Posted September 18, 2012

Maker of Noni, Nopal, Blood Sugar and Cholesterol Supplements Warned For Drug Claims, Misbranding, and Manufacturing Violations

On August 27, 2012, the FDA issued a warning letter to Naturavit, Inc. for making statements about dietary supplements Noni Imperial Hawaiian, Garlic and Parsley, Cholestol, Nopal and Diatrin that constitute drug claims. The products were also found to be misbranded due to inadequate directions for use.

Noni Imperial Hawaiian contains the alkaloid xeronine from the Polynesian noni fruit, and was promoted for the treatment of diabetes, gastric ulcers, arthritis, heart disease, high blood pressure, kidney disorder and pain relief.

Naturavit’s Garlic and Parsley formula was promoted to maintain blood pressure, lower cholesterol, and treat asthma, arthritis, cold, flu and ulcers.

(See’s Review Article on Noni Juice for more information and Review of Garlic Supplements for tests of related products.)

Cholestol contains spirulina, psyllium husk and chromium picolinate and was promoted to “help fight bad cholesterol.”

(See the Encyclopedia of Natural Products article on Spirulina for more information and the Review of Chromium Supplements for tests of related products.)

The company’s Nopal formula contains nopal, also known as prickly pear, aloe vera, anamu, cat's claw and shark cartilage. It was promoted for the treatment of gastric ulcers and diabetes.

(See’s Encyclopedia of Natural Products articles on Nopal, Aloe, Cat’s Claw and Shark Cartilage for more information about these ingredients.)

Diatrin contains Gymnema sylvestre extract, bitter melon extract, chromium polynicotinate, fenugreek extract, vanadyl sulfate, bilberry extract, cinnamon extract, jambolan, Tinospora cordifolia, and zinc gluconate. It was promoted for the regulation of healthy blood sugar levels and regeneration of pancreatic B cells.

(See’s Encyclopedia of Natural Products articles on Gymnema sylvestre, Fenugreek, Bitter Melon, Bilberry and Tinospora cordifolia for more information on these ingredients and see the Review of Zinc Supplements for tests of related products.)

The company was also warned for violating Current Good Manufacturing Practices for manufacturing, packaging and labeling, which was discovered during two facility inspections earlier in the year.

For more details regarding this warning letter, use the link below.