• Online retailers and other large manufacturers are voicing their opposition to proposed Senate legislation that would require country-of-origin labeling for goods sold online. The Country of Origin Labeling Online Act (COOL Online Act) would require goods sold online to conspicuously indicate in the product description the country of origin of the product as determined by the marking regulations administered by U.S. Customs and Border Protection (CBP). The proposed act states it would be enforced by the Federal Trade Commission (FTC), which currently regulates and enforces “Made in USA” claims, and not CBP, which regulates country of origin marking for imported goods.
  • The COOL Online Act has bipartisan support and is widely revered by many U.S. manufacturers and consumer organizations for promoting transparency with consumers in online sales, which they hope will persuade more online consumers to purchase American-made goods. However, the measure faces strong opposition from online retailers and other industry actors that source goods from abroad that point to the logical complexity of correctly marking a single product description for goods that may come from one of several countries, an obstacle that they say is distinct from country of origin marking on product packaging. The measure has reportedly received pushback from Amazon and other industry associations, including the National Retail Federation and the Consumer Technology Association.
  • Senator Tammy Baldwin (D-Wis) proposed the COOL Online Act as an amendment to the Endless Frontier Act, S. 1260, introduced on April 20, 2021. S. 1260 is part of a broader legislative package that aims to improve U.S. competitiveness in trade, especially against China, as part of the U.S. Innovation and Competition Act. We will continue to monitor and report on this legislation.
  • On May 26, FDA published a constituent update informing the public that it has issued warning letters to five companies for marketing dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health conditions. The warning letters were sent to LeRoche Benicoeur dba ConceiveEasy, EU Natural Inc., Fertility Nutraceuticals LLC, SAL NATURE LLC/FertilHerb, and NS Products, Inc. In the update, FDA noted that consumers seeking safe and effective therapies who rely on these products’ claims could potentially suffer harm and may not receive appropriate treatment.
  • According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to cure, treat, mitigate, or prevent infertility are considered drugs that must undergo appropriate FDA drug approval. In such a review, FDA evaluates issues including safety, effectiveness, drug interactions, and dosage. Examples of claims noted in the warning letter are statements on the supplements’ ability to treat luteal phase defects and ovarian cysts, prevent miscarriages, and enhance in vitro fertilization treatment. The companies also published testimonials alleging that use of the products resulted in pregnancy.
  • The companies have been given 15 working days to provide a response to the FDA. FDA notes that those who do not comply risk legal action in the form of product seizure and/or injunction.
  • On May 25, the FDA published a constituent update notifying the public of released findings from a sampling assignment that tested raw agricultural commodity romaine lettuce at facilities and on farms in the Salinas, California and Yuma, Arizona growing regions for the presence of pathogens linked to foodborne illness outbreaks. The sampling assignment report is available here. The sampling assignment focused on pathogenic Escherichia coli (specifically, Shiga toxin-producing E. coli or STEC) and Salmonella spp. The assignment ran from November 2019 until December 2020, although there was a pause in sampling and testing from March through October 2020 due to the COVID-19 pandemic. No pathogens were detected during the assignment.
  • The FDA focused on sample collection at farms and facilities that had been identified in traceback investigations as suppliers of romaine lettuce that may have been linked to foodborne illness outbreaks from 2017 to 2019. Summaries of the outbreaks are available here, here, and here. During the assignment, the FDA collected and tested 279 samples for both pathogens. Each sample contained 10 subsamples, each of which consisted of one or more heads or hearts of romaine lettuce and weighed at least 300 grams. The Agency noted that this approach increased the probability of detecting pathogens, if present.
  • As stated, no pathogens were detected. However, in the constituent update, the FDA mentioned that they intend to continue to monitor the microbiological safety of leafy greens during growing and harvesting seasons. For instance, as previously reported, the FDA announced a new sampling plan to collect approximately 500 samples of romaine lettuce from commercial coolers and cold storage facilities, which hold lettuce from multiple farms in the Yuma region, for STEC and Salmonella as part of the Agency’s ongoing surveillance efforts.
  • On May 11, 2021, a proposed class action lawsuit was filed against Frito-Lay, alleging that its “Hint of Lime” Tostitos were misleadingly labeled because they contain only “Natural Flavors” and not appreciable amounts of lime.
  • In addition to the “Hint of Lime” designation, the front of the package also recommends that consumers “Squeeze in More Flavor With Some Salsa.” Plaintiff argues that these statements mislead consumers into believing that actual lime is squeezed into the product when in fact it contains only “natural flavors” according to the ingredient list.
  • Plaintiff’s argument appears to require accepting that a reasonable consumer would expect that a product with a “hint” of lime would contain more lime than that contained in “natural flavors” and ignores the fact that the “squeeze in” statement references salsa; while the “squeeze” may be a reference to squeezing lime, there is no doubt that the statement is more intelligible when read with the understanding that the salsa (not the lime) is adding flavor to the Tostitos.
