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Consumer Update |
Before a new drug product can be legally marketed, it must be shown to be safe and effective, and it must be approved by FDA. Here are recent actions the agency has taken to protect the public from illegal products.
Recall Requested for TrueMan Sexual Energy and Energy Max Supplements: In November 2007, FDA requested a recall of TrueMan Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules. Both are illegal products that contain potentially harmful, undeclared ingredients. Often advertised as "all natural" alternatives to approved erectile dysfunction drugs, these products contain substances that are similar to active ingredients in prescription drugs. They could interact with medications and cause dangerously low blood pressure.
More than $300,000 of Drugs and Supplements Seized from General Therapeutics Corp.: In November 2007, U.S. Marshals seized more than $300,000 worth of products from General Therapeutics Corp. of St. Louis , Mo. , at FDA's request. Products included an antifungal called NC Solution, as well as other drugs, dietary supplements, and ingredients. Some of the products lacked FDA approval and all were maintained under grossly unsanitary conditions.
Approximately $71,000 of Supplements Seized from FulLife Natural Options: In October 2007, U.S. Marshals seized approximately $71,000 worth of products from FulLife Natural Options, Inc. of Boca Raton, Fla., at FDA's request. The company marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea. The products are labeled as dietary supplements, but are being promoted by FulLife for treating serious conditions such as diabetes, anemia, and hypertension.
Approximately $41,000 of Products Seized from Charron Nutrition: In August 2007, U.S. Marshals seized an estimated $41,000 worth of products that were distributed by Charron Nutrition of Tallahassee, Fla. The products--Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400 capsules--were promoted for treating diabetes, arthritis, and other serious health conditions.
For More Information
FDA Press Release on TrueMan and Energy Max Supplements
http://www.fda.gov/bbs/topics/news/2007/NEW01737.html
FDA Press Release on General Therapeutics Corp.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01736.html
FDA Press Release on FulLife Natural Options and Charron Nutrition
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01723.html
Final Rule Promotes Safe Use of Dietary Supplements
http://www.fda.gov/consumer/updates/dietarysupps062207.html
Date Posted: November 7, 2007
