FDA Warning Letters about Products (2009)
The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment.
Most sellers do what the FDA requests. In some cases, the product must be removed from the marketplace. In others, marketing can continue as long as the claims to which the FDA objected are stopped.
If the FDA determines that corrective action has been taken, the office that issued the warning letter may issue a close-out letter. This procedure applies to warnings issued on or after September 1, 2009. The corrective actions must actually have been made and verified—usually, by a follow-up inspection. If the warning letter contains violations that by their nature are not correctable, no close-out letter will issue. Should violations be observed later, enforcement action may be taken without further notice.
Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.
- Aluwe LLC / Raymond Kent Hann / (11/30/09): Germ Slayer
- American Cellular Labs / Maurice Sandoval / (7/2709): TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, TT-40-Xtreme
- Balance Ayurvedic Products / Chandru Shahani / (7/9/09): Men's Vitality Herbal Formula, AyurSoothe Herbal Formula, AyurVitality, AllerSupport Herbal Formula, AyurSlim Herbal Formula
- Banyan Trading Company / Banyan Botanicals / (7/29/09): Shilajit, Mahasudarshan, Kanchanar Guggulu
- Bazaar of India / Kush Khanna / (7/7/09): Acnenil, Cold Aid, Sugar Fight, Heart Plus, Hingwastika, Bakuchi, Guggulu, Brahmi, Tagar, Licorice, Triphala
- BestLife International / Paul T. Baugh / (2/4/09): Sammi's Best™ Soy, Sammi's Best™ Cultured Organic Soy, Sammi's Best™ Soya-Rice, Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement, Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement, Sammi's Best™ Soy, Dutch Chocolate Flavor, Sammi's Best™ Soy Nog, and Sammi's Best™ Soychata
- BioCentric Laboratories / (8/18/09): BioEntopic 15% Ibuprofen Creme
- Bodee LLC / David Cyrus Pourmand / (7/27/09): Zencore Plus
- BodySaver LLC / David Perich, Paul Curtis / (1/5/09): Dry Eye Saver Formula, Hearing Saver Formula, Memory Saver Formula and Soothing Colon Formula
- Chi Machine 4U / Tracy Courtney / (5/21/09): Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, E-Power Machine, SOQI Bed
- Circle of Health, Inc. / (6/12/09): Kapikachu Rasayana 22, Somalata Rasayana 21, Shilajit Churna Rasayana 17, and Arjuna Rasayana 4
- Core Products International / Phil Mattison / (8/18/09): Ibunex Topical Ibuprofen
- / DS Waters of America / Stewart E. Allen, Dillon Schickli / (6/8/09): Nursery® Purified Water
- Dynamic Nutritional Associates / Dale H. Grose / (11/6/09): D-17 Tumorell, D-24 Pneumell, D-33 Spasmonell, D-40 Peranemiol, D-46 Goutinol, D-48 Pulmonon, D-62 Rubilin
- EFT Biotech Holdings / Jack Qin / (8/19/09): 2006 Celprotect 1, 2007 Celprotect II Bullet Points, Colostrum #3008, Colloidal Silver #2003, SuperCal #3015, MSM #3003 + IONICS, Re-Live Again #3004, GlucoBalance #3017, Cardio Support #3019, PerformPlus #3006, VisionPlus #3012
- Energy Miracle Enterprises / Gustavo Lopez / (8/8/09): Detox Box
- Galderma Laboratories / Francois Fournier / (8/18/09): Tri-Luma® Cream
- General Mills / Ken Powell / (5/5/09): Cheerios® Toasted Whole Grain Oat Cereal
- Geromatrix Nutraceutical Corporation / Robert A. Magedoff / (8/18/09): LoPain AF 15% Ibuprofen Creme
- Haelan Products / Joseph E. Todesco / (1/15/09): Platinum Formula Haelan 951 Fermented Soy Beverage (Haelan 951)
- Healthy Origins, Eby Sales International / Barrett Eby / (1/14/09): Healthy Origins CoQ10Gels, Healthy Origins E-400, Healthy Origins Inositol Powder, Healthy Origins Lyc-O-Mato, Healthy Origins LycopenePlus, Healthy Origins Seleno Excell Selenium
- Hill Dermaceuticals / Jerry S. Roth / (8/18/09): Tri-Luma® Cream
- Hopewell Pharmacy and Compounding Center a/k/a Drugs Are Us, Inc. / Eugene Ragazzo / (9/28/09): Sodium Tetradecyl Sulfate (STS) Injection, 2%, 4% and 5%
