Posted May 21, 2014

Seller of Gingko and Milk Thistle Warned for Manufacturing Violations and Drug Claims

On April 4, 2014, the FDA issued a warning letter to Xtra Life Natural Systems, Inc., following a facility inspection which found the company's products, including Gingko biloba and milk thistle, 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 the quality control operations and failure to establish and follow written procedures for packing and labeling operations.

In addition, statements made the company's websites, www.vtamins.net and www.xtralifemiami.com, and on labels for Gingko biloba and milk thistle supplements were found to be drug claims.

Gingko biloba was promoted with statements such as "[U]sed to treat Alzheimer's disease and other dementias," and "It helps to treat glaucoma."

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

Milk Thistle was promoted with statements such as "T]herapeutic activity ...of Milk Thistle treatment of almost every known form of liver disease, including cirrhosis, hepatitis, hepatitis C, necrosis, and damage due to abuse alcohol and drugs."

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

See Related Warnings:

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, use the link below.