Posted June 6, 2017

Seller of Herbal Supplements Warned for Manufacturing Violations, Drug Claims

On May 25, 2017 the FDA issued a warning letter to Life Rising Corporation, following a facility inspection which found the company's products, including Stomach Regulator, Fang Feng Formula, Skin Regulator, Regulate Liver, Circulation Regulator, Pancreas Support, Lung Regulator, Pure Tea, Liver Regulator-2, Licorice, Wheat & Date, Spleen Support-GPT, Spleen Regulator, Circulation Maintenance, Lung Support-Y, Liver Regulator-2 and Lung Support 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 specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, failure to establish and follow written procedures for the responsibilities of the quality control operations, and failure to calibrate instruments and controls used in the manufacturing of your dietary supplements, as required by federal regulations.

In addition, statements made about these products on labels and the company's website were found to be drug claims.

For example, Fang Feng Formula was promoted with statements such as "[D]ark and burning urine, skin rashes or infections, boils, carbuncles, hemorrhoids, intestinal bleeding...," Lung Support-Y was promoted with statements such as quot;[B]ronchitis, or pneumonia…"

Other products, such as DHZC-2 Blood Circulation Regulator (Lower Abdomen) tablet, Brain-ECM capsule, TT Side Regulator tablet, and SHT Chest Relief were found to be misbranded, because the labels failed to provide required information, such as the capsule ingredients and/or a full domestic address or domestic phone number.

See Related Warnings:

Seller of Vitamin C, Calcium, Mushroom Supplements and More Warned for Manufacturing Violations

Seller of B Vitamins, Vitamin C, Potassium & More Warned for Manufacturing Violations

Maker of Prelief, Urinozinc Prostate Health Formula Warned for Manufacturing Violations

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

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

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