FDA Warning Letters about Products (2010)
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.
- Artery Health Institute, LLC / Howard Souse (10/12/10): Advanced Formula EDTA Oral Chelation
- BioVeda / Brad Goldstein (11/4/10): Bax3000 device
- Cardio Renew, Inc. / Kevin Raymond / Jay Hoogenakker (10/12/10): Cardio Renew, Cardio Restore
- CTI Science, Inc / Boyd E. Haley (6/17/10): OSR#1
- CVS Corporation (9/27/10): CVS Complete Care Anticavity Mouthwash
- Evenbetternow, LLC / Donald Nichols ,/ Andrea Nichols / (10/12/10): Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, Heavy Metal Screen Test
- Rhonda Henry (10/12/10): Pure Heart, Melatonin, Flaxseed Meal, DHEA, Cardio Chelate (H-870)
- Healthy World / Dr. Leonard Horowitz / Jacqueline G. Lindenbach (5/11/10): Oxysilver, PrimoLife, ZeoLife, Green Harvest, ElectrOEnyzmes, OxySilver Immune Support Hydrosol Concentrate, GI Flora Pro, OxyAdvantage, Love Minerals
- 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.
- Hormonal Health LLC / Richard D. Brooks / Joan R. Campbell (10/12/10): Kelatox suppository, METALDETECTOR Instant Toxic Metals Test
- Johnson & Johnson (9/27/10): Listerine Total Care Anticavity Mouthwash
- Longevity Plus / Van Cleve (10/12/10): Beyond Chelation Improved, EndoKinase, Viral Defense and Wobenzym-N 200ct
- Maxam Nutraceutics/Maxam Laboratories / James G. Cole (10/12/10): PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, Heavy Metal Screening Test
- Walgreen Company (9/27/10): Walgreen Mouth Rinse Full Action
- World Health Products / Jay Salmon (10/12/10): Detoxamin Oral, Detoxamin Suppositories, Metal Detector test kit
This page was revised on May 28, 2011.