintiff has asserted claims for intentional misrepresentation, negligent misrepresentation, fraud, and violation of California’s Unfair Competition Law (UCL), False Advertising Law (FAL), and Consumers Legal Remedies Act (CLRA) on behalf of a class of all California residents that purchased Simply Orange products in the last ten years.
More than a dozen similar cases were filed against Coca-Cola in federal courts around the country in 2012, and later consolidated in a multidistrict litigation proceeding in the Western District of Missouri, In re Simply Orange Orange Juice Marketing & Sales Practices Litigation, No. 12-md-02361 (W.D. Mo.). Indeed, the Phelps complaint appears to largely duplicate the allegations made by these federal plaintiffs. This copycat suit was likely spurred by Coca-Cola’s unsuccessful attempt to dismiss the consolidated complaint in the Multidistrict Litigation (MDL). There, Judge Fernando J. Gaitan denied Coca-Cola’s arguments that: (1) the claims were non-actionable puffery; (2) the plaintiffs failed to allege “injury-in-fact”; and (3) the claims were preempted by existing FDA food labeling regulations.
Phelps falls in line with a recent wave of food misbranding lawsuits filed in California state courts which are largely duplicative, if not identical, to cases already pending in federal courts. This trend may stem from the view that California law is more favorable to consumer class actions. And plaintiffs are catching on that, win or lose the first time around, another forum often provides another chance.
TriVita to pay $3.5 million for deceptive claims about cactus juice product
(July 24, 2014) -- The Federal Trade Commission (FTC) has settled with dietary supplement marketer TriVita over accusations that the company advertised its cactusbased drink, Nopalea, as providing health benefits such as relieving inflammation without evidence to support the claims. FTC v. TriVita, No. 14-1557 (U.S. Dist. Ct., Ariz., stipulation approval order entered July 11, 2014). The suit, resolved the day after its filing, accused TriVita of manufacturing Nopalea and marketing it as an “anti-inflammatory wellness drink” that scientific studies have shown “reduces or eliminates the effects of inflammation on the body, relieves pain, relieves swelling, improves respiration, and provides skin health benefits,” even though no scientific studies had been conducted to support the claims. Under the settlement order, TriVita can no longer make health claims about Nopalea without clinical tests by qualified researchers supporting them. See FTC Press Release, July 15, 2014.
State AGs sue 5-hour ENERGY® makers for deceptive advertising
(07-21-14) -- The state attorneys general (AGs) of Oregon, Vermont and Washington have reportedly filed separate lawsuits against Living Essentials and its parent Innovation Ventures seeking a permanent injunction to stop allegedly misleading and deceptive advertising for 5-hour ENERGY®. According to news sources, other state AGs are expected to bring similar action; some 30 have been investigating the accuracy of company ads for the product.
Washington AG Bob Ferguson has alleged that the defendants violated the state consumer protection statute by (i) airing TV commercials with "survey results" from doctors who "recommend" the product "while misrepresenting survey results and failing to disclose key facts"; (ii) using a misleading "no sugar crash" product tagline given studies demonstrating a caffeine crash; (iii) implying that the product can be consumed by teens with the label statement, "Do not take if you are pregnant or nursing, or under 12 years of age"; and (iv) claiming that the "energy blend" in 5-hour ENERGY® and the vitamins and amino acids in Decaf 5-hour ENERGY® are responsible for the products' energy effects when the energy is actually derived solely from caffeine.
Oregon AG Ellen Rosenblum said, "This lawsuit is about requiring truth in advertising. Plainly and simply, in Oregon you cannot promote a product as being effective if you don't have sufficient evidence to back up your advertising claims." A company spokesperson reportedly characterized the Oregon lawsuit's allegations as "grasping at straws" as well as "civil intimidation" and indicated that the companies intend to mount an aggressive defense. See Oregon Department of Justice Media Release and Courier-Herald, July 17, 2014; Reuters, July 18, 2014.
