FDA Warning Letters about Products (2003)

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.

Advanced Pharmaceutical Research (2/28/03): Thermo Thunder
Advanced Sports Nutrition (2/28/03): Thermalean
Affordable Supplements / David Gray (2/28/03): Speed Stack, Dyma-Bum Xtreme, EPH 833
American Bodybuilding (2/28/2003): Ripped Force and Extreme Ripped Force
American Nutraceuticals Company / Bjarte Rene (11/6/2003): Cholester LOW 2™, Coral Calcium, Apple Cider Vinegar, Staying Power Rx, Horny Goat Weed, epa-sol™ High Concentrate Omega-3, ProstaMAX-1265, Snooze & Lose™, DownSize™
Anabolic Store (2/28/2003): Rage and NitroPhen
Apollo Fulfillment / Margaret Chunias and Nick Chunias (2/28/2003): Dymetadrine Xtreme, Thermbuterol, and Gut Cutter
AST Sports Science (2/28/2003): EPH833, Dymetadrine Xtreme, and 3 Andro Xtreme
Beefcake Nutrition / Dennis Matteson (2/28/2003): EPH 833, Stacker 2, and Dymetadrine Xtreme
Beyond Muscle.com / Shirley Baisden (2/28/2003): Stacker 2
Bio-Engineered Supplements and Nutrtion, Inc. (2/28/2003): Thermonex
BroadVision Nutrition / Kelly Hoerr (1/21/2003): Simply Soy Vanilla Burst, Simply Soy Chocolate Mousse, and Simply Soy Strawberry Swirl
Cherokee Naturals, Inc. (3/31/2003): Organic Ecstacy tablets, Space Cadets capsules, Druids Fantasy capsules, Bliss Extra capsules
Conklin Company, Inc. / Charles Herbster (3/5/2003): Fortress Protective Skin Cream
Cocoon Nutrition / Steven Heuer (3/7/2003): Cocoon GH-Liquid Spray Growth-600 ng
Creating Health Institute (5/8/2003): Millenium CF
D&E Pharmaceuticals, Inc. / Eric Organ (2/28/2003): Ephedra Super Caps, Bolt Natural, and On The Go
Ayoula Dublin (7/22/03): Lipostabil
Extreme Labs (2/28/2003): Extreme 1200
Extreme Sports Nutrition / Brian Gonsalves (2/28/2003): Stacker 2 and Rage
Fitness First U.S.A. / Mark Landsperger (2/28/2003): Dymetadrine Xtreme
GotSupplements.com, (2/28/2003): Dymetadrine Xtreme and Thermbuterol
Green Shack Direct / Sandie Smith-Fuller (7/22/2003): No-Rad, Body Gold
Greenvalley, LLC / Michael Peng (9/6/2003): Revitalize, Revitalize II™, and Prostete Pads™
Healthy Christian Living (5/7/2003): Colloidal Silver
Herbal Fields Supplements (5/8/2003): Curcumin and Pycnogenol
Higher Power Nutrition / Ryan DeLucca (2/28/2003): Higher Power Ephedra, Xen Xtreme XS, Xen-Extreme 1200, Ripped Action, Dymetadrine Xtreme, ThermoneX, Stacker 2, Ripped Fuel Thermogenic Protein Mix, Ripped Fuel, Ultimate Orange Speedball, and Simply Cut
Life Extension Center, Inc. / Marcelo Luna (1/10/2003): Dolgel 100mg
LifeLine Energetics, Inc. / Virginia Donohue, Tim Donohue (4/25/2003): Baseline™- Essential Multi-Mineral Concentrate, MagneCal™ Magnesium/Calcium Mineral Concentrate, Immunitol™ Mineral Concentrate for a Healthy Immune System , Performance +™ Ultimate Performance Enhancer Concentrate, Germanium™ Mineral Ultra-Concentrate , Chromium™ Mineral Ultra-Concentrate , Vanadium™ Mineral Ultra-Concentrate, Silver™ Mineral Ultra-Concentrate, Potassium™ Mineral Ultra-Concentrate, NutriZyme™ Essential Multi-Enzyme Blend, VitaCore™ Essential Vitamins and Antioxidants, SDG-35™ Concentrated Flax Lignans
Jeffrey Maehr, D.C. (5/8/2003): Beta Glucan
Media Power, Inc. / Kenneth Byers 3/6/2003): CalMax, Nu- Zymes and Bl-Bomber
Metagenics, Inc. / Jeffrey Catch (10/1/2003): UltraClear®, UltraMeal®, UltraInflamX™, and UltraGlycemX™
Muscle Shoppe (2/28/2003): Ripped Force, Nitro Speed, Gut Cutter, Ripped Fuel, and Dymetradrine Xtreme
Natural Balance Inc. (2/28/2003): Turbo Charge and Power Shape
Natural Ovens of Manitowoc, Inc. / Paul Stitt (4/8/2003): 7 Grain Herb Bread, Multi-Grain Stay Trim Bread, Right Wheat Whole Grain Bread, and 100% Whole Grain Bread, Ultra Omega Balance TM Flax Based Supplement with Added Soy, Sunny Millet Bread and Health Max Whole Wheat Bread
The Muscle Shop (2/28/2003): Thermal Cuts
Peter M. Zeischegg MS, DC (5/7/03): Arabinex, Pleo-Quent, Pleo-Not, Im-Encap
Powerhouse Supplements / Bryan Green (2/28/03): Thermbuterol, Gut Cutter, Dymetadrine Xtreme, 3-Andro Xtreme
Pure Prescriptions (5/8/2003): Alleged SARS prevention products
Regency Medical Research: KI-Spray™, Vitamist
Scientifically Advanced Nutrition (2/28/03): Ephredrine-25
SCS Intensive Nutrition (5/8/2003): Suggested Regimen (for preventing SARS)
Selfworx / Jeffery Kral (4/17/2003): Skin Zinc Spray and Skin Zinc Cream
Shredded Texan Nutrition / Paul Richardson (2/28/03): Thermadrene and Thermbuterol
Similasan Corporation / David Hinton (5/5/2003): Healthy Relief HOMEOPATHIC Ear Drops
Twinlab / Ross Blechman (2/28/2003): Diet Fuel, Ultimate Diet Fuel, and Energy Fuel
Underground Sports / Mike Rocheleau (2/28/2003): Ephedrine 25
Universal Nutrition (2/28/03): Hot Shot, Animal Stak, Animal Cuts, Natural Sterol Extreme, Kwik Energy, Unidyne, and Rage
Vitamins Etc. / Thomas Wick (2/28/03): Stacker 2
Young Again Nutrients (5/7/2003): Better Immunity BETA 1,3/1,6 GLUCAN

This page was revised on October 3, 2007.