FDA actions on supplements, 2013-2014

Many experts say that dietary supplements have long been held in high esteem by the American public. The Food and Drug Administration regulates dietary supplement products and their ingredients. The $30-million industry has an estimated 150 million customers in the United States.

Here is information on product recalls, public notifications and warning letters issued by the FDA involving dietary supplements from the beginning of 2013 until mid-May 2014. And here is more about about health and dietary supplements.

Showing
of 137 records
Product Problem substance Problem FDA action Company Date
Asset Bold Sibutramine Contains sibutramine, which may cause heart attack/stroke Warning letter All Natural Bee~lievers 5/16/2014
MV5 Days - Rhino Power Male Libido Sexual Enhancer Sildenafil Sildenafil can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure. Warning letter MV5 Days 5/16/2014
Pure Green Coffee Bean The FTC filed a lawsuit against Pure Green Coffee for making unsubstantiated weight loss claims and deceiving consumers with fake 'news' websites. Federal lawsuit Pure Green Coffee; Nationwide Ventures 5/15/2014
Asset Bee Pollen Sibutramine Contains sibutramine, which may cause heart attack/stroke Warning letter All Natural Bee~lievers 5/12/2014
Black Ant, Black Ant, and Mojo Risen Dietary Supplements Sildenafil, tadalafil The products contain undeclared amounts of sildenafil and tadalafil, which can interact with prescription drugs causing lower blood pressure. Recall Eugene Oregon, Inc 5/5/2014
Natural Body Solution & Slim Trim U Sibutramine Contains sibutramine, which can cause heart attack/stroke Warning letter BeeAmazing2 5/5/2014
Lite Fit USA Sibutramine Contains sibutramine, which can cause heart attack/stroke Recall Bacai Inc. 4/29/2014
Super Arthgold Chlorzoxazone, diclofenac and indomethacin Contains chlorzoxazone, diclofenac and indomethacin, which can cause fatal reactions Recall Nano Well-being Health Inc. 4/21/2014
Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products Products are adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. Warning letter Select Herbs, LLC 4/18/2014
Grounded, Limbic Balance Morning Formula, Limbic Balance Evening Formula, TobacOff, and JittersAway Adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. Warning letter CDJ Holding, Incorporated, d.b.a. Pacific BioLogic 4/17/2014
S.W.A.G Sildenafil Sildenafil can cause symptoms, such as headache and flushing, and can interact with medications containing nitrates such as nitroglycerin, resulting in dangerously low blood pressure. Warning letter www.SexWithAGrudge.com 4/16/2014
Thinogenics Sibutramine Contains sibutramine, which can cause heart attack/stroke Recall Nature's Universe 4/9/2014
Swanson Premium Brand Full Spectrum Cilantro (Coriander), Salmonella (bacteria) Recall Swanson Health Products 4/4/2014
CRAZE New ingredient Product is adulterated because it contains the new dietary ingredient Dendrobex. The product label states it contains dendrobium extract and alkaloids B-Phenylethylamine, N, N-Dimethyl-B-Phenylethylamine, and N, N-Diethyl-B-Phenylethylamine, which do not appear to be present in the Dendrobium species Warning letter Driven Sports Inc. Franklin Square, Long Island 4/4/2014
New You Sibutramine and phenolphthalein Contains sibutramine and phenolphthalein, which can cause heart attack/stroke. Warning letter New Reflections LLC 4/2/2014
African Black Ant, XZen Gold, Xzone and more Sildenafil, tadalafil The products contain undeclared amounts of sildenafil and tadalafil, which can interact with prescription drugs causing lower blood pressure. Recall Nova Products, Inc. 4/1/2014
Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10 Products are adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. Warning letter Bio-Recovery, Inc. 4/1/2014
Lean Slow Motion ...Potion (Easta Pink, Purp, and Yella varieties) Melatonin Adulterated because it contains melatonin. Melatonin is allowed as a dietary supplement ingredient, but is not approved as an ingredient in conventional foods and beverages Warning letter Dewmar International BMC, Inc. 3/27/2014
Bella Vi Sibutramine and/or combination of sibutramine and phenolphthalein Products contain undeclared sibutramine and/or combination of sibutramine and phenolphthalein Recall Pure Edge Nutrition, LLC. 3/26/2014
Super Fat Burner, Maxi Gold, and Esmeralda Unapproved new drug Recall New Life Nutritional Center 3/25/2014
GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. Warning letter Aloe Man International Corp. 3/21/2014
Vitaccino Coffee Sibutramine Contains sibutramine, which can cause heart attack/stroke Warning letter Rose Int'l Guangdong China / Mperia Elta 3/19/2014
Pleo Penicillin contamination Recall Terra-Medica, Inc 3/18/2014
Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 pack Kratom The products contain kratom, which is associated with respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal symptoms. Warning letter SNI National 3/14/2014
Reumofan Plus tablets Methocarbamol and diclofenac Product contains the active pharmaceutical ingredients methocarbamol and diclofenac, which poses a serious heart risk. Recall Pain Free By Nature 3/12/2014
Adipotrim XT, Burn 7, Reductrol Fat Burner Formula Fluoxetine, sibutramine, phenolphthalein, acetaminophen Adipotrim XT contains fluoxetine an SSRI that is associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures, and can interact with other common medications such as aspirin and ibuprofen, , which can cause ventricular arrhythmia or sudden death. Burn 7 contains sibutramine and phenolphthalein associated with increase blood pressure and pulse rate and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Reductrol Fat Burner Formula was found to contain acetaminophen and phenolphthalein, which can cause liver damage. Recall Deseo Rebajar Inc 3/7/2014
Weekend Warrior Thiosildenafil Weekend Warrior contains undeclared thiosildenafil, which is chemically similar to sildenafil and can cause seriously low blood pressure. Warning letter Nutrition Specialists 3/7/2014
