For our June review, the action stays largely in the litigation arena with vanilla getting thrown out and sustainability as well as settlements getting called into question.  Meanwhile, environmental and health stakeholders are pushing FDA to ban PFAS from food contact uses as many in industry move away from PFAS-containing packaging.  How to digest all of it?  Consider some yogurt.  FDA updated the standard of identity, making it more delicious than ever.  Let’s take a look….

LITIGATION

Two More Vanilla Cases Get Thrown Out of the Food Court

In Robie v. Trader Joe’s Co., the Northern District of California dismissed claims that Trader Joe’s Almond Clusters cereal should have been labeled as “artificially flavored.”  The court held that, because the vanilla flavor can from both the vanilla plant and vanillin derived from tree bark, it was properly labeled as “Vanilla Flavored With Other Natural Flavors” under applicable FDA regulations and the plaintiff’s claims suggesting otherwise were preempted.  The court also found that the plaintiff had failed to allege facts suggesting that reasonable consumers would interpret “vanilla” on the product label to mean that the product’s flavor is derived exclusively from the vanilla plant, especially given that the challenged label did not contain any other words or pictures suggesting that the flavor was derived exclusively from the vanilla bean.
Continue Reading Food Industry Regulatory and Litigation Highlights – June 2021

Food and Beverage Litigation HighlightsWelcome to our April + May combined report on food litigation, regulatory trends and events.  We have a lot to report in the food world, with a number of litigation currents starting to form, and some new waves building.  Let’s see what happened….

New Filings

Cheesy Goodness?  General Mills was hit with five putative class actions challenging its Annie’s mac and cheese marketing representations that the product is “Made with Goodness” when, in fact, it contains potentially harmful chemicals known as ortho-phthalates which are linked to asthma, breast cancer and diabetes.  The cases are pending in the Southern and Eastern Districts of New York and the Northern District of California.  The Kraft Heinz Company was named in similar suits filed in the Northern District of California and the Northern District of Illinois.

Sparkling Water/Seltzer:  A number of companies were named in putative class actions alleging that various sparkling water products misrepresented the nature of the flavoring agents used.  For example, a complaint against Whole Foods (filed in the Southern District of New York) alleges that the Lemon Raspberry Italian Sparkling Mineral Water does not contain an appreciable amount real lemons or real raspberries.  Similarly, a complaint against Kroger (filed in the Northern District of California) challenges the non-disclosure of artificial flavoring chemicals.  Finally, Molson Coors Beverage Company was named in a class action alleging that its “Vizzy” brand hard seltzers are marketed as containing a significant amount of healthful qualities and nutrients such as vitamin C which, according to the complaint, falsely implies that alcoholic beverages could provide health benefits.

More Vanilla:  April and May saw two new vanilla filings, including a case against Prairie Farms Dairy, Inc., alleging that the defendant’s “Premium Vanilla” ice cream was falsely labeled as containing “natural colors and flavors” (Northern District of Illinois) and a case against Hostess alleging that its vanilla wafer products were falsely advertised as containing real vanilla (Missouri state court).

More Natural: The past two months have seen a slew of new “natural” filings in the food industry.  Such filings challenge of synthetic preservatives and other ingredients including citric acid (3 cases), ascorbic acid (1 case), artificial coloring (1 case), and monk fruit extract, which is alleged to be natural but processed with artificial solvents and additives (1 case).  The filings were made across the country, including in Missouri state court (4 cases), the Central District of California (1 case), and the Southern District of Illinois (1 case).  In addition to the natural allegations relating to monk fruit extract, a case against Chobani also challenges claims relating to “complete nutrition,” “advanced nutrition” and the use of a “+” symbol in connection with prebiotics and probiotics which, according to the complaint, falsely suggests that the product has more pre- and probiotics than other comparable foods.

Coffee, Please:  We have also seen an uptick in coffee-related class actions, with two actions alleging that ground coffee products artificially inflate the number of cups that can be made from their contents given the directions for use.

Delivery Fees:  April and May saw a continued trend of challenges relating to food delivery charges during the pandemic, with cases filed against GrubHub, alleged to have charged an undisclosed $2.50/delivery fee on top of its $9.99/month “Unlimited Free Delivery” for GrubHub+ users, and against Panera, alleged to have falsely promised a flat delivery charge on food deliveries ordered through Panera’s app and website.  Both cases are pending in California state court.