  • Furthermore, according to the federal flavor labeling regulation, a product may be designated as “flavored” [with the ingredient in question] where it “contains natural flavor derived from such ingredient and an amount of characterizing ingredient insufficient to independently characterize the food.”  In other words, a product can be lime flavored where it is only flavored with “natural flavoring” derived from lime. Plaintiff characterizes a “Flavored Tortilla Chips” statement in the bottom corner of the packaging as a “disclaimer,” but alleges that this statement is hidden from the consumer’s view by the crumpling of the packaging; it is not clear what “disclaimer” is needed since it is readily apparent that Tostitos are a lime flavored product and not a product containing lime for nutritive value.
  • This is yet another case filed by Spencer Sheehan and associates, a firm well-known for filing class-actions in the food litigation space. Keller and Heckman will continue to monitor and report on this case and other flavoring litigation.
  •  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.
  • U.S. Senators Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR) introduced S. 1698 on May 19, a bill to allow the use of cannabidiol (CBD) and other hemp derivatives in foods and dietary supplements. As our readers know, FDA has stated it does not consider CBD to be a legal food additive or dietary ingredient because it has previously been the subject of clinical investigations for use in drugs and is currently the active ingredient in the approved drug Epidiolex, marketed by GW Pharmaceuticals for treatment of seizures related to epilepsy.
  • If passed, the Hemp Access and Consumer Safety Act (bill text available here) would specifically amend the definition of a dietary supplement in 21 U.S.C. § 321(ff)(3)(B) to except “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from the requirement that dietary ingredients may not include articles that have been approved as new drugs. It would also except the same substances from the requirement in 21 U.S.C. § 331(ll) that foods may not contain articles that have been approved as drugs or the subject of substantial clinical investigations. It would further permit FDA to establish requirements for labeling and packaging of dietary supplements and foods containing hemp and hemp derivatives and take enforcement actions regarding products that are labeled as dietary supplements but that do not meet the definition of dietary supplements in § 321(ff)(3)(B).
  • The bill would allow firms to move forward with submissions to FDA seeking an appropriate clearance for CBD as a dietary ingredient or food additive through existing pathways, such as through a New Dietary Ingredient Notification, Food Additive Petition, GRAS Notice (a submission demonstrating that a food additive is “generally recognized as safe” for its intended use). It would also allow FDA to begin inspecting manufacturing facilities where hemp derivatives and related products are made.
  • S. 1698 has bipartisan support in Congress and industry backing. It joins a CBD-focused House bill, H.R. 841, that was introduced in February and seeks to allow CBD for use in dietary supplements only. We will continue to track CBD-related legislation and report on the progress of these bills.
  • On May 16, a proposed class of yogurt buyers filed suit against Chobani LLC for its misleading label claims. The proposed class alleged that Chobani’s “Complete” branded Greek yogurts contain several misleading components on its labels, including inappropriate plus signs to signal that the product contains more probiotics and prebiotics, as well as claims that the food contains “complete nutrition” even though yogurt “does not have all the necessary and appropriate parts related to an average consumer’s nutritional needs.”
  • The complaint also alleged that the claim “only natural ingredients” is false, deceptive, and misleading because the product contains monk fruit extract, which is a high-intensity, non-nutritive sweetener. The proposed class argued that monk fruit extract is not natural because solvents and additives are used in the making of the monk fruit extract, and thus would not be understood to be “natural” by consumers.
  • The yogurt buyers brought claims under the Illinois Consumer Fraud and Deceptive Business Practices Act, as well as for breach of warranty, fraud, and unjust enrichment. The buyers are seeking monetary damages and an injunction that would stop Chobani from marketing the product with the symbols and words in the future.
  • Keller and Heckman will continue to monitor and report on this case and other food litigation news.
  • A proposed consumer class action has been filed against Kashi Sales, LLC for allegedly deceptively labeling its “Ripe Strawberry Soft Baked Breakfast Bars.”
  • The thrust of the complaint is that the bars are being marketed as a so called “healthy indulgence” — a desirable snack that is also healthy—by conspicuous promotion of healthy ingredients on the product labels, including strawberries, oats, and honey, even though these ingredients are allegedly present in small quantities. The packaging largely has a red background and includes pictures of fresh, ripe strawberries.  The front of the package also states that the bars are “made with wildflower honey” while the back states that the bars are made with a “[l]ove for simple ingredients, like strawberries and whole grains.”
  • The lawsuit alleges that, in contrast to the prominent strawberry representations on the packaging, the ingredient list suggests that pear and apple ingredients predominate over the strawberry ingredient and that these ingredients are less desirable than strawberries, which have many health benefits and are more expensive. In particular, the primary ingredient in the bars, “strawberry filling,” is in fact composed of more apple and pear than strawberry; the only strawberry (sub)ingredient is “strawberry puree concentrate” which is the 5th most predominant (sub)ingredient in the strawberry filling, after both pear juice concentrate and apple powder. The complaint also suggests that the “made with” honey claim is misleading because the product contains more sugar than honey.
