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

The U.S. House of Representatives has voted 415-11 to pass the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), a bill that will expand the definition of "major food allergen" to include sesame. The bipartisan bill, which passed the Senate in March 2021, will head to the White House for President Biden's signature. Upon enactment, sesame will become the ninth major food allergen, joining milk, egg, wheat, peanuts, shellfish, tree nuts, fish and soybeans.

The National Organic Program can continue to include foods grown through hydroponics following a ruling from a California federal court holding that the U.S. Department of Agriculture (USDA) acted reasonably in concluding that the statutory scheme does not exclude hydroponics. Ctr. for Food Safety v. Perdue, No. 20-1537 (N.D. Cal., entered March 18, 2021). The Center for Food Safety (CFS) had sought to limit foods labeled as "organic" to only foods grown in soil, but the USDA denied the advocacy group's petition. "The petition denial should not be disturbed because USDA reasonably defends its determination that [the Organic Foods Production Act (OFPA)] does not compel the prohibition of hydroponics," the court held. "USDA’s ongoing certification of hydroponic systems that comply with all applicable regulations is firmly planted in OFPA. It therefore provides the 'reasonable explanation' required on review, so its denial will not be vacated."

A California federal court has ruled that the state "has not shown that the cancer warnings it requires are purely factual and uncontroversial" or "that Proposition 65 imposes no undue burden on those who would provide a more carefully worded warning." Cal. Chamber of Com. v. Becerra, No. 19-2019 (E.D. Cal., entered March 29, 2021). The California Chamber of Commerce filed a lawsuit seeking to enjoin new lawsuits from enforcing the Safe Drinking Water and Toxic Enforcement Act (Prop. 65) against foods that contain acrylamide. The court considered evidence on the toxicity of acrylamide, finding that "some evidence does support such an inference" that eating food with acrylamide will increase a person's risk of cancer, but "dozens of epidemiological studies have failed to tie human cancer to a diet of food containing acrylamide. Nor have public health authorities advised people to eliminate acrylamide from their diets. They have at most…

A Minnesota federal court has ruled that the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) violated the Administrative Procedures Act (APA) when it adopted the New Swine Inspection System (NSIS), which eliminated line speed limits for pork processing. United Food & Com. Workers Union, Local 663 v. USDA, No. 19-2660 (D. Minn., entered March 31, 2021). The court found that the final rule establishing the NSIS "contains no discussion, analysis, or evaluation of the worker safety comments" that it received during the notice-and-comment period. "The only response FSIS gave to the worker safety comments it solicited was to state that it lacked authority to regulate worker safety. In context, the agency appeared to suggest that it wanted to consider the comments but was not legally permitted to do so," the court held. "By offering its lack of legal authority and expertise on worker safety as its only…

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…

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