FDA Warning Letters about Products (2007)
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.
- Alternative Health Approaches (9/24/07): Virupel
- Avazzia, Inc / Timothy B. Smith (6/20/07): Tennant Biomodulator™, Body-Stim™ Device, Best-Pro 1 Biofeedback Device, Best-RSI Device, Med Best and Med Sport Device.
- Beehive Botanicals, Inc. / Linda Graham (3/2/07): Standardized Bee Propolis Dietary Supplement, PropolPom; Bee Propolis Pomegranate Dietary Supplement, Bee Pollen Whole Grain Dietary Supplement (capsules, tablets and granules), Royal Jelly Dietary Supplement (1000 mg), Propolis & Herb Throat Spray, Propol-Guard Lip Balm, Therapeutic Derma Cream, Propolis 50% and 65% Tinctures
- Biotivia America / Biotivia Bioceuticals (10/15/07): Bioforte 500, Bioflu Vital
- BioForm Medical, Inc. / Steve Basta (2/15/07): Cutanix Dramatic Relief for Oily and Acne Prone Skin, Cutanix Dramatic Relief for Normal to.Dry Skin, Cutanix Dramatic Relief for Sensitive Skin, Cutanix Dramatic Relief Extra Strength products.
- Cephalon, Inc. / Frank Baldino, Jr (2/27/07): Provigil
- Efficas, Inc. (9/28/07): Efficas Care
- Eidam Diagnostics Corporation / Bernard Armani (7/26/07): CRT 2000 Thermographic System
- F.H.G. Corporation d/b/a Integrity Nutraceuticals International / Lloyd E. Slabach / Timothy J. Romero (8/22/07): NutraVitals™ Cinnulin
- Freedom Plus Corporation / Harold Zander (3/29/07): Nano Cower Facial Spray, Synergized DHEA Facial Spray, Vitamin C Facial Spray, Oxygen Facial Spray, Sunburn Relief Spra, Facial Spritzer Spray, HG/EF Hair Growth Enrichment Formula, Raahj Cosmetica Acne Skin Care, "CRS" Acne Products, Nano Zinc Dietary Supplement, Nano Potassium Dietary Supplement, Breathing Relief (Asthmatic Aid) Program, MagCal-Ionic with Vitamin C, Evening Tonic Dietary Supplement
- Fusion Brands International SRL / Randi Schinder (4/24/07): LiftFusion, brand products, Micro-injected M-To, Transdermal Face Lift, Mini Micro-injected M-Tox, Transdermal Face Lift, Micro-injected M-Tox,Transdermal Eye Lift
- Health Freedom Nutrition, LLC / Dale T. Fowkes (10/18/07): Huperzine-A, Notoginseng Extract, Prosera, Emblica Extract, Cranberry Extract, Banaba Leaf Extract, Magnolia Extract, Magnolia Max, Joint Freedom, Glucosagen On, Devil's Claw Extract, TransMis, Linolenic Ester Cream
- Health MarketPlace.com / Michael Kellett/ (10/16/07): Boswella Cream, Choless Control, Aller-DMG
- Heartland Products Inc. / Richard J. Dietrich (10/22/2007): Flax naturally Concentrated Lignans (powder), Aqua Min Concentrate, Coconut Oil and Coconut Cream Concentrate, Uber Greens, Uber Balance Progesterone, NaturGesic Cream, "Heartland Natural Joint & Pain Cream, Lice Arrest
- Jen-On Herbal Science International, Inc. / Dr. William Chang (12/12/07): H S Joy of Love
- Langer Juice Company, Inc. / David W. Langer (4/17/07): Pomegranate 100, Cranberry Berry 100, Cranberry Raspberry 100
- Lorraine Day, MD (5/9/07): BetaBeet
- Martin Nutraceuticals (aka MNI Nutraceuticals / Anthony Martin (9/10/07): Arthrizyme, Maximum Slim
- North American Medical Corporation / Carlos Becerra (3/2/07): Accu-Spina device
- Novis PR d/b/a Kramer-Novis / Carlo Cortinovis (8/8/07): Supress-DX Pediatric Drops, Gumsol Spray & Oral Solution, Tussi-Pres Pediatric Liquid, Bicarsim Antiflatuient Tablets, Bicarsim Forte Antiflatulent Tablets, Vasoflex Tablets, Vasoflex Forte Capsules, Vasoflex HD, Apetigen, Apetigen Plus Liquid, Apetigen Plus Tablets, Bio-Immunex
- Panacea Products / Barbara Brierre (5/24/07): SEABLUE Balance, SEABLUE Power, SEABLUE Vigor, SEABLUE Calm, and SEABLUE Strength
- Pjzak Enterprises / Paul Zakrzewski (3/14/07): Sea Vegg
- Proctor and Gamble / Alan G. Lafley (9/14/07): Vicks Early Defense Foaming Hand Sanitizer
- Redux Beverages, LLC / James Kirby (4/4/07):
- Sunburst Bioorganics (7/7/07): Cholestrix
- Swanson Health Products, Inc. / Lee Swanson (8/8/07): Red Yeast Rice, Red Yeast Rice/Policosanol Complex
- TheraLife, Inc. / Lily Yang (6/1/07): Wrist; Fatigue; Neck; Back & Leg (herbal products)
- Vigor Nutriceutical Healthcare, Inc. / Peter N. Choi (8/20/07): Neophase
- Zeo Health Ltd (6/27/07): Destroxin, Esdifan, Zeo
This page was revised on March 27, 2019.