Two judges in the Central District of California dismiss labeling class actions, finding claims challenging strawberry images on nature's path's cereal boxes and "natural" statements on Hain Celestial's cosmetics implausible
(07-01-14) -- Judges George Wu and Manuel Real both recently dismissed two class actions in the Central District of California that challenged the labeling of food and cosmetics as false and misleading. Defendants (represented by a team of MoFo litigators led by William Stern) persuaded the courts that the plaintiffs' claims were implausible as a matter of law. The judges dismissed both cases with prejudice.
In the first case, Shaker v. Nature's Path Foods Inc. et al, No. CV-13-1138-GW (OPx), plaintiffs claimed that the label for "Optimum® Blueberry Cinnamon" cereal was deceptive because the cereal did not contain dried strawberries and failed to meet plaintiffs' notions of "optimum." The claim was based on the image of fresh strawberries shown on top of a bowl of cereal on the front label. The court found plaintiffs' claims implausible, ruling that:
"no reasonable consumer would be deceived into believing that the Cereal – whose packaging prominently features the words ‘Blueberry Cinnamon' – contained dried strawberries by virtue of the photograph of fiber/flake cereal in a bowl, with a spoon, milk, blueberries, and a topping of fresh strawberries."
The court further held that the brand name "Optimum®" is non-actionable puffery.
Judge Real arrived at the same conclusion in Balser v. The Hain Celestial Group, Inc., No. CV-13-5604-R. There, plaintiffs claimed that the "natural" statement on the labels of Hain's Alba Botanica®line of lotion, shampoo and body wash was false and misleading because the products contained synthetic ingredients. The court disagreed, finding that "natural" is a vague and ambiguous term, and plaintiffs' alleged definition -- "existing in or produced by nature; not artificial -- is "implausible as applied to the products at issue: shampoos and lotions do not exist in nature, there are no shampoo trees, cosmetics are manufactured." The court further found that the "defendant actively defines what its use of natural means, so that no reasonable consumer could be deceived."
Together the opinions might signal renewed willingness of judges to dismiss cases on plausibility grounds and to rule on the "reasonable consumer standard" at the pleading stage. This is especially welcome news for cases challenging "natural" labels -- a favorite claim of plaintiffs' attorneys that often survives motions to dismiss.
In August of 2013, the FDA issued a regulation that defines the term "gluten-free" for food labeling.
"Gluten-free" is a voluntary label that manufacturers may elect to use in the labeling of their foods. However, manufacturers that label their foods gluten-free are accountable for using the claim in a truthful and not misleading manner, and for complying with all requirements established by the regulation and enforced by the FDA. The FDA has set a gluten limit of less than 20 parts per million (ppm) for foods that carry the label "gluten-free," "no gluten," "free of gluten," or "without gluten."
Sellers have until August of 2014 to bring their labels into compliance with the FDA regulation. After August 2014, a food that is labeled "gluten-free" but fails to meet the requirements of the regulation will be subject to regulatory action by the FDA. On its website, the FDA states: "We expect that restaurants' use of gluten-free labeling will be consistent with the federal definition . . . Given the public health significance of gluten-free labeling, we encourage the restaurant industry to move quickly to ensure that its use of gluten-free labeling is consistent with the federal definition."
Since use of the phrase "gluten-free" on a product label is voluntary on the part of the seller, and since gluten is not a nutrient whose levels must be disclosed on labels under FDA regulations, use of "gluten-free" labeling does not come within the nutrition labeling mandates of Subpart A of Title 21, Part 101 of FDA regulations governing food labeling.
See 21 C.F.R. 101.9(c) Furthermore, there are nutrition labeling exemptions for small businesses under FDA regulations. See:
21 C.F.R. 101.9(j)(1) (" The following foods are exempt from this section [on nutrition labeling of food]: Food offered for sale by a person who makes direct sales to consumers who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, provided that the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising" ); and
21 C.F.R. 101.9(j)(18) (" The following foods are exempt from this section: Food products that are low-volume [meaning] the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States" ).
Soy was never intended for human consumption. What?
· September 28, 2009 – 8:10 am
· Tagged block iron, enzyme inhibitors, GM soy, GMO, goitrogens, growth inhibition, hemagglutinin, natto, phytate, phytic acid, soy, soy sauce, soybean, tempeh, tofu
Soy Nutrition… The Whole Soy Story
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