In 2000, FDA began issuing "cyber" letters, (letters sent
electronically via the Internet), to web sites whose online sales of
prescription drugs may be illegal. The letters warn these website operators that they may be
engaged in illegal activities and informs them of the laws that govern prescription drug
sales. A Press Release dated
February 2, 2000 describes these "cyber" letters in more detail.
These "cyber" letters, sorted by month, are supplied by FDA's
Center for Food Safety and Applied Nutrition (CFSAN) and CDER Division of Information Disclosure Policy. Cyber
letters issued from CFSAN are to Internet Website Operators promoting dietary supplement products that claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class of diseases. Matters described in all FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain additional information on the current status of an issue
in a particular warning letter or notice of violation on this website, please contact the
Agency or the recipient of the letter directly. Inquiries to FDA should be sent to:
Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane,
Rockville, MD 20857. Instructions for how to submit an FOI request can be found on the FDA FOI Page.
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|
December, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Nattokinase, Tryptozen, and Coral Calcium [PDF] |
Michael Zaccardo
New Life Foods |
12/15/2005 |
8/6/2008 |
Starters' Traditional Chinese Ephedra Herbal Tea [PDF] |
Life Enhancement Products, Inc. |
12/1/2005 |
12/20/2005 |
November, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Soy Futura [PDF] |
All Natural Pain Relief Inc. |
11/9/2005 |
11/10/2005 |
Z-LABS Progesterone Cream [PDF] |
Bio-Health |
11/9/2005 |
11/10/2005 |
Estro Femme [PDF] |
BuyInnovations.com |
11/9/2005 |
11/10/2005 |
Growyoung Soy Isoflavones with Genistein and Daidzein [PDF] |
CHS International Research Ltd. |
11/9/2005 |
11/10/2005 |
Soy Isoflavone Extract 40% (250mg) [PDF] |
ComCore 21 Corporation |
11/9/2005 |
11/10/2005 |
Phyto-Soy [PDF] |
Greatest Herbs on Earth |
11/9/2005 |
11/10/2005 |
HMS Queen's Progesterone and HMS King's Progesterone [PDF] |
HMS Crown, Inc. |
11/9/2005 |
11/10/2005 |
Soy Isoflavones E [PDF] |
Healthworks 2000 |
11/9/2005 |
11/10/2005 |
Solaray PhytoEstrogen [PDF] |
Healthy Days, Inc. |
11/9/2005 |
11/10/2005 |
HebaSoy [PDF] |
Heba Laboratories, LLC |
11/9/2005 |
11/10/2005 |
Soylife Isoflavones 1000mg [PDF] |
Herbal Fields Supplements |
11/9/2005 |
11/10/2005 |
Soy Isoflavone Extract 250mg (PDF] |
Nutriteam, Inc. |
11/9/2005 |
11/10/2005 |
Barbec Basics Natural Progesterone Cream [PDF] |
One Life USA |
11/9/2005 |
11/10/2005 |
Solaray Genistein PhytoEstrogen [PDF] |
Suzanne's Natural Foods |
11/9/2005 |
11/10/2005 |
Remifemin and Prolongevity Mega Soy Extract [PDF] |
The Way Up |
