FDA asks for recall of two America True Man Health products, citing harmful ingredients
ROCKVILLE, Md. The Food and Drug Administration on Friday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men’s Formula Capsules, stating that they are considered illegal drug products that contain potentially harmful, undeclared ingredients.
The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health, of West Covina, Calif.
“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure,” stated Janet Woodcock, deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.
As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil, a substance similar to the active ingredient in the approved erectile-dysfunction drug Viagra; or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
The FDA issued an alert on May 10, 2007, advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request, the agency stated.
Twinlab launches liver detox formulated for athletes
GRAND RAPIDS, Mich. Twinlab on Friday announced the launch of Liver D-Tox Fuel, a daily liver detoxifying formula that combines L-glutathione and alpha lipoic acid along with an exclusive Purification Matrix formula.
Designed with athletes in mind, Liver D-Tox is made with natural ingredients and contains no harsh chemicals that interfere with the natural detoxification process.
“Most people would benefit from a detoxifying product, but athletes have additional needs,” stated Thane Slagowski, Twinlab director of research and development. “Not only do they introduce more free radicals into their system through intense exercise, but the additional stresses they put on their body also increase the toxins in their system, making their liver work even harder.”
L-Glutathione and alpha lipoic acid are antioxidants that help to dissolve toxic substances and maintain healthy enzyme levels, the company stated. The Purification Matrix formula contains: kudzu (root) powder and extract, milk thistle (seed) extract (standardized to 80 percent silymarin), artichoke (aerial part) and sarsaparilla (root).
FiveMoms.com receives Web creativity award
Launched in May as part of the association’s larger campaign to alert parents to the dangerous trend of teens abusing cough medicine to get high, FiveMoms.com is a place parents can go to learn how to spot the warning signs, as well as what to do if they suspect their child is abusing. The site provides parents with information about cough medicine abuse, features blog entries and offers links to additional resources.
The W3 Awards is a well-regarded online awards program. Sanctioned by the International Academy of Visual Arts, the awards honor creative excellence on the web and recognize the creativity of the professionals behind the winning sites, videos and marketing programs.