LV Shou Reduces Fat Sibutramine and phenolphthalein Contain sibutramine and phenolphthalein, which can cause heart attack/stroke. Warning letter LV Shou 2/18/2014
Arth-Q Ibuprofen Product found to contain ibuprofen negative side effects may include signs of bleeding such as unusually dark stools or urine, stomach pain, or increased bruising. Warning letter www.kaymall.com 2/13/2014
Reduce Weight Fruta Planta Phenolphthalein Product found to contain phenolphthalein, which cause potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. Recall MyNicKnaxs, LLC 2/4/2014
BioRhythm Androbolix, BioRhythm Androbolix 300 Unapproved dietary ingredients Contains Tribulus terrestris, protodioscine, saponins, 6, 7-dyhydroxybergomottin (DHB) and 4-etioallocholen-3, 6, 17-trione, an unapproved new dietary ingredient. Warning letter Exclusive Supplements Inc 1/31/2014
Mega Slim Herbal Appetite Management capsules DMAA Product contains DMAA, which has been linked to a number of serious adverse effects, including narrowing of blood vessels and arteries, and increased risk of elevated blood pressure, shortness of breath and heart attack. Recall YoungYou International 1/30/2014
Bali Mojo, JINQIANGBUDOR Red Dragon , Vitamax, Tiger King, SexRX Sildenafil, tadalafil The products contain undeclared amounts of sildenafil and tadalafil, which can interact with prescription drugs causing lower blood pressure. Recall Multiple companies 1/28/2014
Citrus Fit Gold, Thinogenics, Tonic Life BP, Hot Detox Sibutramine and phenolphthalein Products contain sibutramine or phenolphthalein, which can cause heart attack / stroke. Warning letter Multiple companies 1/28/2014
Tanalbit Failure to establish finished product specifications for purity, strength, and limits on heavy metal contaminants and failure to establish and follow written procedures for the responsibilities of quality control operations. Warning letter Intensive Nutrition Incorporated 1/22/2014
Dream Body Slimming Capsule and Magic Slim Sibutramine and phenolphthalein Products contain sibutramine and/or phenolphthalein, which can cause heart attack / stroke. Warning letter www.dreambodyweightloss.com/ 1/21/2014
Pro ArthMax Diclofenac, ibuprofen, naproxen, indomethacin, nefopam, chlorzoxazone The was found to contain multiple drugs, including diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone. These drugs can cause serious side-effects, and may increase the risk of serious side-effects in people who are taking other medications, especially anti-inflammatory drugs. Recall Human Science Foundation 1/15/2014
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men, 'New' Extenze, and Sildenafil, tadalafil The products contain undeclared amounts of sildenafil and tadalafil, which can interact with prescription drugs causing lower blood pressure. Recall Midwest Wholesale 1/9/2014
7 Days Herbal Slim Dietary Supplement/Adulterated. The product was found to contain sibutramine. FDA laboratory analysis confirmed that 7 Days Herbal Slim contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Public notification 12/19/2013
Asset Extreme Plus Dietary Supplement/Adulterated. The product was found to contain sibutramine. FDA laboratory analysis confirmed that Asset Extreme Plus contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Public notification Asset Extreme Plus 12/19/2013
Best Whips Unapproved New Drug/Adulterated/Misbranded FDA laboratory analysis confirmed that Best Whips contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Public notification Best Whips 12/19/2013
SlimEasy Herbs Capsule Dietary Supplement/Adulterated. The product was found to contain sibutramine. FDA laboratory analysis confirmed that SlimEasy Herbs Capsule contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Public notification SlimEasy Herbs 12/19/2013
Sliming Diet Berry Plus Dietary Supplement/Adulterated. The product was found to contain sibutramine. FDA laboratory analysis confirmed that Sliming Diet Berry Plus contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Public notification 7 Days Herbal Slim 12/19/2013
CONTROL All Natural Unapproved New Drug/Adulterated/Misbranded CONTROL All Natural male enhancement contains the undeclared ingredients sulfoaildenafil and dimethylsildenafil. Sulfoaildenafil and dimethylsildenafil are structurally similar to sildenafil, the active ingredient in Viagra. Warning letter issued N/A 12/19/2013
Meizitang Citrus Dietary Supplement/Adulterated. The product was found to contain sibutramine. FDA laboratory analysis confirmed that Meizitang Citrus contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Warning letter issued Meizitang Citrus 12/19/2013
Night Bullet Male Sexual Enhancer Capsules and Hemp Garden Tea Unapproved and Misbranded New Night Bullet Male Sexual Enhancer Capsules (Night Bullet).1 Laboratory analysis by FDA concluded that lot # B43N032 of your product Night Bullet contains sulfohydroxyhomosildenafll and thiosildenafll, which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafll. Warning letter issued Green Planet Inc 12/19/2013
EnhanceRx Undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume the affected product. Product recall Stone Independent Research, Inc. 12/13/2013
Zanocap Undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume the affected product. Product recall Stone Independent Research, Inc. 12/13/2013
TriMedica, Oseto Help and TriMedica Pure MSM CGMP/Dietary Supplement/Adulterated/Misbranded TriMedica Oseto Help and TriMedica Pure MSM products are misbranded with the meaning of section 403 of the Act [21 U.S.C. 343]. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov. Warning letter issued PurQuality, LLC 12/4/2013
Hydravax Unapproved drug; contains undeclared Sildenafil. Sildenafil may interact with other prescription drugs to lower blood pressure to unsafe levels. Product recall IQ Formulations 11/29/2013
Showing
of 137 records

advertisement | advertise on Newsday

advertisement | advertise on Newsday