Posts By Shook, Hardy & Bacon L.L.P.

The U.S. Food and Drug Administration (FDA) has released "Closer to Zero," its action plan for reducing infants' exposure to heavy metals following a Congressional report on toxic elements in baby foods. "Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time," the agency states. Under the plan, FDA will (i) "evaluate the scientific basis for action levels," (ii) "propose action levels," (iii) "consult with stakeholders on proposed action levels," and then (iv) "finalize action levels." The agency will then "establish a timeframe for assessing industry’s progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust…

The U.S. Government Accountability Office (GAO) has issued "Imported Seafood Safety: FDA Should Improve Monitoring of Its Warning Letter Process and Better Assess Its Effectiveness," finding that the U.S. Food and Drug Administration (FDA) was inconsistent in following key procedures and meeting goals for monitoring the importation of seafood. The report's recommendation is that FDA "(1) establish a process to monitor whether the agency is following the procedures and meeting the goals established for its warning letter process for imported seafood, and (2) develop performance goals and measures to assess how effective warning letters are at ensuring the safety of imported seafood."

U.S. Sen. Ron Wyden (D-Ore.) and Rep. Earl Blumenauer (D-Ore.) have reintroduced legislation that would "ensure that kombucha beverages are exempt from excise taxes and regulations intended specifically for beer and other alcoholic beverages," according to a press release. The KOMBUCHA Act would increase the alcohol-by-volume level at which alcohol taxes would be applied to kombucha, "a nonintoxicating beverage made from a combination of tea, water, and a symbiotic culture of bacteria and yeast," to 1.25% rather than the existing standard of 0.5%. "This amount of alcohol in kombucha is usually less than 0.5 percent alcohol, but because of the natural process of fermentation, the alcohol content may occasionally increase slightly, especially during transport or handling by third parties," the press release states. "Today, under the Internal Revenue Code, beverages with more than 0.5 percent alcohol-by-volume are subject to excise taxes intended for beer. But the reality is, consumers do…

The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the filing of several lawsuits alleging harm to consumers of the water, including children. The agency announced that Real Water was not cooperating with the investigation because it failed to provide records or access to facilities. “The FDA is committed to protecting the health of Americans and is especially concerned when there is a food safety issue impacting our youngest, and some of the most vulnerable in the population – infants and young children," a press release stated. "Upon learning about reports of acute non-viral hepatitis in Nevada, impacting five young children, the FDA quickly activated a team to further investigate. We are working closely with the CDC, state and local partners to complete our investigation and monitor…

Kilwins Quality Confections Inc. sold chocolate and other candy products in containers that "materially overstate the volume of the contents," according to a plaintiff. Rand v. Kilwins Quality Confections Inc., No. 21-1513 (N.D. Ill., E. Div., filed March 18, 2021). The consumer argues that the company's shredded-chocolate containers "materially overstate the actual volume of, and the number of servings contained in, the containers and packaging in which they are advertised and sold and similarly materially understate the caloric content of a serving." The jars of chocolate were labeled as containing 20 servings of two tablespoons despite containing only 16 servings of that size, the plaintiff argues, and the caloric content of one serving is 140 calories rather than 110 calories as listed on the package. "While Kilwins has recently quietly corrected labeling on the mislabeled products, it has failed to compensate thousands of consumers who, over the three (3) to…

Three consumers have filed a putative class action alleging Kombucha 221 B.C. sells kombucha that contains "more than twice the allowed alcohol" for a nonalcohol beverage. Brothers v. Mad at S.A.D. LLC, No. 21-60542 (S.D. Fla., filed March 9, 2021). The plaintiffs, who allege they purchased the kombucha for consumption at work, argue that the kombucha beverages "are sold to unsuspecting children, pregnant women, persons suffering with alcohol dependence issues, and a host of other people for whom alcoholic consumption may pose a grave and immediate safety risk." The complaint asserts that the nature of kombucha allows the product to continue fermenting, growing to a higher percentage of alcohol by volume by the time the product is consumed. "While Plaintiffs do not know whether BC Kombucha is below 0.5 alcohol by volume at the moment it leaves Defendant’s distribution center, what is clear is that the beverages are significantly above…

U.S. Sens. Amy Klobuchar (D-Minn.) and Tammy Duckworth (D-Ill.) have introduced the Baby Food Safety Act of 2021, which aims to "require manufacturers of infant and toddler food to implement preventive controls to comply with performance standards under Section 104 of the FDA Food Safety Modernization Act (FSMA)." The act would establish action levels for heavy metals in infant and toddler foods at 10 parts per billion (ppb) of inorganic arsenic, 5 ppb cadmium, 5 ppb lead and 2 ppb mercury, effective one year after enactment. The act would also require the Secretary of Health and Human Services to regularly review the regulatory limits and provide reports to Congress summarizing progress on the issue.

The California Office of Environmental Health Hazard Assessment (OEHHA) has announced that it intends to add perfluorooctanoic acid (PFOA) to the list of substances known to cause cancer or reproductive harm under the state's Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). PFOA, known as a "forever chemical," can be found in nonstick surfaces and food packaging, among other items. OEHHA will accept comments on the determination until May 3, 2021.

The European Food Safety Authority (EFSA) has released several guidance documents to aid stakeholders in complying with EU regulations on food issues implemented on March 27, 2021. The publications provide guidance on: Applying for an exemption from mandatory food allergen labeling; Renewing applications for genetically modified organisms (GMOs) in food and feed; Preparing applications for genetically modified plants; Applying for authorization of a novel food; Preparing applications for substances to be used in food-contact plastics; Applying to make health claims about foods; Preparing an evaluation for infant formula manufactured from protein hydrolysates; and Submitting notifications for traditional foods from third countries.

U.S. Sen. Cory Booker (D-N.J.) and Reps. Rosa DeLauro (D-Conn.) and Bennie Thompson (D-Miss.) have reintroduced the Safe Line Speeds During COVID-19 Act "to protect worker, consumer, and animal safety by suspending all current and future [U.S. Department of Agriculture] waivers and regulations that allow companies to increase production line speeds at meatpacking plants during the COVID-19 pandemic," according to a press release. The act would suspend all speed waivers for the duration of the COVID-19 public health emergency declaration as well as suspending implementation of the New Swine Slaughter Inspection System. “The ongoing COVID-19 outbreaks at meat plants over the last year have raised serious questions about the safety conditions inside these plants," DeLauro is quoted as saying. "Even before the COVID-19 pandemic, these workers experienced injuries at a higher rate than comparable occupations. And now, faster line speeds make it impossible for workers to practice social distancing and…

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