  • As a reminder to our readers, there is no private right of action to enforce the food labeling regulations in Title 21 of the Code of Federal Regulations, although the regulations are frequently invoked in deceptive advertising lawsuits as evidence of consumer deception. However, interestingly this lawsuit does not mention the flavor labeling regulation (21 C.F.R. § 101.22) and only in passing references alleged labeling violations; it alleges that the product’s name runs afoul of 21 C.F.R. § 101.18(b) because it only references strawberry, even where pears and apples are included, and also alleges that the percentage of strawberries should have been disclosed per 21 C.F.R. § 102.5(b). Keller and Heckman will continue to monitor and report on this case and other food litigation news.
  •  The largest Salmonella outbreak in over a decade occurred last year when illness from Salmonella Newport associated with consumption of red onions from the Southern San Joaquin Valley and Imperial Valley in California was reported in 1,127 people in the U.S. and 515 people in Canada between June 19, 2020 and September 11, 2020.  Red onions had never previously been associated with a foodborne illness outbreak.  Red onions, as well as yellow, white and sweet onions distributed by Thomson International Inc. were recalled because of the possible Salmonella risk.  The outbreak included 167 hospitalizations and no deaths.
  • On May 13, 2021, FDA released its Investigation Report: Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of Salmonella Newport.  FDA did not make a firm conclusion as to the root cause of contamination of the onions but identified contaminated irrigation water used in a growing field in Holtville, California as the leading hypothetical cause.  Other highlights of FDA’s report include:
    • Out of nearly 2,000 subsamples tested, a total of 11 subsamples (10 water and 1 sediment) were positive for Salmonella Newport representing three different genotypes, but not the same genotype as the outbreak strain linked to consumption of red onions.
    • Aside from irrigation water, FDA identified sheep grazing on adjacent land, as well as signs of animal intrusion, such as scat and large flocks of birds, as plausible opportunities for contamination of the red onions.
    • Further, visual observations and records review of packing house practices confirmed numerous opportunities for spread of foodborne pathogens such as Salmonella, including signs of animal and pest intrusion as well as food contact surfaces which had not been inspected, maintained, cleaned, or sanitized as frequently as necessary to protect against the contamination of produce.
    • FDA found two sediment subsamples and two water subsamples of Salmonella isolates having the same genotype as clinical isolates previously associated with illness from Salmonella Muenchen and Salmonella Montevideo from earlier foodborne illness outbreaks linked to consumption of sprouts in 2016 and 2018, respectively, which FDA said could indicate human pathogen persistence and distribution in the associated growing region, posing a risk of contamination for any produce commodity and, thus, FDA has assigned a follow up investigation at the associated firms.
  • While FDA is considering how best to achieve public health protections in the covered produce agricultural water arena, non-sprout farms are not required to comply with the current agricultural water requirements of the Produce Safety Rule.  Specifically, a March 18, 2019 Final Rule extended the compliance dates for the agricultural water provisions (subpart E) in the Standards for the ‘‘Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ rule (November 27, 2015, 80 FR 74354), for covered produce other than sprouts, to January 26, 2024, for very small businesses, January 26, 2023, for small businesses, and January 26, 2022, for all other businesses.
  • On May 3, 2021, plaintiffs voluntarily dismissed their July 28, 2016 slack-fill lawsuit against Barilla S.p.A. (“Barilla”). The suit had claimed the pasta company deceptively used the same size boxes for its regular and specialized pastas even though the boxes contained different amounts of pasta.  In the 2016 complaint, plaintiffs argued that Barilla products’ slack-fill misled consumers into believing that they were receiving more pasta than they actually were.
  • As we have previously blogged, companies have been challenged for their products’ slack-fill, which is the difference between the actual capacity of a container and the volume of product contained therein.  In the complaint, plaintiffs stated that Barilla’s box of regular elbow-shaped pasta contained 16 ounces of pasta but that the box of ProteinPLUS elbows contained 14.5 ounces of pasta and the box of Whole Grain elbows contained 13.25 ounces of pasta—despite all products using the same size packaging.  Plaintiffs demanded compensatory and punitive damages and an injunction requiring Barilla “to repackage the specialty pastas without non-functional slack fill.”
  • In 2019, a federal judge granted final approval of a settlement where Barilla would pay up to $450,000 in fees, all class members would release Barilla from future claims, and Barilla would include a minimum fill-line on its boxes to indicate the amount of pasta and a disclaimer that clarified that pasta is sold by weight; however, the Second Circuit Court of Appeals later vacated that decision because a fill-line or disclaimer language would not provide a remedy for all class action members.  As a result, and for undisclosed reasons, plaintiffs voluntarily dismissed their complaint with prejudice.