Posted May 30, 2017

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

On May 12, 2017 the FDA issued a warning letter to VitaPurity Corporatio., following a facility inspection which found the company's products, including Ellagic Ultra, Buffered Vitamin C Crystals, Coral Calcium with D3, Miracle Mushroom Blend, Lycopene 25 with Tomato Powder, Citral from Lemon Grass and Pacific Ocean Shark Cartilage to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

The company did not have written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and written procedures for approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by federal regulations.

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

For example, Buffered Vitamin C Crystals were promoted with statements such as "VitaPurity Also Offers Help Against the Flu," and "[R]ecommended VitaPurity Buffered Vitamin C Crystals as an important supplement to include with other antiviral medications."

See ConsumerLab.com's Review of Vitamin C Supplements for tests of related products.

Coral Calcium with D3 was promoted with statements such as "Additional calcium intake may actually lower your risk for kidney stones."

See ConsumerLab.com's Reviews of Calcium Supplements and Vitamin D Supplements for tests of related products.

Miracle Mushroom Blend was promoted with statements such as "These mushrooms are also said to help reduce the risk of heart trouble by producing interferon to fight infections (a group of natural proteins that inhibits viruses from multiplying).."

See this related CL Answer: Do reishi mushroom supplements boost the immune system, or have other benefits? >>

Lycopene 25 with Tomato Powder was promoted with statements such as "Lycopene was the only carotenoid that appeared to reduce the risk of heart trouble."

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

See Related Warnings:

Seller of Amino Acid Supplements & 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