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.
- Above All Health, Inc. / Redgie B. Hansen (11/15/88): germanium, evening primrose oil
- American Image Marketing / Dennis J. Itami, Glen M. Tanner, Ronald R. Wright (7/12/88): Barley Green, Sodex (SOD), Yucca Fiber, High Desert Propolis, Super-zymes, and Dr. Willard’s Catalyst Altered Water Concentrate
- Balamar Women’s Healthcare / Harvey Mizes (9/15/88): Bajamar’s Essential Fatty Acids
- Barth-Spencer / Joseph Ashkin (10/19/88): Beta Carotene capsules {6mg. and 15mg.) , Sea Beta-Carotene capsules, Dry Beta Carotene capsules, Imunoplex tablets, Coenzyme Q10 capsules, Rivital-A Cellular Reactivator Cream, Revitalcreme Skin Revitalizing Treatment, Eye-Vites capsules, Feverfew tablets and Anti-Yeast Complex
- Le Tan / Blake Sawyer (11/15/88): Canthaxanthin
- Manna Products, Inc. / Stephen L. Lucas (8/23/88): herbal and bee pollen extracts
- Proteus Company dba Earthrise Company / Robert W. Hendrikson (6/24/88): Immu-N-Sure Colds & Flu Season Protective Formula, Step Ahead PMS nutritional Supplement Plus Spirulina, Super-Beta Beta Carotene and Antioxidants with Spirulina & Herbs
- R.J. Systems / Albert Balkl, M.H., D.N. (2/18/88): Unsaturated Fatty Acid Capsules
- Revlon, Inc / Ronald Perelman (9/25/88): Age-Less Anti-Aging Daily Face Capsules
- Vibrant Life / Jean Ross (2/29/88): Organic Germanium
- Wakunaga of America Co., Ltd. / Mas Ohkubio (11/3/88): Yeast-Gard
- Willner Chemists / Irving Willner (2/2/88): evening primrose oil products
- Women’s Health Institute / Shirley Saito (11/3/88): Yeast-Gard
This page was revised on July 13, 2018.
