• Hawaii Governor David Ige (D.) has introduced House Bill 994 (HB-994) and its companion Senate Bill 1148 (SB-1148), which would require manufacturers or wholesale dealers of sugar-sweetened beverages, as well as sugary syrups or powders for beverages, to pay a two cents per fluid ounce fee.  Governor Ige stated that these bills aim to lower consumption of sugar-sweetened beverages and thereby prevent weight gain, obesity, prediabetes, diabetes, tooth decay, and heart disease in the state.
  • Under HB-994 and SB-1148, a “sugar-sweetened beverage” is defined as any non-alcoholic beverage, carbonated or noncarbonated, that is intended for human consumption and contains any added “caloric sweetener.”  The bills define a caloric sweetener as “any substance that contains calories suitable for human consumption, that humans perceive as sweet, and includes, sucrose, fructose, glucose, other sugars, or fruit juice concentrates.”  Beverages that consist of one hundred percent fruit juice or vegetable juice with no added caloric sweetener, milk without added caloric sweetener, milk substitutes without added caloric sweetener, dietary aids, and infant formula would not be subject to the fee.
  • Hawaii has tried to pass similar legislation in previous years, but the bills have expired before making it through the full legislative process.  Cities, including Philadelphia and Berkeley, have introduced similar measures in the past, and there are mixed opinions on whether the measures have been effective.
  • On February 16, the FDA published a response about questions about levels of heavy metals in baby food, as indicated in a Congressional report released on February 4. Our summary of that report is available here. In the response, the FDA states that toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air. Thus, they cannot be completely avoided in the fruits, vegetables, or grains that are used in baby foods, juices, and infant cereals. Such elements also cannot be avoided through the use of organic farming practices.
  • The FDA highlighted the following in the response:
    • Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed, through the Total Diet Study. Further, the FDA monitors baby food under FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.
    • The FDA takes steps to reduce levels, such as using science to set action levels, making data public, and working with industry on identifying effective mitigation strategies. For example, food manufactures have made progress in arsenic reduction through selective sourcing and testing, as evidenced by FDA sampling of infant rice cereal since 2011. Further, the Agency has published a final guidance that sets action levels for inorganic arsenic in rice cereal for infants. According to the FDA, infant rice cereal is safer than it was a decade ago because of these efforts, and the Agency expects that such levels will continue to be reduced because of emerging science and good manufacturing practices.
    • The FDA has multiple ongoing Import Alerts for toxic elements in food, including arsenic in fruit juice, bottled water, and dietary supplements, in order to prevent foods and dietary supplements with high levels of heavy metals from entering the US.
    • The FDA provides consumers with actionable advice to limit exposure to toxic elements from food. For example, consistent with the Congressional report’s recommendations, the FDA has communicated advice about the importance of feeding infants a variety of foods. Fortified rice cereal is a good source of nutrients for infants, but it should not be the only source.
  • Keller and Heckman will continue to monitor and report on any developments.

 

  • Kombucha products that contain 0.5% or more alcohol by volume (abv) at any point in the production process are currently classified as beer (see 27 CFR Part 25; see also TTB Kombucha Guidance) and therefore subject to federal alcohol excise taxes and regulations. The Kombucha Act, which would allow Kombucha to contain up to 1.25% abv without being taxed or regulated as alcohol, will reportedly be reintroduced to Congress during this legislative session.
  • Kombucha is made by adding sugar to brewed tea and then fermenting the sugary tea with yeast and bacteria cultures. The fermentation process generates alcohol at levels that can be in excess of 0.5% abv.
  • The Act, which was originally introduced in March of 2019, defines Kombucha as a beverage (1) fermented solely by a symbiotic culture of yeast and bacteria, (2) containing a maximum of 1.25% abv, (3) sold or marketed as kombucha, and (4) derived from “sugar, malt or malt substitute, tea, or coffee” and not more than “20 percent other wholesome ingredients.” Beverages meeting this definition would not be considered an alcohol subject to taxation and regulatory oversight by the Alcohol and Tobacco Tax and Trade Bureau (TTB). This increased ceiling on alcohol content will provide increased manufacturing flexibility to the industry, which has struggled with modifications to the fermentation process to ensure that less than 0.5% alcohol is produced.
