Posts tagged FDA.
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On February 10, 2023, an Illinois federal district court ordered the dismissal of a putative class action lawsuit alleging that an online tool that allowed users to virtually try on sunglasses violated the Illinois Biometric Privacy Act (“BIPA”).

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The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products.  Subject matter may include the latest product recalls, major federal agency developments, and proposed or new federal rules.  The blog’s goal is to provide an overview, rather than a comprehensive report on every development that could potentially affect businesses or consumers.  Nothing herein constitutes legal advice.  If you have questions or comments about the blog, please reach out to the authors.

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With the busy holiday shopping season underway, retailers should remain vigilant in their efforts to protect consumers and themselves from the risks of selling potentially unsafe, ineffective or misbranded products in violation of the U.S. Environmental Protection Agency (EPA’s) federal pesticide law, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  As concerns with the spread of COVID-19 and new variants increase over the winter months, consumers are likely to stock up disinfectant products and devices like air purifiers and air filters marketed to reduce the transmission of COVID-19 and other microorganisms.  These products are tightly regulated under FIFRA, and retailers can unwittingly become entangled in regulatory enforcement actions for selling and distributing products that do not comply with EPA’s regulations.  FIFRA extends legal liability not only to the makers of violative products, but also retailers who sell them to consumers, whether or not the retailer was necessarily aware of the violation. In addition to EPA, state agencies also enforce state regulatory requirements applicable to these products.

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A group of Democratic representatives led by Rep. Jan Schakowsky (D-IL) have introduced a “Safer Beauty” bill package that would ban certain chemicals in cosmetics and require more ingredient transparency in the supply chain.  The Safer Beauty bill package is comprised of four separate bills targeting certain “chemicals of concern” commonly used in cosmetics—including PFAS, phthalates, and formaldehyde.

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While the eleven January recalls are summarized below, this first “Roundup” focuses on the evolving use of cashierless technology and what role it may play in the context of product recalls.  Broadly speaking, cashierless technology refers to using technology at brick-and-mortar business locations that allows shoppers to enter the location and purchase consumer products without standing in a checkout line or interacting with a cashier.  Rather, cameras and sensors track the products selected and charge the shoppers upon exit.

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With the prevalent spread of COVID-19, hand sanitizers have become this spring and summer’s “fidget spinners,” cycling through the process from market shortage to glut in short order.  With such a rush to meet the drastic spike in demand, product missteps seem inevitable.  Although the Recall Roundup generally focuses on recalls under CPSC jurisdiction, the numerous FDA recalls involving hand sanitizers merits mention here.  Since June 27, 2020, there have been 15 recalls noted on the FDA’s “Recalls, Market Withdrawals, & Safety Alerts” website.  Retailers looking to meet market demand should keep an eye on this FDA web site relative to the hand sanitizers they may have stocked for sale.

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The FTC and the FDA jointly sent warning letters to four manufacturers of flavored e-liquid products, citing the absence of particular disclosures in paid social media endorsements as potentially in violation of the Federal Food, Drug, and Cosmetic Act and the FTC Act.

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This past week, several consumer actions made headlines that affect the retail industry.

“Black Truffle Flavored Extra Virgin Olive Oil” Case Dismissed Against Trader Joe’s

On August 30, 2018, the Southern District of New York dismissed class action claims for consumers who purchased Trader Joe’s “Black Truffle Flavored Extra Virgin Olive Oil.” The complaint alleged that the product label contained the words “black truffle” in large black letters, with the words “flavored” and “extra virgin olive oil” in smaller cursive letters underneath. However, DNA testing revealed that the oil did not contain actual truffle, but rather 2,4-dithiapentane, a petroleum-based synthetic injection that imitates the taste and smell of truffles.

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This past week, several consumer actions made headlines that affect the retail industry.

FTC Swats Misleading Advertising Claims Just in Time for Mosquito Season

The FTC and makers of the “Aromaflage” line of products have agreed to settle charges that Mike & Momo, Inc., deceptively marketed its mosquito-repelling perfume sprays and scented candles. The company agreed to stop making unsubstantiated claims that its products repel disease-carrying mosquitos, work for 2.5 hours, and are as effective as 25 percent DEET. The FTC also alleged that Mike & Momo packed its Amazon storefront with five-star reviews written by the owners and close family members; under the proposed consent order Mike & Momo must disclose any “unexpected material connection” between the company and any endorsers.