Food Settlements 
Continue Reading Food Industry Regulatory and Litigation Highlights – April and May 2021

Welcome to our selected regulatory and litigation highlights impacting the food and beverage industry in March 2021.  The food court saw its own brand of March Madness with disputes over food delivery fees kicking off this month’s update.

Litigation Developments

Hidden Delivery Fees

A number of suits were filed in March regarding undisclosed delivery fees. 

Welcome to our curated selection of highlights of regulatory and litigation developments in the dietary supplement and personal care product industries for March 2021.  In case you were wondering what pain relief, teeth whitening, and CBD have in common (and, who wasn’t?) it seems that one year into the pandemic, these are the advertising battles

When it comes to the legal side of working with influencers, smart companies focus on ensuring that influencers clearly disclose that they are working with the company. After all, that’s where regulators have focused most of their attention in recent years. But that’s not where a company’s obligations stop – companies also need to take

Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.  Sit back, relax, and enjoy the read.  February was a short month, with a lot going on.

NAD

Health claim substantiation was front and center before NAD in a monitoring case involving Pendulum Therapeutics and a “medical probiotic” product featuring claims such as “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan.  Results may vary from person to person.”)

The advertiser submitted a 12-week multi-center, randomized, double-blind, placebo-controlled study (the “Perraudeau Study”) to assess Pendulum Glucose Control’s safety and effectiveness in improving glycemic control in Type 2 diabetics and, ultimately, their dietary management of the disease – specifically, the role of certain probiotic strains found in prior research to be associated with the promotion of a healthy gut microbiome through the production of short-chain fatty acids (SCFAs).

The advertiser also provided clinical studies and research articles demonstrating the roles of A1C, fasting glucose and postprandial glucose levels in managing Type 2 diabetes. The advertiser also referred to the FDA’s Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention) to demonstrate what level of reduction in HbA1c was clinically meaningful.

While NAD expressed some concerns about the evidence, ultimately, NAD determined that the Perraudeau Study was a good fit for the challenged claim “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”) but recommended the following modifications: (1) limiting the claim to individuals who are taking metformin; (2) modifying the claim to clarify that the product can be used as part of the dietary management of type 2 diabetes; and (3) removing the references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.

This decision is a helpful discussion of the competent and reliable scientific evidence standard.  Anyone seeking to understand health claims substantiation better should check it out.
Continue Reading Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021

Welcome to our monthly digest of litigation and regulatory highlights impacting the food and beverage industry.  As it has been for many months, the story was mostly about what’s going on in the food court.  Let’s take a look….

Litigation

Vanilla, vanilla, and more vanilla….The plaintiff’s bar remains skeptical of any product labeled as vanilla. 

Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.

NAD

NAD tackled substantiation for “#1 Dermatologist Recommended” claims in a challenge involving L’Oreal’s CeraVe moisturizer and use of syndicated survey data to support related claims.

Health claim substantiation was front and center in

The FDA has published an interim final rule amending definitions related to required notifications regarding drug shortages. 21 C.F.R. 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer certain approved drug products to notify FDA in writing at least 6 months prior to discontinuing manufacture of the drug product. 21 C.F.R. 314.81(b)(3)(iii) now refers to

On December 14, 2011, the Inspector General of the Department of Health and Human Services issued a report finding that the Food and Drug Administration (FDA) failed to properly oversee food facility inspections conducted by states because FDA had not ensured the requisite number of inspections and failed to follow-up appropriately when inspections occurred. The report was issued in response to a request from Rep. Rosa L. DeLauro (D-CT), Ranking Member on the Labor, Health and Human Services Appropriations Subcommittee of the House Committee on Appropriations, following a salmonella outbreak attributed to a Georgia peanut processing plant in 2009.

FDA enters into contracts with state agencies where FDA pays the state to conduct inspections of its food facilities. FDA relied on states for a total of 59 percent of the agency’s food inspections in FY 2009, as opposed to only 42 percent in FY 2004, and spent over $8 million on such inspections.


Continue Reading Health and Human Services Inspector General Report Identifies Shortcomings in FDA Oversight of State Food Inspections