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.
- Dutch Pride Products / Ember J. Safford (6/13/90): BIO-“10”
- Graham Enterprises. Inc. / Mark Graham (6/26/90): Diet TEC 90 Program (Master Formula Diet TEC 90 Tablets, Herbal-Fiber Formula Diet TEC 90
- Health Care Products / Barbara W. Larkins (7/25/90): Cal-Ban 3000
- Highland Laboratories, Inc. / Kenneth D. Scott (3/20/90): Immune Plus, Ge Oxy 132 Capsules, Co Q10 Capsules, Cholesterol Reducer Tablets, Pure Gamma Oryzanol Capsules, Fat Burner Tablets, Smilax Extract Plus, Smilax Officinalis Extract, Women’s Smilax with Royal Jelly, B-12 Folic Acid Drops, Colonic Rinse capsules
- Ingersoll & Associates / Charles B. Ingersoll (6/29/90): Harmony Lecithin Triple Strength Capsules, Harmony Lecithin Granules, Harmony Lwecithin Powder, Harmony Lethicin Keylex Granules.
- J & J Snack Foods Corp. / Gerald Shreiber (9/5/90): Toasted Oat Bran Shake
- Natural Nutrition / Ronald D. Groll (4/11/90): Canthazanthin tablets, Calcium Night Formula
- Pacific Rice Products / Edward Parker (9/5/90): Vita Fiber Rice Bran
- Phoenix International Marketing Corporation / Martin J. Brooks (5/4/90): Phoenix Nutritious Beverage, Phoenix Fiber Cookie, Phoenix Fizzle, Phoenix Vitaaina and Mineral Capsules (all components of the Phoenix for Life Program
- Ruth Ashbrook Bakery / Lee Stiles (5/23/90): Rainer Farms European Sweet Bread
- Select Origins, Inc. / Thomas Siplon (9/5/90): Rice bran oil
- Tyler Encapsulations / Jack T. Simms (9/9/90): Adrenal Complex, Echinarea, Florammune Echinacea, Immunacea,
Hypoglycemia Complex, Immune Support
This page was revised on March 18, 2018.