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This past week, several consumer actions made headlines that affect the retail industry.

Nectar Brand to Put Its “Made in America” Claims to Bed

Nectar Brand LLC has agreed to stop making unqualified claims that its mattresses were made in the United States. According to the FTC’s complaint, Nectar Brand sells mattresses under several brand names, including Nectar Sleep, DreamCloud LLC and DreamCloud Brand LLC. Nectar Brand’s ads and product labeling included statements that the products were “Designed and Assembled in USA.” In fact, the FTC alleged that the mattresses all are imported from China and that Nectar Brand has no assembly operations in the U.S.

Under the settlement terms, Nectar Brand is prohibited from representing that its products are made in the United States unless it can substantiate its claims. Further, Nectar Brand’s officers are prohibited from misrepresenting the country of origin of its products.

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This past week, several consumer actions made headlines that affect the retail industry.

Advertising Agency Pays $2 Million to FTC and State of Maine to Settle Unsubstantiated Weight-Loss Claim

The FTC and the State of Maine have settled a case against ad agency Marketing Architects, Inc. (“MAI”) for MAI’s role in creating and disseminating deceptive radio ads replete with unsubstantiated claims for weight-loss products. MAI had been retained to create the ads by dietary supplement supplier, Direct Alternatives, Inc., whom the FTC and Maine had sued in 2016. Under the agreement with MAI, the ad agency is banned from making any of the seven “gut check” weight-loss claims that the FTC has publicly advised are always false. MAI also must have competent and reliable science to support weight-loss claims and must not misrepresent facts relating to return and cancellation policies of the products marketed. Finally, the order imposes a $2 million judgment on MAI, which may be used to provide refunds to consumers harmed by the conduct.

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With the arrival of 2018, President Trump resubmitted his nominations for CPSC leadership vacancies to the Senate. In 2017, Trump nominated Commissioner Ann Marie Buerkle to serve as CPSC Chair and Dana Baiocco to serve as a commissioner replacing Democrat Commissioner Marietta Robinson, whose term expired. But, under Senate rules, nominations not acted on are returned to the President. At the end of the Senate’s 2017 session, this meant that roughly 120 nominations were returned to Trump. Both nominees—Buerkle and Baiocco—are expected to receive Senate confirmation this year.

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This past week, several consumer protection actions made headlines that affect the retail industry.

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This past week, several regulatory and self-regulatory consumer protection actions made headlines affecting the retail industry.

FDA Continues to Reverse Course on Obama-Era Food Label Regulations

After delaying the Menu Labeling Rule effective date to May 7, 2018, the FDA also has indefinitely delayed the launch of changes to the Nutrition Facts labels. These updates, which include information regarding added sugars and emphasized caloric counts, originally were planned to go into effect in July 2018. Despite the delay, a number of manufacturers already have rolled out new labels.

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This past week, several consumer actions made headlines that affect the retail industry.

The NAD Refers Sports Drink Maker to FTC

The NAD has referred BA Sports Nutrition, the maker of BodyArmor sports drinks, to the FTC after the advertiser failed to alter certain comparative ads. The ad at issue implores customers to “Ditch artificial Sports Drink[s]: artificial flavors, artificial sweeteners, artificial colors” and depicts a bottle of a competing sports drink. The NAD found that the ad implied that the competing sports drink contained artificial flavors, sweeteners and colors when, in fact, many of the competitor’s sports drinks did not.

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The FDA has announced that it will officially delay the compliance date for its Menu Labeling Rule (the “Rule”) to May 7, 2018, in order to consider how to further reduce the regulatory burden or increase flexibility while continuing to achieve regulatory objectives. Among other concerns, the FDA notes that retailers have raised concerns that the Rule lacks flexibility to permit the provision of meaningful nutrition information to consumers in innovative formats.

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This past week, several consumer actions made headlines that affect the retail industry.

