FDA Warning Letters about Products (1997)
The US 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.
- ABCO Laboratories / Akin Baron (10/7/97): Chomper
- Achievers Unlimited / Kathy Connelly (10/23/97): CardioForce; Cytopro; TranQuell; CytoPure; MaxiLeane; Tri.Chromaleane; CytoLife
- Adirondack Purification Co. / Jack C. Bills (5/9/97): Kleen Air-King II Portable Ozone Generators; Duct Air Purification and Disinfecting Systems
- Alva-Amco Pharmacal Co. / Jeffrey Gerchenson (8/1/97): Herpetrol
- America’s Best Nutrition / Jane Blanks (12/24/97): Trim-Phen
- Arise & Shine / Avona L’Carttier (10/7/97): Chomper
- BDI Pharmaceuticals / Richard Deer (2/24/97): Mini Thin
- Bio-Life International Corp. / Won Ok Oh (4/2/97): Jimmy John colon hydrotherapy unit
- Bio Magnetics International / Erik K. Affholter (7/23/97): Magnetic Belts and Straps
- Body Systems Technology / William E. Chase (1/17/97): Easy Trim Spray Formula
- Chain Reactions / Karen Porrazzo (5/8/97): Kleen Air-King II Portable Ozone Generators; Duct Air Purification and Disinfecting Systems
- Chongqing Bashan Instrument Factory / Li Jun Feng (8/13/97): Teding Dianci bo Pu (TDP) Special Electromagnetic Therapeutic Apparatus
- Citi Pharmaceuticals / Melanie Materazzi (1/16/97): Friatroy
- Colon Hygiene Services / Rocky Bruno (6/20/97): colonic irrigation device
- Colon Therapeutics / Jimmy J. Girouard (4/21/97): Jimmy John colon hydrotherapy unit
- Consummated Productivity Co / Melchor R. Jayme (12/9/97): Bio Normalizer
- Equinox Botanicals / Paul Strauss (3/5/97): Golden Salve
- Estee Lauder / Leonard Lauder (12/15/97): Clinique
- Formulation Technology / Keith W. Hensley (10/7/97): Chomper
- Gynecare / Augustine Lien (2/5/97): Uterine Balloon Therapy system
- JB Harris / Harris Schnall (7/14/97): Kolorex Capsules; Kolorex Cream
- Health Advantage / Raymond D. Mutter (1/17/97): TPros
- The Health Connection / Benjamin Cohen (3/5/97): SPV-30
- Herbarium / Nicholas Senchyshak (10/8/97): Chomper
- Heritage Institute / Hannelore M. Davis (6/20/97): 10/4 Chakra charger; Bio Shield 2000; Rare earth magnets; Braasier magnets; Shoe magnets; Gemini Dual Pacer
- Hillestad International / Donald L. Hillestad (1/28/97): Z-23 Prostate Formula; Opti-Cran Freeze-dried Cranberry with Aloe; Citri-C Wafers, Ginseng Plus "C" Chewing Gum; Dialyvite Multi-vitamins for Chronic Renal Failure
- Home Health Products / Dennis Schoen (12/11/97): Vapohaler Inhalant
- 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
- HPF / Brian Haverson (11/5/97): Herbal Phen-Fen; Herbal Phen-Fen Stage 2
- SC Johnson and Son / Samuel C. Johnson (7/24/97): Aveeno Bath Treatment; Aveeno Cleansing Bar
- Kaiser Farms / Al J. Kaiser (11/21/97): Wisconsin Ginseng
- Lane Labs USA / Andrew Lane (9/24/97): BeneFin; Skin.Answer
- Lenco’s Products / Rawle E. Nicholas (11/13/97): Wild Root Tonic; Aunt Betty’s Women’s Tonic; Aunt Linda’s Bitters
- Morris Levin and Son / Paul Atlas (7/23/97): Silver Wain-Water
- LPD USA / Nathalie Guitay (6/5/97): ESI device
- Luxar Corp. / Shimon Eckhouse (8/13/97): Silhouette; Liponic Sculpting System
- Magnetherapy / William L. Roper (2/3/97): Tectonic Magnets
- Melaleuca / Frank Vandersloot (7/3/97): ProVex; ProVex-Plus; Replenex
- Miramar Industries / George Hamilton (9/7/97): H-Wave Powered Muscle Stimulator
- Nature’s Cathedral / LeRoy J. Ballard (10/6/97): Chomper
- Nutraceutical / Bill Gay II (10/6/97): Chomper
- PDK Labs / Michael Krassnof (2/24/97): MaxAlert
- Physicians Botanical / Michael Boumil (10/6/97): Chomper
- RH Cosmetics Corp. / Richard Solomon (2/4/97): Dermetics Australian Tea Tree Oil; Barth’s Australian Tea Tree Oil; Daggett and Ramsdell Australian Tea Oil Skin Tonic
- RichMark International / Richard A. Piccolo (9/24/97): Rejuveness
- Shank’s Extracts / Jeffrey F. Lehman (7/9/97): Rawleigh Internal Anti-Pain Oil; Rawleigh External Anti-Pain Oil Liniment; Rawleigh Rawleigh Internal Liniment; Shank’s Antiseptic Salve; Rawleigh Ready Relief Inhalant; Rawleigh Antiseptic Solution
- Tiller Mind and Body / Jerl C. Tiller (6/2/97): Libbe colonic irrigation device
- Universal Protein Supplement Corp / Clyde V. Rockoff (7/30/97): [redacted]
- Vital Health Products / Conrad LeBeau): (8/19/97): Bio-Oxygen
- Vitalizer 2000 / Peter P. Darula (2/20/97): Vitalizer 2000
- Woodstock Natural Products / William Stern (12/11/97): The Natural Dentist Herbal Mouth and Gum Therapy Daily Oral Rinse; The Natural Dentist Herbal Toothpaste and Gum Therapy
- Yat Chau USA Ginseng City / Kelven K. Yip (10/27/97): Ginseng
This page was revised on August 20, 2006.