Category Archives: Health Claims

Campbell Seeks Dismissal of “Healthy” Labeling Lawsuit

Campbell Soup Company (“Campbell”) has moved to dismiss a putative class action lawsuit alleging that Campbell’s Chunky™ Healthy Request® Grilled Chicken & Sausage Gumbo Soup product is falsely and misleadingly advertised as “healthy” because it contains partially hydrogenated oils (PHO’s, i.e. artificial trans fats) that are harmful to human health.

In its motion, Campbell argues that the USDA’s review and pre-approval process for labels pre-empts the suit because that regulatory framework specifically looks at whether labels are false or misleading and includes “pervasive” regulations relating to “healthy” claims. Campbell contends that these regulations — as propounded pursuant to the Poultry Products Inspection Act and the Federal Meat Inspection Act — prohibit any consumer protection claims under state law.

Ultimately, the key question will be whether the Court accepts that the suit seeks to impose requirements on “approved labels” that add to, or differ from USDA’s requirements relating to “healthy” claims.   In some cases, courts have rejected preemption arguments on the grounds that the lawsuit seeks to help, rather than hinder, the federal objectives.  But Defendants may have an uphill claim to the extent the court agrees with Campbell that its labels fully comply with USDA regulations for “healthy” claims, which do not expressly prohibit the existence of trans fats.

 

ILR: Unprecedented Surge in Consumer Class Action Suits Against Food Manufacturers

The U.S. Chamber Institute for Legal Reform (“ILR,” an affiliate of the U.S. Chamber of Commerce) has released a new report called The New Lawsuit Ecosystem: Trends, Targets and Players that includes a section devoted to “Food Class Action Litigation.”  ILR’s stated mission is to  “restore balance, ensure justice, and maintain integrity within the civil legal system.”  And ILR pulls no punches in asserting that the recent surge in food class action litigation is “lawyer driven” and generally involves questionable accusations.

Some groups use these lawsuits to pursue their own political agendas when they cannot achieve their goals by legitimate means through elected officials or regulatory agencies.  Others are just looking for the next “deep pocket.” While some plaintiffs’ lawyers win lucrative fees, consumers are saddled with higher prices and fewer choices as a result of litigation by the self-anointed food police

Putting aside the strong viewpoint, the report is an excellent summary of the “unprecedented surge in consumer class actions against food  manufacturers.”  Please see the complete report here.

UPDATE: Initial Decision in FTC v. POM Wonderful is Mixed Bag for Both Sides

Decision day has come in FTC v. POM Wonderful (see prior post here) and both sides have claimed victory.  On May 21st, the FTC published the “initial” 335-page decision by FTC Administrative Law Judge (“ALJ”) D. Michael Chappell.   For POM, along with many food and supplement companies, the decision was good news because the ALJ rejected the FTC’s most strident and overreaching positions.  On the other hand, the ALJ found that POM violated the FTC Act by making misleading health claims.

The crux of the FTC’s Complaint was that POM disseminated false and misleading advertising and promotional materials representing (mostly by implication) that “clinical studies, research, and/or trials prove” that consuming certain POM products (POM Juice, POMx Pills, and POMx Liquid) “prevents or reduces the risk of” or “treats” heart disease, prostate cancer or erectile dysfunction.

In his decision, the ALJ squarely rejected the FTC’s contention that  randomized, double-blind, placebo-controlled human clinical trials (“RCTs”) were necessarily required.  Rather, “the appropriate level of substantiation is determined by what the evidence shows that experts in the relevant field would deem adequate.”   The ALJ thus basically agreed with POM’s position that, in addition to “gold standard” RCTs — which can be very costly — “basic science” and  “pilot” studies could also be considered, with basic science referring to test-tube (in vitro) studies, in vivo animal studies, and pre-clinical research.

Under this standard, the ALJ found that the claims that the POM Products could “support prostate health” and “promote erectile health” could be supported.  But he found that the claims that the POM Products could prevent, treat or reduce the risk of prostate cancer, erectile dysfunction and heart disease were not supported by scientific evidence and that they therefore violated the FTC Act.  In other words, he held that POM’s structure/function claims were supported and not misleading, but its health claims and/or qualified health claims were deceptive.

Finally, the ALJ rejected the FTC’s request that POM obtain pre-approval from the FDA for any future health claims as being “unsupported by governing precedent.”   The FTC sought a pre-approval requirement to create a “clear and precise” bright-line rule to eliminate any confusion or ambiguities.   As the ALJ observed, “neither FDA pre-approval, nor FDA standards for obtaining such approval, constitutes the required level of substantiation under the FTC Act or applicable case law.”

On its website, POM claimed victory:

“Through its lawsuit against POM, the FTC tried to create a new, stricter industry standard, similar to that required for pharmaceuticals, for marketing the health benefits inherent in safe food and natural food-based products.  They failed,” explained Craig Cooper, Chief Legal Officer for POM Wonderful LLC.  “While we are still analyzing the ruling, it is clear that we will be able to continue to promote the health benefits of our safe, food products without having our advertisements, marketing or public relations efforts preapproved by the FDA and without having to rely on double-blind, randomized, placebo-controlled studies, the standard required for pharmaceuticals. We consider this not only to be a huge win for us, but for the natural food products industry.”

Likewise, the FTC issued a statement touting that the ALJ upheld the FTC’s Complaint that “POM deceptively advertised its products as treating, preventing, or reducing the risk of heart disease, prostate cancer, and erectile dysfunction.”

It is expected that both the prosecuting arm of the FTC and POM will seek review of the decision by the full Federal Trade Commission and, of course, there may be further appeals to the U.S Court of Appeals.

