The FDA has strict regulations for the labeling of food, drugs, and supplements. Manufacturers must follow not only the labeling conventions under the Code of Federal Regulations, but also the testing requirements for measuring the components of food and drug products. When manufacturers fail to meet these requirements or label their products in a misleading way, they make themselves vulnerable to lawsuits.

When In-House Testing Doesn’t Hold Up to Scrutiny

Manufacturers open themselves up to lawsuits when their product labeling includes claims that have been disproven by multiple third-party studies.

One recent example of this type of case occurred when CVS claimed on the packaging for its Algal-900 DHA dietary supplement that the product was “clinically shown” to improve memory. CVS made this claim based on a single study conducted by Martek, a bioscience corporation that was promoting its own algae-based DHA supplement. Unfortunately, multiple high-quality studies, including a 2014 meta-analysis, showed that DHA was no more effective than a placebo in improving cognitive function. As a result, the FTC discredited Martek’s study and banned them from using it in their marketing.

Because CVS proceeded to use the discredited study in the marketing of their dietary supplement, the Center for Science in the Public Interest sued the company in federal court (Worth et al v. CVS Pharmacy, Inc.). CVS settled in June 2016, agreeing to compensate all customers who had purchased the Algal-900 DHA supplement.

Plaintiffs’ Independent Lab Testing Can Also Fall Short

While plaintiffs have experienced victories in cases such as Worth et al v. CVS Pharmacy, Inc., they typically face an uphill battle in food and drug product liability cases. One major challenge plaintiffs face is proving that their independent laboratory testing complies with strict FDA requirements.

Testing compliance became a key issue in a 2012 case about mislabeled calorie counts (Burke v. Weight Watchers Int’l, Inc. and Wells Enters, Inc.). In this case, a consumer sued the manufacturers of a diet ice cream bar product, claiming that the ice cream bars had a 20 to 30 percent higher calorie count than what was listed on the nutrition label. Ultimately, the case was dismissed because the plaintiff could not show that their independent lab testing adhered to the FDA’s guidelines for measuring caloric content. The plaintiff did not explicitly allege that their team tested the ice cream bars using all five of the methods prescribed by the FDA to calculate total calories, or that the ice cream bars exceeded safe harbor allowances (slight deviations from the calories listed on the label) for the calorie count on all five tests.

For both plaintiffs and manufacturers in product labeling cases, it’s essential to show that all FDA regulations and requirements have been followed when testing product components. It’s important to verify that the lab performing the testing is FDA-registered and experienced in handling projects where the outcome of a court case is on the line.

Avomeen is an FDA-registered, cGMP-compliant chemical testing lab that can do everything from gluten testing in vodka to identifying pesticide contamination in food labeled as organic. When costly litigation is involved, rely on Avomeen to resolve complex food and supplement testing problems.