Posted November 28, 2014

Seller of Herbal Extracts Warned for Manufacturing Violations, Drug Claims

On November 3, 2014, the FDA issued a warning letter to Avena Botanicals, Inc., following a facility inspection which found the company's products, including Black Cohosh Root Liquid Extract, Gotu Kola Liquid Extract, and Echinacea Root Liquid Extract 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 ensure the quality of dietary supplements the company distributes, failure to ensure that the dietary supplements are packaged and labeled as specified in the master manufacturing record, and failure to prepare or follow a written master manufacturing record for each unique formulation of dietary supplement manufactured.

In addition, statements made about Astragalus Liquid Extract, Black Cohosh Root Liquid Extract, Calendula Liquid Extract, Echinacea Root Liquid Extract, Gotu Kola Liquid Extract, Milk Thistle Seed Liquid Extract, Red Clover Liquid Extract, St. John's Wort Liquid Extract, Turmeric Root Liquid Extract, Willow Bark Liquid Extract, Heal-All Salve, Urinary Tract Tonic, U.T.I. Relief, and Lung Tonic, on the company's website were found to be drug claims. 

For example, Astragalus Liquid Extract was promoted to treat respiratory infections with statements such as "It is indicated for people experiencing... shortness of breath... to treat recurrent colds and upper respiratory tract infections." 

Black Cohosh Root Liquid Extract was promoted to treat various conditions with statements such as "[R]educing post-partum pain. It is also traditionally used for easing muscular pain associated with rheumatoid and osteoarthritis, and for relieving asthma." 

(See ConsumerLab.com's Review of Black Cohosh Supplements and Joint Health Supplements for tests of related products.)

Calendula Liquid Extract was promoted to treat various conditions with statements such as "[A]bility to heal cuts, wounds, diaper rash and athletes foot ...Calendula is known to help heal vaginal infections and prevent and resolve herpes." 

Echinacea Root Liquid Extract was promoted to treat colds and infections with statements such as "Echinacea is indicated for acute viral and bacterial infections such as colds, flus, bronchitis, sinusitis, tonsillitis, and ear infections. Use every few hours during the acute stage." 

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

Gotu Kola Liquid Extract was promoted to treat skin conditions with statements such as "[H]elps heal red, hot and inflamed skin afflictions such as Eczema and Psoriasis. Inhibits scar tissue formation and promotes healing after surgery or radiation." 

Milk Thistle Seed Liquid Extract was promoted to treat a number of conditions with statements such as "[U]sed for preventing and treating liver damage, especially when caused by exposure to toxic chemicals and poisons, including mushrooms, alcohol and recreational drugs. Traditionally indicated for conditions such as Cirrhosis of the Liver, Hepatitis A, B and C, and Psoriasis." 

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

St. John's Wort Liquid Extract was promoted to treat pain with statements such as St. John's Wort is traditionally used to... nerve pain... and to reduce painful symptoms of arthritis, gout and injury to nerve endings." 

(See ConsumerLab.com's Review of St. John's Wort Supplements for tests of related products.)

Turmeric Root Liquid Extract was promoted to treat inflammation with statements such as Turmeric has been used to reduce inflammation." 

(See ConsumerLab.com's Review of Turmeric and Curcumin Supplements for tests of related products.)

See Related Warnings:

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.