FDAnews Drug Daily Bulletin

Two Companies Draw Warning Letters Over Misbranded Drugs, Product Specification

Oct. 5, 2016

Ajes Pharmaceuticals and Positive Power Nutrition have been hit with warning letters after the FDA conducted inspections.

Positive Power Nutrition got a warning letter for its 11 products due to claims made, including claims that the products help the body heal from varicose veins; protect against cardiovascular disease; fight bone loss, chronic fatigue, depression, constipation, ringing in the ears, and pernicious anemia; and are found to aid in the healing of gastritis, liver disorders, asthma, and anemia.

There is no data to prove that the claims made by Positive Power Nutrition for its medications are true, and the products fail to bear adequate directions for their intended use.

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