The warning letters were sent to several firms over claims for products that ranged from supplements to topical creams.
Michael Landa, Director of the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA, told attendees at the CRN’s Annual Symposium for the Dietary Supplements Industry in Laguna Beach, CA, last year that products positioned for diabetes and pain/inflammation were on the agency’s radar.
Other areas raising red flags for the agency included statements like “works like” or “better than” an Rx drug, labels in a foreign language or ‘broken’ English, and label contradictions or warnings, said Landa.
The new series of warning letters shows that the agency is indeed scrutinizing this area.
San Diego-based Neuliven Health, Inc., received a warning letter for claims associated with its Glucocil product. According to FDA, the www.glucocil.com website states that the product’s ingredients “help you naturally and safely:”
• “Lower fasting blood sugar levels up to 29%”
• “Lower A1c levels significantly”
PharmaTerra, Inc. from Mercer Island, WA, received a warning letter for claims related to its ProBeta product. FDA alleges: “The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.”
The warning letter to Coral Springs, FL-based Nature Cast Products alleges that the company’s Eradicator and Nature's Gold products both used disease claims, while Health King Enterprise & Balanceuticals Group from Chicago is alleged in a separate letter to distribute products with diabetes claims, and claims on cardiovascular disease, liver damage and immune function.
For the full list of companies and links to the warning letters, please see the table below.