- Inspired Living / Carol A. James / (6/2/09): ASO (Activated Stabilized Oxygen) 25% Professional Solution, Allimax Allicin Rich Garlic Rescue Spray, Harmoniclnnerprizes Etherium Gold, Harmoniclnnerprizes Colloidal Defense, Harmoniclnnerprizes Chamae Rose with Black Walnut, Harmoniclnnerprizes Gentleman's PQ Higher Octive Dietary Supplement
- IntelSource Group, Inc. / Matthew Wolfson / (6/25/09): Wellness Pro 2010
- Kenshin Trading Corporation / Kunio Suzuki / (12/8/09): UNICO ST8 Acupuncture needles, Katsu Natto-Kinase Tablets, Katsu Kelp Root Tablets, Shijimi Capsules, VitalFocus Sanza Capsules, Natural Tree Sap Pouch, Shiunko Burn Cream
- Matrixx Initiatives / William J. Hemelt / (6/16/09): Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, Zicam Cold Remedy Swabs, Kids Size
- MEKT, Inc. / Mitchel S. Meyer / (8/18/09): IB-RELIEF
- Micro Current Technology / David S. Suzuki / (12/24/09): Platinum Nano™ Microcurrent System, Bio-Ultimate Platinum™ Microcurrent System
- Mountain Meadow Herbs / Christa H. Sparks / (9/21/09): Herbs for ADD (a/k/a Natural Attention-Aid), Anti-Inflammatory, Herbal Respiratory, T&C Formula, Flu Season (a/k/a Winter-Immune Booster), Infa-Flu, Blood Pressure Formula (a/k/a/Herbal CardioCare), ClarkRx (a/k/a ClarkFx)
- Nestle HealthCare Nutrition / David Yates / (12/3/09): BOOST Kid Essentials Nutritionally Complete Drink
- Nestle U.S.A. / Brad Alford / (12/4/09): Juicy Juice Brain Development Fruit Juice Beverage (Apple), Juicy Juice All-Natural 100% Juice Orange Tangerine, Juicy Juice All-Natural 100% Juice Grape
- Netproductstore, Inc. dba Afton Communications / Bud Meachum a/k/a Harold Meachum / (9/11/09): Rhythm Touch Q 2-Way
- Ocean Hyperbaric Neurologic Center / Ginger Neubauer / (9/11/09): Sechrist Horizontal Hyperbaric Chamber, Vickers Clam Shell Hyperbaric Chamber
- Pam American Labs, LLC / Eric M. Wingerter / (11/20/09): Neevo caplets prenatal product
- Pantheon Research / John Hubacher / (9/3/09): Electro-Stimulator, Models 4c. Pro, 6c. Pro, 8c. Pro, 12c. Pro PENS, 6c3i. Pro PEN
- Phoenix Medical Devices, LLC / James H. Klett / (9/29/09): Duet, Duet+, Duet Pain Solutions Kit, Quartet, Duet Therapy Garment Kit, SOLO Therapy Supply Kit
- P1atinum Strategies / Jamie Miralles / (9/23/09): Pineapple Fat Reducing Slimming Capsule, Tomato Slimming (Lose Weight), Slim Up, Fresh Lemon Slimming (Xian Ning Meng Shou Shen), Slim Quick Result 3 in 1, Perfect Combination Balishou Capsule, Apple Slim, and Shoufsy Activity Girl
- Pressure-Tech, Inc. / Edward Betts / (9/4/09): Flexi-Lite and Ultra-Lite Hyperbaric Chambers
- Progressive Emu, Inc. / (8/18/09): Emuprofen
- Ridge Medical Products / Michael Curry / (8/11/09): Profen HP
- Samglo Enterprises / Jess Kraft / (5/7/09): Nu-Liver, Nu-Liver PC
- South Beach Supplements / Alan Cohen / (1/9/09): Glycogone Diabetic Formula
- Synflex America / J. Roy Rogers / (7/30/09): Synflex Original Formula, Synflex 1500, Synflex for Athletes, and Synflex for PetsT
- Syntec Nutraceuticals / Joseph Wang, Edward Yeh / (5/13/09): SynOPC, SynOPC-X SynPhyto-K,SynGevity, CardioCare, and BoneCare
- Therasage, LLC / Robert A. Besner / (8/31/09): Therasage RX Healing Pads (Small, Small with Car Adapter, Medium, and Large), Therasage RX Healing Belt, the Therasage Rx Massage Beds (Models: 8000S and 8001), and TheraDesign Clothing, Bandages, and Wraps (Models: Wrist Band, Calf Band, Elbow Band, Knee Band, Ankle Band, Therapy Socks, Shoulder Cover, Therapy T-shirt, and Waist Belt)
- True Renewal / Jenine M. Cohoon / (1/6/09): Miracle Mineral Supplement, Dr Ohhira Essential Formulas Probiotics 12 Plus Original Formula, Graviola, Graviola Max, Livatrex
- U.S. Lab Research (1/6/09): Melanotan ONE, MT2
- Washington Homeopathic Products / Joseph H. Lillard / (8/25/09): CGMP deviations; homeopathic preparations Keppra, Doxorubicin, Prenisone, Lidocaine