Grocers and Convenience Stores Argue FDA's Menu Label Rule Too Broad

The National Grocers Association (“NGA”) and the National Association of Convenience Stores (“NACS”) filed a citizen petition claiming that the FDA's final menu rule, effective on May 5, 2017, requiring calorie counts on menus for "restaurants and similar retail food establishments," is overbroad and imposes significant costs for compliance. The NGA and NACS petition makes several arguments for delaying or changing the proposed final rule, including: (1) the $1 billion compliance cost estimate over 10 years is too low, and instead the $1 billion will be "initial" costs to comply, (2) the FDA has failed to show any evidence that the rule will actually address obesity and consumer health, so the rule would violate the First Amendment, and (3) the rule sweeps in any business that sells prepared food, which was not contemplated by Congress in the Affordable Care Act. The FDA stated that it is considering the petition and an extension of time.

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This past week, several consumer actions were made that affect the retail industry.

NetSpend Settles Deceptive Advertising Claims with FTC

NetSpend Corp recently agreed to settle FTC allegations that the company deceived consumers about access to funds deposited to debit cards. The FTC voted to approve the stipulated final order, with Commissioner McSweeney and former Commissioner Ramirez voting to approve and Acting Chairman Ohlhausen dissenting.

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This past week, several consumer actions made headlines that affect the retail industry.

Kraft Suit Stayed Pending Outcome of FDA Guidance

A federal judge in Puerto Rico granted Kraft Foods Group Inc.’s (“Kraft’s”) motion to stay pending the completion of the FDA’s inquiry into the use of the term “natural” on food labeling. The suit alleges that Kraft falsely labeled its shredded cheese as “natural” despite containing artificial food coloring. The case is stayed until the FDA provides guidance on the use of that term on food labels. 

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This past week, several consumer actions made headlines that affect the retail industry.

Litigation Bubbles Up Over Wal-Mart Beer Claims

Wal-Mart was sued in Ohio last week in a proposed class action, alleging that the company falsely marketed and priced mass-produced beer as craft beer. The plaintiff explains that he bought a 12-pack of beer that was packaged to look like craft beer, and sold at a higher price point than other mass-produced beers. In order to be called a craft beer, the Brewers Association requires that the brewery make fewer than 6 million barrels annually and be less than 25 percent owned by a mass producer. Wal-Mart’s beer is a part of a collaboration with Trouble Brewing, which the complaint alleges does not exist but is a subset of a large mass beer producer.

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October was filled with frights as malfunctioning electronics took center stage. With personal panic devices failing to operate and diving computers posing drowning risks, manufacturers should keep in mind that life-threatening hazards dramatically increase their potential liability.

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The following consumer protection actions made headlines this week:

Self-Regulatory

Zeltiq’s CoolSculpt Claims Referred to FTC and FDA

On October 5, 2016, the NAD referred advertising claims from Zeltiq Aesthetics, Inc., to the FTC and the U.S. Food and Drug Administration (“FDA”) for Zeltiq’s “CoolSculpting Cryolipolysis Body Contouring System,” a medical device that, according to the advertiser, uses a cooling treatment to target fat cells beneath the skin. The device is FDA approved, and the NAD found that the claims that the product is “FDA-cleared” and would result in a “slimmer you” were supported. However, the NAD recommended that Zeltiq add further disclosures about how the product works. Zeltiq said that it would comply with most, but not all, of NAD’s recommendations; per NAD procedure, the matter will be referred to the FTC and FDA.

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Much ado about lithium-ion batteries. If you have watched the news, you have seen that certain smartphones have been recalled due to fire and burn hazards posed by the phones’ lithium-ion batteries. While this recall is important, it is not unique. This year alone, at least nine other companies have issued recalls due to problems with lithium-ion batteries. These recalls include video baby monitors, batteries in laptop computers, batteries in flashlights and other battery packs. Not to mention last year’s slew of recalls over the most popular holiday gift – the hoverboard. While there are advantages to lithium-ion batteries, such as their recharge capability and their low memory effect, there are risks to using them in household electronic devices. Manufacturers must assess these risks when rolling products out to the public. Companies could not only face an expensive recall, but also a potential shift in public perception of the quality of its devices that could have repercussions long after the initial recall is over.

