ConsumerLab.com uses JavaScript to provide the best possible experience for our content, but your browser has it disabled. Learn how to enable it here.

About ConsumerLab.com

Posted December 12, 2014

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

On October 16, 2014, the FDA issued a warning letter to Mr. Leo Medina, following an inspection of his processing facility located in Santo Domingo, Dominican Republic, which found the company's products, including Balsamic Honey Syrup, Arabian Formula Syrup, Limpia Pecho Syrup, Century 22 Purifier Syrup and Watercress and Onion, Radish-Honey Omega-3 Syrup 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 establish identity specifications for each component used in the manufacture of a dietary supplement, and failure to establish and follow written procedures for the responsibilities of the quality control operations.

Limpia Pecho Syrup was also found to be adulterated because it contains salicylic acid, which is an unsafe food additive according to federal regulations.

In addition, statements made on the labels of Balsamic Honey Syrup, such as "As with any drug..." under the WARNING statement" and "Safe and natural ingredients to relieve different symptoms that occur with the flu" were found to be drug claims.

Balsamic Honey Syrup, Arabian Formula Syrup, Limpia Pecho Syrup, Century 22 Purifier Syrup and Watercress and Onion, Radish-Honey Omega 3 Syrup were also found to be misbranded because the labels failed to provide information required by federal regulations.

(See ConsumerLab.com's Review of Fish Oil and Omega-3 Fatty Acid 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.