Posted December 12, 2014

Seller of B-12, Zinc, Echinacea and More Warned for Manufacturing Violations and Drug Claims

On November 14, 2014, the FDA issued a warning letter to Scientific Botanicals Company, Inc., following a facility inspection which found the company's products, including ANANABROM ANANACUR, CURLONGA, HYDROXO-12, K-QUINONE, MAXIFLAV, PEPLIC, ZINC-PLUS, CRATOXY, NatexHIP, NatexROOT, beta-PLEX, Cystaseptic, Echinacea and Tri-Quench, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, and failure to prepare or follow a written master manufacturing record for each unique formulation of dietary supplement manufactured.

In addition, statements made about ANANABROM ANANACUR, CURLONGA, HYDROXO-12, K-QUINONE, MAXIFLAV, PEPLIC, ZINC-PLU, CRATOXY, NatexHIP, NatexROOT, beta-PLEX, Cystaseptic, Echinacea and Tri-Quench on the company's websites, www.scientific-botanicals.com and www.licrogel.com, were found to be drug claims.

For example, HYDROXO-12, which contains vitamin B-12, was promoted to treat a number of conditions with statements such as " Health Benefits: Osteoporosis... Asthma... Alcoholism."

(See ConsumerLab.com's Review of B Vitamin Supplements and Energy Drinks for tests of related products.)

ZINC-PLUS was promoted to treat various conditions with statements such as " Health Benefits... Infections/Wounds... Alopecia... Bone loss... Chronic Fatigue...."

(See ConsumerLab.com's Review of Zinc Supplements and Lozenges for tests of related products.)

Echinacea was promoted to treat various conditions with statements such as " Health Benefits... UTI's... Yeast Infections... Strep Throat."

(See ConsumerLab.com's Review Echinacea Supplements for tests of related products.)

Tri-Quench contains iodide and was promoted to various conditions with statements such as "it inhibits or kills bacteria, viruses, and fungi before they can cause an infection... bladder infection."

See ConsumerLab.com's Review of Potassium Iodide Supplements for tests of related products.

See Related Warnings:

Seller of Herbal Extracts Warned for Manufacturing Violations, Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below.