11/9/2005 |
11/10/2005 |
Estro Femme Tablets [PDF] |
Tip Top Vitamins |
11/9/2005 |
11/10/2005 |
October, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Revivo [PDF] |
Josef Margraf NatureProducts |
10/25/2005 |
12/20/2005 |
Organic Turmeric, Bowel Care Formula, Tulsi, Flexibility Formula and Neem [PDF] |
Michele Sondheimer
Om Organics, LLC |
10/20/2005 |
9/9/2008 |
B.A.V. Botanical Anti-Viral Immune System Support and Arctic Root [PDF] |
John Luby
Viable Herbal Solutions |
10/14/2005 |
9/9/2008 |
Nattokinase Extra-Strength, and VitalZym [PDF] |
Timothy Collins
Organic Pharmacy, Inc. |
10/13/2005 |
8/6/2008 |
Bone Nourisher Menopause Formula and Bone Nourisher Supreme Menopause Formula [PDF] |
Elliott Goodman
IntraCell Nutrition, Inc. |
10/12/2005 |
9/9/2008 |
Internal Cleansing Kit, Lung Rejuvenator, and Essiac Tea Blend [PDF] |
Michael Volchok
Blessed Herbs, Inc. |
10/12/2005 |
8/6/2008 |
SinutonePlus Triple Kit, Stress-Less with St. John's Wort Triple Kit, and Intestinal Rescue [PDF] |
Tierney Salter The Herbalist, Inc. |
10/6/2005 |
12/20/2005 |
SinutonePlus Triple Kit, Stress-Less with St. John's Wort Triple Kit, and Intestinal Rescue [PDF] |
Tierney Salter The Herbalist, Inc. |
10/6/2005 |
12/20/2005 |
Glupride Multi [PDF] |
Sarfraz Zaidi |
10/6/2005 |
12/20/2005 |
September, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
WSN Diabetic Pack and WSN Neuropathy Support Formula [PDF] |
Robert Held Wellness Support Network |
7/27/2005 |
12/20/2005 |
Oregano Oil [PDF] |
Jim Coyne
Botanical Laboratories |
7/23/2005 |
8/11/2008 |
Cat's Claw, 5-HTP, and Ginkgo biloba [PDF] |
Brian Smith Herbal Nurse |
7/22/2005 |
12/20/2005 |
Charantea Ampalaya Tea and Charantea 500mg Capsules [PDF] |
Joseph A. Buenconsejo
Herbcare Corporation of America
FulLife Natural Options, Inc. |
7/22/2005 |
8/29/2008 |
TriMedica Silva Solution Liquid, Olympian Labs Beta Carotene and Twinlab Acetyl L Carnitine 500 mg [PDF] |
Mark E. Kowalski
Value Nutrition Center/Kowalski Chiropractic |
7/21/2005 |
9/9/2008 |
WildSenergy, LiverKlin, and Wild American Ginseng Capsules [PDF] |
Tanya Tang Brighten Corporation |
7/6/2005 |
12/20/2005 |
Green Tea Rx, Garlic and Parsley, and DMAE [PDF] |
David Blanco Life Link |
7/6/2005 |
12/20/2005 |
August, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Aloe Vera Tabs, Echinacea, and E-Plex [PDF] |
Jim L. Fox
Doctor’s Nutrition, LLC |
8/24/2005 |
9/9/2008 |
Cinnamon Extract, Zero Gravity and Extra Virgin Coconut Oil [PDF] |
Kerry Jacobson
Generation Health LLC |
8/19/2005 |
8/29/2008 |
Beta Fast GXR Glucose Balance and Nutramin Body System [PDF] |
David Goldberg Informulab |
8/16/2005 |
9/16/2005 |
Prolipamy, Uricinex, Diabeticine, and Cholestasys Rx [PDF] |
Anh Pham Techmedica Health, Inc./ K.Y.C., Inc. |
8/16/2005 |
9/16/2005 |
Nutri-Health Flora Source, Flora 4-Candida, and Cream of the Crop Colostrum Capsules [PDF] |
