This case involves a nutritional supplement product which the plaintiff in Alaska claimed was contaminated with metallic compounds. The plaintiff also claimed that the manufacturer marketed the product towards special-needs individuals, and that the product claimed to be organic and non-gmo despite indications to the contrary. The plaintiff purchased the supplement over a period of several months, during which time she gave it to her daughter, who suffered from autism, on a daily basis. At the conclusion of this period, the child’s autism had worsened noticeably, allegedly due to the contaminants present in the supplement. The FDA eventually went on to recall the supplement.
Question(s) For Expert Witness
- 1. Will you be able to determine if the product was contaminated?
- 2. Will you be able to determine whether or not there was enough contaminants to affect the child?
Expert Witness Response E-001256
I know regulatory limits exist for metallic compounds in products such as drinking and bottled water, and that manufacturers are required to monitor on a periodic basis. The reason the FDA gave for recalling the product was for undeclared ingredients, which implies it was added as an ingredient and its presence was not on the label. Stevia is an FDA approved sweetener, and therefore would not be considered a contaminant. I would be able to provide a risk assessment on these 2 chemicals and their consumption in the product by the child over the course of the year she was using this product.