OTC/Rx Industrial Drug Test Standards to get a makeover
ROCKVILLE, Md. — The U.S. Pharmacopeial Convention last week announced that it is working with the Food and Drug Administration and the Consumer Healthcare Products Association to update quality standards for widely used medicines and ingredients. Updated test methodologies are crucial to help counter economically motivated adulteration — in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients — and also to address the challenge of impurities that may go undetected with older, nonspecific assays and tests.
The working relationships with FDA and CHPA fit into the group’s overall update initiative. The work will begin with a focus on an initial list of priority medicines and ingredients identified by the FDA. The U.S. Pharmacopeia—National Formulary provides specifications for the identity, as well as quality, purity and strength of drugs and their ingredients, which are enforceable by the FDA in the United States. USP standards are used in more than 130 countries.
Testing procedures for the first few ingredients to be reviewed include the analgesic acetaminophen, cough suppressant dextromethorphan and antihistamine diphenhydramine.
Several years ago, USP put in place a long-term effort to assess written standards for prescription and over-the-counter drugs published in the USP-NF compendia, aimed at stepping up the pace of revising test procedures where needed to reflect scientific advances. Coupled with this is USP’s ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards.
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.