John W. Brimhall Nutri-Health |
8/15/2005 |
9/16/2005 |
Enzymedica Virastop, Enzymedica V-GEST, Enzymedica Repair, Enzymedica pH-Basic, Enzymedica Natto-K, Enzymedica Candidase, Flu Prevention Trio (Quantum Nucleotide Complex, InfectoStat, Quantum Colostrum), Chronic Fatigue Support Kit (DHLA, Quantum Adaptogen Complex, RenewZyme), Fibromyalgia Support Kit (Super Nano Green Tea, DHLA w/ resveratrol, Quantum Kidney Complex, RenewZyme), Super Nano-Green Tea -Potent Polyphenols, Premier Research Labs Quantum Kidney Complex - Cordyceps / Agaricus Bisporus Extract, and Premier Research Labs Quantum Bone and Joint Complex [PDF] |
Toby L. Coriell V.P. Consultants, Inc. |
8/8/2005 |
9/16/2005 |
Vitalzym, VitalzymSEB, and NattoQ10 (PDF) |
Ryuji Hirooka World Nutrition, Inc. |
8/2/2005 |
9/16/2005 |
July, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Kold Kare Cold & Flu Sinusitis and Cholestene [PDF] |
Jeanine Bogashewicz All Natural Health |
7/19/2005 |
9/16/2005 |
Nature's Purest 5 HTP 100 mg 120 caps and NVE Stacker 3 (Ephedra Free) 100 caps [PDF] |
Lian Jin Chong Chong's Health Care Enterprise, Inc. |
7/19/2005 |
9/16/2005 |
The Greatest Vitamin in the World [PDF] |
Donald Lapre Torica Productions, Inc. |
7/19/2005 |
9/16/2005 |
Nature's Way Alpha Lipoic Acid 50 mg, Capsules, Nature's Way Garlicin, Cholesterol Control, Tablets, and Nature's Way Garlic, Capsules [PDF] |
Henry Liu
MyNutrition.com |
7/18/2005 |
9/16/2005 |
Mega Protein, Liver Purifier 1, and U-O-Clear [PDF] |
S.M.C., Inc. |
7/18/2005 |
9/16/2005 |
IDS Carb Shuttle, Source Naturals Coral Calcium, and IDS Alpha Lipoic Acid [PDF] |
Wayne Ragsdale Supplement Giant AKA Home Fitness Exercise Equipment |
7/18/2005 |
9/16/2005 |
Alpha betic, Kwai Garlic Supplement, Kwai Heart Fit Garlic, Kwai Every Day, and Flu and Cold Times [PDF] |
Abkit, Inc. |
7/14/2005 |
9/16/2005 |
PerformaFlex and EnergyFizz [PDF] |
Andy Smith
NFI Dietary Supplements |
7/1/2005 |
8/6/2008 |
June, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Elix COLD/FLU, Elix MIND POWER, and Elix ENERGY [PDF] |
Hank Wuh Daily Wellness Company |
6/28/2005 |
9/16/2005 |
New Sun Cold/Flu Virus, Children's Breathe Easy, and HBS [PDF] |
M. Sheen, III M.R.S. Marketing |
6/21/2005 |
9/16/2005 |
Fruits of Life, ARIZONA NATURAL CHAPARRAL, and RM-10 [PDF] |
Brant Shapiro Smartbomb, Inc. |
6/14/2005 |
8/29/2005 |
Flite Tabs, Neem, and Feverfew [PDF] |
Gerald Wolke Natural Health Consultants |
6/6/2005 |
8/29/2005 |
May, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Longevity, Serenity, and MyDailyDose [PDF] |
Urban Nutrition |
5/24/2005 |
8/29/2005 |
Vitamin A, Niacinamide, Pantothenic Acid, Phosphatidyl Choline, Inositol, Vitamin C, Vitamin E, Bioflavonoids-Hesperidin-Rutin-Quercetin, Calcium, Ginger, Gotu Kola, and Histidine [PDF] |
Charles Hill Austin Nutritional Research |
