FDA Warning Letters about Products (2014)
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
- Bio-Recovery / Mark K. Mathews (4/1/14): Bio-Lithium, Niacinamide, Bio-Aminos, and CoQ-10products
- 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
- 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
- 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
- Plexus Worldwide, Inc / Tarl Roninson (7/30/14): Fast Relief, ProBio5, BioCleanse
This page was revised on June 25, 2015.