Maine Natural Health, Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

“Vitamin D [an ingredient in the product] may improve heart health….heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.”

“[T]he omega-3 fatty acids in fish oil [an ingredient in the product]….have shown beneficial results for a variety of health problems….likehigh blood pressure and arthritis. This means regular consumption of fish oil may help stave off disease….”

“[F]ish oil [an ingredient in the product] may play a key role in preventing preterm births, which is the leading cause of perinatal mortality and morbidity….fish oil targets premature cervical ripening, a cause of preterm birth”

Potential Health Risks

“[G]rass fed whey [an ingredient in the products]….naturally higher in Omega-3…benefits include: reduces inflammation….reduces risk of irregular heartbeats…reduce risk of plaque buildup in arteries….”

“[A]lso found in Recovery are..omega-3s…may help to reduce inflammation….reduce the risk of plaque buildup in the arteries.”

Regulatory Context

Identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)];

Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)];

Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 111.140(b)(3)(iii)];