FDA Warning Letters about Products (2008)

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. Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.

A1 Discount Vitamins (9/11/08): C-1000, Colloidal Silver, Graviola, Red Raspberry Extract, Juice Complex, Lycopene, and Pomegranate
Ageless Cures LLC / Atman Homes LLC (5/20/08): Curcumin C3 Complex, Super Curcumin C3 Complex® w/ Bioprerine and Super Curcumin C3 Complex Eco Pack
Aidance Skincare and Topical Solutions, LLC / David Goldsmith (3/3/08): Tetrasil, Genisil, Tetrasilver Tetroxide (TST) Ointments
Aviralex International / Caroline Buckley (3/3/08): Aviralex
Bayer HealthCare LLC / Gary Balkema (10/27/08): Bayer Women's Low Dose Aspirin + Calcium
Bayer HealthCare LLC / Gary Balkema (10/27/08): Bayer Aspirin With Heart Advantage
Behavioral Therapeutics / Timothy H. Morgan / Connecticut Educational Services / Robert F. Reynolds, Ph.D. (4/24/08): Good Vibrations Device
Best on Earth Products / (5/20/08): Black Salve, Black Salve with DMSO, and Black Salve Bloodroot Capsules, Ellagic Insurance Formula
Cansema / Burt Hampton (5/20/08): Cansema Black Salve Mix
Care Tech Industries / John O. Shannon (1/3/08): Odatus recirculating air cleaners
Coca-Cola Company / Muhtar Kent (December 10/08): Diet Coke Plus
Cura-Care.com / WallCann / Bill Chain (5/21/08): Curaderm-BEC5
Daniel Chapter One / James Feijo (4/15/08): 7 Herb Formula, Apple Pectin Plus, CoQ10
Dherbs.com (6/2/08): Astragulus-Goldenseal-Echinacea (extract), Full Body Detox Kit, Prostate Formula, Oxy-Drops, Parasite and Worm Kit & Regimen, Bio Insulin, and Female Breast Oil
Diapro, Inc. / John A. Gentile (10/17/08): Diapro All Natural PentosePlus
FemHealth / John Stigaard (6/2/08): New Sun NKC-C Agaricus Blazei capsules, New Sun NKC-C Agaricus Blazei Super Concentrate Vial, New Sun Green Tea, New Sun Grape Seed Extract, New Sun LIV Combination, New Sun Flax Seed Oil, New Sun Super Sam (Super Sam Generic Samento, Cat's Claw), New Sun Vital PR. & BR., and New Sun Yew/Olive Combination
Food For Life Baking Company / Robert James Torres (5/27/08): Food For Life Spelt Bread
Gaunitz Hair Sciences / William F. Gaunitz (8/7/08): THL-1 Handheld Laser
Gemtronics / William Isely (4/17/08): Agaricus dried Grade A, Agaricus dried Grade A Powder, Agaricus Capsules, Agaricus sweet Extract, Agaricus strong Extract, RF 1000 Extract, APM Extract, RAAX11 Extract, and OPC Extract
Generation's Black Salve / Peggy Booth (5/20/08): Generation's Black Salve
Joe Glickman, M.D. (3/4/08): Beta-Mannan, Micronutrient
Goosefoot Acres / Peter A. Gail (11/19/08): Dandy Blend
Iloveblow.com / Jennifer Gulla (1/31/08): Blow (cocaine alternative)
H & L Worldwide (5/20/08): Best Curcumin with Bioperine, Curcumin, Breast Health - Breast Support Formula, Comprehensive Prostate Formula, Coral Calcium, Grape Seed Extract, Organic Flaxseed Oil, Immune Ace, IP-6 Inositol Hexaphosphate, Lycozyme, Lycozyme Extra Strength, and Shark Cartilage
Hato Potrero Farm / Gustavo Perez (4/3/08): Yo Gusto Smoothie Drinkable Yogurt, Kumis, and Hato Potrero cheese products
Health Center For Better Living / Todd Weardon / Aaron Weardon (8/22/08): Green Tea Capsules, Lycopene, Melatonin, Omega 3-6-9, Omega 3, `Prostate Support, Selenium and Turneric
Institute For Health Aging / Mark A. Rosenburg (6/2/08): Green Tea Extract, Melatonin, Myco-Immune Complex, Selenium,Shark Liver Oil, Squalamine and Vitamin K2
Herbal Hope, Inc. / Morrell Neely (2/25/08): Restoration, Real Relief, Invigorate, Breathless, and Immunity
