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.
- Alice Man International Corp. / Mark A. Moran (3/21/14): GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, Low Thyroid Regulator
- AMS Health Sciences / Dhamendra Lachman (7/25/14): ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, Mobilite
- Bio-Recovery / Mark K. Mathews (4/1/14): Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10 products
- Biogenix USA, LLC / John Brad Leggett (12/11/14): HAM, CE6, SARMZ
- Bodyhealth / David Minkoff (2014): BodyHealth Optimum Health Survival Kit, which includes Complete + Detox, MAP amino acids, Body Detox, Silver Biotics, Lugol’s Solution Iodine,Vitamin C, Vitamin D3 and Vitamin A
- C.P. Health Products / Helen Yang (7/15/14): BellyKetone, LifeBoost, Diabetes Control, BreastCare, Blood Sugar Control, NeuroCare (homeopathic)
- Cell Vitals / Irene Hardy (11/24/19): “ReLuma Advanced Stem Cell Facial Moisturizer, ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser,” ReLuma Stem Cell Eye Cream
- Deseo Rebajar Inc / Jose Polanco-Ortiz (3/7/14): Adipotrim XT, Burn 7, Reductrol Fat Burner Formula, Adipocleanse. Adipocleanse XT, Lipozene, Slim Patch
- Dewmar Internatonal BMC, Inc. / Marco Moran (3/27/14): Lean Slow Motion
- doTERRA / David Stirling (9/22/14): Essential oil products
- Driven Sports Inc. Matthew J. Cahill (4/4/14): CRAZE
- Exclusive Supplements Inc. / Mark A. Mangieri (1/21/14): BioRhythm Olio and ReGenerate products
- Herbalife Ltd. /Michael O. Johnson (12/17/14): Order to stop implying that the FDA considers Herbalife products effectiuve.
- Intensive Nutrition Incorporated / Olivia B. Melaugh (1/22/14): Tanalbit
- Lifesilver.com (11/28/14): ASAP Solution, Patis 30 Fortified Silver Solution, ASAP Ultimate Skin & Body Care Gel (also referred to as ASAP 365 Skin Gel).
- Libi Labs, Inc. / George L. Stuart (3/13/14): Green Coffee Bean Capsules and Weightloss Supplement Capsules
- Maximus Niterider International Group Inc. / Wagdy M. Morcos (2/11/14): Nite Rider, Nite Rider Super Size, Nite Rider Plus, Pro-Male Quick Fix, Nite Tiger Max
- Natural Solutions Foundation / Rima Laibow, Ralph Fucutola (9/23/14): “Dr. Rima Recommends™ The Silver Solution” (also called Silver Sol Nano Silver, CBD Organic Dark Chocolate Bars (also called High Potency CBD Hemp Oil). Personal Protection Pack, Family Protection Pack.
- NatureAll-STF Holding, LLC, DBA: Spinal Touch Formulas / Rockland N. Draper (1/31/14): Colostrum, Valerian-Plus, Wormwood, Black Walnut-Plus, Lung-Plus, Yucca-Plus, MSM Plus, White Willow Plus, Thymus-Plus Capsules, Myrrh products
- Pacific Standard Distributors, Inc. / Bajanov Vladimir (1/23/14): Modifilan
- PI Pharma Inc. also d/b/a Nature’s Extra / Donald W. Jessup (10/20/14): Argentia Silver Cream
- Plexus Worldwide, Inc / Tarl Roninson (7/30/14): Fast Relief, ProBio5, BioCleanse
- SANUM-Kehlbeck GMBH & Co. KG / Reuiner G.D. Kehlbeck (4/11/14): Violations of good manufacturing practices
- Shoreside Enterprises / Brian D. Moses (12/23/14): Triple MiracleZEN Platinum Male Sexual Performance Enhancement (“Triple MiracleZen Platinum”)
- Slim Beauty / Paul D. Martin (1/31/14): Dr. Ming’s Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule
This page was revised on March 16, 2019.