FDA warns consumers to stop using Soladek Vitamin Solution
SILVER SPRING, Md. — The Food and Drug Administration on Monday warned consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.
The FDA received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting and diarrhea.
According to the FDA, symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage and coma. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities and birth defects.
Soladek is marketed with claims that the product treats "hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium — i.e., bronchial, glandular, ocular and cutaneous — corticotherapy, aging and pregnancy." The product is sold in a box labeled in Spanish and contains a vial of the solution.
Soladek currently cannot be legally marketed in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA. However, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning, the agency stated.
MB Innovations makes weight loss ‘Slimple’
HOLLYWOOD, Fla. — MB Innovations on Monday launched a new weight loss supplement called Slimple.
Slimple contains MaCoca, a proprietary blend derived from a de-cocainized coca leaf.
The extract is processed using a method that carefully removes the alkaloids while retaining all of the active ingredients, enabling it to be legally used as a food additive, the company stated. According to MB Innovations, the coca leaf contains flavonoids, triterpenoids, vitamin C, amino acids, carotenoids, vitamin B complex and essential oils.
The product is being marketed online at ItsSlimple.com for $59.95.
Aloe Cadabra to hit H-E-B shelves
VENTURA, Calif. — Aloe Cadabra has gained retail distribution at H-E-B.
The brand, which is touted as the first all-natural personal lubricant made with 95% certified organic aloe vera, also is available at Albertsons and The Vitamin Shoppe, the company said.
Aloe Cadabra is an all-natural line completely free of parabens, glycerin and harmful petroleum products. The line consists of three varieties made with aloe and vitamin E oil, along with such aromatic essential oils as Tahitian vanilla and French lavender, the company added.
Aloe Cadabra will be featured on H-E-B shelves beginning mid-April.