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Posted May 6, 2014

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

On April 18, 2014, the FDA issued a warning letter to Iowa Select Herbs, LLC, following a facility inspection which found the company's products, including Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products, 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 conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, failure to quarantine components prior to their use in the manufacture of dietary supplements, and failure to have quality control operations for components, packaging, and labels before use in the manufacture of dietary supplements. In addition, statements made on the company's website about Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products were found to be drug claims.

Flax Seed was promoted with statements such as "Flax Seed, and the omega-3's contained within it have been credited with preventing, curing, and treating a number of diseases and conditions. Everything from cancer to diabetes to constipation to heart conditions to arthritis."

(See ConsumerLab.com's Review of Flaxseed Evening Primrose and Seed Oils for tests of related products.)

Holy Basil was promoted with statements such as "Holy basil can be used for the common cold, influenza ("the flu"), H1N1 (swine) flu, diabetes, asthma, bronchitis, earache, headache, stomach upset, heart disease... viral hepatitis, malaria, and tuberculosis," and "It is also used for mercury poisoning.... and to counteract snake and scorpion bites."

Papaya Leaf Extract was promoted with statements such as "...slows cancer growth."

Ginkgo Leaf Extract was promoted with statements such as "to treat or help prevent Alzheimer's disease and other types of dementia; to decrease intermittent claudication (leg pain caused by narrowing arteries); and to treat sexual dysfunction, multiple sclerosis, tinnitus."

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

See Related Warnings:

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.