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This past week, several consumer actions made headlines:

Claims Against Advertisers for the Misuse of “Natural” Gain Traction

Claims that Nature’s Bounty's “natural” menopause remedy is ineffective and contains synthetic ingredients and lead survived a motion to dismiss and may proceed as a class action, according to a judge in the Eastern District of New York. The named plaintiff accuses Nature’s Bounty of advertising its black cohosh menopause remedy as “natural” and “nonsynthetic”; she also alleges that the effectiveness of the remedy is not supported by scientific evidence. A key issue before the court was whether a reasonable consumer would assume that the product – labeled as “natural” with a disclaimer that it contains “other ingredients” – contained only natural ingredients. The court found that a reasonable consumer would make this assumption and allowed the plaintiff’s advertising claims to proceed on that basis.

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This past week, several consumer, self-regulatory and regulatory actions made headlines:

Clearblue Label Not So Clear

A Second Circuit panel affirmed a district court ruling that SPD Swiss Precision Diagnostics GmbH, maker of the Clearblue Advanced Pregnancy Test with Weeks Estimator, violated the Lanham Act. While medical professionals estimate the length of pregnancy by the date of a woman’s last menstrual period, the Clearblue test estimates it by the length of time since a woman ovulated, but does not disclose this difference in measurement. The appeals court rejected Clearblue’s argument that the Lanham Act claim was precluded because it's label and marketing materials had been approved by the U.S. Food and Drug Administration. The case was brought by competitor Church & Dwight Co. Inc.

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Hunton & Williams LLP focuses on product issues ranging from compliance, recall issues, investigations and products-related litigation in state and federal courts and in various administrative forums. Our lawyers have managed and consulted on recall or potential recall issues for a number of clients requiring involvement with the Consumer Product Safety Commission, the Federal Trade Commission, the Food and Drug Administration, the Bureau of Alcohol, Tobacco, Firearms and Explosives, and the state attorneys general. Our lawyers have conducted broad-based federal and 50-state research to identify applicable regulatory schemes, consulted with clients regarding compliance strategy and litigation risk management issues, and litigated numerous products liability claims (gas controls, valves, water heaters, tires) in state and federal courts.

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This past week, several consumer and regulatory actions made headlines:

Federal Guidance

D.C. Federal Judge Vacates Part of FDA Tobacco Guidance

A D.C. federal judge vacated a portion of FDA guidance relating to the labeling of tobacco products. The key issue before the court was whether changing a tobacco product’s label to a distinct new label creates a new tobacco product subject to FDA approval. The court also considered the question of whether changing a product’s quantity resulted in the creation of a new tobacco product subject to the FDA’s “substantial equivalence review process.” The court found that while a change in the existing product’s label did not create a new tobacco product, a change in a product’s quantity did.

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This past week, several consumer protection and regulatory actions made headlines:

Technology

Volkswagen to Pay an Additional $86 Million to California

On July 6, California Attorney General Kamala Harris announced that Volkswagen (“VW”) will pay the state an additional $86 million in a second partial settlement over VW’s emissions “defeat devices.” This civil penalty sum is the largest amount ever recovered by California from an automaker, and comes on the heels of the recently announced $14.7 billion settlement negotiated by the EPA and the FTC over the German automaker’s emissions-cheating scandal. The $86 million is part of a total $603 million VW has agreed to pay to resolve consumer-protection claims with 46 jurisdictions. As part of the settlement, VW agreed to strict injunctive terms, including prohibitions on false advertising and affirmative disclosure of defeat devices.

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This week, the following consumer protection actions made headlines:

Teavana Settles with Consumer Product Safety Commission

Teavana, a Starbucks-owned tea retailer, settled allegations with the Consumer Product Safety Commission (“Commission”) that Starbucks failed to report complaints of exploded tea tumblers. The settlement split the Commission on a company’s obligation to report complaints to the agency. Commissioner Joseph P. Mohorovic, who opposed the settlement with its $3.75 million civil penalty, said that Teavana did not have a clear obligation to report the complaints saying, “The [Consumer Product Safety Act] and our rules under it do not establish a clear line for when a company must report, but at best blurred zone of indecision.”

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This week, the following consumer protection actions made headlines:

Mortgage Scammer Under Water After FTC Settlement

On May 9, 2016, the FTC announced that it is returning $1.87 million to 1,630 consumers who lost money in the Expense Management America telemarketing scheme that never provided debt or mortgage relief services after absconding with homeowners’ up-front fees. The repayment to consumers is a capstone on a three and a half year joint effort with the DOJ, FBI and HUD to crack down on mortgage scammers taking advantage of distressed homeowners. Related efforts, underway since 2008, resulted in a new FTC rule providing increased protection to homeowners by prohibiting any collection of fees until the homeowner has an acceptable written offer from their lender. In prosecuting Expense Management America, the FTC worked closely with various enforcement agencies in Canada to track down and prosecute the scammers.

