FDA Warning Letters about Products (1991)
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.
- Ameritron, Inc / Zane R. Kime, M.D. (9/19/91): Ameritron Micronutrients Tablets
- Armco Food Products Manufacturing / Armand Mingione (8/28/91): Country Chocolate Jerzee Blend, Country White Jerzee Blend, Nuri-Tonic Q-10
- C.R. Eggs / Robert Fuhrman (2/9/91): High iodine content of Heartland's Best Eggs
- Decatur Fitness Systems / David Decatur, M.D. (6/17/91): Meal in a Bottle B.L.D. Vanilla Citrus
- Ecomer, Inc. / Hokan Cederberg (5/20/91): Strix Tablets, Exsativa, Ecomer, Alkaglycerols (shark liver oil), Super Glandin (day and night creams)
- Life Enthusiast Co-Op / Larry B Meier, Judy E. Meier (3/4/91): Excela, Trace Minerals, Andean Treasure, Cell Guard, Soyessence, Green Gold, Sparkling Energy
- Lifestyles U.S.A. / Stanley A. Leitner (2/8/91): Health claims for cookies
- Marlo Manufacturing Corp. / Eugene F. McKay (3/21/91): Bouquet Bubbling Bath Oil, Princess Nyla Youth-Life, GSK Concentrate Cream, Delicate Skin NIght Cream, Dry Skin Night Cream
- Michigan Pharmacal Corp. / Jeffrey K. Farber (12/20/91): Protein A High Protein Food with Lecithin & Ameino Acids
- Natrol Inc. / Elliott Balbert (9/9/91): Natrol Ester C products, Natrol High, Natrol ACE, Natrol SAF Stress & Anxiety Formula, Natrol A Beta Carotene C C-Vitamin C E-Vitamin E Plus Herba; extracts
- Now Foods / Elood Richards (8/7/91): Natural Foods VIT-MIN 75+
- Pure Life Systems, Inc. / Robert A. Spicer (2/2/91): Cookie Diet cookies
- Vita Life Sport Products / Marc Vodofsky (6/17/91): Solar Tan tablets
This page was posted on September 13, 2014.