Posted March 10, 2015

Seller of Vision Supplements Warned for Manufacturing Violations, Drug Claims

On February 26, 2015, the FDA issued a warning letter to Biosyntrx, following a facility inspection which found the company's products, including BioTears Oral Gel Caps, ZoOmega-3 Concentrated Pharmaceutical-Grade Fish Oil, EpiCor A Nutrient-dense High Metabolite Immunogen, Sight C+ Mineral Buffered Vitamin C, Oculair Multiple Nutrients for Your Eyes and Body, and Eye & Body Complete Multiple Nutrients for Optimal Eye and Body Health (formerly Macula Complete) 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 and follow written procedures for the responsibilities of quality control operations, and failure to make and keep a written record of every product complaint that is related to good manufacturing practice, as required by federal regulations.

In addition, statements made about these products in brochures were found to be drug claims. For example, BioTears Oral Gel Caps were promoted with statements such as "Safer small amounts of Omega-3 fatty acids, EPA and DHA, like the amount included in BioTears, are proven capable of... preventing ocular surface inflammatory response..." and "It is an oral capsule, taken by mouth, to systemically address the root cause of Dry Eye Syndrome."

ZoOmega-3 Concentrated Pharmaceutical-Grade Fish Oil was promoted with statements like "The research also strongly suggests that the active ingredients in ZoOmega-3, the long chain polyunsaturated acids EPA and DHA, may act in a retinal disease preventive role."

See ConsumerLab.com's Reviews of Vision Supplements, Fish Oil and Omega-3 Fatty Acid Supplements and Vitamin C Supplements for tests of related products.

See Related Warnings:

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

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