5/24/2005 |
8/29/2005 |
LC Balancer and EzAir Capsule for Asthma [PDF] |
Dr. Jeffrey Wei Wei Labs, Inc. |
5/24/2005 |
8/29/2005 |
Myalgistat [PDF] |
Tim Allyn Patterson, Biotest Laboratories, LLC |
5/24/2005 |
8/29/2005 |
Longevity, Serenity, and MyDailyDose [PDF] |
Urban Nutrition |
5/24/2005 |
6/6/2005 |
Vitamin A, Niacinamide, Pantothenic Acid, Phosphatidyl Choline, Inositol, Vitamin C, Vitamin E, Bioflavonoids-Hesperidin-Rutin-Quercetin, Calcium, Ginger, Gotu Kola, and Histidine [PDF] |
Charles Hill Austin Nutritional Research |
5/24/2005 |
6/6/2005 |
ACUTE COLD & FLU and ADD Attention [PDF] |
Lester Burks Lifeline Foods, LLC |
5/16/2005 |
6/6/2005 |
Blood Sugar Balance, ClearLungs Red, and VisionAid [PDF] |
Paul Warnock Ridgecrest Herbals, Inc. |
5/16/2005 |
6/6/2005 |
Vitamin E & Selenium Antioxidant Complex, Green Tea Extract Capsules, and Bee Propolis 500 mg Capsules [PDF] |
George Rivera Health Image |
5/9/2005 |
6/6/2005 |
Echinacea, Choline, and Magnesium [PDF] |
David Radel Global Information Concepts |
5/9/2005 |
6/6/2005 |
April, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Chamomile Extract and Red Clover [PDF] |
Naren Dasu Universal Herbs, Inc. |
4/25/2005 |
6/6/2005 |
NSI BerryVin (FKA Berryvida) High ORAC Berries, NSI Glucomannan - 2,000 mg - 180 Caps, NSI Cinnamon - 500 mg - 240 Caps, and NSI Sytrinol - 150 mg - 120 Caps [PDF] |
Allen Josephs Vitacost.com |
4/25/2005 |
6/6/2005
|
IMMUNO-PFS and Hepacition [PDF] |
Citi Pharmaceuticals Inc. |
4/22/2005 |
12/28/2006 |
Yellow Emperor Eleuthero Extract, Yellow Emperor Rhodiola Rosea, Phytotherapy Echinacea and Goldenseal Roots, Phytotherapy Dandelion Root, Phytotherapy Goldenseal Root, Phytotherapy Feverfew, and Phytotherapy Echinacea [PDF] |
Andrew T. Levine Yellow Emperor, Inc. |
4/21/2005 |
6/6/2005 |
March, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Arnica,Immune Defense Compound, and Cat's Claw Liquid Extract [PDF] |
Kyle Bujnicki Vitamin Connection |
3/28/2005 |
4/22/2005 |
Anorex Stimulant Free and ACCUSLIM Advanced Fat Burner [PDF] |
Mark Gelato The VitaminBin.com |
3/28/2005 |
4/22/2005 |
Caprylic Acid 350 mg tabs 100, Caprylic Acid 350 mg tabs 250, apple pectin poweder 4 oz, and apple pectin powder 8 oz [PDF] |
Hilife Vitamin and Herb Co. |
3/28/2005 |
4/22/2005 |
Pushkaramula Rasayana #3 Asthma Ease,Shilajit Rasayana #17 Diabetes Ease, and Skullcap Rasayana #16 Epilepsy Ease [PDF] |
Lakshman Kruger Circle of Health, Inc. |
3/14/2005 |
4/21/2005 |
CLA, Cayenne/Goldenseal, AC-Q, and Asthmol [PDF] |
Judy Gaines, Gaines Nutrition |
3/14/2005 |
6/6/2005 |
Cold & Flu Defense Seasonal Relief, Extra Virgin Coconut Oil, and RM-10 [PDF] |
David Bowman Health Food Emporium |
3/14/2005 |
4/22/2005 |
February, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
