FDA Warning Letters about Products (2011)
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.
- Abba Pharma Inc. / Carlos Gomez (2/9/11): Proteinex Liquid Predigested Protein, Proteinex Wound Care, Nephronex Liquid Dietary Supplement
- Central Coast Thermography / Breast Health Imaging Centers (1/6/11): FLIR Series Infrared cameras
- Chronicity Inc. / Robert S. Baurys II (9/7/11): Anti-Viral, Artemisinin, Cellular Health, Chol-Less, GastroHealth, Leuko-Stim, Omega 3, and Selenium
- HCG 1234 LLC d/b/a the hCG Drops LLC / Michon Stahle (11/28/11): Homeopathic hCG
- CocoKefir LLC / Michael Larsen (11/22/11): CocoKefir probiotic products
- Galloway Technologies / Joseph S. Galloway (8/25/11): Asyra Galvanic Skin Response Measurement devices
- HCG Diet Direct LLC / Clint Etherington (11/28/11): HCG Diet Direct Homeopathic Drops
- hcg-miracleweightloss.com / Greg Grimshaw (11/28/11): HCG Extra Weight Loss Homeopathic Drops
- Inno-Health Technology (1/21/11): Aculife electro-acupuncture device
- International Institute of Holistic Healing / Aundrea Adams (4/28/11): Colloidal Silver 500 ppm (Liquid), Essaic Tonic Liquid Drops, and Oil of Oregano P73 Physician's Strength
- Meditherm Inc / Dr. Peter Loando (4/4/211): Meditherm Med2000 infrared cameras
- Dr. Joseph Mercola / Dr. Mercola's Natural Health Center (3/22/11): Meditherm Med2000 infrared cameras
- Neuroscience / Gottfried H. Kellermann, Ph.D. (12/18/11): Avipaxin, Calm-PRT, Cerelist, DL-phenylalanine, GI Reset™, NorLox, Recolonize-1: Th1 Inhibitor™, Taurine, Zymenta
- Nutri-Dyn Midwest Inc / David S. Peterson (1/15/16): Pau D’Arco (DNA Laboratories brand), SAMe-200 (Progressive Labs brand), Gugulipids, Standardized Extract 340 mg (Progressive Labs brand), Metal Detox, D3 5000, CardioAuxin™ BP, Coenzyme Q10, OmegaGenics™ Mega 10™, d ArginCor™, Allergy Drops, HCG Plus, Flu Terminator,
- Nutri Fusion Systems / Richard Matmer (11/28/11): Homeopathic products: HCG Fusion 30, HCG Fusion 43
- Precision Herbs / James R. Overman, ND ( 12/1/11): Chi Max Protectors, Chi Max Water Wand, Chi Modulator Attachment, Electrolysis Foot Tub, Harmonic Combo, Harmonic Quad HQ, Harmonic Transmitter, Healing Detox Attachment, Heart-Shaped Pocket Diode, Reflective Blanket
- QLaser Healing Light LLP, Robert L. Lytle (3/3/11): Q10 Laser, 808 Enhancer Probe, Q1000 Laser, 660 Enhancer Probe
- Spinetronics / Dr. Scott Bass (7/25/11): Antalgic-Track spinal decompression machine
- 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
- Theoriginalhcgdrops.com / Dr. Gary Arbuckle, Amy Freeze (11/28/11): Homeopathic Original HCG, Homeopathic HCG
This page was revised on September 25, 2018.