Industry Insights: FDA Sends First Warning Letter Under Recent Rule Regarding Imported Food

The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign Supplier Verification Programs (the “FSVP Rule”). These programs set forth certain requirements to ensure food safety and appropriate labeling for food imported into the United States. The FSVP Rule requires that importers verify that the food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.

Just this week, the FDA announced the issuance of its first warning letter under the FSVP Rule. The warning letter was sent to an importer of tahini, which was implicated in a Salmonella outbreak earlier this year. The tahini was recalled after four illnesses were reported. Per a statement attributed to Acting Commissioner Ned Sharpless, “The warning letter follows an FDA inspection conducted in response to a recent Salmonella outbreak, which revealed that the importer was not in compliance with the FSVP.” Continue Reading

PC Food Litigation Index: July 2019

July was a hot month in food litigation. There were twenty-eight new filings, which puts total new food litigation filings at about 100 in 2019.  More than half of the new filings were in California state and federal court, with several new filings in D.C. Superior Court and federal court in Illinois and Florida.

Plaintiffs in several new cases allege that defendant’s foods or beverages contain heavy metals, and defendants had a duty to disclose the presence of those metals to consumers.  In Labajo v. Welch Foods, Inc., 5:19-cv-01306 (C.D. Cal.), for example, the plaintiff alleges that Welch Foods fails to warn individuals that Welch’s White Grape Juice and Concord Grape Juice products expose consumers to heightened levels of heavy metals.  Plaintiffs allege Welch’s has a duty to disclose that the products contain metals independent of any duty imposed by Proposition 65.  Likewise, in Arellano v. Mead Johnson Nutrition Co., 2:19-cv-06462 (C.D. Cal.), plaintiff alleges that testing has found Mead Johnson’s Enfamil Premium infant formula contains high levels of the contaminants arsenic, cadmium, lead and mercury, noting that the levels of lead are above the USFDA Provisional Tolerable Intake Level for children six years and under.   Continue Reading

Industry Insights: Outgoing FDA Commissioner Proposes Expedited Steps for Approval of CBD

On July 31, Dr. Scott Gottlieb, the outgoing FDA commissioner, published an editorial in which he proposed how the FDA could expedite approval of food and beverage products that contain cannabidiol (CBD).           

In this update, we review Dr. Gottlieb’s proposal which highlights areas of concern for business involved in the CBD industry, such as labeling and deceptive marketing. Read more here.

Industry Insights: States Have Beef With Labeling of Meat Alternatives

Across the country, states are enacting laws related to the labeling of meat alternative products. Missouri, Mississippi, Arkansas, and Louisiana have passed laws restricting the ability of vegetable-based proteins and other meat alternatives from labeling their products as burgers, hot dogs, sausage, or other meat-like descriptions.

Proponents of the laws argue that the laws are essential for protecting “consumers from being misled or confused by false or misleading labeling of agricultural products that are edible by humans.” These laws have drawn several federal lawsuits so far and will likely be the subject of further controversy. Continue Reading

PC Food Litigation Index: May 2019

There were seventeen new cases filed in May, putting total filings for the year at seventy-two. By this time last year, plaintiffs had filed sixty-nine food and beverage cases. Most of the new filings were in California, with a few in New York and one in Missouri. All seventeen of the new cases were false labeling cases.

In a continued expansion of the “sustainability/human rights” cases, several tuna companies were sued in the Northern District of California for allegedly misleading consumers about whether their tuna is dolphin safe. Plaintiffs allege that the tuna suppliers use fishing tactics that can be harmful to dolphins, rendering their “Dolphin Safe” labels misleading under California law and similar laws from all fifty states. These cases evoke similar human rights supply chain cases pursued, largely without success, in the last few years in the Ninth Circuit including the Chipotle GMO supply chain case, Schneider v. Chipotle Mexica Grill, Inc., and the recent Ninth Circuit omissions case, Hodsdon v. Mars.