Ellagic Ultra, Lycopene 25 with Tomato Powder, Buffered Vitamin C Powder, Joint Recovery Formula, Saw Palmetto, Ocean Splendor Omega-3 Fish Oil, and Miracle Mushroom Blend [PDF] |
Otto Roder Vita Purity |
2/24/2005 |
4/22/2005 |
Spirulina Powder [PDF] |
Allen Baron ABCO Laboratories, Inc. |
2/23/2005 |
3/10/2005 |
SangoCal, SangoCaps, and Coral Water [PDF] |
Robert Bremner, Nutronix |
2/23/2005 |
3/10/2005 |
Doctor's Trust Astragalus 400mg 100 capsules and EuroPharma Allergy Relief [PDF] |
Andrew Goldstein, Direct Marketing Advertising Distributors |
2/23/2005 |
3/10/2005 |
A.M.P. Molo-Cure [PDF] |
Frederick Leto GMS Corporation |
2/23/2005 |
3/10/2005 |
Defenz and Lithium [PDF] |
Barry Warkenstein Premier Labs, Inc. |
2/16/2005 |
3/10/2005 |
Living Fuel Rx, Tropical Traditions Virgin Coconut Oil, and Chlorella [PDF] |
Joseph Mercola, Optimal Wellness Center |
2/16/2005 |
3/10/2005 |
Tribulus (Bulgarian), Ashwaganda, Boswellia, Ginger, Gotu Kola, Gymnema, Noni, Turmeric, Artichoke, Bacopa, Cat's Claw, DHEA, Evening Primrose Oil, Valerian, St. John's Wort, Squalene, and Milk Thistle [PDF] |
Richard A Merriam GCI Nutrients Worldwide, Inc. |
2/16/2005 |
3/10/2005 |
Folate-5 plus, Lipoic Acid, and L-Arginine [PDF] |
Denis Deluca, Biotics Research Corporation |
2/16/2005 |
3/10/2005 |
ArthPlus, Allergium, Asafetida (Oleo-Gum-Resin), Broncitone, and Astragalus [PDF] |
Mushtaq Jafry Herbs MD |
2/3/2005 |
3/10/2005 |
Borage, EPA (Fish Lipid Concentrate), Flax (100% Organic Flax Seed Oil), Evening Primrose Oil, Attention Support, Barley (Barley Juice Powder), Cat's Claw, COQ10 (Co-Enzyme Q10), DHEA (Dehydroepiandrosterone), St. John's Wort, and Valerian Root [PDF] |
Tim Lally Optimal Nutrients |
2/2/2005 |
3/10/2005 |
Vitamin E & Selenium Antioxidant Complex, and Green Tea Extract Capsules [PDF] |
David Friedlander Vitamin Power, Inc. |
2/1/2005 |
3/10/2005 |
January, 2005 |
Product/Description |
Company/Individual |
Released |
Posted |
BioCell Collagen II [PDF] |
Isaq Suhail BioCell Technology, LLC |
1/28/2005 |
3/1/2005 |
MSM, Methylsylfonylmethane 1000, Octacosanol+, TAP Garlic, Saw Palmetto, Cranberry, Echinacea, Rapid Balance-G.I., and Fibro-My-DMG [PDF] |
Dom Orlandi, President Food Science Corporation |
1/28/2005 |
3/1/2005 |
NutriBiotic CapsulesPlus GSE 90 Capsules, NutriBiotic GSE Tablets, 100 count, New Chapter Zyflamend 120 sg, New Chapter Zyflamend Easy Caps 180 sg New Chapter Zyflamend PM 60 sg, and New Chapter Zyflamend 60 sg [PDF] |
Gregg Kiviko Discount Vitamin Shop, Inc.
|
1/26/2005 |
3/1/2005 |
beCALM'd,NeuRecover-BZ, and NeuRecover - DA [PDF] |
Albert Bieser NeuroGenesis, Inc. |
1/25/2005 |
3/1/2005 |
Astragalus Support, and Seasonal Relief [PDF] |
Lance McNamara Seacoast Natural Foods, Inc. |
1/25/2005 |
3/1/2005 |
BeCALM'd [PDF] |
Marilyn Boerner Victorie, Inc. |
1/25/2005 |
3/1/2005 |
beCALM'd [PDF] |
Fred Stone ADHDrelief |
1/25/2005 |
3/1/2005 |