Herbs For Cancer / Mary Spohn (5/27/08): Bladder Cancer Tea Formula, Bone Cancer Tea Formula, Breast Cancer Tea Formula, Colon Cancer Tea Formula, Esophageal Cancer Tea Formula, Lung Cancer Tea Formula, Malignant Lymphoma Tea Formula, Nasal Cancer Tea Formula, Prostate Therapy Tea Formula, Skin Cancer Tea Formula, Special Tea Formula, Stomach Cancer Tea Formula, Tongue and Oral Cancer Tea Formula, Uterus and Cervical Cancer Tea Formula, and Ellagic Acid
Herb Time / Karyl Sellinger (5/22/08): C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream
HoMedics, Incorporated / Roman S. Ferber (6/16/08): TheraP Deluxe Automatic Blood Pressure Monitor and Therapist Select Massagers
Imulux LLC / Jon F. Stoneburner (3/4/08): Imulux
Jerusalem Manufacturing Natural Foods & Wholesalers, Inc. / Albert S. Batshon (9/2/08): Jerusalem World Pure Foods brand Turnip Pickle and Jerusalem brand Pita Bread, Spelt Wheat Free
JHS Natural Products / John Seleen (5/20/08): Pectasol
Kids Co., Ltd. / Yugengaisha Kids / Johdic Takano (December 3/08): Pyro-Energen II and Pyro Nerve Stimulator Devices
Laser Therapeutics, Inc. / Neil Camera (3/21/08): Softlaser, Beurer, Etrans, and Vitalmed
LifeGuard Health / Kenneth A. Krieg (7/29/08): Cardio Omega Benefits, Flex Omega Benefits, and Kid's Omega Advantage
OXi-MED / Blair McKinnon (3/4/08): OXi-MED
Millenium Health LLC (5/21/08): Ellagic Acid 1000mg
Natural Biology, Inc. / James Bruner (10/9/08): Nano HGH and Vintage Resveratrol
Nature's Alternatives (6/2/08): African Pygeum Bark, Brazilian Pau d'Arco Bark, Burdock Root, Chinese Astragalus Root, Chinese Fo-Ti Root, Chinese Ligustrum (Privet) Fruit, Cleavers Flowering Herb, Fresh Venus Flytrap, Indian Turmeric Rhizome, Japanese Maitake Mushroom, Peruvian Cat's Claw Bark (Una de gato), Red Reishi Mushroom, Sheep Sorrel Herb, Shiitake Mushroom, Stillingia Root, Hoxsey's Red Clover/Burdock Plus, Immun-Essence Plus, Mai-T Mushroom Plus, Venus Flytrap/Cat's Claw 50/50, Native Essense Original Dry Tea, Native Essense Plus Dry Tea, Native Essense with Cat's Claw Dry Tea, Native Essense Original Liquid Extract, Native Essense Plus Liquid Extract, Native Essense with Cat's Claw Liquid Extract, American Ginseng/Kava Kava Plus, Astragalus/Ligustrum 75/25, Bilberry/Schizandra Plus, Black Walnut/Wormwood Plus, Cat's Claw/Astragalus/Reishi, Cat's Claw/Pau d' Arco Plus, Catuaba/Fo-Ti Plus, Damiana Plus, Dandelion/Milk Thistle Plus, Devil's Claw/Cat's Claw Plus, Dong Quai/Fo-Ti Plus, Echinacean Plus, Gravel Root/Uva Ursi Plus, Laxa-Tonic Plus, Milk Thistle/Schizandra Plus, Panax Power Plus Ginseng Tonic, Prosta-Tonic Plus, Red Root/Cleavers Plus, Slim-Tonic Plus, and SumaCeps Plus
Nature's Way / Dirk Reischig (1/25/08): Red Yeast Rice
NeumaLife / Martin Williams (3/4/08): Qina
Newman's Own Organics / Peter Meehan (December 22/08): Second Generation Spelt Pretzels
New Sun, Inc. / Cecilia Salvadori (6/9/08): New Sun Grape Seed Extract, New Sun Super Sam (TOA Free Cat's Claw) and New Sun Yew/Olive Combination
Nutrition 2000 (6/3/08): Cesium and Potassium Combo, Curcumin, Men's Prosta-Life, PC Hope, Platinum, Protocel Formula 23, Protocel Formula 50, and Surcan
Nutritonal Counselors of America / 6/M. Wiles (6/9/08): Zinc Citrate, L-Glycine, Graviola, Hawthorne Berry, Cloves, Olive Leaf Extract, Beta 1-3, 6D Glucan
Omega Supply / Erick Del Rio (Seprember 17/08): Amygdalin/Laetril (sic) tablets, Amygdalin/Laetril inyectable (sic) solution, Cyprenil/Selegiline, Hydrazine Sulphate capsules, Clodromax (Clodronate Disodium) capsules, and Cloracesium/Cesium Chloride capsules