Other cases of note include DiGregorio v. Kellogg Sales Company, a Northern District of New York case alleging that Kellogg misleadingly marketed high-sugar cereals as healthy. This case mirrors Hadley v. Kellogg Sales Co., which currently pending in the Northern District of California. Plaintiffs in Hadley and DiGregorio make the same claims and are represented by the same plaintiffs’ counsel. Continue Reading

Industry Insights: Coffee Products Exempted from Proposition 65

On Monday, June 3rd, California’s Office of Environmental Health Hazard Assessment (OEHHA) approved a new regulation exempting coffee from Proposition 65 warnings. The rule states that: “Exposures to chemicals in coffee, listed on or before March 15, 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”  OEHHA announced the approval of the coffee exemption regulation on Twitter and confirmed that the new rule will take effect on October 1, 2019.

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Industry Insights: FDA Considers Pathway for Legalizing CBD at Public Hearing

The CBD industry is widespread and very lucrative, but the FDA has sent mixed messages regarding CBD use. On the one hand, the FDA has stated that CBD is “unsafe” and not an approved additive to food, beverages and supplements; on the other hand, the FDA has not taken a single enforcement action against a company for marketing CBD-related products.

In a public hearing on May 31, 2019, the FDA gathered information in order to help develop a pathway forward to a coherent policy regarding CBDs.

In this update, we outline the takeaways from the public hearing and how clear regulatory guidelines regarding CBD products will help encourage additional investment and growth in the CBD market. Read More.

PC Food Litigation Index: April 2019

With fifteen new cases filed in April, total filings on the year are slightly down from last year—there have been sixty-nine total new filings in 2019 compared with seventy-seven by this time last year. Most new filings were in California. Only one new case was filed in New York, down from six last month.

Most of the new cases were false labeling cases, with only one slack fill and two all-natural cases.  Plaintiffs in Shand v. Original New York Seltzer, 19STCV14020 (La. Supp. Ct.), alleged that defendant seltzer beverages are labeled as though they are a product of New York, when the drink is neither bottled in New York nor contains New York water. Shand adds to a recent trend of similar “origin” lawsuits, including several suits last month challenging coffee manufacturers’ characterization of beans as “Kona-style” when they were not grown on the Big Island. Tea beverages were under fire in April. Plaintiffs in several cases alleged that defendants misleadingly labeled their tea products as providing energy from ginseng when the products do not contain detectable amounts of ginseng.

On the natural front, plaintiffs in one case alleged that defendants misleadingly labeled their parmesan cheese product as “all natural” when it contains starch and potassium sorbate. In another, plaintiffs claim defendant misleading labeled its tapenade as “all natural,” even though it contains xanthan gum. Continue Reading

Industry Insights: Highlights from the 2019 ACI “Food Law” Summit

Imported food contaminants, potential criminal liability for allergen-related deaths, and a growing demand for hemp seed and cannabidiol (CBD) products amidst regulatory uncertainty were all topics of discussion at this year’s American Conference Institute (ACI) Advanced Summit on Food Law Regulation, Compliance, and Litigation, held in Chicago.  Representatives from the country’s largest food manufacturers, food and beverage agency regulators, and food litigation experts gathered in April to discuss recent product trends and regulatory developments in the food and beverage space. To read about the highlights from the conference, please click here.

PC Food Litigation Index: March 2019

As we end the first quarter of 2019, we are seeing that the pace of class action filings in the food and beverage industry is consistent with the pace we saw in 2018.  California and New York continue to be hotbeds for activity with New York slightly outpacing California.

Most of the filings in the first quarter were related to general false labeling claims. Several separate cases targeted the “Kona” labels on coffee, claiming that the coffee products at issue do not originate from the Kona District of Hawaii’s Big Island. In addition, the labels of coconut-based products continued to come under attack.  The plaintiffs in several separate lawsuits alleged that the defendants’ coconut milk is misleadingly marketed as healthy, claiming that there are harmful cardiovascular effects associated with the consumption of fat from coconuts. Fruit snacks, a frequent target in this area of health-related claims, are also at the center of a new lawsuit. The plaintiff in Jones v. Welch Foods, Inc. contends that the packaging of defendant’s fruit snacks suggest that they are “nutritious, healthy, satiating and composed of non-synthetic ingredients.”

Among the more novel false fact challenges this month was a class action contesting the claims on A2 Milk Company’s milk, which is touted as “Easier on Digestion” and “Naturally Easy to Digest,” nixing the A1 proteins that “can cause you tummy discomfort.” The plaintiff argues that these claims are scientifically unsubstantiated, and that it is lactose—not A1 proteins—that causes digestive difficulties.

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