  • Keller and Heckman will continue to monitor and report on an updates to the proposed legislation.
  • Senators Mike Lee (R-Utah) and Angus King (I-Maine) introduced a bill on February 8, 2021 that proposes to amend 15 U.S.C. § 45a and create a single national standard for “Made in the USA” (MUSA) claims. The bill is identical to S.4065 that passed the Senate last year with bipartisan support but lost momentum.
  • Under current law, MUSA claims are voluntary and subject to Federal Trade Commission (FTC) regulation. As we reported last year, the FTC published a proposed rule in July 2020 that intends to codify its long-time enforcement policy for products labeled as MUSA: “all or virtually all” of the product must be made in the United States. The “Reinforcing American-Made Products Act” seeks to prevent a patchwork of state regulation and preempt state laws like that of California, which has slightly different requirements from the FTC’s standard.
  • MUSA claims have become popular targets of class action lawsuits in recent years, including suits against Bigelow Tea, beef producers, beer producers, and other food companies. The suits typically allege that products marked with a MUSA claim are sourced in part from foreign countries and mislead consumers. Keller and Heckman will continue to monitor and report on legislation and litigation related to MUSA claims.
  • On February 10, 2021, the Center for Science in the Public Interest (CSPI) sent a letter to the U.S. Food and Drug Administration urging it to take enforcement action against the marketing of various products labeled as infant formula but marketed for use by children over 12 months.
  • In its letter, CSPI argues that the Federal Food, Drug and Cosmetic Act defines “infant formula” as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.”  CSPI notes that because “infant” is defined by regulation as a person no more than 12 months old, infant formulas that are marketed for children over 12 months old are misbranded and should be labeled as “transition formula.”  Further, CSPI argues that any food product marketed for children over 12 months old must bear FDA’s standard Nutrition Facts label, not an infant formula nutrition label.
  • CSPI claims that the infant foods that are marketed for children over 12 months old are primarily composed of powdered milk, vegetable oil, corn syrup solids (or other sources of added sugars), and added nutrients, which are appropriate for infants but not toddlers.  Thus, CSPI claims that these products’ labeling may mislead consumers to believe that infant formula and/or infant formula-like products are necessary for children beyond infancy.  CSPI’s letter to FDA follows recent class action lawsuits against baby food manufacturers for allegedly failing to disclose the presence of unsafe levels of heavy metals in baby foods.  We will continue to monitor any developments.
  • On February 5, Starbucks became the most recent food producer to be sued for deceptive and misleading labeling on its vanilla Frappuccino. Glen Skalubinski filed a proposed class action against Starbucks claiming the company misled customers into believing its Frappuccino drink contained real vanilla as an ingredient, when it contained only natural vanilla flavoring. Skalubinski argued that by failing to disclose that vanilla was not an ingredient, Starbucks violated federal and state food labeling laws and regulations.
  • Specifically, Skalubinski points to the Frappuccino’s front label. According to the complaint, “[t]he Product’s front label prominently and conspicuously displays the words ‘vanilla With Other Natural Flavors.’ The prominent and conspicuous display of the word ‘Vanilla’ on the Product’s front label misleads reasonable consumer to believe that the Product contains vanilla as the Product’s characterizing ingredient that delivers the Product’s promised characterizing vanilla flavor.” The plaintiff further argues that the front label should have disclosed that it contained no real vanilla. Peter Wasylyk, attorney for Skalubinski, said that “consumers should be able to rely on accurate information on a food product’s labeling to inform them what ingredients a product contains. That information should be on the front label.”