PDQ Herbals / Richard McPhail (5/20/08): P.D.Q.! Herbal Skin Cream and Medicardium
Pilex Corporation / International Pharmaceutical Corporation / Som Pruthi (2/7/08): Malariam, Arthritan, Hepatan, and Pilex
Plant Cures Incorporated / The Herbal Healing Place / Desert Dragon Healing Center / Christoher Gussa (5/27/08): Bloodroot Extract, Ojibwa Tea or Essiac, and C-Cell 4 Destroyer
Precision Herbs, LLC / Overman's Healthy Choices / James R. Overman (5/21/08): Activase, Amorph, Apritum, CanAlk, CancerGene, Carcinogex, Fungustum, Molex, Neoplasmex, Pau d Arco Bark, ThermaPop, TNF-Max, TumGo, Tumorex and VX-O
Prismic Light International / Sandent Co. / Timothy M. Sanders (8/14/08): Cell Renew and Cell Renew Essential Silica
ReBuilder Medical Technologies / David B. Phillips (7/16/08): ReBuilder and ReBuilder EMS devices
Road To Healing (5/29/08): Cat's Claw, Chlora Plasma, Melatonin, Native Herbal Tea Rene Caisse's Original Formula, and Red Clover Plus
Saferex Laboratories International Corporation / Thomas Perry (3/4/08): SlicPlus
Savec Health Systems / Admar Jinga (December 10/08): Omnivir device
SeniorLife Health (8/21/08): Green Tea Extract, Healthy Heart Essentials, Men's Multi 45 Plus Daily Essentials, Omega 3-6-9 Complete, Prostate Health Essentials, and Women's Multi 45 Plus Daily Essentials
Sharp Labs, Inc. / Stephen C. Sharp (7/9/08): Acai Juice, Alkaline Herb Drops, Ph Drops, Cesium Bladder Package, Cesium Breast Support Package, Cesium Colon Package, Cesium Liver Health Package, Cesium PH Antioxidant Package, Cesium Prostate Package, Cesium Skin Package, Chlorophyll with Aloe Vera Juice, Cranberry Drops, Flax Complete 3000, Green Tea Extract, Healthy Greens, Liquid Cesium Ionic, Liquid . CoQ10 - 8 oz, Liquid CoQ10 Natures Answer, Liquid Germanium, Liquid Selenium, Liquid Vitamin C (Dynamic Health), Molybdenum, Pau Darco [sic] - Alta Health, jShark Cartilage, Vitalica Broccoli, and Wheatgrass Drops
Sleeping Bear Apiaries / Kirk D. Jones (10/22/08): Michigan Montmorency 100% Pure Cherry Juice Super Concentrate and Real Raw Honey
Sunetics International Corporation / Charles Maricle (8/7/08): Sunetics Laser Hair Brush and Laser Skin Brush
Tattva's Herbs / Peter Bowes (7/9/08): Body Pure, Evening Primrose Oil, Female Plus, Organic Ashwagandha, Organic Mucuna, Organic Neem, Premium Turmeric - BCM95 BioCurcumin, Turmeric Extract - Bulk, Turmeric Plus, Prostate Support, and Organic Ghee
Teeter Creek Herbs Company / Robert M. Liebert / Jan M. Liebers (5/19/08): Hrt-Tone, Immunaid, St. John's Wort Oil, St. John's Wort, Sugarease, Lvr-Tone, and Echinacea/Goldenseal
TriHerba Marketing / Carson Krogh Christensen (5/21/08): Triherba Black Salve, Triherba Black Salve Tonic, Herbal Horizons Heart Drops, and Glucose Balance
USA Golden Vision, Inc. / David Tan / Paul Brucato (5/21/08): SunRecome in Packets and SunRecome in Capsules
VIBE Technologies / Gene E. Koonce (4/11/08): VIBE Machine
Vital Nutrients / Enrico Liva (11/108): DMSA, co-enzyme Q10, glucosamine
Vitapurity Corporation (5/20/08): Citral, Ellagic Ultra, Lycopene 25, Pacific Ocean Shark Cartilage, Miracle Mushroom Blend, and Buffered Vitamin C Crystals
Vitasalus, Inc. / Nu-Gen Nutrition, Inc. / Robert Cloutier (6/3/08): Ocean Treasure Coral Calcium,Colostrum, Electrolyte Formula (Cantron), Ellagenol, Squalamax, Ultramarine Omega-3TM Virgin Salmon Oil Gelcaps and Ultramarine Shark Liver Oil

This page was revised on July 19, 2010.