- Washington Homeopathic Products / James Hoyt / (10/6/09): Influenzinum
- Wellspring International / Andrew J. Baechler / (11/20/09): Eniva Cholesterol Reducer
- Wonder Laboratories / (8/18/09): Ibu-Relief 12
Between May and December 2009, the FDA sent warning letters to the following online sellers of products falsely claiming to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus:
- http://www.drinking-water-filter-system.com / (5/13/09): Pandemic Swine Flu Kit for Child or Small Adult
- Ageless Herbs / (5/11/09): Great Protector Formula, Curing Pills
- Allera Health Products / (6/10/09): Immunextra
- AllerAir.com / (5/14/09): AirMedic+ Exec
- American Ultraviolet / (6/4/09): American Ultraviolet CM 15 Series, TB Series, CC Series, Eliminator Series
- Amrita Aromatherapy / Christoph Streicher / (5/28/09): Echinacea Full Spectrum, Golden Shield, and Respiratory Health
- Amyron Enterprises dba Duram Products / (5/12/09): Duram Swine Flu Kit
- Argenius Worldwide LLC / / (11/30/09): StaSafe Santizer
- Atrium Innovation Ltd. / (6/2/09): Cleanaer Room Pack, Cleanaer Home Pack.
- Becton Dickinson / (5/11/09): BD Directigen EZ Flu Test
- http://www.bestswinefluvaccine.com / (11/30/09): Best Swine Flu Vaccine
- Bioset / (5/29/09): Lymph Immune, Nose and Throat, Protease Plus, Probiotic
- Boss Safety / (5/12/09): Swine-Flu Preparedness Kit
- http://www.breathemoreeasily.com / (5/13/09): Second Wind Model 2000 Air Purifier, Second Wind Model 2018 Air Purifier
- Circular Enterprises / (6/2/09): Acai Burn
- Emergency Disaster Systems / (5/13/09): Swine Flu Protection Kit, Swine Flu Protection Synthetic Blue Vinyl Gloves, Swine Flu Protection" Nitrile Exam Gloves
- Extreme Immunity / Robert Burrows / (5/6/09): Extreme Immunity 100% Pure Immunolin
- Field Control Devices / (6/2/09): UV Aire® Air Purifier
- Fitura LLC / (5/29/09): Fitura Power immune.
- Flucinex/ (5/29/09): Performance Brand Flucinex
- Galloway Safety and Supply / (5/14/09): FlexAir PAPR Complete Kit, FlexAir PAPR High Efficiency Particulate Filter, Model S-70013-001
- GlycoMeds / (5/19/09): Cold Booster Formula, Cold Booster Plus Formula
- Guilin Hospital of Sino-Western Medicine / (5/26/09): TCM Discovery Herbal Teas
- Healing Edge Sciences / (5/15/09): Lysinol MBI, Thymus Complex BMI, Lymph Complex MBI, Argentum Elixir MBI, Inflenz Drops MB6, Inflammation Drops MBI, Olive Leaf-Mushroom Capsules MBI
- Health Food Emporium / (6/8/09): Life Extension Vitamin D3, Garden of Life RM-10, Garden of Life RM-10 Ultra, Immunity Take Care
- Healthy Choice Naturals / (5/23/09): Immune Essentials
- Herbal Remedies / (6/22/09): Sambucus Immune System Formula with Elderberry and Echinacea
- Huntington Beach Sunset / (5/13/09): Triosyn Antimicrobial Mask (Models T-5000 and T-5000V), Triosyn Folding T-3000 Antimicrobial Mask
- Hyde Park Holistic Center / David Dahlman / (11/30/09): Immune Support Formula
- Inhalation Products / (5/28/09): No Colds, No Flus inhaler, Flu Away inhaler
- Bradish Enterprises dba Island Supplements / (6/23/09): Macro Greens Nutrients Rich Super Food Supplement, Miracle Reds Anti-Oxidant Super Food Supplement
- LifeSecure / (5/12/09): On-The-Go Swine Flu Personal Infection Protection Kit, the Family Swine Flu Infection Protection Kit, Extended Swine Flu Infection Protection Kit
- Living Streams Missions / Ken Wozny / (8/11/09): Living Streams Liquid Probiotic, lora PMTM
- Luminex Corporation / (5/14/09): xTAG Respiratory Viral Panel
- Master Supplements / Jeff Thurston / (6/16/09): Theralac
- Meridian Lifeforce Inc. / (6/11/09): Symphony of Excellence Deluxe Immune System Booster & Support Package, Daily Nutrition Package, Custom Vitai Healing Steps Starter Package, No-Cold
- MicroHealth Laboratories / (9/14/09): Viraban Hand Sanitizers
- Muvezi, Inc. / (5/5/09): Guardian Silver Sol Supplement.
