FDA Warning Letters about Products (1999)
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.
- Ag-Mark / Kevin D. Lynch (8/2/99): Pine-I’Dine Livestock Preparation; Canine Preparation; Livestock Preparation; Pinee An Unmixed Oil of the Long Leaf Pine
- Amrep / Kevin Gallagher (8/2/99): Misty Barrier Cream
- Atlas Operations / Gustavo Barni (6/21/99): Longevity
- Aubrey Organics / Aubrey Hampton (2/5/99): Aminoderm Gel; Maintenance for Young Skin Moisturizer; Arninoderm Gel; Egyptian Henna Shampoo; Egyptian Henna Hair Rinse; Selenium Natural Blue Shampoo; Calaguala Fern & Pine Tar Skin Treatment Cream; Calaguala Fern & Pine Tar Bath Emulsion Treatment; Calaguala Fern & Cade Tar Scalp Treatment Shampoo; Saponin A.A.C. Herbal Root Shampoo; Primrose & Lavender Herbal Shampoo; Green Tea Herbal Cream Rinse; Polynatural 60/80 Hair Rejuvenating Shampoo and Conditioner; Swimmers Conditioner; Biotin Hair Repair; Ginseng Shampoo; Tan Up Natural Tan Accelerator; After Sun Natural Tanning Maintenance and Moisturizer
- Ayla’s Hair;Skin and Fine Fragrances Ayla Hightower / (12/7/99): Ayla’s Formula 777 Skin Creme
- Bethurum Research and Development / George M. Bethurum (3/17/99): Inter-Fear-On-Magic; Iso-Ceptic; Easy-IW; Sting-A-Way; Beach-Aid
- Biotech / Gregory Kelley (7/27/99): Shen Min Activator with Minoxidil; Shen Min Topical
- Cellulite Reduction of New York / Leah Louis (11/19/99): ES 1 therapeutic massager
- Chattem / Alec Taylor (4/20/99): Echinex; Propalmex
- Digital Diagnostics / Jonathan Shedler (11/2/99): Quick PsychoDiagnostics Panel
- Discovery Experimental and Development / James T. Kimball (8/16/99): Liquid Deprenyl Citrate
- Dotolo Research / Raymond Dotolo (7/21/99): Colon Hydrotherapy Instrument model 1085
- Easy Way International / Michael W. Marlin (8/24/99): Gentle Changes with Activin essential balancing cream; EZ Cleanse capsules; EZ Calm capsules; EZ Energy; EZ Greens; EZ Omega 3+; EZ OPC
- Empowering Technologies / Michael Cloud (4/21/99): Pro-Symbio PLUS
- En Garde Health Products / Abraham A Chaplan (5/7/99): Chelo Garde; Chelo Garde Plus; FM; ginkgo biloba; Eliminetal/Out; DLPA In/Out; Colloidal Gold; Colo Zone Plus; Oxy MSM; Super Oxy DMAE-PABA; Royal Arterial Flush (kit); Improved Royal Arterial Flush; ADHD Nutritional Kit; Total Body and Colon Cleanse Kit; Nicotine/Out; Sea Salt Nasal Spray; Diatomaceous Earth; DynamQ; B12/Folic Acid Boost; Cell-regen; Colloidal silvers; Eden’s promise; G3 factors; Oxy-DHEA; Oxy-dioscorea; Oxy-dioscorea; Oxy-herbs; Oxy-herbs; Oxy-melatonin; Oxy-moxy; Oxy-MSM with Vitamin C; O2C; O2K; O2B1; Pure deanol; and Zinc; Manganese & B6 Boost
- GemKen Enterprises / James W. Herring (8/23/99): Pelocell Shampoo
- Ginesis Natural Products / Thomas C. Alsup (10/20/99): All Natural Ginesis Exclusive Formula Shampoo; Progesterone 950 mg Natural Woman Essential Body Cream; Pregnenolone Natural Aura Arthritis Joint Relief
- Health Thru Nutrition dba Health Technologies Network / Gregg Barna (8/20/99): ALKA-LINE Coral Calcium, Coral Calcium Gold, DENTAL-MAX, Metabolizer Health Aids, Metabolizer Lax-Max, Pro-Max, HTN Superfood Children's CHEWABLES, Super C & P Max, Omega 3/50+ with Shark Liver Oil
- Hobe Laboratories / William F. Robertson (8/18/99): Col-S-Rol; Lapacho; Psona-Gard Skin Treatment System Steps 1, 2, and 3
- Immunex / Edward V. Fritzky (8/23/99): Leukine
- Invigorate International / Chris Plumeri (3/8/99): Invigorate
- Kegler’s Vending Service / Arrie Kegler (3/17/99): Keg’s Arthritis Relief Formula
- Leader / Anthony D. Presutto (4/21/99): Aloe Vera Gel
- Natural Bodylines / Randal G. Park (2/4/99): Natural TrimPatch
- Natural Revelations / William S. Gandee (6/8/99): Nature’s Gel
- Nature’s Vision / Margaret M. Burco (6/7/99): Alpha Lipoic Acid; Cardio Care; Golden Seal; Kava Kava; Pregnenolone; Melatonin; MSM (Methyl Sulfonyl Methane); Natural Progesterone Cream; Saw Palmetto; Shark Cartilage Plus; St. John’s Wort; 5-HTP
- Naturopathic Labs International / David Popofsky (6/24/99): Nature’s Chemist topical ointment
- Nutritional Concepts / Michael Moore (2/11/99): Firewater (with GBL)
- Performance Health / Christopher D. Cox (4/21/99): Biofreez with Ilex
- Phillips Gulf / Brett J. Phillips (8/6/99): ARTH-Rx Oral Capsules
- Premier Direct / Paul Romano (3/11/99): XP-100; Sore No-More; AHF Anti-homocysteine Formula; CoQ10-Forte; European Health Capsule; Clear Lungs; Eye-Bright; OXY-Life; Pros-Tanima PLUS; G.I./Colon Cleansing Kit
- Scientific Health Products / David R Wimmer (8/4/99): Prevent; Life-Mate; Garden Greens; Aloe Wonder; Vein-Flex; Intimate-M; Pan-Balance; Barley-Gold; Flex-Able; S-E-T Free; Workout; Kleen-Sweep-I; Kleen-Sweep-L; Me Again; Herb-A-Derm; Depression; Inflammation-B
- Sombra Cosmetics / AIfredo Cortazar (7/14/99): Sombra Natural Pain Relieving Gel; Sore No More
- Sombra Cosmetics / Alfiedo Cortazar (8/4/99): Sombra Natural Pain Relieving Gel; Sore No More
- Something 4U / Perry Challenger (4/21/99): AmigdalindVitamin B-17 tablets; Amigdalina ampules; Apricot seeds
- Sybaritic / Steven Daffer (1/9/99): GX-99 MassageTherapy System
- TRY-Lean / Larry C. Ormson (8/31/99): TRY-Lean Formula 1 & 2
- Unique Health Solutions / Richard W. Seeley (8/6/99): MSM Eye and Ear Drops
- Vancol Industries / Robert E. Yates (10/1/99): Immunity Green Tea; Vitality Orange Pineapple; High Energy Citrus Punch; Potency Fruit Punch; Focus Watermelon Kiwi
- Vitalabs / Victor A. Shun (12/10/99): Chelated Mega Min High Potency Mineral Tab
- Viva America / David P. Fan (11/10/99): Viva Green Barley; Viva Royal Jelly
This page was revised on September 1, 2012.