• Last year we reported on FDA’s New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint focused on tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and promotion of food safety culture.
  • On June 1, the FDA launched a public challenge in tangent with the New Era of Smarter Food Safety initiative to encourage the development of affordable, tech-enabled traceability tools to protect people and animals from contaminated foods.  The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge aims to develop scalable traceability hardware, software, or data analytics platforms that are low- or no-cost to the end user, while promoting innovation.  Entries will be evaluated on the following criteria:
    • Ability to address the needs of the targeted segment of the food supply chain.
    • Uniqueness and innovativeness of the technology developed.
    • Likelihood of utilization and ease of navigation.
    • Affordability to enable inclusive and viable traceability approaches.
    • Scalability and interoperability for the solution to be used by a majority of the targeted segment of the food supply chain.
  • FDA’s Office of Food Policy and Response is overseeing the public challenge, which runs from June 1, 2021 to July 30, 2021.  Up to 12 entrants will be announced as challenge winners, with their respective video submissions posted to FDA’s website and shared at an FDA webinar.  Entrants are not required to transfer any intellectual property rights to FDA nor provide an open source code.
  • On June 1, the FDA published a press release announcing that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
  • As our readers may recall, the FDA has been investigating an outbreak of acute non-viral hepatitis of unknown cause in Nevada. The consumption of Real Water brand alkaline water was the only known common link between five cases of acute liver failure in children that occurred in November and December 2020. An additional 11 cases of acute non-viral hepatitis in adults, including one death, have since been identified as possibly linked to the consumption of Real Water brand alkaline water.
  • According to a complaint filed by the Department of Justice (DOJ) on behalf of the FDA, defendants violated the FD&C Act by operating facilities that failed to meet preventive controls requirements to control food hazards, and also failed to follow current good manufacturing practice (cGMP) requirements for bottled water. The Real Water Inc. products were also deemed adulterated within the meaning of the FD&C Act because they were prepared, packed, or held under insanity conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.
  • U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction between the US and AffinityLifestyles.com Inc. (a majority shareholder of Real Water Inc.), Real Water Inc., Brent A. Jones (president of Real Water Inc.), and Blain K. Jones (vice president of Real Water Inc.). The consent decree requires defendants to cease operations until they complete corrective actions, including hiring a qualified independent expert to inspect their facilities. Further, defendants may not resume operations until procedures are implemented to ensure continuing compliance with food safety requirements.
    • On May 24, 2021, the consumer protection groups Food & Water Watch and Empire State Consumer Project, Inc. (ESCP) requested (via letter) that the FDA take action to address the allegedly high levels of arsenic and lead found in many vinegar products.
    • ESCP tested 24 samples of major brands of vinegars or vinegar reductions or glazes and found that 11 contained arsenic or lead and 7 contained both. And, of the 11 products, 10 were balsamic products and all were imported from Italy, Greece, or Spain. Arsenic levels in contaminated products ranged from 70 parts per billion (ppb) to more than 1,040 ppb, which means at maximum levels, one tablespoon serving of vinegar would exceed FDA’s maximum allowable level of 0.01 mg arsenic in one liter of drinking water (equivalent to 10 ppb arsenic). Lead levels ranged from 68.6 to 127 ppb, which exceeded the 34 ppb safe harbor level for balsamic vinegars under California’s Proposition 65.
    • Citing to the dangers of arsenic and lead exposure, particularly to developing fetuses, the letter requests FDA to perform product testing and establish limits and warnings addressing lead and arsenic in vinegars and vinegar reductions or glazes.
    • This letter comes in the wake of the fallout from the Congressional report on heavy metals (including arsenic and lead) in baby foods, which has prompted FDA’s Closer to Zero Plan as well as proposed legislation in Congress, both aimed at reducing heavy metals levels in baby foods. Keller and Heckman will continue to monitor any developments in the regulation of heavy metals in food.
  • 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.