FDA Warning Letters (56)
Nearly all of these ordered the seller to stop claiming that products could effectively treat specific diseases of conditions. Some ordered the seller to stop claiming that products were vaccine equivalents. Some involved failure to use good manufacturing practices (GMP).
- A Nelson & Co / Najib Fayad (7/26/12): Arnica, Rhus Tox
- ABCO Laboratories / Allen Baron (6/19/12): IBU-RELIEF, Sexual Virility Max
- Aurora Health and Nutrition (Robert G. Thompson, M.D.12/01/16): Homeopathic product: Cold Sore Rescue
- B. Jain Pharmaceuticals Pvt. Ltd. / Kuldeep Jain {3/21/19): Ring Relief Ear Drops, Ring Relief Fast Dissolving Tablets
- Bill Gray Medical Corp / Bill Gray, M.D. (4/2/03): Dr. Gray’s Smallpox Shield
- Bio-Botanica Inc / Josephine Perricone (6/11/87): Nature’s Answer Homeopathic Herpes Cream
- Biological Homeopathic Industries (BHI / Dr. Hans-Heinrich Rechweg (12/11/84): BHI Anticancer Stimulation Tablets, BHI Antivirus Homeopathic Remedy, and all other products
- Botanical Laboratories /James M. Lyons (12/11/84): Microbiotic No. 2 Aurinatia, Micro-Biotic No. 33 Spasrepilin, and all other homeopathic products
- Celletech / John W. Cain (3/9/00): Tetanus/LM 1, Nux Vomica, and Udder Symptom
- Celletech / Temple E. Palmer (8/28/18): Winter Tonic Plus
- Chelationcare Centers USA / Dr. Gordon Josephs (9/30/03): Anti-THRAX, Viral Immune
- C.P. Health Products / Helen Yang (7/15/14): NeuroCare (homeopathic)
- Dae Young Foods Company, Ltd. / JongWoo Kim (11/20/17): Smoker’s Appetite Relief
- Deserving Health International Corp / Bernard Amani (12/18/17): Symbio Muc Eye Drops 5X homeopathic drug product
- Dolgencorp, Inc. / Todd Vasos (9/25/13): Homeopathic product: Rexall Earache Relief Drops
- Everglo-Natural Veterinary Services / Gloria Dodd (6/24/04): Homeopathic West Nile Virus Nosode Vaccines
- Feel Good Natural Health Stores (5/21/10): Homeocan’s Thymo Immune Booster and Influenzinum 9c.
- Grato, Inc / Jesse E. Rettig (7/30/2012): Homeopathic products: Vital Male Sexual Energy,Vital HGH Skin Hair Nails, Vital HGH Immune Booster, Vital HGH, TinnitusDX, Fibro Relief, AR Arthritis.
- Health Thru Nutrition dba Health Technologies Network / Gregg Barna (8/20/99): ALKA-LINE Coral Calcium, Coral Calcium Gold, DENTAL-MAX, Metabolizer Health Aids, Metabolizer Lax-Max, Pro-Max, HTN Superfood Children’s CHEWABLES, Super C & P Max, Omega 3/50+ with Shark Liver Oil
- Healthy World Distributing / Leonard Horowitz, DMD (5/19/04): Urbani SARS Formulas
- Heel / Chris Rusnock (1/3/05): Engystol, Gripp-Heel
- HomeoCare Laboratories / Edith Scheiner (9/7/17): HBP Relief, Cholestop, IBS Relief
- Homeolab USA Inc. / Michele Boisvert (9/19/13): Kids Relief Earache
- Homeolab USA Inc. / Michele Boisvert (8/2/17): GMP violations
- Homeopathy for Health (India) / Dr. Mukesh B. Sheth (4/13/10): Swine Flu Drops, Immune Drops.
- Homeopathy Store / Jeffrey Kagan (7/6/15): Influenzinum 9C, Influenzinum & Thymuline Combo
- HomeoPet / Daniel Farringtono (1/8/97): Homeopet Miliary Eczema; Homeopet Skin and Seborrhea; Homeopet Sinusitis; Homeopet Trauma; HomeopetUrinary Incontinence; Homeopet Anxiety; Homeopet Arthritis; Homeopet Cough; Homeopet Fleas; Homeopet Hot Spots; Homeopet Gastroenteritis; EquioPathics Asthmas and Allergy; EquioPathics Worms; EquioPathics Gastroenteric-Colic; EquioPathics Hoof; EquioPathics Musculo-Skeletal; EquioPathics Nose and Sinus; EquioPathics Urinary Disfunction; EquioPathics Travel Anxiety; EquioPathics Pre-Performance Stress
- Insight Pharmaceuticals, LLC / Gary R. Downing (9/25/13): Auro Earache Relief Ear Drops
- King Bio, Inc. / Dr. Frank J. King Jr (3/20/19): Cold Sores & Herpes, Adrenal Burnout, Lymph Detox
- The Magni Group d/b/a/Magnilife / Evan Reynolds (7/15/13): Diabetic Neuropathy Foot Cream, Diabetic Foot Cream, Diabetic Hand & Body Cream, Fat Dissolver Cream, Fibromyalgia Relief Tablets, Lung Cream, Sciatica Relief Tablets, Sciatica Pain Relief Cream, Shingles Recovery Cream, Tinnitus Relief Tablets, Urinary Incontinence Relief Tablets.
