SAN DIEGO (Leal Newsline) – A class action lawsuit alleges PharmaCare’s elderberry products are illegal to sell.
The case, filed Jan. 25 in San Diego federal court, says claims made on the company’s elderberry products trick consumers into thinking the immune system boost they provide will protect from diseases.
Moreover, PharmaCare’s elderberry extract does not meet the definition of a dietary ingredient under the federal Food, Drug and Cosmetic Act, which leads the products to be mislabeled as dietary supplements, the suit says.
“For dietary ingredients not used in the United States prior to 1994, the manufacturer or distributor must, at least 75 days before the introduction of the new dietary ingredient (‘NDI’) into the market, provide the FDA with information that demonstrates that the ‘history of use or other evidence of safety establish that the NDI when used under the conditions recommended or suggested in the labeling of the NDI will reasonably be expected to be safe,’” the suit says.
“Although required to do so, Defendant did not provide the FDA with the required NDI notification for its extract.”
Greg Coleman Law PC in Los Angeles is pursuing the case.