This decision is most significant in its implicit recognition that companies selling food products that are unquestionably safe have the right to engage in commercial speech to inform consumers about the qualities of those products without government constraints such as FDA pre-approval or a requirement of double-blind, randomized placebo-controlled clinical trials.

Finally, it is worth noting that the claims held to be misleading were primarily found to have been health claims by implication.   As the ALJ observed with regard to POM’s heart disease claims:

The evidence shows that [POM] disseminated advertisements that impliedly represented that the POM Products treat, prevent, or reduce the risk of heart disease and, in many of these same advertisements, are clinically proven to do so, by lowering blood pressure, reducing arterial plaque, and/or increasing blood flow to the heart. [POM] made these claims indirectly and obliquely, typically by presenting, through words and images, a logical syllogism that: free radicals cause or contribute to heart disease; the POM Products contain antioxidants that neutralize free radicals; and, therefore, the POM Products are effective for heart disease.   Against this background, many of the advertisements further state or represent that the POM Products have been shown in one or more clinical, medical, or scientific studies, to reduce plaque, lower blood pressure, and/or improve blood flow to the heart, in a context where it is readily inferable that the referenced study results involve heart disease risk factors and, therefore, constitute clinical support for the effectiveness claim.

Ominous Trend in Latest Nutrient Content Claim Class Action Suit v. Bumble Bee Foods

To no one’s surprise, the filing of class action lawsuits against food companies continues at a rapid pace in California.  The latest suit, filed on April 12th, alleges that certain King Oscar products labeled as “Rich in Natural Omega-3” and “Excellent Source Omega-3” are misleading and fail to disclose “risk-inducing” nutrients.

First, the Complaint alleges that “[w]here a particular nutrient does not have an established daily value (DV) under FDA regulations, food producers may not state on their food labels that their food product is a ‘good source’ of the nutrient, or use a comparable phrase, such as ‘excellent source’ or ‘rich in.’  21 C.F.R.  § 101.54.”  It then alleges that Bumble Bee violated this regulation “by representing that its products are an ‘excellent source’ of omega 3 or ‘rich in’ omega 3 and by failing to specify whether its omega 3 nutrient content claims are referring to ALA, DHA or EPA omega 3 fatty acids.”

Second, the Complaint alleges that these same products were improperly labeled under 21 C.F.R. § 101.13 because they fail to include a disclosure statement that the products included more than 13.0 g of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, and/or 480 mg of sodium per serving.  This prong of Plaintiff’s complaint is included, no doubt, as a means of bolstering the contention that plaintiff and “similarly-situated persons” were somehow harmed by Bumble Bee’s labeling practices.

Significantly, the Complaint continues the ominous trend of citing FDA warning letters to bolster its claims.   This time, Plaintiff quotes extensively from an FDA Warning Letter to Natural Guidance LLC to help legitimize its claims and asserts that “[o]ther companies that sell similar Omega 3 nutrient content claims have been found to be in violation of the laws concerning such claims.”  That warning letter involved some relatively strident claims by a maker of nutritional supplements.  Notably, the Bumble Bee products have more in common with the walnuts sold by Diamond Food which also received of an FDA warning letter regarding Omega 3.  The Diamond Food warning letter was the target of legitimate criticism because it seemingly condemned the communication to consumers of properly qualified scientific research.  This is similar to the criticism that POM Wonderful has leveled against the FTC, i.e., it is improper to ban non-deceptive speech regarding properly supported, qualified health claims.

Putting aside the FDA’s and FTC’s respective views on this topic,  I think the Plaintiff here will a difficult time convincing anyone that they were actually mislead by the Bumble Bee labeling at the time of purchase.

Please see the entire Complaint here.

FTC v. POM Wonderful: Decision Day Approaches

A decision is expected by April 17, 2012 — at the latest — in the closely watched matter of the FTC v. POM Wonderful, Doc. No. 9344.

The FTC’s administrative complaint charges “the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements with making false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction.”   The targeted advertisements include statements such as:

  • “SUPER HEALTH POWERS! … 100% PURE POMEGRANATE JUICE. … Backed by $25 million in medical research.  Proven to fight for cardiovascular, prostate and erectile health.”
  • “NEW RESEARCH OFFERS FURTHER PROOF OF THE HEART-HEALTHY BENEFITS OF POM WONDERFUL JUICE.  30% DECREASE IN ARTERIAL PLAQUE … 17% IMPROVED BLOOD FLOW … PROMOTES HEALTHY BLOOD VESSELS … ”
  • Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;

Unlike other companies, however, POM is determined to fight these allegations to the end.  Its primary argument is that the FTC has improperly changed its standard for how advertisers substantiate the truth of their claims.  Specifically, “(1) the FTC now requires advertisers to obtain prior FDA approval before making certain types of health related claims about food, beverages, and dietary supplements, … and the FTC is requiring prior FDA approval regardless of whether or not the claims are true or supported by competent, reliable scientific evidence; and (2) the FTC is also requiring two ‘well controlled’ clinical studies for non-disease claims, which also represents a dramatic change in the level of substantition required to establish the truth of these types of claims.”   According to POM, this new standard is improper because it did not go through the the formal rulemaking process and, more significantly, it “constitutes a ban on both deceptive and non-deceptive speech, the latter of which is protected by the First Amendment.”   

In effect, POM is arguing that for an undisputedly healthy product, the FTC is seeking to bar properly supported, qualified health claims that are protected under the First Amendment.  For its part, the FTC maintains that the advertisements were still “deceptive.”

This matter has been fully tried before an FTC Administrative Law Judge and all post-trial briefs have been filed.  A decision expected by April 17, 2012 at the latest.  Needless to say, it is likely that the FTC’s own court will find in favor of the FTC so expect this one to be appealed.