- Medtech Products, Inc. / Matthew M. Mannelly (9/19/13): Murine Ear Drops for Earache Relief
- NativeRemedies.com / George Luntz (11/22/05): OralFlu Protect
- Natural Bodylines / Randal G. Park (2/4/99): Natural TrimPatch
- Natural Medicine Associates, Inc. / Arthur Yakubovsky (3/12/13): Asthma H12, Cold Sores H16, Eczema H23, Rheumatic Pain H57, Eye Irritation H25, Fever & Infection H27, Acne H11, Flu H28, Prostate H39, Chicken Pox H72, Earache H77, Fever Aid H78, Phobia & Anxiety H56, Rosacea & Redness Relief H58, Measles H80.
- Newton Laboratories / Luc Chaltin (2/20/02): Newton RX Bio-Protect
- Nova Homeopathic Therapeutics / Dr. Charles L. Bernaert (9/1/17): Depression Complex, Circulation Complex, Liver Comple
- Nutra Pharma Corp. / Rik J. Deitsch (3/11/19): Nyloxin Oral Spray, Nyloxin Topical Gel Nyloxin Topical Roll-On, Nyloxin Topical Roll-On ES, Nyloxin Professional Size Pump Topical Gel, Regular Strength Sample Pack
- Nutri-Dyn Midwest, Inc. / David S. Peterson (1/15/16): Allergy Drops, HCG Plus, Flu Terminator.
- Nutrition Dynamics / Winston G. Morrow (3/12/01): Valerian Root; Chinese Garlic; Coenzyme QIO; Optimum Health Essentials; Nux Vomica Homaccord
- Origin BioMed Inc / Richard Ceervelli, Robert Silverstein (7/15/13): Neuragen PN, Neuragen Cream
- Raritan Pharmaceuticals (6/20/17): Homeopathic Infant’s Teething Tablets
- Ratis LLC / Jeffrey Kagan (7/6/15): Influenzinum 9C, Influenzinum & Thymuline Combo
- Red Mountain Inc/ Henry B. Schur (3/20/19): Bioven
- SANUM-Kehlbeck GMBH & Co. KG / Reiner G.D. Kehlbeck (4/11/14): Violations of good manufacturing practices
- Schwabe North America / Michael Devereaux (2/15/12): Umcka® ColdCare Original Drops, ColdCare Alcohol Free Drops, ColdCare Syrup (Mint-Menthol), ColdCare Syrup (Cherry), ColdCare Sugar-Free Syrup (Grape), ColdCare Soothing Hot Drink (Lemon), ColdCare Chewable (Mint-Menthol), ColdCare Chewable (Cherry), ColdCare FastActives Powder Packets (Cherry), ColdCare Children’s Syrup (Cherry), ColdCare Children’s FastActives Powder Packets (Cherry), Cold+Flu Syrup (Berry), Cold+Flu Syrup (Orange), Cold+Flu Chewable (Berry), Cold+Flu Chewable (Orange), and Cold+Flu FastActives Powder Packets (Berry)
- Scientific Health Products d/b/a Natural Wonders / David R Wimmer (8/4/99): Depression, Inflammation-B
- Similasan Corporation / David Hinton (5/5/2003): Healthy Relief HOMEOPATHIC Ear Drops
- Standard Homeopathic Company / Mark S. Phillips (4/29/11): Hyland’s Teething Tablets, Leg Cramps with Quinine Tablets, Nighttime Cold ‘n Cough 4 Kids, Bedwetting Tablets
- Standard Homeopathic Company / John P. Borneman, Ph.D. (9/25/13): Arnicaid, Arthritis Pain Formula, Earache Tablets, Earache Drops, Infant Earache Drops, Hyland’s Kid’s Kit, Restful Legs, Teething Tablets, Teething Gel, Vaginitis, Antimonium Tartaricum, Arsenicum Album, Belladonna, Bryonia Alba, Silica, Chamomilla, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Hypericum Perfoliatum, Ipecacuanha, Magnesia Phosphorica, Mercurius Vivus, Nux Vomica, Phosphorus, Ruta Graveolens, Spongia Tosta, and Cell Salts: #4 Ferrum Phos, #6 Kali Phos, #7 Kali Sulph, #8 Mag Phos, #11 Nat Sulph, #12.
