Posted December 16, 2015

Maker of Red Yeast Rice, St. John's Wort, Valerian and More Warned for Manufacturing Violations, Drug Claims

On December 2, 2015, the FDA issued a warning letter to Nature's Health, LLC, following a facility inspection which found the company's product, including Ginkgo & Rhodiola, Blood Sugar Balance IV, Cinnamon Extract, Choles-Balance Red Yeast Extract, Lecithin, Milk Thistle Seed Extract, Intestine Relaxer I for IBS, Intestine Relaxer II (for crohns), Red Sage, Selfheal, BUN Balance, Bronchi Relaxer I, Lung Cleaner II, Hyper-care, Hypo-care,St. John's Wort, Standardized Valerian Extract, Head Relaxer I, Head Relaxer II, Urinary Balance,and Urinary Balance II to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish product specifications for each dietary supplement 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 and failure to prepare and follow written master manufacturing records (MMR) for each unique formulation of dietary supplement, 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, Choles-Balance Red Yeast Extract was promoted with statements such as "Cholesterol Balance contains red yeast rice extract, which may lower blood cholesterol, low-density lipoprotein (LDL or bad cholesterol) levels," and "Red yeast rice inhibits the action of an enzyme in the body that helps make cholesterol and is extremely effective."

(See ConsumerLab.com's Review of Red Yeast Rice Supplements for tests of related products.)

St. John's wort was promoted with statements such as "It is most commonly used to... treat mild to moderate depressions as well as the symptoms that may go along with it such as anxiety, difficulties sleeping, tiredness, and loss of appetite."

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

Standardized Valerian Extract was promoted with statements such as "Valerian ...use ...to help those suffering from insomnia... Other uses for valerian may include treating migraines... anxiety, depression."

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

See Related Warnings:

Seller of "Hangover" Supplement Warned for Manufacturing Violations & Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

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