  • The complaint points to a few competitor products that plaintiff argues is correctly labeled. The coffee product labels declare “VANILLA FLAVORED WITH OTHER NATURAL FLAVORS” on its front label and the words “NATURAL FLAVORS” on its ingredient list. Essentially, Skalubinski is arguing that he and other consumers were misled by the missing word “flavored” on the front label, despite the fact that the front label declares that the product is naturally flavored and “vanilla” is not listed as an ingredient in the ingredient list, but does declare “natural flavors.”
  • Skalubinski’s lawsuit is one of many vanilla-related labeling lawsuits. For instance, as we previously reported, Topco Associates LLC, Westbrae Natural, Inc., Trader Joe’s Company, and McDonald’s have all been recently sued over vanilla labeling, however notably, most cases have either been dismissed or are pending a motion to dismiss ruling. You can access our past reporting on vanilla labeling lawsuits here.
  • As some of our readers may know, the U.S. House of Representatives subcommittee on Economic and Consumer Policy released a report on February 4th 2021 which reported on the levels of heavy metals— including arsenic, lead, cadmium, and mercury— found in baby foods produced by seven of the largest baby food manufacturers in the U.S. The baby food manufacturers named in the report were: (1) Nurture Inc. (which sells Happy Family Organics, including baby food products under the brand name HappyBABY); (2) Beech-Nut Nutrition Company; (3) Hain Celestial Group (which sells baby food products under the brand name Earth’s Best Organic); (4) Gerber; (5) Campbell Soup Company (which sells baby food products under the brand name Plum Organics); (6) Walmart Inc. (which sells baby food through its private brand Parent’s Choice); and (7) Sprout Foods, Inc.
  • The report is based on results from the first four of the above-listed companies because the others did not comply with the subcommittee’s requests for internal documentation and test results. While acknowledging that for the majority of heavy metals the FDA has not set thresholds for the level allowed in baby foods (one notable exception is a 100 ppb limit for arsenic in infant rice cereals), it concluded that “commercial baby foods contain dangerous levels of arsenic, lead, mercury, and cadmium . . . [that] pose serious health risks to babies and toddlers.” The report advocates several changes to the regulation of baby foods including mandatory testing of finished products for heavy metals, reporting of heavy metal content on food labels, and new regulations setting limits for heavy metals in baby foods.
  • As expected, the report has instigated the filing of class action lawsuits against the baby food manufacturers named in the report. On February 5th, the day after the report’s release, a pair of consumer class action complaints were filed—one against Gerber in the U.S. District Court for the District of New Jersey (see filing; Law360 subscription required) and the other against Plum, PBC in the U.S. District Court for the Northern District of California.
  • The complaint against Gerber draws heavily from the report’s conclusions and alleges violation of various consumer protection statutes on the theory that Gerber falsely and deceptively failed to disclose the presence of unsafe levels of heavy metals in their baby foods. The complaint against Plum takes a broader approach and alleges that their baby food products were falsely and deceptively advertised because the manufacturer was obligated to disclose (and did not disclose) “any level of Heavy Metals or undesirable toxins or contaminants” (emphasis added). While a court is unlikely accept the latter theory (see our prior post rejecting a similarly broad theory of deceptive advertising in the petfood context), allegations that the levels of heavy metals in the baby food products are unsafe may present viable litigation theories.
  • Keller and Heckman will continue to monitor and report on the outcome of the congressional investigation, including the resulting litigation and any responsive regulatory actions or developments.
  • After an Environmental Assessment of factors potentially contributing to the contamination of romaine lettuce with E. coli O157:H7 that was implicated in a 2018 multi-state foodborne illness outbreak (discussed here), FDA announced plans to test samples of romaine lettuce grown in the Central Coast, Central Valley, and Imperial Valley in California and in Yuma, Arizona, for Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp.  There have been five suspected or confirmed multistate outbreaks of foodborne illness linked to produce harvested in the Yuma growing region since 2012 and it is suspected that other farms in that area, in addition to the one farm implicated during FDA’s investigation, may have contributed to the spring 2018 E. coli outbreak.