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This past week, several consumer protection actions made headlines:

FTC to Let the Sun Shine on Consumer Protection Issues in Rooftop Solar Panel Businesses

The FTC announced that it will be holding a workshop focused on competition and consumer protection in the growing industry of consumer-oriented rooftop solar panels. The workshop, which will take place in Washington D.C. on June 21, 2016, is meant to expand the FTC’s understanding and approach to the growing consumer solar panel industry. Planned topics of discussion include: (1) how consumers can get needed information when deciding whether to install rooftop solar panels; (2) how utility regulators currently approach compensating consumers for power generated on their solar panels; and (3) competition in the solar power generation industry.

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We previously reported on the U.S. Food and Drug Administration’s (“FDA’s”) request for public comment concerning the use of the term “natural” on food labels, and we noted that businesses should consider seeking a stay of any pending lawsuits challenging their use of the term “natural” on food labels under the primary jurisdiction doctrine. The Ninth Circuit, home of the infamous “Food Court,” has now invoked that doctrine and has ordered the stay of a pending “natural” mislabeling class action in Kane v. Chobani, LLC, No. 14-15670.

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This past week, the following consumer protection actions made headlines:

Food Marketing: Consumers Respond to Motion to Dismiss their Claims Against Walmart’s Missing Pork

On March 9, 2016, plaintiffs in a suit against Walmart Stores, Inc. responded to the company’s  motion to dismiss, saying that their complaint sufficiently put the retailer on notice of allegations that Walmart’s Great Value Pork & Beans in Tomato Sauce lacked an important ingredient: pork. The plaintiffs argue that the USDA requires pork and beans products to contain at least 12 percent pork in order to advertise pork on its labels, and that plaintiffs’ testing did not show any traces of pork in the product. Walmart contends in its motion to dismiss that its labels plainly state that the product contains less than 2 percent pork, and that plaintiffs’ claims are preempted by food labeling laws.

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This past week, the following consumer protection actions made headlines:

Retail Pricing: Class Action Complaint Against Gap Dismissed

A putative class action, alleging that The Gap, Inc.’s deceptive advertising in stores confuses customers as to what products are actually discounted and tricks many into buying products at full price, was tentatively tossed by a California state judge last week. The Court granted Gap’s demurrer in part because the named plaintiff failed to identify particular advertisements relied upon in her purchases and, more importantly, could not allege that she was actually injured by Gap’s alleged practices. In fact, the Court stated that being “psychologically committed” to an item such that the named plaintiff did not return it was not enough to state a claim. The court gave the plaintiff one last chance to allege an injury.

Time 5 Minute Read

For the past several years, the industry and the plaintiffs’ bar have been litigating over what is “natural” and what is not when it comes to food products. This issue hit home with retailers with news of multimillion dollar settlements resolving claims concerning use of the term “natural” on food product labels. The issue certainly became blurred when it came to modern processing methods and advances in biotechnology, particularly with respect to ingredients like high fructose corn syrup or genetically modified fruits and vegetables. Late last year, however, in response to four consumer petitions, the U.S. Food and Drug Administration (“FDA”) requested public comments concerning the use of the term “natural” on food labels. Whether and how the FDA ultimately defines the term “natural” will surely impact cases in the long-run. But the FDA’s decision to request comment has more immediate effects. It arms defendants with potential means to bring pending litigation to an immediate halt.

Time 5 Minute Read

This past week, the following regulatory and consumer protection actions made headlines:

Outlet Retailers Sued over Allegedly Deceptive Pricing Practices

Class action lawsuits against several retailers, including Burberry and Dooney & Bourke, allege that outlet discount prices tags that compare the outlet price with purported retail prices deceive consumers into believing they are getting a bargain when, in fact, they are not. Reference pricing rules (e.g., the FTC’s Guides on Deceptive Pricing) prohibit sellers from offering fictitious bargains. In these cases, the plaintiffs allege that the retailers’ practice of offering for sale made-for-outlet goods that never were sold at the referenced price is deceptive.

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