From ice cream to pet food to protein powder, food and supplements manufacturers increasingly must defend against allegations that their products do not measure up in "independent laboratory testing" of ingredients. New York Attorney General Eric Schneiderman adopted this strategy last month, asserting that DNA bar coding tests run on herbal supplements sold by national retailers showed that four out of five of the tested products did not contain any of the herbs on their labels.
Plaintiffs' tactic of referring to conclusive pre-litigation product testing is not new. In 2012, a consumer of diet ice cream bars sued product manufacturers, claiming laboratory tests revealed that calorie counts for the challenged products were 20-30 percent greater than listed on the box. Burke v. Weight Watchers Int'l, Inc. and Wells Enters., Inc., Case No. 12-cv-6742 (D.NJ). In 2013, Honest Tea was hit with class allegations that bottles of its Honey Green Tea did not contain the amount of antioxidants represented on labels. Salazar v. Honest Tea, Inc., Case No. 13-cv-2318 (E.D. Cal.). See also Gubala v. CVS Health Corp., Case No. 14-cv-9039 (N.D. Ill.) (alleging defendant engaged in deceptive amino acid spiking of whey protein products and "scientific testing" showed products did not contain claimed amino acid ingredients).
Despite the expanded use of these claims by class counsel and other consumer advocates, product testing allegations have proven vulnerable to 12(b)(6) challenges on preemption grounds. The problem rests in plaintiffs' failure to specifically assert that their testing complies with strict FDA guidelines and the products do not satisfy "safe harbor" provisions that allow for limited deviation from labeled contents. In essence, cursory allegations of "independent laboratory testing" of product claims are themselves coming up short. Absent clear adherence to prescribed testing methods, courts are dismissing complaints (often without prejudice) because reliance on an alternative testing regime would impose state labeling requirements inconsistent with controlling federal regulations.
In Burke, Plaintiff asserted generally that all calorie count testing was conducted in compliance with FDA rules, but her complaint was dismissed because she failed to explicitly allege that: (1) the ice cream bars were tested using each of the five alternative methods prescribed by FDA regulations for calculating total calories, and (2) the bars exceeded safe harbor calorie allowances on each of the five tests. Burke, 983 F.Supp.2d 478 (2013). See also Salazar v. Honest Tea, Inc. (E.D. Cal. June 10, 2014) (dismissing Plaintiff's complaint against tea manufacturer over allegedly inaccurate antioxidant claims due to failure to assert compliance with FDA 12-sample test method for nutrient content claims established by 21 CFR § 101.9(g)).
Plaintiffs have earned limited victories along the testing road. In 2014, a pair of lawsuits were filed against pet food company Blue Buffalo, one by a putative consumer class and the other by rival pet food manufacturer Purina, claiming that laboratory testing showed some Blue Buffalo pet foods contained poultry by-product meal (contradicting the company's "no poultry by-products" pledge), as well as rice hulls in its purportedly "grain free" products. Stone v. Blue Buffalo Co., Case No. 14-cv-520 (S.D. Ill.); Nestle Purina PetCare Co. v. Blue Buffalo Co., Case No. 14-cv-859 (E.D. Mo.). Blue Buffalo countersued Purina for defamation but within months, Blue Buffalo had posted a public letter of apology to its customers stating that a supplier had mislabeled poultry by-product meal as chicken meal. Nonetheless, manufacturers are expected to continue to vigorously challenge laboratory testing allegations, both in motions to dismiss and in the court of public opinion.
In January, consumers of MusclePharm's "Arnold Schwarzenegger Series Iron Mass" dietary supplement filed suit in California federal court, alleging that "scientific testing" showed the company had misrepresented the nature and amount of protein in the product. Durnford v. MusclePharm Corp., Case No. 15-cv-413 (N.D. Cal.). MusclePharm's responsive pleading is pending. Meanwhile, the four retailers targeted in New York are mounting a defense against product testing claims, asserting that the DNA testing method used to evaluate their supplements is unproven for botanical extracts, due to expected denaturing and destruction of plant DNA during processing. According to media reports, the companies' skepticism of the state AG's test results has considerable support in the scientific community. See, e.g., Alex Morrell, Did The NY AG Flub Its Testing in Herbal Supplement Smackdown?, Forbes March 14, 2015; Nicola Twilley, How Not to Test A Dietary Supplement, The New Yorker February 10, 2015.
Keywords: products liability, litigation, product testing, food labeling, nutrient content claims, supplements, independent laboratory testing