  • On February 5, 2021, FDA announced plans to soon begin collecting over the growing season 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.  By contracting with an independent laboratory located near the collection sites, FDA expects to receive test results within 24 hours from receipt of the sample by the laboratory.  While not required, the industry may choose to hold the sampled lots pending notification of test results to help prevent potential recalls of any contaminated lettuce that could have entered commerce.
  • In similar testing conducted last year, no STEC of concern to human health and no Salmonella spp. were detected in 118 samples from the Yuma growing region.  Microbiological testing of Romaine lettuce from the Yuma growing region is among several actions identified in FDA’s Leafy Greens Action Plan that seeks to identify potential sources and routes of contamination, inform what preventive measures are needed, and help prevent outbreaks of foodborne illness.
  • Two lawsuits filed against Sargento Foods in December 2020 (Phan v. Sargento Foods Inc., No. 5:20-cv-09251 (N.D. Ca.)) and January 2021 (Beyond Pesticides v. Sargento Foods, No. 2021-CA-000178 B (Sup. Ct. D.C.)) assert that “no antibiotics” claims on Sargento’s cheese products mislead consumers into thinking that the cows that produced the milk used in the cheeses are never treated with antibiotics.  Sargento’s labels include a disclaimer that “no antibiotics” means that “our cheese is made from milk that does not contain antibiotics.”
  • The claims in the litigation alleging false advertising rely on a 2018 publication from Consumer Reports that says a majority of consumers believe a “no antibiotics” statement on a food label means that animals producing the food never received antibiotics, and as such, a reasonable consumer would be misled by Sargento’s “no antibiotics” claim, despite the disclaimer. The suits also allege that one Sargento cheese product did present detectable levels of sulfamethazine, an antibiotic that is prohibited from use in lactating dairy cattle. Sargento has not yet responded to either lawsuit.
  • Both FDA and USDA are working to address consumer concerns about antibiotic stewardship in food animal production. While antibiotics are sometimes used to treat bacterial infections in dairy cows, the Pasteurized Milk Ordinance developed by the FDA and adopted by most states require dairy farms to discard milk from cows treated with antibiotics for a specified withdrawal period and milk processers to test all milk, including organic milk, for the presence of beta-lactam antibiotics (such as penicillin and amoxicillin, among others) upon arrival at the milk processing facility before being added to a bulk supply. A fact sheet from the National Milk Producers Federation provides more details on antibiotic testing and this page from FDA provide more details on antibiotic testing. The USDA Food Safety and Inspection Service has also provided guidance for food labels that make animal raising claims, including claims about antibiotics.
  • On January 23, 2021, plaintiffs filed a putative class action complaint in the United States District Court Southern District of New York against Icelandic Provisions, Inc. (“Company”), which sells Skyr, a traditional Icelandic cultured dairy product.  Plaintiffs allege that the Company’s marketing and advertising misleads consumers to believe that the Skyr is made in Iceland when actually it is produced in Batavia, New York.
  • The complaint alleges fraud, negligent misrepresentation, unjust enrichment, and violation of state consumer-protection statutes.  Plaintiffs claim that the depiction of the Icelandic countryside with a snow covered backdrop, the statement “Traditional Icelandic Skyr,” and Company’s name, “Icelandic Provisions” misleads consumers to believe that the product is made in Iceland.  Additionally, the plaintiffs claim that Company’s inclusion of “Developed in partnership with MS Iceland Dairies, Reykjavik, ISL” is misleading because it furthers the impression that the Skyr is made in Iceland.
  • The plaintiff’s counsel is Sheehan & Associates, a firm that has become known in recent years for its pursuit of class action litigation claiming harm to consumers from allegedly misleading food labeling.  The Sheehan firm has represented a number of class action plaintiffs in recent flavor labeling challenges.  Origin and geographic claims have drawn scrutiny from the Federal Trade Commission, state regulators, and most recently, class action plaintiffs’ lawyers.