- Natren / (6/18/09): Natren Healthy Trinity
- Nature's Health Supply / (5/19/09): Immune-System-Plus
- VoiceBio Neva dba Nature's Sunshine / (6/5/09): Silver Shield
- Nexera Medical / (5/11/09): SpectraShield™ 9900 and SpectraShield™ Plus FFP3 Antimicrobial Respirator Masks
- Nitro Pak Preparedness / (9/13/09): Super Spectrim 10-Yr Vitamins (Super NutriVita), CeraFlu
- Nova Computers dba Nova Tech Gadgets / (5/14/09): Triosyn T-5000™ Anti-Microbial Respirator Face Mask
- Novalist Integra / (9/29/09): Swine Flu Natural Immunization, Swine Flu Monitoring [corrective letter issued 10/8/09]
- Nozin LLC / (5/22/09): Nozin
- Nutronix International / Christy Daniel, Bob Bremner / (6/23/09): New Silver Solution
- Nzymes division of Biopet / (5/18/09): Ox-E-Drops
- Perelandra Ltd. / (5/19/09): FSBS+
- Prodesse / (5/11/09): Prodesse ProFlu+ Assay
- Q-Based Solutions / (6/22/09): All Stop™ Healing and Protection Spray and Healing Gel products, All Stop™ Medicated Body Washes and Soap products, Swine Flu Enviro Pack, Swine Flu Prevention Kit, Swine Flu Family Super Pack
- Quake Kare / (5/12/09): Basic Pandemic Swine Flu Kit, Standard Pandemic Swine Flu Kit, Deluxe Pandemic Swine Flu Kit
- Rebuilder Medical / (5/3/09): Swine Flu Protection Kit
- Resolve Swine Flu / (5/14/09): Back To Health Minerals
- Rocky Mountain Environmental dba Spill Depot / (5/19/09): Noveko Surgical Masks/Respirators, riosyn T3000 Masks
- Sanuvox / (5/13/09): HFX HEPA Filter /UV Air Purifier, UV Bio-Wall Quattro Air Purifier
- Seacoast Vitamins / (6/4/09): Buried Treasure ACF High Potency
- Secrets Of Better Health / (12/1/09): Zeolite Internal Detox
- Secrets Of Eden / (5/5/09): Swine Flu... Gone
- Simple Clinic / (5/29/09): (Swine Flu) Anti-Viral Support Tablets, Children's (Swine Flu) Anti-Viral Support Tablets
- Skilling Institute / (5/14/09): Photon Genie
- SKW Ventures / Charles W. Reynolds / (9/14/09): SkinWear Hand Sanitizers
- MGS Representations dba Soapopular / (6/15/09): Soapopular hand sanitizers
- Supplements To Weight Loss / (9/3/09): Defend-Rx
- Susan Ambrosino's Herb Club / (5/4/09): Amazon A-V, Four Thieves Spray, Swine Flu Formula
- Sylvane, Inc. / (6/2909): AirFree Air Sterilizers, Verilux CleanWave Wands
- Tib Molbiol / (8/25/09): LightMix® InfA swine H1 (A/H1N1 Mexico)
- Union Springs Pharmaceuticals / (5/27/09): T-5000 Respirator, T-5000V Respirator
- Universal Health Sciences / (7/10/09): Ionic Silver
- UV Health Direct / (5/09): Eliminator Ventilation Germicidal System, AUV Eliminator RPT Air Purification System, Eliminator 14/24 Ventilation Purifier
- Viral Defender / (5/14/09): Triosyn surgical mask, Triosyn T 3000 P95 Particulate Respirator, Triosyn T 5000 P95 Particulate Respirator
- VitaCroft / Edward W. Campbell / (5/8/09): Swine Flu H1N1 Nutritional Support Kit (adults), Swine Flu H1N1 Nutritional Support Kit, age 2 to 5, Swine Flu H1N1 Nutritional Support Kit, infant to age 2
- Weil Lifestyle / (10/15/09): Immune Support Formula
- Wellness Resources / (5/19/09): Colloidal Silver, Super Immune Booster™, Activator Plus™, GI Soother™, Monolaurin, Immune Plus™, and Daily Protector™
- Whole World Botanicals / (5/12/09): Royal Camu products
This page was revised on July 19, 2011.