- TEC Laboratories / Steven D. Smith (4/2/19): LiceFreee Spray! Head Lice Treatment, Calagel First Aid Antiseptic, Skin Protectant, and Topical Analgesic
- Topco Associates LLC / Randall J. Skoda 9/25/13): TopCare Earache Relief Ear Drops
- University of Berkley (2/13/13): Homeopathic products: Berkley Body-Immune Flu Prevention
- Washington Homeopathic Products / Joseph H. Lillard / (8/25/09): CGMP deviations; homeopathic preparations Keppra, Doxorubicin, Prenisone, Lidocaine
- Vireo Systems, Inc. / Mark C. Faulkner (8/24/18): AminoActiv Pain Relief Capsules, AminoActiv Topical Cream
- Washington Homeopathic Products / James Hoyt / (10/6/09): Influenzinum
- ZooScape.com / Simona Heather (4/22/05): Vaccininum-Injeel
Joint FDA/FTC Warning Letters (10)
- GUNA, Inc. / Alessandro Pizzoccaro (1/11/18): GUNA-ADDICT
- HCG Diet Direct LLC / Clint Etherington (11/28/11): HCG Diet Direct Homeopathic Drops
- HCG Platinum LLC / Kevin Wright (11/28/11): Homeopathic products: HCG Platinum, HCG Platinum X30, HCG Platinum X-14″
- HCG 1234 LLC d/b/a The hCG Drops LLC / Michon Stahle (11/28/11): Homeopathic hCG
- hcg-miracleweightloss.com / Greg Grimshaw (11/28/11): HCG Extra Weight Loss Homeopathic Drops
- Homeopathy for Health / Katheryn Jones (6/8/10): Micro Nutrition Plus Flu Combo 2009-10, Micro Nutrition Plus Flu Influenzinum 200C, Micro Nutrition Plus Flu Kit Economy 1 oz Thymuline and 1 oz Winter Tonic, Micro Nutrition Plus Flu Protection Kit 3 Remedies, Micro Nutrition Plus Influenzinum 30C, BHI Bronchitis, BHI Bronchitis Chewable Tablets, BHI Flu Plus with Influenzinum, NaturalCare Flu Wellness Kit Flu and Respiratory Support, Heel Gallium Heel, Standard Homeopathic Nux Vomica 30C, Hyland’s Nux Vomica 30X, Standard Homeopathic Nux Vomica 200C, Boiron Oscillococcinum, Micro Nutrition Plus Pnemococcinum 200C, Micro Nutrition Plus Pneumococcinum 30C, Micro Nutrition Plus Thymuline 12C Immune Support, Micro Nutrition Plus Upper Respiratory Balance, and Micro Nutrition Plus Winter Tonic Influenzinum Blend
- King Bio Inc / Dr. Frank J. King, Jr. (1/11/18): Addictaplex
- Natural Medical Supply, LLC d/b/a HCG Complete Diet / Tom Hall (11/28/11):Alcohol Free hCG Weight, Loss Formula, hCG Diet Pellets Weight Loss Formula, hCG Diet Drops Weight Loss Formula
- Nutri Fusion Systems LLC / Richard Marmer (11/12/11): HCG Fusion 30, HCG Fusion 43
- Theoriginalhcgdrops.com / Dr. Gary Arbuckle, Amy Freeze (11/28/11): Homeopathic Original HCG, Homeopathic HCG
Product Recalls (4)
Recalls are generally voluntary actions taken after the FDA notifies the company that a product poses an unacceptable risk.
- King Bio Inc. (8/27/18): All water-based products for human and animal use
- Raritan Pharmaceuticals / Dr. Vin K. Nayak (11/24/16): CVS Homeopathic Infants’ Teething Tablet, CVS Homeopathic Kids’ Ear Relief Liquid, Kids Relief Homeopathic Ear Relief Oral Liquid .
- Standard Homeopathic Company (4/13/17): Hylands Baby Teething Tablets, Hyland’s Baby Nighttime Teething Tablets
- Terra-Medica (3/20/14): Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level.
Federal Trade Commission Judgments (4)
- HCG Diet Direct, LLC (2014), HCG Platinum, HCG Platinum X-14
- Iovate Health Sciences. USA, Inc., Allergy MD Rapid-Tabs
- Quigley Corporation: Cold-Eeze for cold and allergies
- Positive Response Marketing / Michael S. Levey (1993): Challenging weight-loss and impotency treatment claims for purported homeopathic products
This article was revised on September 24, 2019.
